COSMETICS versus drugs

The US Food and Drug Administration (FDA) regulates the food, drugs, cosmetics, medical devices, etc. in the United States; and this is codified in law under Title 21 and the federal Food, Drug, and Cosmetic Act (FD&C Act). Only a small part of this Act addresses cosmetics. For those of us in the cosmetics (skincare) industry; especially when using natural/naturally-derived ingredients, have to be very conscientious of how we describe our products and their intended uses. We cannot make any drug claims with any of our products or ingredients unless the FDA has approved the product or ingredient for use as a drug. We will discuss more below.


WHAT’S A DRUG

The FD&C Act defines a drug as a product that is intended for use in the 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. Additionally, a product containing an ingredient that is known to relieve pain or help with sleeplessness could be construed as a drug depending on how it is presented to the consumer. ALL drugs must be approved by the FDA before it can be marketed in the United States.


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what’s a cosmetic

The FD&C Act 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. Included in this definition are products such as skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.


WHAT WE CAN AND CAN’T SAY

As a business in the cosmetics industry and one that uses natural and naturally-derived ingredients, we can never say (or have the intended use) our products can treat, heal, cure, or affect the structure of the body. To do so is making an unapproved drug claim and this is a clear violation of federal law.

Intended use may be established in a number of ways. Following are some examples: 

  • Claims stated on product labeling, in advertising, on the Internet, or in other promotional materials that the intended use of a cosmetic is to treat or prevent disease or affect the structure or function of the body. Some examples are claims that products will restore hair growth, reduce cellulite, treat varicose veins, increase or decrease the production of melanin (pigment) in the skin, or regenerate cells.

  • Consumer perception, which may be established through the product's reputation. This means asking why the consumer is buying it and what the consumer expects it to do.

  • Ingredients that cause a product to be considered a drug because they have a well-known (to the public and industry) therapeutic use. An example is fluoride in toothpaste.

This principle also holds true for essential oils. For example, a fragrance marketed for promoting attractiveness is a cosmetic. However, a fragrance marketed with certain aromatherapy claims, such as assertions that the scent will help the consumer sleep or quit smoking, meets the definition of a drug because of its intended use. Similarly, a massage oil that is simply intended to lubricate the skin and impart fragrance is a cosmetic, but if the product is intended for a therapeutic use, such as relieving muscle pain, it's a drug.

For these reasons, all the products we make are only intended for cosmetic use and we only describe them according to these uses. The intended uses for our product line include helping the skin appear more attractive, smell better, moisturize, cleanse, soften, and look younger; soothing the skin; helping hair appear fuller; adding definition to skin and hair; adding color to lips/skin; helping relax; and any other cosmetic description. You will never read or hear us describing any of our products as having the ability to heal, treat or cure a disease, prevent or stop a disease or aging, relieve pain, or kill germs. If you have a question about any of our product descriptions or intended uses, please contact us for clarification.