Does the FDA consider Aromatherapy and Essential Oils a Cosmetic or a Drug?

Essential Oils Product Descriptions: Am I a Cosmetic of 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.

It’s important to note that the FDA regulates labeling for cosmetics and drugs but advertising claims are regulated by the Federal Trade Commission. No cosmetic such as essential oils may be labeled or advertised with statements suggesting that FDA has approved the product. Under Florida Statute §499.003(2), “advertisement” is defined as any representation disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or which is likely to induce, directly or indirectly, the purchase of drugs, devices, or cosmetics.

In 2014, the FDA sent a warning letter to an essential oils company called Young Living and stated that some of their products that were marketed on their websites and social media accounts were promoted to treat conditions which caused them to be viewed as drugs. These products included “Cinnamon Bark,” “Oregano,” “Rosemary,” “Sandalwood,” “Peppermint,” “Frankincense” and others. The FDA argues that these are “new drugs” because they are not generally recognized as safe and effective for the intended use under the conditions prescribed, recommended or suggested in the labeling in the Young Living case. If you intend to market and describe these products as some type of treatment or disease prevention then you would need to seek FDA approval first. Further if used for those purposes, they would have to be provided under the supervision of a practitioner licensed by law to administer it. If you don’t make any medical claims in your advertisements you likely won’t trigger any action by the FDA or FTC.

Also, in 2014, the FDA sent a warning letter to another essential oils company called DoTerra for marketing its products that they claimed would treat, diagnose, cure, mitigate and prevent medical conditions.

You should avoid using language such as, “It has some crucial medical benefits as well” and “relieving medicine”  in the product details for your products.  Refrain from making claims that these products will  reduce stress-related headaches, reduce or eliminate acne problems, help with sleep, cure food poisoning.

Also, I would suggest that you include a Disclaimer for both product details and any blog posts. You should include in the disclaimer that says something like “The information in this post about essential oils is not intended to diagnose, cure, mitigate, treat or prevent any disease. According to the FDA, only drugs can make those types of claims, which these products on our website are not.”

Typically, any products marketed as “antibacterial,” “antiseptic,” “antiviral,” “anti-inflammatory,” “ant-cancer,” or “antimicrobial” are drugs according to the FDA. If a product is intended to affect the structure or function of the body, or for a therapeutic purpose, such as treating or preventing disease, they’re drugs. Avoid using these words in descriptions or blog posts or else you risk receiving a warning letter from the FDA.

You should avoid making claims like “Essential oils are the natural remedies for curing damaged skin and tightening loose skin” or that “essential oil has tremendous health benefits” . This implies some type of medical benefit and you do not want to make those types of claims. Simply avoid making any medical treatment, diagnosis or preventative claims. This is true even if these are not included in product  descriptions but in blog posts on your website or social media posts. Making research claims that any individual product may treat  ailments or diseases on your blog or social media may also  result in a warning letter issue to you from the FDA. Instead of using words like “treat” you should try using “rejuvenate,” “revitalize” or “reinvigorate” because those aren’t really medical terms.

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It should be noted that I am not your lawyer (unless you have presently retained my services through a retainer agreement). This post is not intended as legal advice, it is purely educational and informational, and no attorney-client relationship shall result after reading it. Please consult your own attorney for legal advice. If you do not have one and would like to retain my legal services, please contact me using the contact information listed above.

 

All information and references made to laws, rules, regulations, and advisory opinions were accurate based on the law as it existed at this time, but laws are constantly evolving. Please contact me to be sure that the law which will govern your business is current. Thank you.