Today the FDA (U.S. Food and Drug Administration) sent doTerra and Young Living Inspections, Compliance, Enforcement, and Criminal Investigations Warning Letters. This is huge news. In light of the comment wars that went on in my blog post Warning dōTERRA and Young Living Won’t Tell You it is clear that many misunderstand the law as it applies to essential oils.
In my book The Art, Science and Business of Aromatherapy I addressed the FDA laws regarding claims, labeling, usage and so forth in Chapter 11 titled Cosmetics, Drugs and Soaps . . . Oh My! I am including an excerpt here to explain today’s FDA action.
To explain my stance regarding essential oils being classified as a cosmetic rather than medicine I have included an excerpt from Chapter 10, Do Not Pass Go Without Collecting Safety Information below.
In my early years as an aromatherapist, I longed for the day when essential oils would become part of traditional medicine, or at least be considered as over the counter drugs. After years in the cosmetic industry, I am grateful that aromatherapy remains an alternative treatment available to everyone. I have been through the process of manufacturing an OTC sunscreen and learned that the cost, paperwork, and regulation of making essential oils into OTC drugs would put the majority of aromatherapists out of work.
Below is an excerpt from Chapter 11 Drugs, Aromatherapy and Cosmetics from The Art, Science & Business of Aromatherapy.
NOTE: All italics that follow were added by me as examples and not official FDA comments. All quotes are from the FDA.
What is a Cosmetic?
A cosmetic is defined in the Federal Food, Drug, Cosmetic Act, Section 201 (i) as being:
“Articles intended to be rubbed (serums, moisturizers, etc.), poured (bubble baths, oils, etc.), sprinkled (body powders, bath powders, etc.), or spray on (body deodorant, perfumes, body mists, etc.), introduced or otherwise applied to the human body or any part thereof for cleansing (cleansers, exfoliants, etc.), beautifying (exfoliants, moisturizers, makeup, etc.), promoting attractiveness (makeup, perfumes, deodorants, etc.) or altering the appearance (cleansers, exfoliants, serums, moisturizers, makeup, etc.)”
Cosmetics: are not as regulated as drugs. They do not require pre-clearance by FDA, and GMP is not required. Cosmetics have simple labeling regulations, and voluntary adverse effects reporting. You cannot make any claims other than cosmetic usage even if it is accurate or nature’s wonder “drug.”
The Cosmetic Legality Principle does not require pre-market approval or notification of products or ingredients, clearance of products safety, or substantiation of product performance claims (moisturizing, cleansing, deodorizing, etc.). Mandatory establishment or product registration is currently voluntary. [Continue reading]