The Regulation of The Regulation of CosmeticsCosmetics

Food LawFood LawFSC-421FSC-421

FDCA DefinitionFDCA Definition

Articles intended to be rubbed, Articles intended to be rubbed, poured, sprinkled, or sprayed on, poured, sprinkled, or sprayed on, introduced into, or otherwise applied introduced into, or otherwise applied to the human body...for cleansing, to the human body...for cleansing, beautifying, promoting attractiveness, beautifying, promoting attractiveness, or altering the appearance." or altering the appearance."

FDCA DefinitionFDCA Definition

Included in this definition are Included in this definition are products such as products such as skin moisturizers, skin moisturizers, perfumes, lipsticks, fingernail perfumes, lipsticks, fingernail polishes, eye and facial makeup polishes, eye and facial makeup preparations, shampoos, permanent preparations, shampoos, permanent waves, hair colors, toothpastes, and waves, hair colors, toothpastes, and deodorantsdeodorants, as well as any material , as well as any material intended for use as a component of a intended for use as a component of a cosmetic productcosmetic product

Cosmetic RegulationCosmetic Regulation

FDA is only able to regulate FDA is only able to regulate cosmetics after products are cosmetics after products are released to the marketplace released to the marketplace

No cosmetic products or cosmetic No cosmetic products or cosmetic ingredients are reviewed or ingredients are reviewed or approved by FDA before they are approved by FDA before they are sold to the publicsold to the public

Animal TestingAnimal Testing Law does not specifically mandate Law does not specifically mandate

animal testing for cosmetic safetyanimal testing for cosmetic safety FDA strongly urges cosmetic FDA strongly urges cosmetic

manufacturers to conduct whatever manufacturers to conduct whatever tests are appropriate to establish that tests are appropriate to establish that their cosmetics are safetheir cosmetics are safe

FDA believes that the use of animals FDA believes that the use of animals remains necessary to ensure the safety remains necessary to ensure the safety of cosmetic ingredients and products. of cosmetic ingredients and products.

CosmeticsCosmetics

FDA cannot require companies to FDA cannot require companies to do safety testing of their cosmetic do safety testing of their cosmetic products before marketingproducts before marketing

If the safety of a cosmetic product If the safety of a cosmetic product has not been substantiated, the has not been substantiated, the product's label must read:product's label must read:

WARNING: The safety of this WARNING: The safety of this product has not been determined."product has not been determined."

CosmeticsCosmetics

FDA FDA does notdoes not have the authority to have the authority to require manufacturers to register require manufacturers to register their cosmetic establishments, file their cosmetic establishments, file data on ingredients, or report data on ingredients, or report cosmetic-related injuriescosmetic-related injuries

FDA maintains a FDA maintains a voluntaryvoluntary data data collection programcollection program

Companies that wish to participate in Companies that wish to participate in the program forward data to FDA. the program forward data to FDA.

Cosmetic RecallsCosmetic Recalls

FDA FDA is not permittedis not permitted to require to require recalls of cosmetics but does recalls of cosmetics but does monitor companies that conduct a monitor companies that conduct a product recallproduct recall

If FDA wishes to remove a cosmetic If FDA wishes to remove a cosmetic product from the market, it must product from the market, it must first prove in a court of law first prove in a court of law that the that the product may be injurious to users, product may be injurious to users, improperly labeled, or otherwise improperly labeled, or otherwise violates the lawviolates the law

CosmeticsCosmetics FDA collects cosmetic product FDA collects cosmetic product

samples as part of its plant samples as part of its plant inspections, import inspections, and inspections, import inspections, and complaints of adverse reactionscomplaints of adverse reactions

FDA acts through the FDA acts through the Department of Department of JusticeJustice to remove adulterated and to remove adulterated and misbranded cosmetics from the misbranded cosmetics from the marketmarket

Domestic and foreign manufacturers Domestic and foreign manufacturers must follow the same regulationsmust follow the same regulations

Labeling CosmeticsLabeling Cosmetics

Regulations require ingredients to be Regulations require ingredients to be listed on product labels in descending listed on product labels in descending order by quantityorder by quantity

Based on the amount used, an ingredient Based on the amount used, an ingredient such as water is usually found at the such as water is usually found at the beginning of the product's ingredient beginning of the product's ingredient listinglisting

Color additivesColor additives and fragrances, used in and fragrances, used in small amounts, are normally seen at the small amounts, are normally seen at the end of the ingredient listing. end of the ingredient listing.

Labeling CosmeticsLabeling Cosmetics

Cosmetic ingredient declaration Cosmetic ingredient declaration regulations apply only to retail products regulations apply only to retail products intended for intended for home usehome use

Products used exclusively by Products used exclusively by beauticians in beauty salons and beauticians in beauty salons and labeled labeled “For Professional Use Only”“For Professional Use Only”

Cosmetic samplesCosmetic samples are not required to are not required to include the ingredient declaration. Must include the ingredient declaration. Must state the distributor, list the content's state the distributor, list the content's quantity, and include all necessary quantity, and include all necessary warning statements. warning statements.

Labeling CosmeticsLabeling Cosmetics

FDA regulates only the labeling FDA regulates only the labeling that appears on cosmetic products that appears on cosmetic products themselvesthemselves

Unfair and deceptive advertising Unfair and deceptive advertising that appears in magazines, in that appears in magazines, in newspapers, or on television falls newspapers, or on television falls under the authority of the under the authority of the Federal Federal Trade CommissionTrade Commission

““Puffery”Puffery”

Promotion of "gimmick" additives, Promotion of "gimmick" additives, combined with more sophisticated combined with more sophisticated cosmetic ingredientscosmetic ingredients

Lotion contained bovine albumin Lotion contained bovine albumin and the label claimed it would give and the label claimed it would give a "face lift without surgerya "face lift without surgery

Exaggerated claims of beauty or Exaggerated claims of beauty or long-lasting effectslong-lasting effects

““PufferyPuffery”” Product claims should be based on Product claims should be based on

skin care realities, promises banked on skin care realities, promises banked on achievable benefitsachievable benefits

In the past, cosmetic manufacturers In the past, cosmetic manufacturers have depended upon mysterious have depended upon mysterious gimmick additivesgimmick additives, such as turtle oil to , such as turtle oil to promote skin rejuvenation or tighten promote skin rejuvenation or tighten chin muscles, shark oil, queen bee chin muscles, shark oil, queen bee royal jelly, chick embryo extract, horse royal jelly, chick embryo extract, horse blood serum, and pigskin extracts.blood serum, and pigskin extracts.

““PufferyPuffery”” Cosmetic claims, even those Cosmetic claims, even those

considered "puffery," are allowed considered "puffery," are allowed without scientific substantiationwithout scientific substantiation

But if a cosmetic makes a medical But if a cosmetic makes a medical claim, such as removing dandruff, claim, such as removing dandruff, the product is regulated as a the product is regulated as a drugdrug for which scientific studies for which scientific studies demonstrating safety and efficacy demonstrating safety and efficacy must be submitted must be submitted

““Alcohol FreeAlcohol Free”” In cosmetic labeling, the term “In cosmetic labeling, the term “alcoholalcohol”, ”,

used by itself, refers to ethyl alcoholused by itself, refers to ethyl alcohol To prevent the ethyl alcohol in a To prevent the ethyl alcohol in a

cosmetic from being diverted illegally cosmetic from being diverted illegally for use as an alcoholic beverage, it must for use as an alcoholic beverage, it must contain an added "denaturant" that contain an added "denaturant" that makes it undrinkablemakes it undrinkable

Cosmetic manufacturers market Cosmetic manufacturers market cosmetic products that do not contain cosmetic products that do not contain ethyl alcohol as ethyl alcohol as “alcohol free”“alcohol free”

““HypoallergenicHypoallergenic”” Manufacturers claim produce fewer allergic Manufacturers claim produce fewer allergic

reactions than other cosmetic productreactions than other cosmetic product No regulations that govern the use of the No regulations that govern the use of the

term "hypoallergenic”term "hypoallergenic” Term means whatever a particular Term means whatever a particular

company wants it to meancompany wants it to mean Cosmetics labeled as hypoallergenic are Cosmetics labeled as hypoallergenic are

not required to submit substantiation of not required to submit substantiation of their hypoallergenicity claims to FDAtheir hypoallergenicity claims to FDA

CosemeceuticalsCosemeceuticals Products that are cosmetics but are also Products that are cosmetics but are also

intended to treat or prevent disease, or intended to treat or prevent disease, or affect the structure or functions of the affect the structure or functions of the human bodyhuman body

Considered to be drugs and must comply Considered to be drugs and must comply with with bothboth the drug and cosmetic provisions the drug and cosmetic provisions of the lawof the law

Flouride toothpaste, hormone creams, sun Flouride toothpaste, hormone creams, sun tanning preparations, antiperspirants that tanning preparations, antiperspirants that are also deodorants, and antidandruff are also deodorants, and antidandruff shampoos.shampoos.

SummarySummary FDA does not pre-approve cosmetic FDA does not pre-approve cosmetic

products or ingredients, with the products or ingredients, with the important exception of color additivesimportant exception of color additives

Cosmetic firms are responsible for Cosmetic firms are responsible for marketing safe, properly labeled products; marketing safe, properly labeled products; using no prohibited ingredients; and using no prohibited ingredients; and adhering to limits on restricted ingredientsadhering to limits on restricted ingredients

Considered good practice to follow Considered good practice to follow industry safety guidelines and industry safety guidelines and recommendations.recommendations.

SummarySummary

Must carry warning if safety no Must carry warning if safety no determined but can still market determined but can still market productproduct

FDA must “go to court” to remove a FDA must “go to court” to remove a cosmetic from the marketcosmetic from the market

Different labeling requirements for Different labeling requirements for different marketsdifferent markets– Does not include all labelingDoes not include all labeling– FTC regulates ads (unfair and deceptive)FTC regulates ads (unfair and deceptive)

Puffery is OKPuffery is OK