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.
Cosmetics exclude soap, but if your soap claims to be “cleansing, beautifying or moisturizing,” it is a cosmetic and must be labeled appropriately. This means you are required to include a full International Nomenclature of Cosmetic Ingredients (INCI) ingredient list on every bar of soap and follow all cosmetic regulations ONLY if you make claims that go above and beyond cleansing, beautifying, or moisturizing. The Manufacturer is responsible for making cosmetics safe and they must not be adulterated or misbranded.
Adulterated is defined as harmful or injurious to user under customary conditions of use such as microbiology, unapproved color additive, chemical contaminant or prohibited ingredient.
Misbranded is defined as when labeling is false or misleading; Package does not exhibit labeling information required by statute or regulation; Packaging not in compliance with 1970 Poison Prevention Packaging Act (PPPA). All cosmetic ingredient lists must use INCI (International Nomenclature of Cosmetic Ingredients) names for all cosmetic ingredients in a finished product. The use of trade or common names is not allowed on cosmetic ingredient lists.
What is a Drug?
A Drug is defined in Federal Food, Drug, Cosmetic Act, Section 201 (g) as being:
“Articles intended for use in the diagnosis, cure (anti-wrinkle, antibacterial, anti-fungal, anti-acne etc.), mitigation (pain reliever, headache reducer, muscle relaxant, etc.), treatment (acne treatment, fungal treatment, wrinkle cures, psoriasis and eczema, anti-cancer treatments, etc.) or prevention (anti-scar, wrinkle cure, cancer prevention, anti-perspirant, etc.), of disease. Articles (other than food) intended to affect the structure (wrinkles, perspiration, scars, etc.) or any function (cell regeneration, collagen formation, etc.) of the body.”
Drugs: are highly regulated and require pre-clearance by FDA, and GMP is required. Drugs have highly regulated labeling laws (i.e. Drug Facts). They require reporting of all and any adverse effects known, and they can make proven, specific, and tested claims that follow the monographs requirements.
In the Drug Legality Principle, a product meets the definition of drug if it complies with ALL requirements for drugs (even if it also meets the definition of cosmetic). All cosmetics that meet the definition of a drug have to be registered and regulated by the FDA. A product is considered a drug if it makes claims such as being a sunscreen, antibacterial soap, anti-dandruff shampoo, anti-acne, anti-wrinkle, antiperspirant, etc.
“The FDA interprets the term “soap” to apply only when:
• The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product’s detergent properties are due to the alkali-fatty acid compounds, and
• The product is labeled, sold, and represented solely as soap [21 CFR 701.20].” FDA
What is Soap?
It is very common to find melt and pour soap, as well as true soaps, improperly labeled and containing drug claims. However, most melt and pour soaps do not meet the first standard, because the bulk of the product is not alkali salt and fatty acids.
“If a product intended to cleanse the human body does not meet all the criteria for soap, as listed above, it is either a cosmetic or a drug. For example, if a product consists of detergents or primarily of alkali salts of fatty acids and is intended not only for cleansing but also for other cosmetic uses, such as beautifying or moisturizing, it is regulated as a cosmetic.”
Melt and pour soaps consist of detergents and, according to the FDA’s definition, they are a cosmetic and not soap. Detergents are essentially defatting agents which allows them to remove fats, lipids, dirt, make-up, and debris from the surface of the skin. Detergents aren’t bad; they just aren’t soap by definition. You are required to include a full International Nomenclature of Cosmetic Ingredients (INCI) ingredient list on every bar of melt and pour soap, and you must follow all cosmetic regulations.
Your Products Intended Use Can Make Your Cosmetic a Drug
Example #1: Product’s Intended Use: Drug – A product with any of the following intended uses is a drug: antiperspirant/deodorant (stops perspiration), dandruff shampoo (treats dandruff), sunscreen/suntan preparation (prevents sunburn), fluoride toothpaste (prevents cavities), and skin protectants (helps heal cuts).
Example #2: Product’s Intended Use: Cosmetic – A product with any of the following intended uses is a cosmetic: deodorant (cover up odor), shampoo (cleanse hair), suntan preparations (moisturized while tanning), toothpastes (cleans teeth or freshens breath), skin protectants (moisturize skin). Notice that both the ingredients and the intended use of the product make a difference in whether it is considered a drug or a cosmetic.
For the most up to date information about labeling go to the FDA page to read “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)
Three Types of Claims that Can Cause Your Cosmetic to be a Drug
- Claims that suggest physiological change – For instance, if you say “younger looking” rather than “younger” you are a cosmetic. If you say “removes” or “prevents” wrinkles, rather than “covers” your product is a drug.
- Claims that sound scientific – For instance, if you claim that your soaps are “Compounded in our laboratory under the most sterile conditions,” or “If blemishes persist, see a doctor,” your products is a drug.
- Claims that appear in an applicable OTC monograph – Sunscreen products, hormone products, acne, eczema, psoriasis, skin bleaching, etc. Even implied claims by known effects of ingredients. For example, with skin bleaching products, the presence of many ingredients automatically make your product a drug. Remember that even if a cosmetic has a drug action, it must qualify as a drug first and then a cosmetic.
If an ingredient has a monograph it automatically makes a product a drug with the intended use as described in the monograph. The FDA has published monographs for OTC ingredients stating what ingredients can be used and their intended use. Using those ingredients, in most cases, in a product makes your cosmetic a drug. Remember, if you use an ingredient with a monograph, that product then meets the definition of a drug, and it must comply with ALL requirements for drugs (even if it also meets the definition of cosmetic).
Are You Transforming Your Cosmetic Into a Drug?
The trick is this, it doesn’t matter whether the claim is true or not, it’s whether the claim transforms the cosmetic into a drug. You might know that your aromatherapy helps lighten hyper-pigmentation, your ointment helps cure eczema, your serum irons out wrinkles, but as soon as you state or imply that fact on your label, in your literature, in any print advertisement, on your website, or anywhere, you are placing your product into the drug category.
Therefore, you must follow all drug regulations and present your product to the FDA before it hits the market. You will also need to present case studies to the FDA to back up your claim. For more information on this, go to The Center for Drug Evaluation and Research (CDER) homepage.
Watch Your Advertising Claims
- Environmental Claims: Claiming something is recyclable, even if true in your area, might not be true in other areas. For example, Polyethylene caps on your containers. There are only a few recycling outlets in the entire USA that recycle PE.
- Made in America (or the USA Flag): Though your product might be made in the USA, the FTC/FDA requires that all the ingredients originate and remain in the States, too.
- Claiming to be an FDA approved product or an FDA approved facility
- Organic Claims: If you are an organic certified entity, you will be notified of what you can place on your labels. If you are not then you can state “X-percent organic content” on the back of your packaging, but you can’t state “organic” on the principal display panel. The verbiage must clearly state it is not certified.
- Natural Claims: involves almost no regulation, however, integrity is recommended.
- Product Claims Based on Ingredients: You can’t advertise the effects of a known ingredient. All test studies must be done on the product itself.
- Unsubstantiated endorsements (such as Celebrity Infomercials): Again, though a personal claim could be true, it might not necessarily be true for the average person.
- Disclaimers like “results may vary” or “not typical for the average consumer”: It is currently being noted that these disclaimers are not read, but rather the claims are just being heard. Therefore, disclaimers will probably go by the wayside.
- Using the term “cosmeceuticals”: A product can be a drug, cosmetic or a combination of both following the rules of both standards. But the term “cosmeceutical” has no meaning under the law.
- Mimicking: Just because you see another company making claims does not mean you should. If the FDA looks into your claim, you can’t use another company’s bad judgment as an excuse for your choices. And you don’t know if the other company is actually complying with the law since much of it is behind the scenes, with the exception of “drug facts” on the label.
To learn more about the art, science and business of aromatherapy and cosmetics check out my book The Art, Science and Business of Aromatherapy: Your Guide for Personal Aromatherapy and Entrepreneurship available in paperback and Kindle.
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IF YOU ARE CURRENTLY EXPERIENCING AN ESSENTIAL OIL INJURY PLEASE READ: What to do When Injured While Using Essential Oils.