FDA Regulation of Aromatherapy and Essential Oil Products

Aromatherapy and essential oil products are becoming more popular by the day, and marketing these products in compliance with federal regulations must be a key consideration for marketers and distributors of these products. On September 22, 2014 the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Young Living for alleged violations of the Federal Food, Drug & Cosmetic Act (FDCA) in connection with the marketing of their aromatherapy essential oils. According to the FDA, these violations stemmed from the Company’s claims of curing and treating diseases with the usage of Young Living Essential Oil aromatherapy products, causing the products to be deemed unapproved drugs by the FDA. The Warning Letter may be found here.

The FDA issued this warning to Young Living and its distributors for claiming numerous benefits on the labels of aromatherapy essential oil products with ingredients such as cinnamon, eucalyptus blue, ylang ylang and other essential oils. In addition to their labels, Young Living promoted these essential oils online, including the Company’s websites and social media platforms – with claims that the essential oils treat various conditions.

Here, Young Living was targeted by FDA because its aromatherapy and essential oils were incorrectly labeled and marketed. In particular, the Company failed to follow FDA guidance and regulations applicable to cosmetic products, and instead labeled their products for conditions that caused the products to be deemed drugs by the Agency. Thus, it is important for marketers and sellers of aromatherapy and essential oil products to understand and comply with FDA regulations.

As the aromatherapy and essential oil industry has recently seen a rapid increase in popularity, we expect to see more attention to and FDA enforcement in this area. Compliant labeling of products will help to ensure the successful marketing and sale of the aromatherapy and essential oil products. Our Firm offers the comprehensive label and marketing reviews to help our clients ensure that their products are fully compliant with all applicable FDA regulations. If you would like assistance with your products, please contact us at contact@sglawfl.com or (305) 507-9843.