Fact or Fiction: On the Topic of FDA Approved Brands
Fiction: Brand XYZ is FDA approved.
Fact: The FDA regulates cosmetics and has authority over the industry, but the FDA does not approve any cosmetics or aromatherapy product or brand.
According to the FDA, “FDA’s legal authority over cosmetics is different from our authority over other products we regulate, such as drugs, biologics, and medical devices. Under the law, cosmetic products and ingredients do not need FDA premarket approval, with the exception of color additives. However, FDA can pursue enforcement action against products on the market that are not in compliance with the law, or against firms or individuals who violate the law.”
You may argue that essential oils are not cosmetics. Then what are they? Drugs? Many make medical claims, however those claims are in direct violation of the Food, Drug and Cosmetic Act.
According the the FDA, “The FD&C 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” (FD&C Act, sec. 201(i)). Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product. It does not include soap. (To learn what products are considered “soap” for regulatory purposes, see “Soap.”
But, if the product is intended for a therapeutic use, such as treating or preventing disease, or to affect the structure or function of the body, it’s a drug (FD&C Act, 201(g)), or in some cases a medical device (FD&C Act, 201(h)), even if it affects the appearance. Other “personal care products” may be regulated as dietary supplements or as consumer products. To learn more, see “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)” and “Cosmetics Q&A: Personal Care Products.”
Are essential oils a cosmetic or a drug?
According to the FDA regarding aromatherapy, “Under the law, how “aromatherapy” products are regulated depends mainly on how they are intended to be used.
FDA determines a product’s intended use based on factors such as claims made in the labeling, on websites, and in advertising, as well as what consumers expect it to do. We also look at how a product is marketed, not just a word or phrase taken out of context. Finally, we make decisions on a case-by-case basis.
If a product is intended for a therapeutic use, such as treating or preventing disease, or to affect the structure or function of the body, it’s a drug. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or help you sleep are drug claims.
Such claims are sometimes made for products such as soaps, lotions, and massage oils containing “essential oils” and marketed as “aromatherapy.” The fact that a fragrance material or other ingredient comes from a plant doesn’t keep it from being regulated as a drug.
Under the law, drugs must meet requirements such as FDA approval for safety and effectiveness before they go on the market. To find out if a product marketed with drug claims is FDA-approved, contact FDA’s Center for Drug Evaluation and Research (CDER), at firstname.lastname@example.org.”
Most essential oils are not listed among the Over-the-counter monographs of current drugs. I handful are listed for specific usages. If a product that conforms to an OTC monograph it may be manufactured and sold without an individual product license. This does not mean that the product is “FDA approved” as some brands like to claim. If a product with a monograph does not conform then it must go through a new drug approval process. You can learn more about how drugs are approved here. You can also check if the company that is making medical claims or suggesting that they are FDA approved is listed in the Orange Book of Approved Drugs. The FDA has cited at least two of the MLM essential oil companies claims for making unsubstantiated medical claims, which in itself disproves the marketing ploy of products being FDA approved.
Sue Sawhill Apito explains, “People think they can just add the essential oil and be in compliance and go ahead and make the allowable OTC Drug Claims, labeling and marketing. They can’t unless the FOLLOW the monograph AND the Drug Good Manufacturing Practices—which are mandatory—not optional like the cosmetic good manufacturing practices! You can’t just make drugs alongside your cosmetics manufacturing unless your cosmetics practices are up the the drug codes!“
Talking about the FDA always brings about some FDA-bashing from people, however one cannot address claims that company XYZ or ABC have made about their product being approved by the FDA approved without an in depth explanation of how the FDA works. Until essential oils have approved final monographs, they fall solidly under the cosmetic definition. Claims can put a company into the drug side of the FDA, which would make them out of compliance. As a cosmetic formulator who has worked on OTC sunscreen products, I would rue the day that essential oils become over-the-counter drugs. The cost, paperwork, and red tape of essential oils becoming an OTC drug would put 99.9% of us out of business.