Cosmetic Entrepreneurs- Are You Actually Making Drugs?

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Cosmetic Entrepreneurs- Are You Actually Making Drugs?

The beauty industry is straddling three groups defined by the FDA: cosmetics, drugs, and soap. Note that a product can be both a cosmetic and a drug.

The Food & Drug Administration (FDA) 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” (FD&C Act, sec. 201(i))

You would correctly guess that lipstick, perfume, hair dye, shampoo, and nail polish are all considered cosmetics.

The FDA defines drugs as, “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals”  (FD&C Act, sec. 201(g)(1)).

Think of soap as an exception to the cosmetics category, and not its own category.  Soaps defined by the FDA are only made fats and an alkali. These soaps are completely outside of FDA regulations, and are governed by the Consumer Product Safety Commission. However, most “soaps” sold today will be considered cosmetics or drugs because of added ingredients, and therefore are required to follow FDA regulations. For example, a perfumed soap is a cosmetic. An anti-acne soap is a drug. A perfumed anti-acne soap is both a cosmetic and a drug.

To apply these definitions, the FDA considers a few factors when deciding if a product is drug or a cosmetic:

1. Marketing– If the marketing of the product includes claims that the product provides a therapy, cures or prevents illnesses, or improves the structure or  function of the body, then it is considered a drug. Ask yourself if you are marketing the product as doing more than merely masking or covering the body for a temporary amount of time to change it aesthetically.

For example, in 2012, Avon received a Warning Letter from the FDA for these marketing claims of their Anew Clinical Advanced Wrinkle Corrector:

  • “The at-home answer to wrinkle-filling injections. Start rebuilding collagen in just 48 hours.”
  • “4D WRINKLE-REVERSE TECHNOLOGY IS DESIGNED TO: Rebuild collagen to help plump out lines and wrinkles.Stimulate elastin to help improve elasticity and resilience. Regenerate hydroproteins to help visibly minimize creasing.”
  • “Formulated to boost shock-absorbing proteins to help strengthen skin’s support layers.”
  • “Improve fine & deep wrinkles up to 50%. Immediately plumps out wrinkles and fine lines. Within 48 hours begins boosting collagen production.”

The FDA believed these marketing claims would require the Wrinkle Corrector to be tested and labeled as a drug.

2. Consumer Perception– For consumer perception, go back to those above definitions. Which one would consumers believe the product is in? Would consumers believe that they are healing or altering their bodies with the product?

3. Ingredients Used– Some ingredients are traditionally used in drugs or cosmetics. If an ingredient in a product has a reputation for healing or preventative care uses, the FDA will be more likely to consider the product a drug because consumers will be more likely to assume that the product will act as a drug.  The FDA website offers fluoride as an example. Another ingredient that may be easily placed into the drug category based on consumer perceptions is Aloe vera.

Why Is It Important To Know The Difference

Knowing if a product would be considered a drug or a cosmetic has huge consequences on a business. These categories dictate how products will be manufactured, tested, labeled, and registered in compliance with FDA regulations. If you would like more guidance on determining if your product is a cosmetic, drug, or both, and guidance on complying with FDA regulations, please email rachel@lawontherunway