Cosmetic Labeling Claims, and the ways in which they are monitored by the FDA and the US Cosmetic Laws

It is not mandatory for cosmetic manufacturers to have FDA approval for cosmetic labeling before their products go on the market. This makes it easier for them to release their products with the respective claims, especially because FDA too does not have any official list of accepted or approved claims for cosmetic products. However, there are some limits that apply to the claims made in cosmetic labeling.

The law states that, all kind of information that appears along with the cosmetic labeling, including product-related claims, has to be true and genuine, and never misleading to the users. Moreover, if a cosmetic product appears with claims for treatment or prevention of a disease, or affects any kind of bodily function or structure, including skin, then the product would be treated as drug, as per the definition of the FDA’s law, and hence, the product in question needs to meet the requirements for drugs, even if the appearance of the product is affected.

Since the USFDA has not been empowered with the authority of approving claims before the cosmetic products hit the market, it is not uncommon to find products in which one might find claims going beyond what the cosmetic law permits.

However, the United States Food and Drug Administration authority monitors and controls the standards of all kinds of cosmetics available in the market, and one can take actions against manufacturers that have been found breaking the laws. FDA has been issuing warning letters to cosmetic companies from time to time that have been found making unapproved drug claims for such products that have been marketed as cosmetics.

In this context, it is also important to know that while the Food and Drug Administration is responsible for regulating claims related to cosmetic labeling, the Federal Trade Commission has been entitled with the authority to regulate claims related to advertising of such products.

No matter how much claims the cosmetic companies make, or whether the claims sound to be promising too much, the general awareness of the consumers is important before they move on to buy any kind of cosmetics being influenced by such claims. In general, the consumers need to keep a few basic points in mind which would help them differentiate between products by themselves:

  • Such products that are intended to either cleanse or beautify any part of the body are usually regulated as ‘cosmetics’.
  • Those products that intend to prevent or treat any kind of ailment or disease, or affect the general bodily functions or the body’s structure in any form, are considered as ‘drugs’.
  • Some of the products, however, can be both cosmetics and drugs at the same time. Products like antiperspirant-deodorants, sunguard moisturizers or makeups with SPF (sun protection factor), anti-dandruff shampoos, etc., are a few such examples. Either way, these products must meet the requirements as mentioned in the regulated standards of the FDA for both cosmetics and drugs.


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