Another FDA Warning Letter

FDA signage

The FDA just (July 2017) published a warning letter to a cosmetic manufacturer in St. Louis. Once again, the FDA reviewed the website and cited drug claims:

“…the claims on your website establish that the products are drugs under the … Food Drug and Cosmetic Act … because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or they are intended to affect the structure or function of the body.”

What Did the FDA Find Objectionable?

There were four specific products mentioned. For each of them, the FDA cited statements that were made in the description of the product, mostly having to do with describing the ingredients used in the product. The following exactly quotes from the FDA letter, but I have highlighted the key disease or structure/function phrases for reference):

  • “The result is a nutritious concoction rich in anti-inflammatory Omega fatty acids …”
  • “Hemp [(an ingredient in your product)] … reduces redness and is recommended for the treatment of psoriasis and eczema.”
  • “Organic Tamanu [(an ingredient in your product)] oil has proven antibacterial, anti-inflammatory and skin rebuilding properties …”
  • “Beta glucans … are anti-inflammatory
  • “Organic oils of Baobab, Pomegranate, Perilla, and Pumpkin [(ingredients in your product)] make a synergy to soothe irritations whether they be from sun, wind, allergies, or chronic inflammatory conditions.
  • Each of these oils is known to be helpful for eczema, dermatitis, chapping, and dryness.”
  • “St. John’s wort [(an ingredient in your product)] is anti-inflammatory and analgesic for skin irritations and damage.”
  • “100% natural, botanical recipe anti-redness and anti-inflammatory …”
  • “Marshmallow [(an ingredient in your product)] provides soothing mucilage and Plantain leaf infuses reknowned anti-redness abilities. Self Heal comes packed with gentle but effective antimicrobial properties to keep acne and other skin disturbers at bay.”
  • “Heather Flowers [(an ingredient in your product)] provide the anti-allergenic flavonoid Quercetin which also helps synthesize new collagen.”
  • “Cold-extracted Olive Leaf [(an ingredient in your product)] offers a fraction called Oleuropein known for its potent antibacterial and anti-inflammatory effects.”
  • “Niacinamide [(an ingredient in your product)] is included at 4% which is a level proven in studies to be more effective than a 1% clindamycin antibacterial gel at preventing acne breakouts. It maintains ceramide levels …, synthesizes collagen, and evens coloration of the skin.”
  • “Organic Evening Primrose oil and Pomegranate Oil [(ingredients in your product)] are rich in omega 5, 6, and 9 essential fatty acids including GLA which helps balance hormones, …”
  • “Omega 5 is a rare fatty acid that acts as an… anti-inflammatory,…”
  • “Pomegranate oil [(an ingredient in your product)] also has phytoestrogen to assist with hormone balancing, …”
  • “Tamanu [(an ingredient in your product)] has been used … for its anti-inflammatory, antibacterial, and regenerative properties.”
FDA warning


What’s the Problem?

First of all, even if all of these statements are true (and even if based upon proven scientific studies) those ingredients are not approved by the FDA for the treatment of the diseases/issues mentioned. So, right at the point these claims are made, the result is an “unapproved new drug.”

Secondly, even if those statements are approved for an over-the-counter drug (which they are not), the manufacturer would need to be an approved, inspected, and licensed drug manufacturer in order to legally (and safely) make them. It’s virtually impossible for a handcrafter to meet those standards.

Making Cosmetics vs. Making Drugs

It’s all about the intended use. What is the product supposed to be used for? What is its purpose?

Cosmetics are products that are intended to cleanse, improve appearance, and beautify. They are “surface” products, changing the way things LOOK.

Drugs are intended to cure, mitigate, treat, or prevent disease, and/or affect the structure or function of the body. They work “under the hood” and make changes inside the body.

Drugs are highly regulated for the safety of consumers; cosmetics are much less regulated. Handcrafters can make cosmetics; handcrafters cannot make drugs without being an FDA-approved and state-approved drug manufacturer.

It’s Your Choice

When you come up with an idea for a new product, keep in mind the intended use. YOU decide this when you create the product. This isn’t a passive, accidental action; this is (or was at some point) an active decision on your part.

If your newest, greatest, brightest idea is an “anti-itch poison oak soap”, you have already started down the path of creating an unapproved new drug. Your decision that the intended use is “anti-itch” and the “treatment of poison oak” moves your product away from a legal cosmetic product and turns it into an illegal drug product.

No matter how you try to go around it, to be “tricky” and characterize your product as a cosmetic when the actual intended use is as a drug, if the consumer “gets it” then so will the FDA. The FDA isn’t stupid and they have lots of experience reading between the lines.

It’s a lot harder to stay in business when you start out with products that skirt the law.

Make it easy on yourself.  Make and sell soap and cosmetics, not drugs!

Navigating the Rules and Regs book by Marie Gale

Besides labeling, there are many other laws and regulations that apply to handcrafters. To find out which ones apply to you and how to comply with them, buy my book and keep it handy!


5 responses to “Another FDA Warning Letter”

  1. Teresa Giegler

    Am I right that exfoliating and for dry, normal, or oily skin or hair is allowed?
    What about saying: draws moisture to the skin; nourishing; moisturizing; soothing; moisture locking; removes, draws out, or absorbs excess oils; refreshing; energizing; caffeinated; includes natural sun blocking ingredients; softens skin; may reduce the appearance of redness (soap); or tinted to reduce the appearance of redness (lotion); is believed to attract fish; high in iodine, protein, minerals or vitamins; leaves a pleasant fragrance; acts as an astringent; has antibacterial or antiseptic properties; has a history of use in cosmetics (without specifying ANY condition it was believed to treat);
    Can you put an asterisk after the lye ingredient then as a footnote say all lye has been combined with oils to make soap leaving extra nourishing and moisturizing oils behind.
    In non cosmetic. soap can you use fully saponified, partially saponified and non saponified for your oils.

    1. Marie Gale

      Any claims that a product will treat, mitigate, cure, or prevent disease, or that it will alter the function or structure of the body, renders the product an unapproved drug because the intended use is as a drug. Sun blocks and sun screens alter the function of the body. Reducing redness (other than just covering it up like a concealer) is altering the structure or function (or curing/treating a disease). Antibacterial or antiseptic properties are preventing or mitigating potential disease.

      Most of the other statements you asked about are either cosmetic claims (promoting attractiveness or beautifying) or are just marketing hype (vitamins, minerals, etc.).

      You can put an asterisk in the ingredient declaration to explain what you want. That’s just marketing (provided it doesn’t make any healing claims).

      In non-cosmetic soap you can say saponified or not. But remember that the chemistry of soap is such that it is NOT complete oils that are not saponified when you superfat or lye discount. See materials by Kevin Dunn, PhD in Scientific Soapmaking about which fatty acids saponify first.

  2. Hi Marie,
    I’m in the process of starting a soap and cosmetic business in FL (thank goodness for no more product registrations!) and I’ve been scouting some existing cosmetic business websites and such to get a feel for my market. A few of them who create cosmetics also make some “drug” claims, yet they have a disclaimer at the bottom of their website stating that the claims are not approved by the FDA. I’ve seen this disclaimer numerous times on a variety of products and was wondering if you knew the legality behind it. If they (or I) make claims about products, yet have a disclaimer, is that legal and will it prevent the FDA from knocking on my door? I know the FDA has their “discretionary enforcement,” and while I am not looking to make claims about my products that would classify them as drugs, I do want my customers to realize the potential benefits of the ingredients I use. I know you are not an attorney, but I thought you might have some kind of information on this interesting aspect of the FDA, especially in light of all the warning letters arriving on doorsteps.

    1. Marie Gale

      There are two types of disclaimer notices you might see on cosmetics, neither of which really mean squat, and neither of which allow any types of claims to be made.

      First, there is the “not reviewed by the FDA” disclaimer. That’s actually for NUTRITIONAL SUPPLEMENTS, and has nothing whatsoever to do with cosmetics. I wrote a blog post covering it several years ago; you can see it here: Using an FDA Disclaimer on Cosmetics.

      Second, there are the legal disclaimers that sometimes come from lawyers and are an attempt to get out of any liability if someone had issues using the product. I doubt they would have much effect (if any!) and most of them aren’t written by lawyers, they are written by people copying what other people have written. The best protection against any liability issues is having good insurance.

      There is no disclaimer or statement that will allow you to make claims that your products (or their ingredients) are intended to be used in the treatment, mitigation, cure, or prevention of diseases, or that they can alter the function or structure of the body.

      As soon as you start trying to tell your customers the “potential benefits” of the product or ingredients, if those “potential benefits” include the treatment, mitigation, cure, or prevention of disease, then you have already crossed the line. Why mention the point if you’re not trying to communicate to the customer that those benefits are “potentially” in your product?

  3. Excellent, and important information, especially for new and small artisan skincare makers! I shared this with my students, and added that large companies can afford fines, legal fees, reformulation and new labeling–but for a small business, this can be disastrous.

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