EDUCATION: Does the FDA consider Aromatherapy and Essential Oils to be a Cosmetic or a Drug?

Whether an aromatherapy product is a cosmetic or a drug under the law is determined by the product’s intended use. The Federal Food, Drug and Cosmetic Act defines “cosmetics” by their intended use, 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.” Florida Statute §499.003(12) adopted the FDA’s definition of “cosmetic” verbatim, but further stated that the definition does not include soap. The law doesn’t require cosmetics to have FDA approval before they go on the market. But FDA can take action against a cosmetic on the market if they have reliable information showing that it is unsafe when consumers use it according to directions on the label, or in the customary or expected way, or if it is not labeled properly. The FDA Act defines “drugs”, in part, by their intended use, 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. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or help you sleep are drug claims. Intended use may be established by claims stated on the product labeling, what consumers expect it to do, in advertising on the internet, or in other promotional materials. Ultimately, the FDA makes decisions on a case-by-case basis. Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic. It may also be established that a product is a drug based upon the ingredients that have a well-known therapeutic use. Essential oil fragrances 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. Under Florida Statute §499.005(5) it is a crime to disseminate false or misleading advertisement of a drug, device or cosmetic, which is punishable as a misdemeanor of the second degree. It is also a violation of the Florida Drug and Cosmetic Act to disseminate any false advertisement of any drug, device or cosmetic, which includes misleading advertisements according to Florida Statute §499.0054(1)(a). These advertisements include those on a website or social media account. Keep in mind that a cosmetic product must be labeled according to cosmetic labeling regulations. Web: www.JonesHealthLaw.com Phone: (305)877-5054 Instagram: @JonesHealthLaw Facebook: @JonesHealthLaw Youtube: #JonesHealthLaw