Two warning letters made public last week were issued to Hopewell Essential Oils, in Ross, TX and Santiste Labs LLC in Doylestown, PA.
Multiple delivery modes
While essential oils are generally used as fragrance ingredients, and in aromatherapy where they are diffused via vaporizers, they also have along history of topical use. And some herbal practitioners and essential oil manufacturers advocate for their internal use as well. Hopewell, for example, has an extensive reference on its website for the internal use of various essential oils for respiratory problems, digestive issues, depression and other mood issues and more.
Santiste, non the other had, sells a blend of herbal essential oils infused into a patches for transdermal delivery.
In both cases, the companies were alleged to have made illegal coronavirus treatment claims on the products. Examples cited by the warning letters include:
“Scientists are looking into many approaches to combating a corona virus epidemic. One of the products that offers possible resistance to the novel corona virus is a transdermal patch . . . “Coronavirus. . . The new Coronavirus strain (COVID-19) is a respiratory virus with typical respiratory symptoms such as fever, shortness of breath and difficulty breathing. . . . If we become ill [sic], we follow these tips: . . .”
Added to permanent list of offenders
In both cases the companies were notified that they will be added to a list of companies having received warning letters for making allegedly fraudulent COVID-19 disease treatment claims. If the companies take prompt corrective action (like other such warning letters the companies were given 48 hours to do so) the list will be updated with that information.
“From an FDA regulation point of view, essential oils that are not ingested as dietary supplements are very limited in what they can claim to do. While of course they cannot claim to treat or prevent COVID-19 or any disease, they also cannot claim to affect the structure or function of the body by their scent or otherwise. Doing so causes them to be unapproved new drugs,” said Ivan Wasserman a partner in the law firm Amin Talati Wasserman.
“While FDA did not need to state it in [the Santiste Labs] letter, essentially any product claiming to be delivered transdermally is automatically is a drug. End of story. It is not a dietary supplement, which must be ingested, and it is not cosmetic which is applied topically but is not systemically absorbed,” he added.
To sum up, Wasserman said FDA and FTC are still on high alert for virus disease treatment claims, which still seem to coming thick and fast.
“These warning letters show that the doors are still open at the FDA and the FTC, and they continue to work diligently together during this crisis to ‘sniff out’ illegal products and claims in all product categories,” Wasserman concluded.
