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FDA Warning Letters – Drug Claims for Cosmetics

I receive notices whenever the FDA sends out warning letters, and it seems like there has been an increase in warnings to cosmetic companies for drug claims. So I checked. Yes, there definitely has been an increase. One would guess that the FDA is looking a little more carefully at the claims being made. So far in 2015, there have been 5 warning letters on the subject of drug claims made for cosmetic products. That’s more than any year from 2005 until now (except for 2012 which had 11 warning letters for the whole year).

So, what sort of claims are these companies making for their products?

Direct Claims for The Products

Two of the companies made direct claims that their products would alter the function or structure of the body. Some examples:

  • “Invigorate[s] the circulatory and lymphatic system”
  • “Stimulate[s] circulation…”
  • “Clinically proved to change the anatomy of a wrinkle”
  • “… Neck Cream. Now even more tightening, lifiting …”

Claims for Ingredients

All of the letters referenced healing/treatment type claims for the ingredients in the products. A few examples include:

  • “Vitamin D3 (cholecalciferol) – Helps reduce inflammation, calm irritation….”
  • “Glycolic Acid – Helps open follicles and reduce oil production.”
  • “Retinol (.01%) – …collagen stimulator.”
  • “Arnica – Reduces swelling….”
  • “Aloe Barbadensis (Aloe Vera) Extract – Calms inflammation with an anesthetizing response.”
  • “Spanish Lavender… inhibit muscle fibers from contracting….”
  • “Willowherb… control inflammation….”

Recommendations for Product Use

While not direct healing claims, two of the products made drug claims in the way they recommended the product be used:

  • “Recommended for: redness-prone skin, experiencing overall redness, flushing, and sensations of discomfort.”
  • “Used to treat dark spots and discolorations….”

In the Identity of the Product

One of the required items on the front label of a cosmetic is it’s “identity”what it is. It’s the common name or a generic statement, not the brand name or name of the product. It can be simple (“soap” or “lotion”) or can be a descriptive name that tells the consumer what it does (“eye area moisturizer” or “cuticle cream”).

These two examples from L’Oreal are cases where the description of the identity was used to make a drug claim for the product.

  • “Concentrated Dark Spot Correcting Serum” (L’Oreal Rosaliac AR Intense)
  • “Localized Redness Intensive Serum” (L’Oreal Mela-D Pigment Control)

Testimonials

Testimonials are another place the FDA looks for drug claims about a cosmetic product. If you promote a testimonial that makes drug claims, you are forwarding the idea that the intended use of the product is to do the same thing that was claimed in the testimonial. Otherwise, why would it be out there for all to read? Several examples from the L’Oreal warning letter:

  • “I have rosacea on my neck when I get warm or undress stress. This product really works to keep it under control!!!”
  • “I have broken capillaries and generalized redness on several areas of my face. I was told laser treatment was the only fix. Then… themiracle of Rosaliac AR!”

Snake Oil?

And then there is the product for which all the regulations were written in the first place; blatant and irresponsible claims for a product.

The product cited in one the FDA warning letters this year claims that the primary ingredient (magic Chaga mushrooms) in its products is anti-cancer, antiviral, antimicrobial, antifungal, anti-Candida, anti-malarial, anti-tumor, anti-inflammatory, and that it will treat or cure HIV and AIDS, arthritus, influenza, asthma, H1N1, allergies, hepatitis, Lyme disease, ear infections, Wilson’s disease, bronchitis, Crohn’s disease, multiple sclerosis, Alzheimer’s, ADHD, Down Syndrome, Hodgkin’s Lymphoma, tuberculosis, rheumatoid arthritis, high cholesterol, diabetes, blunted sense of taste (hypogeusia), tinnitus (ringing in the ears), head injuries, ulcerative colitis, peptic ulcers, sickle cell disease and inherited disorders, erectile dysfunction, male infertility, benign prostatic hyperplasia, osteoporosis, muscle cramps associated with liver disease, corneal ulcers, burn injuries, inflammatory diseases, inflammatory bowel disease, long-term damage from exposure to smoke and radiation, facial wrinkles, scar tissue, and protect agains harmful UV rays.

Umm, really?

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!

Comments

11 responses to “FDA Warning Letters – Drug Claims for Cosmetics”

  1. Marie, Thank you for all you do for the handcrafted cosmetic and soap community. We are blessed to have you help us to understand the legal complexities of labeling and legislation for our industry.

    I have been making an itch-relief spray for personal use for the last couple of years. I only use plant extracts, essential oils, ACV and grain alcohol. I’ve never tried to sell it for fear of treading into the drug label. Yet, I see lots of itch relief products at health food stores and online that don’t include drug facts. Can you suggest how I might phrase the product name to be legal (cosmetic) and not a drug? The spray has been calming for my skin irritations from working in my landscaping and for bug bites. If I can just stop scratching, then my skin can heal itself. That’s about all that I’d want to communicate and make no claims of the product healing the body. Thank you again for all you do for the handcrafted soap and cosmetic community.

  2. I did a festival this weekend and there was a vendor that had a huge banner that read, “Helps with Eczema & Psoriasis, No More Cracked Heels.” I checked the label of the product they were selling and it amounts to sea salt and oils, or a “Salt Scrub”. I wanted to ask them how long it took to get their product through Regulatory at FDA, but didn’t want to be confrontational.

    1. Marie Gale

      I think that might be a national company that hires sales people to do home shows, county fairs, and big shows. I saw something similar at a home show here locally. Makes me crazy! I wanted to yell at the gal selling, but she really didn’t know anything more than the company told her.

  3. Thank you for the informative post, Marie!
    If a particular ingredients is proved by some studies or research that it do this and that – is it ok to include this info in the product description?
    Also, can you give an example of few cosmetic brands or a single brand that describe their products in a right way following FDA guidelines and still bringing the message to the consumer what their product does?

    1. Marie Gale

      If the “this and that” you are talking about are COSMETIC claims (that is, they are claims that the product or ingredient cleanses, beautifies or improves appearance), then there is no issue.

      If the “this and that” you are talking about are actually drug claims (that the product or ingredients treat, prevent, mitigate disease or change the function or structure of the body), then NO, you cannot put that in the product description, on the label, on a website, or in accompanying materials. You can’t even link to a scientific study that proves it absolutely.

      Good examples are all around. But they are examples where the intended use is to cleanse, beautify, or improve appearance. That’s what the product does. Anything beyond that and it’s a drug and the only “good” examples are drug products.

  4. Mary Pasley

    Great post Marie Gale. Are you able to tell if there has been an uptick of warning letters for soap or are they all cosmetics? Also, if my soap name is WillOWisp and my logo says Hill House Soaps, does that suffice for the identity or do I have to have WillOWisp Soap as the name of the bar?

    Thank you for all you do

    Mary

    1. Marie Gale

      All the letters have to do with cosmetics (creams, lotions, and that sort of thing). I haven’t actually seen any that address soap as a cosmetic. I guess people don’t tend to make claims for soap as a cosmetic. Soap as a non-cosmetic is covered by the FTC, and I haven’t seen any warnings there, either. (Although, I don’t check the FTC site often for that.)

      So long as it is clearly identified what your product is (“soap”) and the consumer understands, it should be okay. HOWEVER, if you make any other products under the name of “Hill House Soaps,” then it would important to identify that it is soap and not something else. You could, just to be on the safe side, put that it is “handcrafted soap” or something. That also works to your marketing.

  5. Thanks as always for a great blog. And would you believe, the Google ad on your blog page was for “2015 Best Skin Tighteners – Products to Tighten Loose Sagging Face Skin Without Plastic Surgery.” Grrr. Maybe Google would benefit from a letter!

    1. Marie Gale

      Oh, how funny is that!

  6. So if one has a product that does actually work and people want to purchase it for the intended use how does one go about getting it registered? I am sure it’s quite expensive and lengthy process.

    1. Marie Gale

      If the intended use is to treat, cure, heal, mitigate, or prevent disease, or to alter the function or structure of the body, then it takes getting an approval as a new drug. It’s the same process that drug companies have to go through for any prescription drug approval. So yes, it’s an expensive and lengthy process.

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