Under section 201(ff)(2)(A)(i) of the Act [21 U.S.C. § 321(ff)](2)(A)(i)], a Dietary Supplement is defined, among other things, as a product intended for ingestion.
Dietary supplements are neither evaluated nor regulated for efficacy or safety under the Dietary Supplement Health and Education Act (DSHEA) of 1994. In addition, FDA approval is not required for dietary supplements to be marketed.
Topical products and other products that are not intended for ingestion are not dietary supplements.
Whether or not they are intended for ingestion, medical claims make a product a drug under section 201(g)(1)(B) of the Act; meaning a dietary supplement with medical claims, is no longer a dietary supplements under section 201(ff) of the Act. Both Young Living and doTerra were warned by the FDA for selling essential Oil products which they marketed as dietary supplements, but which are offered for topical use and/or intended for inhalation.
A *true* dietary supplement will be formulated to provide nutritional benefits missing from the diet – that is why they are called dietary supplements – they supplement the diet. The FDA regulation DSHEA also allows products to be formulated for and marketed with claims that they will impact the structure or function of the body. What is a structure/function claim? This page answers that question:
One thing I have read more than a few times, which is false, is that the FDA Mandatory Disclaimer mean the FDA has approved the product. It ACTUALLY means the opposite!
” If a dietary supplement label includes such a claim, it must state in a “disclaimer” that FDA has not evaluated the claim. The disclaimer must also state that the dietary supplement product is not intended to “diagnose, treat, cure or prevent any disease,” because only a drug can legally make such a claim. “
This is basically a consumer WARNING not a FDA endorsement!
Essential oils sold as “dietary supplements” are doing so in order to take advantage of two *loopholes*: many essential oils are Generally Recognized as Safe as food flavorings, and the laws regulating dietary supplements [DSHEA] allows them to be marketed with the structure or function claims which are not allowed for essential oils sold for topical or inhalation use. They are NOT selling them as “dietary supplements” because they actually supplement the diet in any way. No ones diet is missing essential oils. They do not contain vitamins.
Essential oils are occasionally ingested for medicinal/therapeutic purposes. Oral dosing has risks which often outweigh any potential benefits.