Cosmetic regulations in the United States
While initially appearing more tolerant than the European cosmetic regulation, the American cosmetic regulation is still present and strict. Failure to comply with the requirements can result in the holding of goods in customs or sanctions. This is why cosmetic products should never be launched on the American market without prior knowledge of their specifics.
In the USA, the FDA (Food and Drug Administration) regulates cosmetic products at a national level. The FD&C Act (Food, drug and cosmetics Act) defines cosmetics as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body... for cleansing, beautifying, promoting attractiveness, or altering the appearance". There are, however, some products, considered cosmetics in the European Union (EU), that are considered differently in the United States: they are Over the counter products (OTC), which are a mix between cosmetics and drugs. Another unique feature is that soap is not regulated by the FDA as a cosmetic, but it is regulated by the Consumer Product Safety Commission (CPSC).
Who regulates cosmetics in the USA?
In addition to the FD&C Act, the following legislation also regulates cosmetics:
- The Code of Federal Regulation (CFR), which defines, for example, some labeling requirements or the authorized color additives in cosmetics ;
- The Fair Packaging and Labeling Act (FPLA), regarding labeling and packaging ;
- The Safe Cosmetics Act (2001), which aims at improving the safety of cosmetic products distributed in the USA.
The Personal Care Products Council is the leading national trade association representing cosmetic and personal care products companies in the USA. It is the counterpart of the FEBEA in France or Cosmetics Europe in the EU. Formerly known as the CTFA (Cosmetics, Toiletry and Fragrance Association), it maps out cosmetic ingredients in the International Cosmetic Ingredient Dictionary and Handbook, an INCI database. The online version, the wINCI, is accessible for INCI name lookup on subscription. The initial work on the INCI nomenclature was made by the CTFA.
PCPC link: https://www.personalcarecouncil.org/
wINCI link: https://www.personalcarecouncil.org/science-safety/winci/
Demonstrating safetyIn the EU, the annexes of the Cosmetic regulation (UE) n°1223/2009 specify the substances that are banned from cosmetics (almost 1300) or restricted. Only 10 substances and families of substances are prohibited or restricted in the USA. Does this mean the American cosmetic regulation is weaker? Not so much. The European cosmetic regulation gives very strict guidlines by listing banned and restricted substances, giving a positive list for some (color additives, preservatives, or UV filters), by requiring a Product Information file (mettre le lien PIF EN) containing a Cosmetic product safety report, or Good manufacturing practices (GMP) (mettre le lien article BPF EN). If the American laws do not provide a precise guideline to follow, the end goal is the same: To put a product on the market that is safe to use. If FDA conducts a review, the company must be able to provide proof that the ingredients and finished product are safe. Products that contain a forbidden ingredient or are contaminated due to a bad preservative system will be considered to be adulterated.
However, if the product contains color additives, their authorization by the FDA will need to be checked along with their intended use. Two types exist :
- Color additives derivated from petroleum. They must be certified: the FDA's lab must assess their purity (a sample per batch must be sent) ;
- Color additives from animal, botanical or mineral origin, that don't need to be certified.
It is not mandatory for cosmetic products to be registered in the USA, but voluntary registration is available nonetheless, through the Voluntary Cosmetic Registration Program. The FDA can verify whether the product is compliant before it is launched on the market if it has any doubts, and avoid the product being retained at customs or further sanctions.
Lien VCRP : https://www.fda.gov/cosmetics/voluntary-cosmetic-registration-program
Following the FDA's requirements concerning the product's labeling is also critical to having the product considered misbranded.
Regulated labeling and claimsFD&C Act protects consumers from any false or misleading labeling. The labeling of a cosmetic product in the USA must be compliant with the "Cosmetic Labeling Guide". (mettre lien article étiquetage EN). The latter specifies each mandatory mention, their size, the required language, the list of ingredients, etc., step by step. It provides examples and answers to the most commonly asked questions. In addition to mandatory information, the labeling must include any directions or warnings necessary to ensure safe use. If there is a problem with a cosmetic, the company might be held responsible if the FDA claims that the labeling is not adequate.
When the product is put on the American market as an OTC product, the corresponding rules of labeling must be followed (mettre lien article OTC).
In addition to labeling, the claims concerning the product must be controlled. They are regulated by the FDA and the FTC (Federal Trade Commission) and must honest and fair (non-misleading and non-deceptive). Be careful: all communication about a cosmetic product is considered as a claim, including a website, advertisements, social media, etc. Furthermore, a claim may cause a cosmetic product to be considered an OTC once it conveys a drug-like effect, as defined by the FD&C Act.