DATE OF ISSUANCE: 1/2016 PAGE 1

FORM FDA 2438 (7/92)

FOOD AND DRUG ADMINISTRATION

COMPLIANCE PROGRAM GUIDANCE MANUAL PROGRAM 7329.001 

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 emergency.operations@fda.hhs.gov 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 noalcohol 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 the 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 bovinederived 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 Jeffrey.Hamer@fda.hhs.gov). 

 
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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 coaltar 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 “syntheticorganic 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 

120oF. 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 section 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 section 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., 
COSMETICS PROGRAM 7329.001

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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

(Wendy.Good@FDA.HHS.GOV)at 240-402-1146, Office of Cosmetics and Colors 

(OCAC), Cosmetics Staff (HFS-125). Many types of cosmetic products are 
COSMETICS PROGRAM 7329.001

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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 (1⁄2 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.
COSMETICS PROGRAM 7329.001

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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. 
COSMETICS PROGRAM 7329.001

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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 

valerie.tournas@fda.hhs.gov 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 gregory.noonan@fda.hhs.gov 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 

Julie.Barrows@FDA.HHS.GOV (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 

Nakissa.Sadrieh@fda.hhs.gov 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 Beth.Tirio@fda.hhs.gov 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 37oC 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 25oC, 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). 
COSMETICS PROGRAM 7329.001

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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
COSMETICS PROGRAM 7329.001

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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) 
COSMETICS PROGRAM 7329.001

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FORM 2438 g (10/91)

• 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 
COSMETICS PROGRAM 7329.001

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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): 
COSMETICS PROGRAM 7329.001

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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 
COSMETICS PROGRAM 7329.001

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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 
COSMETICS PROGRAM 7329.001

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FORM 2438 g (10/91)

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. 
COSMETICS PROGRAM 7329.001

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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. 
COSMETICS PROGRAM 7329.001

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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 

or

Valerie Tournas, CFSAN/ORS/DM/MMSB at (240)402-1963. 
COSMETICS PROGRAM 7329.001

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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.
COSMETICS

PROGRAM 7329.001 ATTACHMENT A

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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
COSMETICS

PROGRAM 7329.001 ATTACHMENT B

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FORM FDA 2438b (2/95)

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.
COSMETICS 

PROGRAM 7329.001 ATTACHMENT C

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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 
COSMETICS 

PROGRAM 7329.001 ATTACHMENT C

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FORM 2438 g (10/91)

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
COSMETICS 

PROGRAM 7329.001 ATTACHMENT D

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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, Quaternium75, 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),
COSMETICS 

PROGRAM 7329.001 ATTACHMENT D

TRANSMITTAL NO: 2016-CPGM-CFSAN-001 PAGE

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). 
COSMETICS 

PROGRAM 7329.001 ATTACHMENT E

TRANSMITTAL NO: 2016-CPGM-CFSAN-001 PAGE 1

FORM FDA 2438b (2/95)

Food and Drug Administration, Office of Cosmetic and Colors

FACT SHEET FOR COSMETIC MANUFACTURERS, PACKERS AND DISTRIBUTORS

This 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 AZ 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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FORM FDA 2438b (2/95)

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