Are Cosmetics Regulated By The FDA?

Are Cosmetics Regulated By The FDA?

“Do they or don’t they regulate makeup and skincare products? Inquiring minds want to know!” This is a question that I am routinely asked by my fellow beauty enthusiasts who are confused by news reports and bloggers - all who mean well. 

Since 1938, the FDA has regulated the safety and effectiveness of cosmetic products through the Federal Food, Drug, and Cosmetic Act (FDA). Several bills have been introduced in Congress, yet cosmetics reform remains stagnate.  As early as 2010, The Personal Care Products Council (the lobbying association for the cosmetics industry) and the FDA entered into talks to draft legislation that would update the current law giving the FDA increased oversight of cosmetics, but the talks collapsed, and those once-promising private discussions have given way to public pronouncements of disillusionment, frustration and distrust. The most recent bill, H.R.575 the Cosmetic Modernization Amendments of 2017 was introduced into Congress on January 13th, by Congressman Pete Session of Texas. 

What’s the Reality?
Despite the cosmetics industry having experienced significant change with the inclusion of more complex ingredients, the FDA’s authority to regulate cosmetics has not changed since 1938. Thus, cosmetic companies are individually responsible for substantiating the safety of their products before they go to market.

What Is Considered A Cosmetic?
The  term “cosmetic” is broadly defined 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 appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap”…“Common examples of cosmetics include makeup, face and body lotions, nail polishes, shampoos and conditioners, some toothpastes, mouthwashes, deodorants, perfumes, and baby powders.” (FDA)

What If A Product Is Both A Cosmetic & A Drug?
According to the FDA, drugs are products intended to help treat or prevent disease or to change the way the body works. If a product has been classified as both a cosmetic and a drug, it must pass the FDA’s pre-market approval process.

Who Ensures Cosmetic Safety?
The current regulatory framework allows for industry-initiated reviews as well as voluntary reporting.  Cosmetics manufacturers are responsible for ensuring that their products are “adequately substantiated” before they go to market through an independent, industry-funded, ingredient safety assessment conducted by the Cosmetic Ingredient Review (CIR) who publishes the results in peer-reviewed scientific literature.

Voluntary Registration, Does It Work?
FDA operates a voluntary registration program, the Voluntary Cosmetic Registration Program (“VCRP”).  The program is designed for manufactures to voluntarily register their products and ingredients. However, only about a third of cosmetics companies participate in VCRP at any given time, which is still a bit misleading since new brands come and go while industry leaders mostly do provide information to the registration program. 

Is There An Advanced Approval Process?
The current law does not require cosmetics products to go through an advance approval by the FDA before going to market, unless a product is both a cosmetic and a drug.

What Action Can The FDA Take?
The current law only allows the FDA to take action working with other governmental agencies to remove cosmetic products deemed to have been “adulterated” or “misbranded” from the marketplace. Also, the FDA does not have a system to capture adverse effects of cosmetics.

The States Can Fill In Federal Law
Some states have acted to supplement the limited role of the FDA by passing their own more restrictive legislation. For example, California enacted the California Safe Cosmetics Act of 2005 (CSCA), requiring manufacturers to inform state regulators about cosmetics that “contain any ingredient that is a chemical identified as causing cancer or reproductive toxicity,” including chemicals used for fragrance or flavoring, regardless of the concentration of the chemical.

So, Do They Or Don’t They Regulate Cosmetics
The simple answer is yes. Yes, the FDA does regulate cosmetics. However, on certain situations the FDA does not have a law outlining requirements. 

What do you think about cosmetics and the FDA? Do you think cosmetics are well regulated? Share your thoughts. 


  • Congress.GOV
  • FDA, Cosmetics Authority 
  • Image: Flickr Unknown