“Do they or don’t they regulate makeup and beauty products? Inquiring minds want to know!” This is a question that I am routinely asked by beauty and grooming start-ups and bigger brands alike who are frustrated with the current law. With this in mind, this week I am going to look at how the Federal U.S. Food and Drug Administration (FDA) regulates cosmetics.

Since 1938, the FDA has regulated the safety and effectiveness of cosmetic products through the Federal Food, Drug, and Cosmetic Act. Several bills have been introduced in Congress, yet cosmetics reform remains stagnate.  In early 2013, The Personal Care Products Council (the lobbying association for the cosmetics industry) and the FDA entered into negations to draft legislation that would update the current law giving the FDA oversight of cosmetics, but the talks collapsed, and those once-promising private discussions have given way to public pronouncements of disillusionment, frustration and distrust.

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 allowing the FDA to ensure products are safe before going to market.

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.

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 to remove cosmetic products deemed to have been “adulterated” or “misbranded” from the marketplace.

The States Fill In Regulatory Gaps

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.

Complying With The Current Law

Earlier this year the FDA updated the agency’s Cosmetics page to assist cosmetics manufacturers, particularly small manufacturers, with understanding and complying with federal regulations. If you are considering or are entering the cosmetic manufacturing market visit the site for more information.

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

1938 is the online magazine blog for Well-Kept Beauty, formally entitled Primer.

3 Comment on “Are Cosmetics Regulated by the FDA?

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