This overview on the FDA website about aromatherapy gave me pause:
“Traditionally, perfumes have been considered cosmetics by FDA. The Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics in part as articles intended to be applied to or introduced into the human body “for cleansing, beautifying, promoting attractiveness, or altering the appearance” (FD&C Act, Section 201).
On the other hand, articles intended for use in the diagnosis, mitigation, treatment, or prevention of disease, and intended to affect the structure or any function of the body, are considered to be drugs — with all “new drugs” requiring FDA’s premarket approval.”
So far the way I’ve seen this interpreted is that it’s wisest not to make any specific claims, or to add a disclaimer stating that the material is not approved by the FDA and the product’s effects are unproven. However, the way this is phrased, legally, someone in the FDA can turn around and test you for pharmaceutical claims at any time - making aromatherapy labeling a risky choice. While I personally do benefit from using some of my own aromatherapy products - such as my sinus clearing oil - to date everything I’ve found on PubMed and in my public library databases suggests that for aromatherapy, we’re all still running on placebo theory. I’m going to have to think long and hard about my aromatherapy labeling, and I may at some point retract it altogether. Best to be within the limits of the law!
I do sell some “aromatherapy” products so I have to think about this carefully - I do not make any guarantees about the effectiveness of my products, but they are skin safe and I’ve tested them for their application in that respect, with the caveat that they are intended for smell and not for massage. Still, if recommending them for any specific condition is against FDA regs, I’d better fix it or pull it.
It also isn’t just the FDA regulating aromatherapy. The Federal Trade Commission oversees advertising claims and the Consumer Product Safety Commission also tests for aspects of use.
