Sep 26 2014

FDA Takes On Essential Snake Oils

The Food and Drug Administration (FDA) is tasked with ensuring quality and transparency in the foods and drugs that are sold to consumers. This is a daunting task, and by all accounts the FDA is commonly understaffed, without the resources to thoroughly do its job. Further, politics often hamstrings the agency, so they don’t have the actual authority to do their job.

The most egregious example is the Dietary Supplement Health and Education Act of 1994 (DSHEA). This law (courtesy of Hatch and Harkin) effectively removed “supplements” out of the control of the FDA, and broadly defined supplements to include herbal drugs and other products that are not actually dietary supplements.

Essentially DSHEA created two categories of consumable health products. Drugs, by definition, are any products for which specific disease claims are being made. If you say your pill or ointment treats diabetes, then it’s a drug, because diabetes is a disease. A supplement, by definition, makes no claims to cure or treat a disease, but is allowed to make “structure function” claims. This is a giant loop hole manufactured by DSHEA and wrapped as a present for the supplement industry, at the expense of consumers.

A “structure function” claim is one in which some biological function is enhanced or helped in some way, but no specific disease is mentioned. So a supplement manufacturer can claim that their supplement “enhances sugar metabolism” as long as they don’t mention “diabetes.” Companies have also discovered that they can pair this structure function claim with a doctor saying they prescribe the supplement to their patients with diabetes. They can also include testimonials of patients saying it helped their diabetes. These implied claims are in the gray zone, but they are rampant on the internet, so either the FDA cannot stop them, or does not have the resources to.

Another requirement for supplement marketing is what we call the “quack miranda warning” – ” This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Despite the extremely lax regulations for supplements, many supplement marketers violate these regulations, either omiting the required disclaimer or venturing from the gray zone into maknig clear disease claims.

Making a disease claim essentially classifies a product as a drug, causing it to fall under FDA regulations for drugs, which require pre-marketing approval from the FDA. A recent example is a letter from the FDA to companies making disease claims for essential (snake) oils, including treating Ebola. They write:

“This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed websites and social media accounts (e.g., Facebook, Twitter, Pinterest, YouTube) used to promote your dōTERRA Essential Oil products in August 2014. Based on our review, FDA has determined that several of your dōTERRA Essential Oil products including, but not limited to, “Melaleuca,” “Oregano,” “On Guard,” “Clove,” “Eucalyptus,” “Frankincense,” “Geranium,” “Lavender,” “Lemongrass,” “Myrrh,” “Peppermint,” “Rosemary,” “Wintergreen,” “Clary Sage,” and “Vetiver” are promoted for conditions that cause them to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The intended use of a product may be determined by, among other things, its labeling, advertising, and the circumstances surrounding its distribution, 21 C.F.R. § 201.128. As described below, the marketing of your dōTERRA Essential Oil products with drug claims and without FDA approved-applications is in violation the Act.”

The website is currently down while the company makes changes to bring them into compliance with the FDA. This, unfortunately, is usually the most the FDA can do – send a strongly worded letter, which at best forces the company to be a bit more clever with the wording of their claims.

Yet the web is still full of websites making outrageous claims about essential oils:

A great example of one natural, God-given, and Bible recommended, antibiotic ideally used to resist the plagues of yesteryear, and today, including biological weapons attacks such as Anthrax and smallpox, is essential oils.

The scientific evidence is not favorable to the claims made for essential oils. Harrient Hall already reviewed this on Science-Based Medicine. The bottom line – evidence is either lacking or negative.

It is interesting, however, that some people will prefer what are essentially drugs being marketed without the backing of scientific evidence for safety and effectiveness but with flowery claims of being “natural’ and vague pseudoscientific claims, vs products with plausible mechanisms and reviewed evidence. It is the triumph of marketing over reailty.

Occasionally they get a slap on the wrist from the FDA, and need to reword their website.


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