Selling Essential Oils in the United States
In 2015, the global essential oil market was valued at over 7.5 billion.1 It’s estimated that the United States is one of the largest consumers of essential oils worldwide, making up approximately 40% of global demand.2 With an increasingly mindful population, more and more consumers are turning to health and wellness products, and are placing a growing value on natural and organic goods.1 Essential oils and aromatherapy products offer a form of Complementary and Alternative Medicine (CAM) that fits within these market trends. As sales are projected to rise in the United States, it’s important to understand how essential oils are classified and regulated to ensure safe products for consumers.
Are Essential Oils Regulated?
In the United States, essential oils are regulated by the U.S. Food and Drug Administration (FDA).3 To date, there is no universal or regulatory definition of essential oils. However, it is widely understood that essential oils are aromatherapy products extracted from plant sources.6
Essential oils are classified and regulated by the FDA depending on their marketed, or intended use. The FDA may determine the intended use through various factors, including how the product is marketed, reviewing label claims and wording used in advertising. Essential oils may also be evaluated on a case by case basis.3
FDA Essential Oil Classification
Under FDA regulation, essential oils may fall into two categories: cosmetics or drugs. It is possible for essential oils to be considered both a cosmetic and a drug.3
If an essential oil is marketed for the sole purpose of aroma, such as a perfume or body spray, it is considered a cosmetic. Additionally, if an essential oil is only intended for cleansing or beautifying, it can be classified as a cosmetic.3
If the intended use has been identified as cosmetic in nature, the product is not required to be approved by the FDA before it can be sold in the United States.
However, essential oils must still comply with the Fair Packaging and Labeling Act (FPLA) and the Federal Food, Drug, And Cosmetic Act (FD&C Act). The FDA holds the right to inspect products, manufacturers and sellers that they believe may be in violation of these laws.4
If an essential oil makes a therapeutic claim, it can no longer be regulated as a cosmetic. In the United States, essential oils are often marketed for aromatherapy. By definition, aromatherapy is the use of plant-based solutions that are intended to benefit users mental or physical well-being through different aromas.5
When a product makes a claim that affects the body, prevents disease or treats a condition, it must be considered a drug under FDA regulation. Even broad claims, such as relieving anxiety, can classify the product as a drug.3 Unlike cosmetics, drugs do need FDA approval before they can be legally sold to consumers.
- Globe Newswire. (2016, February 3). Direct Selling Dominates the Aromatherapy and Essential Oils Market [Press Release]. Retrieved March 30, 2017 from https://globenewswire.com/news-release/2016/02/03/807472/0/en/Direct-Selling-Dominates-the-Aromatherapy-and-Essential-Oils-Market.html – View reference
- Trade and Industrial Policy Strategies & Australian Agency for International Development (n.d.). Trade Information Brief – Essential Oils. Retrieved March 30, 2017 from http://www.sadctrade.org/files/Essentials%20Oils%20TIB.pdf – View reference
- U.S. Food and Drug Administration. (2016, October 5). Aromatherapy. Retrieved March 30, 2017 from https://www.fda.gov/cosmetics/productsingredients/products/ucm127054.htm
- U.S. Food and Drug Administration. (2016, November 15). FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated. Retrieved March 30, 2017 from https://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074162.htm
- Aromatherapy. (n.d.) Gale Encyclopedia of Medicine. (2008). Retrieved March 31 2017 from http://medical-dictionary.thefreedictionary.com/aromatherapy – View reference
- U.S. Food and Drug Administration. (2015, December 29). Fragrances in Cosmetics. Retrieved March 31, 2017 from https://www.fda.gov/Cosmetics/ProductsIngredients/Ingredients/ucm388821.htm