Busy “Warning Letters” Month for Cosmetics

In July, the U.S. FDA issued four warning letters to cosmetics companies.  Although only two were prepared by the same office, there were consistent themes across the four letters.  As previously discussed here, the FDA continues to crack down on companies making what amount to drug claims on various “cosmetic” products.  But what companies need to also be aware of, is that groups of plaintiffs’ attorneys are also beginning to get in the game by sending class action litigation threat letters to companies based on the same marketing claims.  While an FDA warning letter may result in a company having to change its marketing and labeling, a class action litigation threat often also results in a payment of “attorneys’ fees” to the plaintiffs’ attorneys lest they will file suit– and even if the company has already agreed to make revisions to its labeling and marketing.

So how can a company effectively market the wonders of its cosmetics while avoiding the dreaded FDA warning letter or plaintiffs’ threat?  A review of July’s letters provides some guidance.

Drug Comparisons:  In its July 19, 2016 letter to Sircuit Cosmeceuticals, the FDA challenged the company’s comparison of its “intensive anti-wrinkle eye serum” to “Botox-like results.”  One reason comparing a cosmetic to a drug product is problematic is the way in which the United States defines “cosmetics” and “drugs”.  It does not necessarily matter whether the ingredients are or are not traditionally considered “drugs.”  Instead, the definitions fall on the intended purpose or use of the products.  A “drug” is any

“articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)(1)].

Cosmetics, on the other hand, are

“articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” [FD&C Act, sec. 201(i)].

Thus, if a claim compares the function of a product to a known drug, then arguably that product’s intended purpose is similar to the drug to which it is being compared.  A drug, however, must have either been approved through the FDA’s new drug application process or it must comply with an existing OTC drug monograph; otherwise, the product will not be “generally recognized as safe and effective for the…referenced uses.”

Moisturizing Claims are Cosmetic, BUT…The FDA has routinely explained in various OTC Drug monograph rulemaking comments, that moisturizing claims are “cosmetic” and  as such are outside the scope of the OTC rulemaking process.  In its July 15, 2016, letter to Annemarie Gianni Skin Care, however, the FDA challenged the claim that the company’s serum “will increase skin hydration…”  But, the company had not simply stopped at hydration.  Instead, the company went too far by stating the product “will increase skin hydration by inhibiting hyalurondase…” (emphasis added). This is similar to the making of antioxidant claims.  Its okay to identify the fact that a product contains ingredients high in antioxidants, but claiming the product’s antioxidants “fight free radicals to prevent…” would be considered a drug claim.  The lesson here…more can be too much–or the ol’ saying, “you had me at hello.” 

Ingredient Boasting:  Boasting about the wonderful qualities of an ingredient, rather than the whole product, does not circumvent the law, i.e., the definitions of cosmetic versus drug.  I am asked this question multiple times a week.  It doesn’t matter that an ingredient supplier has, for example, studies that calendula is calming and has anti-inflammatory, healing properties (FDA letter to Be Green Bath and Body),  or that caffeine acts like an analgesic (FDA letter to Sircuit® Cosmeceuticals), or that rose geranium strengthens capillaries (FDA letter to Sevani Botanica).  The minute these claims are made in association with the marketing or labeling of a cosmetic, the purpose of that cosmetic is arguably intended to treat, cure, or prevent disease or conditions of the body. 

Addressing Specific Skin Conditions:  Are the products great for those suffering from Rosacea, Eczema, Dermatitis, Acne, Psoriasis, etc.?  (Letters to Be Green Bath and Body, Sevanie Botanica, and Annemarie Gianni Skin Care)  If so, be careful how you say it.  The marketing claims should not indicate that the products treat, prevent, cure, or mitigate skin conditions.

UV Protection:  In the letter to Annemarie Gianni Skin Care, the FDA noted a claim by the company that “Sunflower seed extract adds UV protective qualities.”  Whether or not this is the case, is of no matter.  Only approved sunscreen active ingredients may be claimed to provide UV protection and only when the product meets the sunscreen OTC monograph rules.

Troubled Claims:  So what types of claims should be avoided?  The following is a list of claims I often suggest avoiding (though this list is by no means exhaustive):

  • Heal, repair, reverse
  • Collagen claims: stimulates, encourages, promotes, feeds the formation,
  • Treating sun spots, age spots, acne scarring, hyperpigmentation, etc.
  • Support, increase, improve, cell communication
  • UV protection (where not meeting the OTC monograph)
  • Blood vessel: any claims regarding blood vessels are problematic.  Cosmetics, after all, are intended to beautify the top layer of the skin– the dead layer.
  • Anti-inflammatory, reduces inflammation
  • Aging claims: reverses, prevents or protects from accelerated aging
  • Cells: cellular regeneration, cellular turn over



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