CP 7329.001 - Cosmetics Program, Import and Domestic

DATE OF ISSUANCE: 1/2016

PAGE

FORM FDA 2438 (7/92)

FOOD AND DRUG ADMINISTRATION

PROGRAM

7329.001

COMPLIANCE PROGRAM GUIDANCE MANUAL

CHAPTER 29 – COLORS AND COSMETICS TECHNOLOGY

SUBJECT:

IMPLEMENTATION DATE

COSMETICS PROGRAM; IMPORT AND DOMESTIC

Upon Receipt

COMPLETION DATE

CONTINUING

DATA REPORTING

PRODUCT CODES

PRODUCT/ASSIGNMENT CODES

INDUSTRY CODE : 53

29001 (for both domestic and import work)

USE APPROPRIATE PRODUCT CODES

FIELD REPORTING REQUIREMENTS

Note: To assist the reader in locating various topics in this document,

please see Attachment A “Index”.

1. Investigations Branches

a) Consumer adverse events or complaints, and trade complaints should be

entered in FACTS. FDA Field Offices should handle cosmetic problems and

emergencies on a case by case basis depending on the severity of the

situation. However, since FACTS entries must be closed out before they can

be downloaded into CFSAN’s adverse event database, CAERS, there can be a

significant length of time before FDA headquarters or the Office of Cosmetics

and Colors might be informed of an unusual event. Therefore, in case of an

unusual or high priority situation involving a cosmetic product, please

contact the Office of Emergency Operations (OEO) at 301-796-8240 (24 hours)

or email [email protected] to report the situation (in

addition to data entry into FACTS).

b) Within 30 days after completion of each inspection, electronically submit

into CMS to HFS-608, CFSAN/OC/DE/Labeling and Dietary Supplement Branch, the

following items:

1) a copy of the “Summary of Findings” for each inspection

2) a copy of the vendor/supplier list collected for each

inspection.

2. Laboratory Branches

Report all analyses into the Field Accomplishment and Compliance

Tracking System (FACTS) using the following Problem Area Flags (PAF)

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for the various types of analyses.

Microbiological Analyses - MIC

Toxic Elements - ELE

Color Additive Analyses - COL

Food Economics and Standards (Label Reviews) - FDF

(Result Flag = FDL)

SPECIAL INSTRUCTIONS

1. General

Routine domestic and/or import sample collections/analysis for COL or

MIC should take place as per the current fiscal year (FY) SCOPE.

Collect cosmetic samples under this program on a “for cause” compliance

basis to support and document inspectional evidence of suspected

adulteration and/or misbranding only. Concentrate on the following four

areas:

• Collect product samples for color analysis and prohibited

ingredients.

• Collect samples of labeling to document suspect labeling

violations.

• Collect samples of eye area cosmetics, tattoo inks or skin

care preparations and lotions for microbiological analysis

when adequate challenge test documentation cannot be produced,

the adequacy of preservation is in doubt or non-traditional

preservative systems are used.

• Collect samples of cosmetic products for screening of

prohibited elements, as directed by CFSAN assignment.

Report only COSMETIC import label exams, inspections, sample

collections under this program.

2. Domestic

Conduct routine surveillance inspections only at firms manufacturing or

repacking eye area cosmetics, tattoo ink, skin care preparations and

lotions, non-alcohol oral care products, and products intended for use

by and on infants and children. These products present the greatest

potential health hazard if they become contaminated with bacteria and

fungi. However, once in the firm, conduct review of cosmetics

according to instructions provided in Part III of this program.

3. Imports

In accordance with instructions provided in Part III of this program,

import label examinations should emphasize four primary areas:

• review for compliance with mandatory labeling requirements,

including, but not limited to, required warning statements;

• prohibited or restricted ingredients

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• non-certified and non-permitted color additives; and

• Cosmetics containing bovine-derived tissues imported from BSE

affected or at-risk countries.

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PART I - BACKGROUND

Cosmetics are defined in section 201(i) of the Federal Food, Drug, and

Cosmetic Act (FD&C Act) as “(1) articles intended to be rubbed, poured,

sprinkled, or sprayed on, introduced into, or otherwise applied to the human

body or any part thereof for cleansing, beautifying, promoting

attractiveness, or altering the appearance, and (2) articles intended for use

as a component of any such articles; except that such term shall not include

soap.” Soap meeting the criteria of 21 CFR 701.20(a)(1) and (a)(2) is

excluded from the term "cosmetic" and is not subject to regulation under the

FD&C Act.

Some products perceived by consumers to be cosmetics may also be drugs if, in

addition to their cosmetic function, they are intended to cure, mitigate,

treat or prevent disease, or to affect the structure or any function of the

human body (see the definition of a “drug” in section 201(g)of the FD&C Act).

For example, such products include anti-dandruff shampoos, toothpastes that

contain fluoride, deodorants that are also antiperspirants, moisturizers, and

lip balms and makeup marketed with sun-protection claims (including SPF

values). Such products must comply with the requirements for both cosmetics

and drugs.

In recent years there has been an increase in the number and type of cosmetic

products sold annually, with a variety of new ingredients being introduced

every year. The number of products targeting men’s market has increased

significantly. Likewise, the number of products marketed specifically for

use by infants or children is following an upward trend.

The cosmetic industry is undergoing rapid technological changes, the

manufacturing base becoming more global, and the ingredients ever more

diverse. For some of these ingredients, there is little information

available to substantiate safety. Ingredients, including nano-based

chemicals, which may be subject to stringent drug and/or food pre-approval

processes, are often incorrectly introduced into U.S. commerce through the

cosmetic market due to its low regulatory barriers and may be cause a

cosmetic to be adulterated if the safety of the ingredient has not been

established.

Another change that the cosmetics industry is facing is consumer distaste for

traditional preservatives. As an example, parabens, which are one of the

most effective classes of preservatives, have been suspected of causing

adverse effects to the endocrine system. In the European Union parabens are

being phased out of all cosmetics because of this concern. As a result

manufacturers are applying non-traditional preservative systems in order to

assure the microbial safety of their products. FDA is concerned that

cosmetic products that make a statement in labeling that the product is

“green”, “natural”, “no parabens” and “no preservatives” may not be safe for

consumers without appropriate safety testing. Companies and products that

make such label statements should be given priority over traditionally

manufactured cosmetics during inspection and sampling.

Adverse events have been associated with a variety of cosmetic products for

several reasons including the following:

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• color additive violations

• sensitivities to specific ingredients or the product formulation

• microbial contamination

• product misuse due to inadequate labeling

Surveillance of high risk cosmetics is a useful tool for identifying safety

concerns related to a marketed product. Serious adverse events may warrant an

inspection and/or sample collection. Examples of high risk cosmetic products

that have been associated with serious adverse events include low- or no-

alcohol mouthwash, eye area cosmetics, tattoo inks including permanent

makeup, hair straighteners, and seasonal products (e.g. face paints and

tanning products, which may be reported more frequently in the fall and

summer seasons, respectively).

FDA has received reports from consumers, health care professionals, and salon

experts that associate a loss of vision with the use of contaminated eye area

cosmetics; rashes with the use of contaminated face paints; and local and

systemic infections with the use of tattoo inks, all of which being

contaminated with pathogenic microorganisms. FDA has also received reports of

adverse events involving hair straightening products caused by product misuse

due to inadequate labeling. Labeling may lack a clear statement of the

intended use of the product, warning statements, and directions for safe use.

Some cosmetics are labeled as “professional use only” products, which require

a trained and/or licensed professional to apply the cosmetic. Examples

include hair straighteners and tattoos. Although FDA regulates cosmetic

products, the facilities where these products are used, as well as the

specific practices employed, are regulated by local and state authorities.

FDA consults with the Occupational Safety and Health Administration (OSHA)

and other regulatory agencies as appropriate.

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PART II - IMPLEMENTATION

1. Objectives

To ensure that imported and domestic cosmetics meet regulatory

requirements through inspection, sample collection and analysis.

2. Program Management Instructions

Interaction with other compliance programs

Include coverage of this program during inspections conducted under

CDER’s Drug Process Inspection Compliance Program when it is determined

that the firm manufactures both cosmetics and drugs. Use the

appropriate CFSAN and CDER Program Assignment Codes (PACS) when

reporting time for these inspections.

Planning Instructions

Cover only cosmetics (see Part III, Section 1, for instructions in

determining whether a product is a cosmetic, a drug, or a drug as well

as a cosmetic).

Select firms for inspection in the following order of priority:

a) Manufacturers who have recalled cosmetics because of microbial

contamination during the previous 3-year period;

b) Manufacturers of high-risk products that have had an OAI or VAI

inspection within the previous 3-year period. High-risk products

include:

1. eye area cosmetics

2. cosmetic non-alcohol oral care products

3. wet wipes used by infants or children

4. tattoo ink

5. skin care preparations and lotions

c) Firms that manufacture/repack high-risk products and firms that have

serious Adverse Event reports or are manufacturers of recalled

products. Refer to your district’s cosmetic Official Establishment

Inventory (OEI) to select these firms. To aid the districts in

selecting firms, CFSAN will provide an inventory of firms that have

been determined to be producing high-risk products. Use the firms

provided on CFSAN’s list to supplement OEI inspections.

d) Any routine cosmetic surveillance inspection under this Compliance

Program should be made only at firms’ manufacturing or repacking

locations.

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PART III – INSPECTIONAL

A. General

The instructions in the program apply to cosmetics only. To determine

if a product should be covered under this program, refer to its list of

ingredients. The product should be covered as a cosmetic if no "active

ingredient" is declared and there are no indications of intended drug

use (i.e., labeling claims, promotional statements, etc.). If the

product is determined to be a drug, it should not be covered under this

program.

CDER and CFSAN have agreed to have concurrent jurisdiction, to assist

FDA in implementing the cosmetic and drug provisions of the FD&C Act by

clarifying program responsibilities in light of overlapping

jurisdiction between CDER and CFSAN. Under this agreement, CDER and

CFSAN have concurrent jurisdiction over a product which purports to be

a cosmetic but meets the definition of drug. Both CDER and CFSAN may

bring regulatory action relating to such product. CFSAN will not

include drug charges in any such action without first notifying CDER of

the charges that will be included. CDER will not include cosmetic

charges in such an action without first obtaining CFSAN’s concurrence.

In general, FDA does not have limits on elements allowed in cosmetics,

with a few exceptions. When suspect cosmetics are identified,

CFSAN/OCAC should be consulted prior to initiating further regulatory

action, including sampling and testing.

B. Inspections

General guidelines for the areas to be covered during activities

conducted under this program can be found in the document entitled

“Cosmetic Good Manufacturing Practice Guidelines”

(http://www.fda.gov/Cosmetics/GuidanceRegulation/GuidanceDocuments/ucm3

53046.htm). Items covered under this program include building and

facilities, equipment, personnel, raw materials, production, laboratory

controls, records labeling and complaints.

Note: Additional background information concerning topics related to

cosmetics may also be found on the FDA Cosmetic website

(http://www.fda.gov/Cosmetics/default.htm).

The following additional items should be covered during inspections of

cosmetic manufacturers under this compliance program:

1. Cosmetics Making Drug Claims (DOMESTICS AND IMPORTS)

If product labels, packaging and inserts appear to make claims that

would cause the product to be a drug, the labeling should be collected

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and submitted to the District Compliance Branch for evaluation. For

general information on the differences between cosmetics and drug

products, see “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?).”

For examples of Warning Letters sent to firms marketing cosmetics as

drugs see Warning Letters Address Drug Claims Made for Products

Marketed as Cosmetics

(http://www.fda.gov/Cosmetics/ComplianceEnforcement/WarningLetters/ucm0

81086.htm).

General information on reviewing product labels for cosmetic products

can be found at

he Summary of Labeling Requirements website

(http://www.fda.gov/Cosmetics/Labeling/Regulations/ucm126438.htm).

2. Prohibited/Restricted Ingredients (DOMESTICS AND IMPORTS)

By examination of labels for finished products and raw materials,

determine whether any of the following prohibited or restricted

ingredients are being used by the firm in the production of cosmetic

products. Examination of batch records if provided, and other

documents (e.g. product formulations, certificates of analysis), may

also provide useful information. If these ingredients do not appear in

any of the documents, query the firm directly.

Prohibited (Non-Permitted) Ingredients

• Bithionol (21 CFR 700.11)

• Halogenated Salicylanilides (21 CFR 700.15)

• Chloroform (21 CFR 700.18)

• Vinyl Chloride as an ingredient of aerosol products (21 CFR

700.14)

• Zirconium containing complexes in aerosol cosmetic products

(21 CFR 700.16)

• Methylene chloride (21 CFR 700.19)

• Prohibited cattle material (21 CFR 700.27). See below for

additional information.

Restricted Ingredients

• Hexachlorophene (21 CFR 250.250)

• Mercury Compounds (21 CFR 700.13)

• Sunscreen – must describe cosmetic benefit or be considered a drug

(21 CFR 700.35(b))

• Chlorofluorocarbon Propellants (21 CFR 2.125)

o chlorofluorocarbon 11 (trichlorofluoromethane)

o chlorofluorocarbon 12 (dichloro-difluoromethane)

o chlorofluorocarbon 113 (trichlorotri-fluoroethane)

o chlorofluorocarbon 114 (dichlorotetra-fluoroethane)

o fluorocyclobutane C318 (octofluoro-cyclobutane).

Additional information on prohibited and restricted ingredients can be

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found on the Prohibited & Restricted Ingredients website:

(http://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm127

406.htm).

3. Prohibited Cattle Material(Coverage of Bovine Tissue and Tissue-Derived

Ingredients for Bovine Spongiform Encephalopathy (BSE)

(DOMESTICS AND IMPORTS)

Bovine Spongiform Encephalopathy (BSE), commonly known as mad-cow

disease, is a fatal disease in cattle. The infectious agent has been

linked to Cruetzfeldt-Jakob disease, a neurological disorder in

humans.BSE is thought to be transmitted from infected cattle to humans

via exposure to certain bovine tissues.

The cosmetic industry has historically been a user of bovine-derived

raw materials. Human exposure to the infectious agent can occur

through eye, mouth, or skin. Cosmetics containing infected bovine-

derived materials may act as a vehicle capable of transmitting the

infection to humans.

The agency has determined that certain raw materials from cattle are

potentially highly infectious, and, if obtained from infected animals,

may contain the BSE infectious agent. Cattle tissues prohibited from

use in cosmetics are listed in 21 CFR 700.27, and include:

• The small intestine of all cattle except as provided in 21 CFR

700.27 (b) (2)

• material from non-ambulatory disabled cattle

• material from cattle not inspected and passed

• mechanically separated (MS) (Beef)

• “specified risk materials” identified in 21 CFR 700.27 (a) (5):

o brain

o skull

o eyes

o trigeminal ganglia

o spinal cord

o vertebral column (excluding the vertebrae of the tail, the

transverse processes of the thoracic and lumbar vertebrae, and

the wings of the sacrum)

o dorsal root ganglia of cattle 30 months and older

o tonsils and distal ileum of the small intestine of all cattle

Refer to 21 CFR 700.27 for more information, particularly for more

information on the definition for cattle “inspected and passed” and a

process for foreign countries to be exempted from provisions regarding

prohibited cattle material.

A current listing of countries designated for exemption under paragraph

(e) of 21 CFR 700.27 may be obtained from CFSAN OFS (Jeffrey Hamer

(240)402-4188, or [email protected]).

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BSE Record Keeping Requirements:

In accordance with 21 CFR 700.27(c), manufacturers and processors of a

cosmetic that is manufactured from, processed with, or otherwise contains,

material from cattle must establish and maintain records to demonstrate that

the cosmetic is not manufactured from, processed with, or does not otherwise

contain, prohibited cattle materials.

These records must be retained for 2 years at the manufacturing establishment

or at a reasonably accessible location. Electronic records are acceptable if

they are accessible from an onsite location.

These records must be available to FDA for inspection and copying.

Product labels and cosmetic raw materials, bulk cosmetic formulations, and

finished cosmetic products and relevant records should be reviewed to

determine if any of the products or ingredients contain prohibited cattle

material.

If a firm manufacturing or importing cosmetic products or their ingredients

uses any prohibited cattle material, document the following:

• The finished products containing the prohibited tissue

• The specific country of origin of the tissue

• The name and address of the importer or other responsible party.

The district compliance branch should consult with the CFSAN/OC/DE/Labeling

and Dietary Supplements Compliance Branch (LDSCB) (HFS-608) for regulatory

consideration.

Attachment B “Bovine Tissue and Tissue-Derived Ingredients, Materials with

Suspected Risk of Infectivity” lists high-risk tissues to assist

investigators in the identification of tissues and tissue-derived ingredients

of concern. If a firm manufacturing or importing cosmetic products or their

ingredients uses a tissue or tissue-derived ingredient listed in Attachment B

but not otherwise listed as prohibited cattle material in 21 CFR 700.27, the

FDA investigator should determine whether it has been exported from and/or

originated from a BSE affected or at-risk country. If so, the investigator

should contact CFSAN for further guidance.

A current list of BSE affected or at-risk countries can be found at: USDA’s

Animal and Plant Health Inspection Service (APHIS) website

(https://www.aphis.usda.gov/wps/portal/aphis/home/). Search

“countries/regions affected by BSE.”

Note: FDA labs do not conduct BSE analysis and thus no sampling guidance is

issued for BSE. The basis for any regulatory action on a cosmetic product

with respect to prohibited cattle material relies on review of records as

described above, labeling and other documentation.

4. Adequacy of Preservation (DOMESTICS)

Numerous factors can influence a products susceptibility to microbial

contamination. The choice of preservative system is important, along

with other factors. In some instances, such as products dispensed from

pressurized containers, there may be no need for added preservatives.

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As appropriate, review the manufacturer’s records and determine the

identity and level of preservatives intended for each formulation.

(See Attachment C “Preservation Systems for Cosmetics” for lists of

common cosmetic preservatives, non-traditional preservatives and other

considerations in evaluating a preservative system.) Verify that batch

records indicate the addition of these preservatives to each

formulation.

The susceptibility of a product to microbial contamination is often

determined through a microbial challenge test. This test involves

inoculating the product with bacteria, molds, and yeast and determining

the ability of the formulation to inhibit microbial growth. Ascertain

if the manufacturer has conducted a challenge test on its formulations

and ask for this documentation for verification. Ensure that the

product challenged in this test actually reflects the ingredient

composition of the formulation being produced at the facility. Note

any inconsistencies between the product being manufactured and the

product that was subjected to challenge testing. Since resistance to

microbial contamination is especially important in the case of eye area

products (especially those that are water-based), tattoo ink, skin

lotions and no-alcohol mouthwash, collect samples of recently produced

and retained products when the manufacturer is unable to produce

challenge test documentation or the adequacy of preservation is

otherwise in doubt [see Section III on Import and Domestic sample

collection].

In order to determine adequacy of the testing criteria and results,

when available, forward copies of challenge test results and criteria

to the CFSAN/OCAC Microbiological Analytical Contact listed in the

contacts section in PART VI.

5. Color Additives (DOMESTICS AND IMPORTS)

For an overview, see “Color Additives and Cosmetics”

(http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditivesinSpecific

Products/InCosmetics/ucm110032.htm).

Color additives are subject to a strict system of approval under U.S.

law [FD&C Act, sec. 721; 21 U.S.C. 379e]. Except in the case of coal-

tar hair dyes, failure to meet U.S. color additive requirements causes

a cosmetic to be adulterated [FD&C Act, sec. 601(e); 21 U.S. Code

361(e)]. Color additives used in cosmetics include both color

additives exempt from certification (21 CFR Part 73) and color

additives subject to certification (21 CFR Part 74 and Part 82

[Lakes]). Only color additives specifically permitted by regulation

may be legally used in cosmetics, and then only in accordance with the

provisions of the specific color additive regulation.

For a complete listing and permitted uses of each color additive

approved for use in cosmetics, refer to “Color Additives Permitted for

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Use in Cosmetics”

(http://www.fda.gov/Cosmetics/Labeling/IngredientNames/ucm109084.htm).

Click on the “CFR Section Number” on the right-hand side to view the

actual regulation, including uses, specifications, and restrictions for

each color additive.

Investigators should perform a label review of finished cosmetic

products. Ensure that all color additives are listed on the product

label, and that those being declared in the product as ingredients are

permitted for use in that product type and that they are otherwise

being used in conformance with the specifications in the listing

regulations.

Investigators should pay particular attention to color additives used

in cosmetics intended for the area of the eye (see 21 CFR 70.3(s) for a

definition of “area of the eye”) as there are only a limited number

that are specifically permitted by regulation for use in eye area

cosmetics.

Special Considerations for Color Additives Subject to Certification:

(DOMESTICS AND IMPORTS)

Certifiable color additives, sometimes referred to as “synthetic-

organic colors” must undergo batch testing by FDA. This process, known

as color additive certification, assures the safety, quality,

consistency and strength of the color additive prior to its use in

cosmetics. Part 74, Subpart C and Part 82, Subparts B and C list the

color additives permitted in cosmetics which are subject to batch

certification. When FDA certifies a batch of bulk color additive, the

color additive manufacturer is assigned a unique, six-digit lot number,

beginning with two alpha characters followed by four number characters

(e.g. XX1234). Finished-product manufacturers must ensure that they

purchase certified color additives labeled with the batch certification

lot number from color additive manufacturers.

Investigators may encounter certified color additives as raw material

or as an ingredient listed on a product label. Each color additive

included in a cosmetic product must be included in the product

declaration of ingredients (using either the listed or abbreviated name

e.g., Ext. D&C Yellow No. 7 or Ext. Yellow 7). Laboratory analysis of a

cosmetic cannot determine whether a lot of color additive used was

certified; therefore, investigators should ask manufacturers to provide

FDA certification lot number(s) for color additives used in cosmetic

products. Check the authenticity of each certification lot number by

accessing FDA’s Color Certification database

(http://inside.fda.gov:9003/CFSAN/OfficeofCosmeticsandColors/ucm406788.

htm)and keying in the six-digit lot number in the character field.

The information returned from the site includes:

- the name of the certified color additive

- the batch certification number of the original color additive

that was manufactured

- the name of the company associated with the certified color

additive

- the certification date

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(Note: First time database users will be directed to click on the

“Request Access” box for verification; permission is granted via

email.)

In the case of color additive mixtures, the label should declare a

control number that can be traced to the FDA certification lot number

of the color additives present in the mixture.

6. Cosmetic Product Labeling Requirements– Ingredients (DOMESTIC AND IMPORTS)

Examine the declaration of ingredients on all cosmetic products intended

for sale to consumers to determine compliance with 21 CFR 701.3. Note

that products that are used only in salons and not sold to consumers

(usually labeled "For Professional Use Only") or free samples where

another purchase is not required to receive the free sample, are not

required to bear an ingredient declaration under the FPLA (Section 1459).

If, however, these products are customarily sold to consumers for their

personal use, they are not exempt from ingredient labeling requirements

and must bear an ingredient statement.

As the cosmetic marketplace has become more global, certain situations now

arise with greater frequency and should receive special attention:

Use of a language other than English – All words, statements, and other

information required by or under authority of the FD&C Act to appear on

the label or labeling shall appear in the English language (except in the

case of products distributed solely in Puerto Rico or in a U.S. Territory

where the predominant language is other than English). If the label or

labeling also contains any representation in a foreign language, then all

words, statements, and representations must be made in that language.

“Dual declaration” of certain ingredients – In the mid-1990’s

correspondence between CFSAN Office of Cosmetics and Colors (OCAC)and the

Cosmetic, Toiletry and Fragrance Association (CTFA) (since renamed the

Personal Care Products Counsel (PCPC)) addressed several issues related to

international harmonization of cosmetic labeling requirements and the use

of “dual declaration” for certain types of cosmetic ingredients. These

letters may be viewed online under Cosmetic Ingredient Nomenclature:

Industry Requests & FDA Responses

(http://www.fda.gov/Cosmetics/Labeling/IngredientNames/default.htm#respons

es).

For color additives, FDA does not object to C.I. numbers being used in a

dual declaration with the official FDA-sanctioned name, provided all of

the requirements of the relevant color additive regulations have been met

and the FDA-sanctioned name is listed first. An acceptable dual

declaration will list the FDA-sanctioned name first followed by the C.I.

number in parentheses.

Example: FD&C Blue No. 1 (C.I. 42090)

The Agency also does not object to a similar type of dual declaration for

botanical ingredients where both the Linnaean taxonomic (genus/species)

name and English “common or usual name” are listed, provided that the

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English “common or usual name” is listed first.

Example: Dandelion Leaf Extract (Taraxacum officinale Leaf Extract)

If there is no English “common or usual name” for a botanical ingredient,

FDA does not object to the Linnaean name being used alone, per 21 CFR

701.3(c)(4).

Investigators should refer to Attachment D “Examples of Hypothetical

Cosmetic Ingredient Label Declarations for Domestic and International

Markets” of this compliance program for examples of nomenclature that may

appear on the labels of cosmetic products marketed for domestic and/or

international marketplaces, respectively.

7. Cosmetic Product Labeling Requirements– Warning Statements

(DOMESTIC AND IMPORTS)

a) Required warning statements on cosmetics packaged in self-pressurized

containers (21 CFR 740.11). The wording for this statements is

prescribed by regulation and must be correctly stated as follows:

“Warning—Avoid spraying in eyes. Contents under pressure. Do

not puncture or incinerate. Do not store at temperature above

120

F. Keep out of reach of children.”

In addition to the above warning statement, if the propellant used

consists in whole or in part of a halocarbon or a hydrocarbon the

following additional warning statement must be used:

“Warning—Use only as directed. Intentional misuse by

deliberately concentrating and inhaling the contents can be

harmful or fatal.”

b) Required warning statement for “feminine deodorant spray” (any spray

deodorant product whose labeling represents or suggest that the

product is for use in the female genital area or for use all over the

body) (21 CFR 740.12):

“Caution – For external use only. Spray at least 8 inches from

skin. Do not apply to broken, irritated or itching skin.

Persistent, unusual odor or discharge may indicate conditions for

which a physician should be consulted. Discontinue use

immediately if rash, irritation, or discomfort develops.”

Use of the word “hygiene” or “hygienic” or a similar word or words

renders any such product misbranded under sect

ion 602(a) of the FD&C

Act. The use of any word or words which represent or suggest that

such products have a medical usefulness renders the products

misbranded under section 502(a) of the Act and renders them illegal

new drugs marketed in violation of se

ction 505 of the Act.

c) Statement of appropriate warnings and directions for safe use of

children’s foaming detergent bath products, i.e., children’s bubble

bath products and all foaming detergent batch products not labeled

as intended for use exclusively by adults (21 CFR 740.17). The

product label must bear adequate directions for safe use and the

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following caution:

“Caution—Use only as directed. Excessive use or prolonged

exposure may cause irritation to skin and urinary tract.

Discontinue if rash, redness, or itching occur. Consult your

physician if irritation persists. Keep out of reach of

children.”

d) Required warning statement for sun tanning cosmetic products

containing no sunscreen ingredients (21 CFR 740.19). The warning

statement must read as follows:

"Warning--This product does not contain a sunscreen and does

not protect against sunburn. Repeated exposure of unprotected

skin while tanning may increase the risk of skin aging, skin

cancer, and other harmful effects to the skin, even if you do

not burn."

e) Cautionary statement and adequate directions for use needed for

the exception from adulteration on coal-tar hair dyes (i.e.,

hair dye color additives derived from coal tar or petroleum) as

provided under section 601(a) of the FD&C Act. The labeling

should also include adequate directions for such preliminary

testing and use of the product. Note: these dyes cannot be

used for dyeing the eyebrows or eyelashes.

“Caution— This product contains ingredients which may

cause skin irritation on certain individuals and a

preliminary test according to accompanying directions

should first be made. This product must not be used for

dyeing the eyelashes or eyebrows; to do so may cause

blindness.”

8. Directions for Safe Use (DOMESTICS AND IMPORTS)

Products described below are known to produce adverse reactions in

individuals when not properly formulated or when improperly used by the

consumer.

The firms’ labeling of the products below warrants close attention during

cosmetic inspections. Adequate instructions for use must be provided,

including, but not limited to, any necessary time limits on application,

instructions for washing off, or patch tests on small areas of the body,

as appropriate. Questions about the adequacy of use instructions should

be referred to CFSAN’s Office of Cosmetics and Colors at 240-402-1130.

● Depilatories and hair straighteners;

• Permanent wave neutralizers;

• Nail builders, hardeners, and enamels;

• Artificial or sculptured fingernail glue; and

● Coal tar hair dyes (Under section 601 (a) the label must

bear instructions for preliminary patch testing for

possible

skin irritation)

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9. Cosmetic Product Packaging Requirements (DOMESTIC AND IMPORTS)

Determine whether cosmetic liquid oral hygienic products and all cosmetic

vaginal products intended for retail sale comply with tamper-resistant

packaging requirements and assure that the product label bears the

statement alerting consumers to the tamper-resistant features (21 CFR

700.25).

10. Field Exam and/or Document Review (IMPORTS)

Note: Districts must refer to the FDA Import Alerts and active bulletins

in the Compliance Management System for import alerts and bulletins for

cosmetic products.

ORA includes resources for conducting label examinations of import

entries under this program. Each label examination should cover five (5)

focal areas:

1. Cover cosmetics only. (See Part I “Background,” and Part

III “Inspectional”, Section 1. “General” in this Cosmetic

Program Guidance Manual, for instructions in determining

whether a product is a cosmetic, a drug, or drug as well as

cosmetic. A listing of cosmetic product categories can be

found at 21 CFR 720.4(c));

2. Include a review to ensure the product complies with

mandatory labeling and packaging requirements, including

required warning statements; prohibited/restricted

ingredients; and non-certified or non-permitted color

additives utilizing the instructions provided above under

Part III, “Inspections”;

3. Include a review of cosmetic labels with added “ingredient

stickers” signifying possible re-labeling of a brand name

(so called “gray market cosmetics” produced for markets

outside of the U.S.) Cosmetics formulated for use in other

countries may contain color additives not permitted in the

U.S.

4. Include coverage of imported cosmetics containing color

additives. Color additive violations are a common reason

for detaining imported cosmetic products offered for entry

into this country. See IA#53-06 “Detention Without Physical

Examination of Cosmetics Containing Illegal Colors”

(http://www.accessdata.fda.gov/cms_ia/importalert_130.html)

When performing a field exam, please review Part III,

Section 4, “Color Additives” for instructions in

determining whether a product may contain non-certified or

non-permitted color additives.

In addition, if the label of an imported cosmetic

identifies color additives with their European name or

(“E”) color designation with a corresponding number (e.g.,

E104, E122, E123, and E124), a color index number (e.g.,

C.I. 15985) or the trade name of the color additive (e.g.,

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Sunset Yellow FCF) alone without the U.S. approved

designation, this suggests that the color additive used may

not be certified or permitted. In these situations,

districts should consider detaining without sampling based

on the appearance of adulteration (i.e., the product

appears to contain an uncertified color additive). These

situations can be processed in OASIS using a violative

label exam (Work Type LEX).

If the imported product appears to contain undeclared color

additives, product samples should be obtained and sent to

the designated laboratory for color analysis.

To confirm that a product contains certified color

additives, request that the filer/importer provide a valid

FDA certified Lot number for the color additive(s) used.

Using the Color

Additive Certification Database,

“Color Additives Permitted for Use in Cosmetics,”

(http://www.fda.gov/Cosmetics/Labeling/IngredientNames/ucm1

09084.htm) confirm that the lot number provided can be

validated. Then, the product can be released, provided the

label declares the color additive(s) by the certified name,

such as FD&C Yellow No. 6 or Yellow 6. If the product

contains certified color additive(s), and the certified

color additive(s) is not correctly declared on the label,

process the entry for detention.

5. Include a review for prohibited cattle material.

Please review Part III, Section 2 “Coverage of Bovine

Tissue and Tissue-Derived Ingredients for Bovine Spongiform

Encephalopathy (BSE” for additional information.

OASIS screening criteria allow 100% entry review for any import entry of

finished cosmetic products that may contain bovine tissue or tissue-derived

ingredients. These include all products with industry code 53 R[][][].

Product labels and entry documentation of finished cosmetics should be

reviewed to determine if the products contain any of the prohibited cattle

material listed in 21 CFR 700.27. See above discussion under “Special

Considerations Regarding Prohibited Cattle Material” for more information.

In addition, bulk shipments of bovine tissue and tissue-derived ingredients

are flagged for review under Import Alert 17-04 “Detention without Physical

Examination of Bulk Shipments of High Risk Bovine Tissue from BSE Countries”

(http://www.accessdata.fda.gov/cms_ia/importalert_53.html). Bulk shipments of

bovine material intended for use in cosmetic products are product coded as

53P[][]01 and 53P[][]02. The specific bovine tissues and tissue derived

ingredients of concern are listed in IA 17-04.

If a bulk shipment of a bovine tissue or tissue-derived cosmetic ingredient

is detained under Import Alert 17-04 “Detention Without Physical Examination

of Bulk Shipments of High Risk Bovine Tissue From BSE Countries,” the

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importer or manufacturer may provide documentation that establishes the

bovine tissue or tissue-derived ingredient is from BSE-free cattle or from a

non-BSE affected country. See Import Alert 17-04 for more information.

Attachment B Bovines Tissue and Tissue-Derived Ingredients, Materials with

Suspected Risk of Infectivity” contains a list of tissues to further assist

investigators in identifying tissues and tissue-derived ingredients at high

risk for infection with the agent that causes BSE. This list includes the

“specified risk materials” specifically identified in 21 CFR 700.27 as well

as additional bovine tissues with suspected infectivity. If a firm

manufacturing or importing cosmetic products or their ingredients uses a

tissue or tissue-derived ingredient listed in Attachment B but not otherwise

listed as prohibited cattle material in 21 CFR 700.27, the FDA investigator

should determine whether it has been exported from and/or originated from a

BSE affected or at-risk country. If so, the investigator should contact CFSAN

for further guidance.

A current list of BSE affected or at-risk countries can be found at: USDA’s

Animal and Plant Health Inspection Service (APHIS) website

(https://www.aphis.usda.gov/wps/portal/aphis/home/) and then typing in the

search term “countries/regions affected by BSE” for an up-to-date list of

countries.

11. Alpha Hydroxy Acids (AHAs) “Sunburn Alert” AHA Labeling Statement

(DOMESTICS AND IMPORTS)

Because of the potential for increased sensitivity to the sun,

manufacturers must use the following guidance labeling statement for

topically applied cosmetic products containing AHAs (e.g., glycolic acid,

lactic acid) as ingredients

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that

may increase your skin's sensitivity to the sun and particularly the

possibility of sunburn. Use a sunscreen, wear protective clothing,

and limit sun exposure while using this product and for a week

afterwards.

Investigators are requested to notify firms manufacturing cosmetics

containing AHAs of “Guidance for Industry: Labeling for Topically Applied

Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients”

(http://www.fda.gov/Cosmetics/GuidanceRegulation/GuidanceDocuments/ucm0908

16.htm).

12. Consumer and Trade Complaints (DOMESTICS)

The District Offices should use their own discretion concerning immediate

follow-up on more serious or unusual consumer adverse reactions for

cosmetic products, e.g., multiple or serious complaints for the same

product. Prior to conducting follow-up on a cosmetic adverse event,

including sampling, the district should contact Wendy Good

([email protected])at 240-402-1146, Office of Cosmetics and Colors

(OCAC), Cosmetics Staff (HFS-125). Many types of cosmetic products are

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known to cause adverse reactions under certain conditions, therefore

automatic follow-up and sampling for adverse reaction reports on cosmetics

may not be necessary. CFSAN can provide advice to the investigating

district for appropriate follow-up.

The FACTS Consumer Complaint Cosmetic Report should be used for adverse

events related to cosmetics (See Subchapter 8.4.5 of the IOM). If

collection of cosmetic consumer complaint samples is necessary, follow the

instructions provided in Subchapter 8.4.7 of the IOM. These samples will

be analyzed by the appropriate district servicing laboratory or Center

laboratory as discussed in Part IV of this compliance program.

13. Other coverage during Domestic Inspections (DOMESTICS):

a) Voluntary Registration (DOMESTICS)

During each inspection, determine whether the firm has

registered its manufacturing establishment (21 CFR 710) and/or its

cosmetic product formulations (21 CFR 720) under the

Voluntary Cosmetic Registration Program (VCRP)

(http://www.fda.gov/Cosmetics/RegistrationProgram/default.htm).

If not, encourage participation in these voluntary programs.

b) Fact Sheet for Cosmetic Manufacturers, Packers and Distributors

During an inspection, questions frequently arise as to products

regulated by FDA and questions concerning cosmetics, such as labeling,

BSE, color additives, voluntary registration, importing and exporting

products and small business assistance. A fact sheet has been designed

to answer some of these questions and provide the firm with helpful FDA

links. At the closeout of each inspection, disseminate Attachment D

“Food and Drug Administration, Office of Cosmetics and Colors Fact

Sheet

for Cosmetic Manufacturers, Packers and Distributors” to firm

management.

C) Screening for toxic elements

X-ray fluorescence (XRF) can be used to identify prohibited elemental

substances (I based colors , Hg in other than eye cosmetics, i.e.,

skin whiteners, Pb containing pigments used in religious celebrations

and other facial decorations). XRF can detect up to 80 elements in

the periodic table from a few ppm for some elements. XRF can detect

Hg through the caps of closed vessels lessening the chance to

exposure from volatile Hg from whitening creams containing volatile

forms of Hg. In the lab a quantitative method to determine Hg in face

cream has been developed (Use of Field Portable XRF for Screening and

Quantification of Mercury in Face Creams. Laboratory Information

Bulletins (LIB) 4542).

http://inside.fda.gov:9003/downloads/PolicyProcedures/Laboratories/La

boratoryInformationBulletins/UCM353400.pdf

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Contact the CFSAN/Division of Field Programs, Program Assignment Monitoring

Branch contact BEFORE employing a screening method for toxic elements in any

situation other than as directed in a field assignment.

C. Sample Collections

For cosmetic color additive samples, consult Chapter 4 of the current edition

of the IOM (Chart 9), “Sample Schedule for Color Containing Product, Color

Additive”

(https://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM123507.pdf).

Note: Bulk color additives that are used as cosmetic ingredients should be

collected under Industry Code 50. For straight colors, collect 28 gm (1 oz.)

of powder. For color mixtures, collect 100 gm (4oz.) of liquid, paste or

powder. If the color mixture contains over 50% pure dye, collect 55 gm

(2oz.).

Color additive samples of finished cosmetics should be collected under

Industry Code 53. If the product is strongly colored (e.g., lipsticks, hair

coloring, products, eye mascara, eye liner, make-up, pencils of all types)

collect four retail packages of the same lot code for each shade (color) in

the product line. If the product is lightly colored (e.g., creams, lotions,

shampoos, bath products, shaving preparations and perfumes), collect a

sufficient number of retail packages to equal 1 lb (dry) or 1 pt (liquid) of

sample. Always collect a minimum of two retail units of each product.

For bulk cosmetic products, collect samples for color additive analysis in

the following quantities:

 Dry 454 gm (1 lb.);

 Liquids – Minimum of 36 fl. oz.

DOMESTICS:

For microbiological analysis, collect samples of eye area cosmetics, tattoo

inks or skin care preparations and lotions when adequate challenge test

documentation cannot be produced, the adequacy of preservation is in doubt or

non-traditional preservative systems are used.

If uncertain whether to collect a sample, contact the appropriate CFSAN

regulatory contact listed in Part VI of this program for additional

instructions.

IMPORTS:

If product packaging and labeling indicates that a violation of the Act may

exist, the field should collect samples to support potential regulatory

action. The collected samples should be sufficient to ensure that the

regulatory action is supportable. If the apparent violation is for micro

contamination, undeclared colors, or heavy metals, etc. a physical sample and

laboratory analysis would be appropriate.

Collect the following quantities as determined by the type of analyses

required.

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DOMESTIC AND IMPORTS:

Chemical Analysis — Collect in duplicate (as per specific assignment

guidance)

Chemical analysis of cosmetics is not routine; however, it may be requested

per specific assignment and/or during a for-cause inspection. The products

and quantities listed are included for reference and should not be routinely

collected for chemical analysis.

Aerosol products—680 gm (24 oz)

Bath Salts—680 gm (24 oz)

Bubble Baths--680 gm (24 oz)

Eye Make-up – 56 gm (2 oz)

Facial Make-up—225 gm (8 oz)

Mouthwashes—680 gm (24 oz)

Nail preparations—160 gm (6 oz)

Perfumes—160 gm (6 oz)

Pressed Powders—160 gm (6 oz)

Skin Lotion – 680 gm (24 oz)

Shampoos and conditioners – 680 gm (24 oz)

Microbiological analysis

Individual Retail Units

Collect at least ten (10) units [20 units if less than 14 gm (½ oz) each]

Bulk

One (1) 100 gm (4 oz) subsample from each of ten containers

Note: In the absence of specific sampling instruction for tattoo ink, contact

the Program Analytical Contacts for guidance on adequate sample sizes.

Imports

All import lines sampled under this program must be held pending analysis.

For entries that contain multiple lines of different product types that were

not evaluated, the additional lines can be released if they do not appear to

be violative.

SAMPLE SHIPMENT

Submit samples to your district’s analytical laboratory or specialized CFSAN

laboratory as appropriate to conduct the intended analysis as indicated in

PART IV, Section A.

Important Note: For samples collected for field lab analysis, refer to the

Servicing Laboratories section of the ORA Field Workplan. For this reason,

for each type of analysis to be performed by CFSAN, a contact person is

provided in Part IV, Section B. Collecting districts should contact that

person by e-mail to confirm the shipping address prior to shipping any

samples to CFSAN. For CFSAN, refer to CFSAN contact list.

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PART IV – ANALYTICAL

Implementation

a) To analyze samples of eye area cosmetics, tattoo ink and skin care

preparations and lotions that could become contaminated with pathogenic

microorganisms, due to a questionable preservative system or disregard

for industry good manufacturing practices (see Draft Guidance for

Industry: Cosmetic Good Manufacturing Practices

(http://www.fda.gov/cosmetics/guidanceregulation/guidancedocuments/ucm3

53046.htm)).

b) To analyze cosmetics for color additives and prohibited ingredients and

to conduct label reviews when suspected violations of the FD&C Act and

the FPLA are encountered during inspections and import label

examinations.

A. ANALYZING LABORATORIES

1. Field

a) Microbiological

General microbiological analysis will be performed by the

district's customary microbiological analytical laboratory. (See

the Servicing Laboratories section of the current ORA Field

Workplan for a listing of servicing laboratories.)

NOTE:

Fungal sequencing performed by Pacific Regional Laboratory –

Southwest will be used to identify yeast and mold isolates.

When identification is needed, please make prior arrangements

with the laboratory to ensure resources are available. All

cultures will be shipped by UPS overnight delivery, and

shipments will conform to the rules and regulations regarding

the shipment of infectious agents.

Please send isolates to the following address:

Food & Drug Administration

Pacific Regional Laboratory – Southwest

19701 Fairchild

Irvine, CA 92612

ATTN: Dr. Donna Williams-Hill or Sample Custodian

Telephone: 949 608 3496 or 949 608 4432

b) Color Additives

Servicing Laboratory Tables are being used as an alternative

system to the National Sample Distributer (NSD). However, if a

specific laboratory has been indicated in a sampling assignment

then that laboratory should be referenced during the C/R

preparation process.

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Servicing Laboratory Tables

http://qmis.fda.gov/MC/main/mastercontrol/vault/view_pdf.cfm?ui=0

92315124259&infocardID=2BC257D401BEA04613

NOTE: Initial analysis may be accomplished by the servicing

district laboratory; however, either the original or check

analysis for any potentially violative sample must be done by

an analyst trained in certified color additive determination.

Contact ORA/Office of Regulatory Science (HFC-141) at (301)

796-6600 with questions regarding servicing laboratories and

analyses.

CFSAN/OCAC’s Color Technology Team (HFS-106) Julie Barrows, 240-

402-1119 is available to advise the district servicing laboratory

on analyses involving difficult color samples.

c) Label Review

All servicing analytical laboratories will conduct review of the

labeling (21 CFR Parts 700 and 701) for declaration of

ingredients (21 CFR 701.3), and warning statements (21 CFR 740),

and directions for use as necessary (see Part III 2. f. of this

guidance document). For comprehensive material on cosmetic

labeling requirements that should be used in conducting label

review, refer to the resources listed at Labeling

(http://www.fda.gov/Cosmetics/Labeling/default.htm).

2. Center

The following may be performed by CFSAN. Investigations branches

should e-mail the Center contact listed below before shipping any

samples to the Center for analyses.

a) Species Identification

CFSAN/ORS/Division of Microbiology (HFS-712) is available to

provide added support for the identification of yeast and mold

isolates.

Contact Valerie Tournas at 240-402-1963 or via e-mail at

[email protected] for support.

b) Chemical Analysis

CFSAN/ORS(HFS-700) will provide support for analysis of

cosmetic products for prohibited or other potentially harmful

ingredients or contaminants.

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Contact Gregory Noonan at CFSAN/ORS/DBC (HFS-715) at 240-402-

2250 or via e-mail at [email protected] prior to

shipping samples.

c) Confirmation of Color Additives

The Division Color Certification and Technology, Color

Technology Team (HFS-106) will provide color additive support

for samples of cosmetic products not amenable to the typical

analytical methods.

Contact Dr. Julie Barrows via e-mail at

[email protected] (240-402-1119) for information prior

to shipping samples.

d) Determination of Toxicity

The Office of Cosmetics and Colors, Division of Cosmetics

(HFS-125) will provide support for evaluating topical toxicity

or the potential for systemic toxicity as requested.

Contact Dr. Nakissa Sadrieh at (240) 402-2194 or via e-mail at

[email protected] for help with toxicity questions.

e) Label Review

CFSAN/OC/Division of Enforcement (HFS-608) will provide

assistance for determining violations of cosmetic labeling

requirements.

Contact Beth Tirio at e-mail [email protected] or via

phone at (240) 402-0942.

B. ANALYSIS

a) Microbiological

All method references to the e-BAM refer to the current edition

of the Bacteriological Analytical Manual

(https://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/u

cm2006949.htm).

Refer to the e-BAM, Chapter 23 for methods to determine microbial

contamination of cosmetics, except tattoo ink.

Tattoo ink and materials used to manufacture tattoo ink should be

sent to Pacific Regional Lab (PRL-SW) for analysis. For the

analysis of tattoo ink, refer to an appropriate validated method

such as

http://inside.fda.gov:9003/downloads/PolicyProcedures/Laboratorie

s/LaboratoryInformationBulletins/UCM413090.pdf.

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All Gram-positive and Gram-negative microbial isolates from

aerobic plate counts or enrichments are to be identified to genus

and species level using e-BAM, chapter 23 methods and commercial

identification systems such as Vitek.

Prepare mold and yeast cultures for forwarding and further

classification as follows:

• Potato Dextrose Agar (PDA- BAM Media M127) slants (screw

cap tubes) can be used for culturing the mold isolates.

The mold agar slants are incubated at 37

C to ensure

proper growth before shipping (Reference: e-BAM, Chapter

23:Microbiological Methods for Cosmetics)

• Yeast isolates show optimal growth on Sabouraud’s

Dextrose Agar (SDA) plates incubated at 25

C, these

isolates may need longer incubation time until growth is

evident (Reference: e-BAM, Chapter 23: Microbiological

Methods for Cosmetics).

• Media composition and growth conditions can sometimes

vary depending on specific fungal species under which

circumstances isolates need to be tested for optimal

incubation temperatures and growth media such as

PDA,SDA, malt extract agar (MEA- BAM Media M93) to

ensure proper growth (Refer to e-BAM, Chapter 23:

Microbiological Methods for Cosmetics)

• Pack, label and ship isolates in accordance with Federal

Standards for Etiological Agents.

b) Color Additive Analysis

All determinations of color additives in cosmetic products will

be performed in accordance with the instructions contained in

Newburger’s Manual of Cosmetic Analysis, 2nd Edition, Chapter 19,

Determination of Color in Cosmetics, published by AOAC, 1977.

For additional color additive analytical instructions refer to

the AOAC, Official Methods of Analysis, 15th through 18th

editions, Chapter 46, or most current edition. See also

Compliance Program 7303.803 (Domestic Food Safety; Attachment C,

Analytical Instructions); or 7309.006 (Imported Foods - Food and

Color Additives; Part IV).

c) Toxic Elements (ELE) Analysis

All determinations of Toxic Elements Analysis in cosmetic

products will be performed in accordance with the instructions

contained in the Elemental Analysis Manual method 4.7 (EAM 4.7).

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(http://www.fda.gov/downloads/Food/FoodScienceResearch/Laboratory

Methods/UCM377005.pdf)%20for%20the%20analytical%20method).

d) Label Review

Determine whether proper labeling practices are followed. See 21

CFR 701 for Cosmetic Labeling and 740 for cosmetic Product

Warning Statements.

e) Reporting

Report analytical results into FACTS using the following Problem

Area Flags (PAF):

• Use PAF "COL," for non-permitted color additives and

identify the non-permitted color additives found.

• Use PAF "MIC," for microbiological examinations and

identify the microorganisms(s) and level.

• Use PAF “ELE” for toxic elements

• Use PAF "FDF," Result Flag "FDL" for label reviews (Food

Economics and Standards) and identify specific violation(s)

found.

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PART V - REGULATORY/ADMINISTRATIVE STRATEGY

1. Situations Warranting CFSAN Contact

Contact CFSAN, Office of Compliance (OC), Division of Enforcement (DE),

Beth Tirio, Labeling and Dietary Supplement Compliance Branch (HFS-608)

at (240) 402-1626 for instructions in the following situations:

a) If there is a suspected health hazard (see Part III for situations that

may constitute a health hazard). In such cases, a health hazard

evaluation should be requested from CFSAN/OC/DE. Refer to the

Regulatory Procedures Manual

(RPM)

(http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/d

efault.htm), Chapter 7 and

21 CFR 7.41(a) for information regarding

health hazard evaluations.

The receipt of a large number of adverse event reports for a

particular product and/or adverse events involving severe chemical

burns or severe eye injuries may also be indicative of a potential

health hazard situation.

b) If a product presenting a potential health hazard has been

distributed.

c) Cosmetic products are not expected to be aseptic; however, they must

be completely free of high-virulence microbial pathogens, and the

total number of microorganisms per gram must be low. CFSAN is

currently using the following level of concern for aerobic plate

counts (APCs):

• For eye-area products, counts should not be greater than

500 colony forming units (CFU)/g;

• for non-eye-area products, counts should not be greater

than 1000 CFU/g. Some examples of bacterial and fungal

pathogens or opportunistic pathogens whose incidence

would be of particular concern, especially in eye-area

cosmetic products, include Staphylococcus aureus,

Streptococcus pyogenes, Pseudomonas aeruginosa,

Aspergillus sps, Candida albicans, Klebsiella

pneumoniae, and other species.

The list of microorganisms noted above is not all-inclusive. When

determining the pathogenicity of a specific microorganism and the

potential health risk to consumers as a result of its presence in a

cosmetic product, OCAC microbiologists consider several factors.

Evidence in the available literature regarding cases of infection in

healthy populations without intervening factors such as prior

surgery or compromised immune systems is of primary significance.

Mode and frequency of product application and container design,

among other factors, are also taken into consideration when

evaluating potential risk to the consumer. For example, some

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organisms are capable of causing eye diseases in healthy individuals

when the eye, or area around the eye, is punctured or abraded.

Questions regarding the pathogenicity and potential health risks of

a given microorganism in a specific type of cosmetic product should

be referred to CFSAN.

In addition, OCAC recognizes that the skin and ocular surface of

healthy individuals inherently supports a moderate population of

bacteria, typically coagulase-negative staphylococci (CNS), which

are believed to exist as commensals. Under normal conditions, in

healthy individuals, there is little or no opportunistic microbial

colonization and infection resulting from these commensals, such as

Staphylococcus epidermidis, Staphylococcus hominis, and Micrococcus

luteus. As long as the overall microbial population in a cosmetic

product is below regulatory limits, the sole presence of commensal

microorganisms does not pose a significant health risk and does not

render the product adulterated.

If a cosmetic appears to be making drug claims:

CDER and CFSAN have agreed to have concurrent jurisdiction to assist

FDA in implementing the cosmetic and drug provisions of the FD&C Act

by clarifying program responsibilities in light of overlapping

jurisdiction between CDER and CFSAN. Under this agreement, CDER and

CFSAN shall have concurrent jurisdiction over a product which

purports to be a cosmetic but meets the definition of drug. Both

CDER and CFSAN may bring regulatory action relating to such product.

CFSAN will not include drug charges in any such action without first

notifying CDER of the charges that will be included. CDER will not

include cosmetic charges in such an action without first obtaining

CFSAN’s concurrence.

Districts may submit recommendations for advisory (e.g., Warning

Letter) or enforcement action to CFSAN, and CFSAN will coordinate

the action with CDER.

e) Contact CFSAN/OC/DE/ Labeling and Dietary Supplement Compliance

Branch (HFS-608) if necessary for assistance when

an import shipment is detained in accordance with I.A. #17-04 for

bulk shipments of high-risk bovine tissues and tissue-derived

ingredients.

If a cosmetic product contains or appears to contain prohibited

cattle material, it should be detained. In order to obtain release

of the product, the importer should provide records sufficient to

demonstrate that the cosmetic is not manufactured from, processed

with, or does not otherwise contain, prohibited cattle material.

Examples of documents that may be useful to the reviewer in making a

determination include:

- a relevant USDA/APHIS veterinary certificate

- a country of origin certificate

- relevant manufacturing records

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2. Direct Reference Seizure Authority

Updated instructions regarding direct reference seizure authority for

Pseudomonas aeruginosa contamination of cosmetics used in the eye area

may be found in Section 590.300 of the Compliance Policy Guide Manual

(CPG). The specimen charge is stated in the CPG.

SPECIMEN CHARGE:

The article (was adulterated while introduced into and while in

interstate commerce) or (is adulterated while held for sale after

shipment in interstate commerce) within the meaning of the Act, 21

U.S.C. 361(a) in that it contains a poisonous or deleterious substance,

Pseudomonas aeruginosa, which may render it injurious to users under

such conditions of use as are customary or usual.

Complete labeling and worksheets must accompany direct seizure

recommendations when forwarded to the Office of Chief Counsel through

the Division of Enforcement in the Office of Enforcement and Import

Operations (HFC-210).

3. Seizure with Center Review

All other cases must be submitted to the Center for Food Safety an

Applied Nutrition (CFSAN) through the electronic MARCS-CMS system.

MARCS-CMS is a collection of modules supporting Agency compliance

management and work flow for compliance-related activities. MARCS-CMS

provides the mechanism to electronically send this information to the

appropriate organizational unit based on individual organizations’

business practices. It also provides the means to associate all

evidence needed to support the Compliance Action. This evidence may

contain enforcement, precedent scientific, or interpretive information

relating to the Compliance Action.

Users can access the system by navigating through INSIDE.FDA.GOV. From

this screen select MARCS-CMS link. A user’s Guide is available within

the application under the User’s Guide link located at the top of the

MARCS-CMS Main Screen.

If any of the situations below are encountered for domestic products,

and the firm involved does not voluntarily recall all of the affected

products districts should submit a recommendation for seizure

(including sample analyses), electronic copy (e.g., .doc, .pdf files,

etc.) through the MARCS-CMS system to HFS-608, CFSAN/OC/DE/Labeling and

Dietary Supplement Branch. CFSAN will review to determine Center

support for the recommended action.

a) Prohibited/ Restricted Ingredients. Determine whether prohibited or

restricted ingredients (21 CFR 2.125, 21 CFR 250.250 and part 700)

are being used. (Confirm status of ingredients at all 3 “bullets”

below)

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• Prohibited as cosmetic ingredients:

i. bithionol (21 CFR 700.11);

ii. halogenated salicylanilides (di-, tri-, metabrom-salan

and tetrachlorosalicylanilide) (21 CFR 700.15);

iii. chloroform (21 CFR 700.18); and

iv. methylene chloride (21 CFR 700.19).

• Prohibited as ingredients of cosmetic aerosol products:

i. vinyl chloride (21 CFR 700.14); and

ii. zirconium (21 CFR 700.16).

• Restricted ingredients of cosmetic products unless used as

specified in the regulations:

i. hexachlorophene (HCP) (21 CFR 250.250);

ii. mercury compounds (21 CFR 700.13); and

iii. chlorofluorocarbon propellants (21 CFR 700.23 and 2.125).

SPECIMEN CHARGE:

The article is adulterated within the meaning of Section 601(a) of

the Act in that it bears or contains a poisonous or deleterious

substance, namely [name of substance], which may render it injurious

to users under the conditions of use prescribed in the labeling

thereof or under such conditions of use as are customary and usual.

b) Non-Certified or Non-Permitted Color Additives. Determine whether

non-certified or non-permitted color additives (21 CFR 73, 74, 81,

82) are being used. Refer to

Color Additives Permitted for Use in

Cosmetics

(http://www.fda.gov/Cosmetics/Labeling/IngredientNames/ucm109084.htm)

for more information. If undeclared colors are identified in an

imported product, process the entry for detention.

For cosmetics containing non-permitted color additives (for products

other than hair dyes), if seizable size lots are not found, the

district should consider a Warning Letter recommendation using the

sample warning letter language found in Chapter 4 of the Regulatory

Procedures Manual

(http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManua

l/default.htm).

SPECIMEN CHARGE:

The article is adulterated within the meaning of Section 601(e) of

the Act in that it bears or contains a color additive, namely

[color], which is unsafe within the meaning of Section 721(a).

When a certifiable color additive is not declared on the label, FDA

may or may not have certified it for use in cosmetic products.

Without evidence that the color came from a batch that has been

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certified (e.g., FDA certification lot number), the appropriate

charge would be a 601(e) adulteration charge.

c) Tamper-Resistant Packaging. Cosmetic liquid oral hygiene products,

e.g., mouthwashes and breath fresheners, and any kind of cosmetic

vaginal product introduced into interstate commerce must be packaged

in tamper-resistant packages if intended to be accessible to the

public while held for retail sale under 21 CFR 700.25. If not in

tamper-resistant packaging, the product is adulterated under Section

601 of the Federal Food, Drug and Cosmetic Act (the Act). (See

Section 4b Mandatory Labeling and Packaging Requirements for

misbranding charges regarding tamper-resistant packaging and labeling

requirements.)

SPECIMEN CHARGE: The article is adulterated within the meaning of

Sections 601(a) and/or 601(c) of the Act in that it is not packaged

in a tamper-resistant package as required in 21 CFR 700.25.

4. Other Findings

If the situations described in this section are found, enforcement

action may be warranted. This is not an all-inclusive list of

potential deviations. Districts should use their best judgment to

determine the appropriate action (i.e., warning letter, seizure, etc.)

and submit a recommendation to CFSAN. If additional assistance is

needed, districts should contact the regulatory contacts listed in Part

VI.

Mandatory Labeling and Packaging Requirements. Cosmetics must bear

labeling as specified in the FD&C Act, the FPLA, and the cosmetic

regulations (21 CFR Part 701). Failure to include necessary labeling

elements may cause a product to be misbranded under section 602 of the

Act.

• This article may also be misbranded within the meaning of section

1454(c)(3)(B) of the Fair Packaging and Labeling Act in that it

appears that the label fails to bear an ingredient declaration in

accordance with 21 CFR 701.3 (See Part III—Inspectional for

additional information on ingredient declaration)

Some cosmetic products are also subject to the packaging provisions

of the Poison Prevention Packaging Act of 1970 and the implementing

regulations (16 CFR Part 1700 et. seq.). Products which do not

comply with the regulations promulgated under this law are misbranded

within the meaning of Section 602(f) of the FD&C Act.

• Appropriate Cautionary Statements and Directions for Safe Use.

The following products may be deemed adulterated or misbranded if

the labeling does not contain an appropriate warning statement(s)

and/or directions for safe use (see the appropriate section of the

Act in parentheses):

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i. Depilatories and hair straighteners (Section 602(a) of the

Act);

ii. Cosmetic hair dye products containing lead acetate (21 CFR

73.2396), bismuth citrate (21 CFR 73.2110), and/ or henna

(21 CFR 73.2190) (Sections 601(e) and 602(a) of the FD&C

Act);

iii. Coal-tar hair dyes (Section 601(a) of the Act); and

iv. Nail builders, hardeners, and enamels (may require immediate

CFSAN review depending on the facts involved (Section 602(a)

of the Act).

• Child Resistant Packaging

The following products must be packaged in child-resistant

packaging:

i. Home permanent wave neutralizers containing sodium bromate

or potassium bromate [16 CFR 1700.14(a)(19), Section 602(f)

of the Act]; and

ii. Artificial or sculptured fingernail glue removers containing

acetonitrile [16 CFR 1700.14(a)(18), Section 602(f) of the

Act].

• Sun-tanning Products

These products may be drugs and/or cosmetics, depending on the

claims. If the product labeling includes any of the following

claims, the product will be regulated as a drug:

i. The labeling bears any direct or implied statement that the

product screens out ultraviolet sunlight, prevents or treats

sunburn, prevents wrinkles, or prevents premature aging of

the skin;

ii. The label bears a number representing the sun protection

factor (SPF) value; or

iii. The sunscreen ingredient is declared as an active drug

ingredient and is listed before the listing of the cosmetic

ingredients - Section 502(e)(1) of the Act and 21 CFR

701.3(d).

Suntan cosmetic products that do not contain a sunscreen must bear

adequate directions for safe use and the warning statement

required under 21 CFR 740.19. If the products do not comply with

the regulation, they are misbranded under Section 602(a) of the

Act.

There are "tanning pills" manufactured as capsules intended for

ingestion. These products usually contain beta carotene and/or

canthaxanthin. They act by entering the blood stream and are

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partially deposited in skin tissue, giving the skin a tan-like

color. Neither beta carotene nor canthaxanthin is approved for

this use, and tanning pill products containing these color

additives are considered adulterated under Section 601(e). (NOTE:

"Suntan accelerators" are new drugs within the meaning of Section

201(p) of the Act).

• Cosmetics Containing Sunscreen Ingredients

These products may contain a sunscreen ingredient for purposes

other than sun protection (e.g., as a color additive or to protect

the color of the product). Such products are required to be

labeled with qualifying information in conjunction with the term

“sunscreen” or other similar protection terminology used in the

labeling as required in 21 CFR 700.35. If the products do not

comply with the regulation, they are misbranded under Section

602(a) of the Act.

• Cosmetics packaged in self-pressurized containers

Cosmetic aerosol products are misbranded unless the labeling bears

the label statements required for cosmetics in self-pressurized

containers (21 CFR 740.11, Sections 602(a) and 201(n) of the Act).

• Children’s foaming detergent bath products

Such products (e.g., bubble bath products) are misbranded unless

the labeling bears adequate directions for safe use and

precautionary statement (21 CFR 740.17, Sections 602(a) and 201(n)

of the Act).

• Feminine deodorant sprays

Such products are misbranded unless the labeling bears explicit

warnings and directions for safe use (when applicable) (21 CFR

740.12, Section 602(a) of the Act). Additionally, these products

may be considered misbranded under Sections 602(a) and 201(n) if

the labeling contains the word “hygiene” or a similar word. If

the product is represented to have a medical usefulness, it may be

considered a drug and would be misbranded under Section 502(a) (21

CFR 740.12).

• Tamper-resistant packaging

Cosmetic liquid oral hygiene products and vaginal products are

required to include a statement regarding the tamper-resistant

features of the packages [21 CFR 700.25(c)]. If a product does

not contain such statement, or if the labeling contains a

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statement that the package is tamper-proof, the product may be

misbranded under Sections 602(a) and 201(n) of the Act. (See

Section 3c Direct to Seizure with Center Review for an

adulteration charge regarding tamper-resistant packaging

requirements.)

c) Insanitary conditions. Enforcement action may be warranted if the

inspection finds that the product may become contaminated with filth

or may be rendered injurious to health (Section 601(c) of the Act).

6. Imports

Refer to the Regulatory Procedures Manual

(RPM) Chapter 9

(http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/

ucm179264.htm )for instructions concerning recommendation for detention

based on one violative sample found to contain illegal color additives,

unsafe or prohibited ingredients, or that present a health hazard for

other reasons as outlined in Part III of this program. Recommendations

for Detention Without Physical Examination (DWPE) must be referred to

ORA/ORO Division of Import Operations (HFC-170) through the Compliance

Management System (CMS). Recommendations must be accompanied by a

complete regulatory package consisting of all analytical worksheets for

original and check analyses (if required—see note below), and other

appropriate documentation (e.g., entry paperwork, collection reports,

original labels, etc.).

Note: In the case of cosmetic products bearing ingredient labels

identifying colors with ONLY their European “E” color designation

(e.g., E110), color index number (e.g., C.I. 15985), or a trade or

common name of the color additive (e.g., Sunset Yellow FCF), FDA

laboratory analysis to confirm the presence of the color is not

necessary for Detention/DWPE Actions.

At this time, FDA is developing an enforcement strategy for cosmetics

containing glitters and mica-based pearlescent pigments.

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PART VI - ATTACHMENTS REFERENCES AND CONTACTS

1) ATTACHMENTS

Attachment A--Index

Attachment B— Bovine Tissue and Tissue-Derived Materials with Suspected

Risk of Infectivity

Attachment C— Preservation Systems for Cosmetics

Attachment D- Examples of Hypothetical Cosmetic Ingredient Label

Declarations for Domestic and International Markets

Attachment E- FDA OCAC Fact Sheet for Cosmetic Manufacturers, Packers,

and Distributors

2) REFERENCES

Online IOM—

http://www.fda.gov/ICECI/Inspections/IOM/default.htm

DFI Inspection Guide--

http://www.fda.gov/ICECI/Inspections/InspectionGuides/default.htm

Compliance Policy Guide--

http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManu

al/ucm119194.htm

Regulatory Procedures Manual--

http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/d

efault.htm

3) CONTACTS

Compliance Program Inquiries:

Shannon Ingram, CFSAN/Office of Compliance/Division of Field

Programs/Program Assignment Monitoring Branch (HFS-615),(240) 402-4885.

Regulatory Action Inquiries (both domestic and import):

Beth Tirio, CFSAN/Office of Compliance/Division of Enforcement/Dietary

Supplement and Labeling Assessment Branch (HFS – 608), (240)402-0942

(or)

Carrie Lawlor, CFSAN/Office of Compliance/Division of Enforcement/

Dietary Supplement and Labeling Assessment Branch (HFS-608), (240)-402-

0315.

Complaints/Consumers Question:

Kapal Dewan, Office of Cosmetics and Colors (OCAC) (HFS-125), (240)402-

2908 (or)

Wendy Good, Office of Cosmetics and Colors (OCAC) (HFS-125), (240) 402-

1146.

Inspectional procedures Inquiries:

Lourdes Andujar, ORA/HAF-W/DDHAFO/DHAFOB, (787) 238-0114.

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Import Inquiries:

Matthew Brown, ORA/Division of Import Operations (HFC-172), at (301)

796-6690 (x 3885).

4) ANALYTICAL CONTACTS:

BAM Chapter 23 Inquiries:

Jo Huang, Ph.D., Microbiologist, CFSAN/OCAC at (240)402-1344.

John Misock, Pharmacology, CFSAN/OCAC at 240-402-1423.

ORS Compliance Program Contact:

Terri McConnell, ORA/ORS at (404)253-1217.

Chemical Analyses Inquiries:

Mohammed Islam, ORA/ORS at (240)402-0552.

Microbiological Analyses Inquiries:

Toni Morales, ORA/ORS at (301)796-3589.

Color Additive Methodology Inquiries:

Julie Barrows, Ph.D. CFSAN/OCAC/Color Technology Team (HFS-106) at

(240)402-1119.

Mold Species Identification Inquiries:

Dr. Donna Williams-Hill, Pacific Regional Laboratory – Southwest at

(949)608-3496

Valerie Tournas, CFSAN/ORS/DM/MMSB at (240)402-1963.

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PART VII - CENTER RESPONSIBILITY

Program Evaluation

During the course of this program, the Office of Cosmetics and Colors will

monitor and evaluate the progress and results of the field operations

conducted under this program.

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INDEX

Adverse events and trade complaints – III

Analytical work – IV

Background - I

Bacteriological Analytical Manual (e-BAM) – IV

BAM (microbiology) inquiries – VI

BSE – III

Cautionary statements and product directions, violations – V

Chemical analyses inquiries – VI

Child resistant packaging – V

Color additive inquiries and analytical - VI

Color additives, about, check certification lot numbers – III

Compliance program inquiries – VI

Consumer adverse events and trade complaints - III

Contact CFSAN – V, VI

Cosmetics making drug claims - III

Domestic and import Inspections - III

Drug claim determination, Inter-Center agreement CFSAN/CDER – III, V

Field reporting requirements - page 1

Import inquiries – VI

Imports field exam – III

Inspectional procedures inquiries – VI

Inspections, general guidelines – III

Labeling, mandatory requirements - III

Labeling examples for ingredients – Attachment D

Microbiological analytical – IV

Planning cosmetics work – II

Product preservation - iii

Prohibited/restricted Ingredients – III, V

References, various topics – VI

Regulatory action inquiries – VI

Bovine Tissues and ingredients – Attachment B

Sample collection, Domestic – III

Sample collection, Imports – III

Seizure authority – V

Seizure with Center review – V

Selecting firms for inspection - II

Special field instructions (General, Domestic, Imports) - page 2

Sun-tanning products (not sunscreens) – V

Tattoo ink - III

Toxicity determination – IV

Violative products charges – V

Voluntary Cosmetic Registration Program (VCRP) – III

Warning statements – III, V

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BOVINE TISSUE AND TISSUE

-DERIVED INGREDIENTS

MATERIALS WITH SUSPECTED RISK OF INFECTIVITY

Adrenal gland Rowamyelin

Basal ganglia/basal ganglion Sciatic nerve

Bone marrow Sphingosine phosphatide

Brain Sphinogomyelin

Brain extract Sphingolipid

Ceramide B-lactoside Spinal cord

Ceramide dihexoside Spleen

Cerebellum Suprarenal gland

Cerebroside (sulfate) Tetraglycosylceramide

Cerebrospinal fluid Thymus gland (sweet-bread)

Cranial nerves Tonsil

Collagen (soluble) Triglycosylceramide

Colon (proximal and distal) Trinitrophenylaminolauroylglucocerebroside

Disialoganglioside Trinitrophenylaminolauroylgalactocerebroside

Dura mater Trisialoganglioside

Elastin (source: oxen neck ligaments)

Eye

Galactocerebroside

Galactosylcerebroside (sulfate ester)

Ganglioside

Glucosylcerebroside

Glycerophospholipid

Glycosaminoglycan

Glycosphingolipid

Glycosylceramide

Hypothalamus

Ileum

Intercellular Lipids (ICL's)

Lactocerebroside

Lactosylceramide

Liposomes

Liver

Lung

Lymph nodes

Monoglycosylceramide (cerebroside)

Monosialoganglioside

N-Nervonoyl cerebroside

N-Oleoyl cerebroside

N-Palmitoyl cerebroside

Nasal mucosa

Olfactory bulb or gland

Pancreas (including pancreatin)

Phospholipids

Pineal gland

Pituitary gland

Placenta

NOTE: If any bovine tissues or tissue derived ingredients are offered for

import or being used as an ingredient in cosmetics, if the ingredient

is from a BSE affected or at-risk country, refer to Part III of this

program for additional instructions.

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Preservation Systems for Cosmetics

Preservative Compounds Commonly Used in Cosmetics:

Parabens (methyl, ethyl, propyl, and butyl)

Quaternium 15 (aka “Dowicil”)

Diazolidinyl urea

Imidazolidinyl urea

DMDM Hydantoin

2-bromo-2-nitropropane-1,3-diol (aka “Bronopol”)

Sodium hydroxyglycinate

Phenoxyethanol

Sorbic acid / Potassium sorbate

Methylisothiazolinone (aka “MI”)

Methylchloroisothiazoline (aka “CMI” often in combination with MI as

Kathon CG)

Sodium benzoate

Caprylyl glycol

Sodium dehydroacetate

Formaldehyde

Non-traditional Preservatives (examples):

Non-traditional preservatives are typically extracts of botanicals, organic

acids, alcohols and glycerols. Fermentation products are also used as

preservatives. The presence of these types of chemicals in a cosmetic, in the

absence of traditional chemicals, indicates they may be used a part of a

preservative system. This list is a small sample.

Glyceryl caprylate

Levulinic acid

p-anisic acid

Eucalyptus globulus

Glycyrrhiza Glabra (Licorice) Root Extract

Salvia officinalis

Citrus grandis (organic grapefruit) extract

Arnica montana (organic arnica) extract

Boraxitrus seed extracts

Leuconostoc/Radish Root Ferment Filtrate

Goldseal (Hydrastis canadensis root extract)

Citrus Medica Limonum (Lemon) Peel Extract

Caprylhydroxamic acid

Other Important Factors in Evaluating a Preservation System:

1. Appropriate packaging - Is product packaging and closure consistent with

the preservative system of the product? For example, a product dispensed with

a pump, a container with a flip cap, or a single use container would require

a much less vigorous preservative system than a product in a wide mouth jar

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or mascara that the consumer can contaminate with every use.

2. Water activity - Products such as powders with little or no water do not

require as strong a preservative system as aqueous emulsions.

3. pH control - Microorganisms grow best between pH 6.5 to 7.5. Products

with pH in this range require more microbial control than products outside

this range.

Often described as “self-preserving”:

Ethanol – when present at >15%

Butylene glycol – when present at >10%

Propylene glycol – when present at >20%

Other Substances Used as Preservatives in Cosmetics:

MDM Hydantoin

Sodium hydroxymethylglycinate

Benzisothiazolinone

Benzyl Alcohol

Dehydroacetic acid

Benzoic acid

Salicylic Acid

Iodopropynyl Butylcarbamate

Chloroxylenol

Methyldibromo Glutaronitrile

Chlorphenesin

Triclosan

Benzalkonium Chloride

Chlorhexidine

Polyaminopropyl Biguanide

5-Bromo-5-Nitro-1,3-Dioxane (Bronidox)

Hexamidine Diisethionate

Pentylene Glycol

1,2-Hexanediol

1,2-Octanediol

Ethylhexylglycerin

Triclocarban

Glyceryl Caprylate

o-Cymen-5-ol

Chlorphenesin

Glyceryl Monolaurate

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Examples of Hypothetical Cosmetic Ingredient Label Declarations For

Domestic and International Markets

Examples of hypothetical cosmetic ingredient label declarations are provided,

as they might appear under current regulations PCP on international

harmonization of ingredient nomenclature.

a) Cocoa Butter and Coconut Oil Lotion for Extra Dry Skin

Caveat: It has been proposed (and we currently allow) that FDA listed color

additives be permitted to be declared in cosmetic ingredient labels by

abbreviated names (c.f., 61 FR 8372 @ 8417, March 4, 1996)

Current Cosmetic Ingredient Label Declaration:

INGREDIENTS: Water, Cocoa Butter, Coconut Oil, Glyceryl Stearate, Mineral

Oil, Propylene Glycol, Glycerin, Petrolatum, Cetyl Alcohol, PEG-8 Stearate,

Tocopheryl Acetate, Methylparaben, Propylparaben, FD&C Yellow No. 5, D&C

Orange No. 4.

Proposed Interim Harmonization Cosmetic Ingredient Label Declaration:

INGREDIENTS: Water (Aqua), Cocoa (Theobroma cacao) Butter, Coconut (Cocos

nucifera) Oil, Glyceryl Stearate, Mineral Oil (Paraffinum liquidum),

Propylene Glycol, Glycerin, Petrolatum, Cetyl Alcohol, PEG-8 Stearate,

Tocopheryl Acetate, Stapyrium Chloride, Methylparaben, Propylparaben, Yellow

5 (CI 19140), Orange 4 (CI 15510).

b) Moisturizing Herbal Shampoo

Caveat: Certain botanical (plant) ingredients may have Linne System (Latin

genus/species) names that have no English language ‘common or usual name’

equivalents (e.g., “Sambucus nigra Extract”). Semi-synthetic derivatives of

botanical (plant) ingredients are not subject to the Interim Harmonization

Proposals (e.g., “PEG-40 Hydrogenated Castor Oil”).

Current Cosmetic Ingredient Label Declaration:

INGREDIENTS: Water, Sodium Laureth-7 Sulfate, Lauramide DEA, Cocamidopropyl

Betaine, Disodium Laureth Sulfosuccinate, Fragrance, Panthenol, Quaternium-

75, Sambucus Nigra Extract, Yarrow Extract, Comfrey Extract, Boysenberry

Extract, Sweet Grass Extract, Sweet Cherry Pit Oil, Butylene Glycol, PEG-40

Hydrogenated Castor Oil, Benzophenone-4, Disodium EDTA, Citric Acid, Sodium

Chloride, Methylchloroisothiazolinone, Methylisothiazolinone, Ext. D&C Violet

No. 2.

Proposed Interim Harmonization Cosmetic Ingredient Label Declaration:

INGREDIENTS: Water (Aqua), Sodium Laureth-7 Sulfate, Lauramide DEA,

Cocamidopropyl Betaine, Disodium Laureth Sulfosuccinate, Fragrance (Parfum),

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FORM 2438 g (10/91)

Panthenol, Quaternium-75, Sambucus Nigra Extract, Yarrow (Achillea

millefolium) Extract, Comfrey (Symphytum officinale) Extract, Boysenberry

(Rubus deliciosus) Extract, Sweet Grass (Hierochloe odorata) Extract, Sweet

Cherry (Prunus avium) Pit Oil, Butylene Glycol, PEG-40 Hydrogenated Castor

Oil, Benzophenone-4, Disodium EDTA, Citric Acid, Sodium Chloride,

Methylchloroisothiazolinone, Methylisothiazolinone, Ext. Violet 2 (CI

60730).

Abbreviated names for color additives (e.g., Ext. D&C Violet No. 2 can be

stated as Violet 2, and the lake of FD&C Yellow No. 5 can be stated as Yellow

5 Lake) specified in the 1996 Federal Register proposed rule Permanent

Listing of Color Additive Lakes (March 4, 1996, 61 FR 8372, at page 8417).

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Food and Drug Administration, Office of Cosmetic and Colors

FACT SHEET FOR COSMETIC MANUFACTURERS, PACKERS AND DISTRIBUTORS

his fact sheet provides answers to some frequently asked questions and lists some useful Web

resources.

For more information, please visit FDA’s homepage at www.fda.gov. You can access Cosmetics from the

list in the upper right-hand corner, or go directly to the Cosmetics home page

(http://www.fda.gov/Cosmetics/default.htm). You can access Color Additives resources by going to the A-

Z Subject Index, selecting “C,” and scrolling down to Color Additives, or going directly to the Color

Additives page (http://www.fda.gov/ForIndustry/ColorAdditives/default.htm).

Are cosmetics regulated by FDA?

Yes. For information on FDA’s regulation of cosmetics, see

“FDA Authority Over Cosmetics”

http://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074162.htm

“Inspection of Cosmetics”

http://www.fda.gov/Cosmetics/ComplianceEnforcement/ComplianceResources/ucm136455.htm

When is a cosmetic considered a drug?

Some products perceived by consumers to be cosmetics may also be drugs if, in addition to their

cosmetic function, they are intended to cure, mitigate, treat or prevent disease, or to affect the structure or

any function of the human body (see the definition of a “drug” in section 201(g)of the FD&C Act). Some

products can be both a drug and cosmetic, in which case, the product must comply with both the drug

and cosmetic regulations. Typical examples of drug/cosmetic claims are: antiperspirant/deodorant

products; sunscreen/suntan products; fluoridated toothpaste/toothpastes; antidandruff

shampoos/cleansing beautifying shampoos; an SPF claim on a moisturizer or other cosmetics.

For more information, see “Is It a Cosmetic, a Drug, or Both? (or Is It Soap?)”

http://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm

For information regarding drug registration and listing, see “Drug Registration and Listing System:

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/default.

htm.

Where can I find information related to cosmetics?

See FDA’s Cosmetics home page: http://www.fda.gov/Cosmetics/default.htm

For a quick-reference list of resources often requested by industry, see Cosmetic Manufacturers,

Packagers, and Distributors: http://www.fda.gov/Cosmetics/ResourcesForYou/Industry/default.htm

Where can I find safety and regulatory information on Bovine Spongiform Encephalopathy (BSE)?

Resources are listed under Bovine Spongiform Encephalopathy (BSE):

http://www.fda.gov/cosmetics/productsingredients/potentialcontaminants/ucm136786.htm

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Where can I find guidance documents?

See the resources listed at

http://www.fda.gov/Cosmetics/GuidanceRegulation/default.htm

Where can I find information related to color additives used in cosmetics?

Information on FDA’s regulation of color additives for use in all FDA-products is listed at “Color Additives”:

http://www.fda.gov/ForIndustry/ColorAdditives/default.htm.

For information specifically on color additives for use in cosmetics, see “Color Additives in Cosmetics”

http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditivesinSpecificProducts/InCosmetics/default.htm.

For a quick-reference list with links to the regulations, see “Color Additives Permitted for Use in

Cosmetics” http://www.fda.gov/Cosmetics/Labeling/IngredientNames/ucm109084.htm.

What is the Voluntary Cosmetic Regulation (VCRP) Database?

The Voluntary Cosmetic Registration Program (VCRP) is an FDA post-market reporting system for use by

manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the

United States. There are two parts to the VCRP, one for registering establishments and another for filing

formulations. You may participate in both parts of the program or only one part. No fees are required to

participate in this voluntary program.

The VCRP does not apply to cosmetic products for professional use only, such as products used in

beauty salons, spas, or skin care clinics. It also does not apply to hotel samples or free gifts or cosmetic

products you make in your home to sell to your friends.

To learn more and participate in the VCRP, see “Voluntary Cosmetic Registration Program (VCRP)”

http://www.fda.gov/Cosmetics/RegistrationProgram/default.htm

Where can I find information on importing and exporting cosmetics?

Importing:

For an overview, see “Cosmetic Imports”

http://www.fda.gov/Cosmetics/InternationalActivities/Importers/default.htm

Additional resources listed at this page include “Federal Agencies Issue Draft Guidance for Industry Good

Importer Practices” http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm109063.htm

and Import Surveillance http://www.fda.gov/Cosmetics/InternationalActivities/Importers/ucm2005216.htm

, for links to Import Alerts and recent Import Refusals related to cosmetics.

Exporting:

For answers to regulatory questions and information about export certificates, see “Cosmetic Exports”

http://www.fda.gov/Cosmetics/InternationalActivities/Exporters/default.htm

Does FDA offer assistance to small businesses?

Yes. For information, visit “Small Business Assistance”

http://www.fda.gov/ForIndustry/SmallBusinessAssistance/default.htm