FDA regulates products under the authority of both the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). These laws and their related regulations are intended to protect consumers from health hazards and deceptive practices, and to help consumers make informed decisions regarding products purchases.
It is illegal to introduce a misbranded product into interstate commerce, when:
- labeling is false or misleading.
- label fails to provide required information.
- required label information is not properly displayed.
If an article or substance, such as Cannabidiol (CBD), is an active ingredient in a drug product that has been approved, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement.
There is an exception, if the substance was “marketed as” a dietary supplement or as a conventional food, before the new drug investigations were authorized.
We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not representing your products as safe and/or effective for a COVID-19-related use for which they have not been licensed, approved, cleared, or authorized by the FDA, and that you do not make claims that adulterate or misbrand the products.
Furthermore, it is unlawful under the Federal Trade Commission Act (FTC Act), to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true when they are made.
Otherwise, your domestic or foreign firm will be added to a published list on FDA’s website, of companies that have received Warning Letters concerning the sale or distribution of COVID-19 related products, in violation of the FD&C Act.
Cosmetic labeling must be truthful and not misleading.
Products intended to affect the structure or function of the body, or for a therapeutic purpose, such as treating or preventing disease, are regulated as drugs. They include:
- Antidandruff shampoo.
- Toothpaste containing fluoride.
- Deodorant that is also antiperspirant.
- Moisturizer and makeup marketed with sun-protection claims.