The FD&C Act 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." Over-the-counter (OTC) drugs are drugs that can be purchased without a doctor's prescription.
What is cosmetic?
How U.S. Law Defines Cosmetics
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.
Even though we are a business in the cosmetics and beauty industry that uses natural and naturally - derived ingredients, we can’t say (or have the intended use) that our products heal, cure treat or affect the structure of the body. In doing so we would be making an unapproved drug claim which is a violation of the law.
Intended use may be established in a number of ways. The following are some examples:
Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials. Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic. Such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human 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. But 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, massage oil that is simply intended to lubricate the skin and impart fragrance is a cosmetic, but if the product is intended for 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; 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.***
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