The term 'cosmeceutical' describes cosmetic products claiming medicinal benefits, but the FDA does not legally recognize it. Products making drug-like claims must meet stricter FDA regulations for approval, while cosmetics are subject to less stringent rules. The FDA has issued warning letters to companies misrepresenting their products as cosmetics when they function as drugs.

1. What are “Cosmeceuticals”?
By: Madison Wheeler
The term “cosmeceutical” has become popular in recent years to describe a cosmetic product that
claims medicinal benefits. While those in the cosmetic industry use the term to advertise the
ingredients and benefits of their products, the FDA does not legally recognize the term.
According to the FD&C Act, drugs are “articles intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease” [FD&C Act, sec. 201(g)(1)], while a cosmetic is
anything “applied to the human body...for cleansing, beautifying, promoting attractiveness, or
altering the appearance" [FD&C Act, sec. 201(i)]. Once a product has made a claim that it’s
intended use will affect some function of the body, such as restore hair growth or regenerate cells
for anti-aging purposes, then it has crossed the line into what the FDA defines as a drug.
While both drugs and cosmetics are regulated under the FDA, they have different rules and
regulations surrounding them; drugs are regulated by 21 CFR 210 and 211 and cosmetics are
regulated by 21 CFR 700 and 701. One example of a difference in regulations is that drugs must
go through the entire FDA approval process before being released to the market, while cosmetics
do not require approval. Most drugs that are used in cosmetic products are considered over the
counter (OTC), such as sunscreens or treatments for dandruff, which still must follow FDA
requirements and have their own specific set of rules titled OTC monographs1. The approval
process isn’t the only thing that’s different: the good manufacturing practices (GMPs),
registration, and labeling requirements all differ between a drug and a cosmetic.
The FDA has issued warning letters to several firms that advertised drug claims associated with
their products. In many cases, the FDA cites claims directly from the firm’s labeling or
promotional materials which indicates it’s intended use as a drug. Since the FDA does not
recognize the products as safe and effective for their intended use, they are considered “new
drugs” and must go through the relevant approval process before being released to the market.2
For a majority of cosmetic firms, the approval process will follow the OTC monographs unless
the drug they are using is something that would require a prescription.
Have questions about the current drug regulations or need help ensuring you are compliant with
the FDA? Contact us at 248-987-4497 or info@emmainternational.com.
1 FDA (August 2018) Is Ita Cosmetic, a Drug, or Both? (Or Is It Soap?) retrieved on 08/26/2019 from
https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap
2 FDA (June 2019) WarningLetters Address Drug Claims Madefor Products Marketed as Cosmetics retrieved on
08/27/2019 from https://www.fda.gov/cosmetics/warning-letters-related-cosmetics/warning-letters-address-
drug-claims-made-products-marketed-cosmetics

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