More FDA Warning Letters: Strong Enforcement Continues in 2015

Traveling to and attending various conferences has prevented me from posting for a couple weeks. So although I have not had time to blog, there has been much to write about– including the latest round of FDA Warning Letters.  In February and March alone, the FDA has issued at least 5 Warning Letters challenging the drug claims on various cosmetic products.  Below is a table summarizing each letter and the challenged claims.  Notably, unlike prior Warning Letters, some of the challenged claims and statements are not as egregious as those previously challenged by the FDA.  Is this an indication the FDA is beginning to cracked down more on the cosmetics industry’s willingness to play fast and loose with their marketing claims?


At the ACI Cosmetics Compliance Seminar I attended in New York earlier this month, Dr. Linda Katz, Director with the Office of Cosmetics and Colors of the U.S. F.D.A., said the FDA continues to view misbranded drugs (i.e., cosmetics making drug claims) as a high priority issue. Accordingly, it is likely we will see more Warning Letters in the coming months.

As with most Warning Letters addressed to cosmetics companies, the letters summarized below each identified several offending claims which the products “are not generally recognized as safe and effective for the…referenced uses.”  As such, FDA deemed the products as “new drugs” under Section 201(p) of the FD&C Act.  In addition, in a majority of the letters, the FDA also viewed the products as mislabeled drugs because they failed to bear adequate directions for the intended use.  This is particularly problematic where the condition for which the product is intended to treat is not one subject to self-diagnosis and treatment by individuals that are not doctors.

Finally, the Warning Letters are a good reminder to companies to actively manage website product testimonials. Testimonials are, after all, a form of claims that may cause a cosmetic to be deemed a drug.

L’Oréal USA, Dated Feb. 12, 2015. Products: Rosaliac AR Intense and Mela-D Pigment Control

Rosaliac AR Intense:

“Localized Redness Intensive Serum”

“RECOMMENDED FOR: Redness-prone skin, experiencing overall redness, flushing and sensations of discomfort”

“Reduces visible redness and sensations of discomfort”

“[F]ormula combining 3 effective ingredients to help reduce redness with a long lasting efficacy”

“I have rosaceaon my neck when I get warm or under 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…the miracle of Rosalic AR!”

“With powerful Ambophenol [0.5%] to visibly reduce redness”

 Mela-D Pigment Control:

“Concentrated Dark Spot Correcting Serum”

“Use to treat dark spots and discolorations”

“Recommended For: Hyperpigmentation and Dark Spots”

“With 2% Kojic Acid to visibly reduce the intensity of dark spots”

Strivectin Operating Company, Dated Feb. 12, 2015. Products: Potent Wrinkle Reducing Treatment; TL Advanced Tightening Neck Cream

Potent Wrinkle Reducing Treatment:

“Clinically proven to change the anatomy of a wrinkle”

“This superb age-fighting serum is super charged with …potent elastin stimulating peptides….”

“Potent elastin-stimulating peptides help enhance skin structure ….”

 TL Advanced Tightening Neck Cream:

“#1 Selling Neck Cream. Now even more tightening, lifting…”

“[F]eatures breakthrough Gravitite-CF Lifting Complex to restore the elastin fiber architecture, providing noticeable lift and improving resistance to gravity.”

“Breakthrough Gravitite-CF Lifting Complex [an ingredient in your product] contains a powerful blend of active ingredients that stimulate elastin synthesis…”

Modern Herb Shop, Inc., Dated Feb. 26, 2015. Products: Burn Ointment | Ching Wan Hung Soothing Herbal Balm

“used for serious third degree burns in hospitals.”

“decreases inflammation, and promotes the regeneration of damaged tissues…”

“Use topically for first, second, and third degree burns with blistering, redness and pain.”

Natural Organic Solutions;, Dated Feb. 26, 2015. Products: High CBD Healing Salve

“High CBD Healing Salve for Wounds, Blemishes and Cancers”

“In the pictures above you can see the amazing results. The patient presented with third degree burns. Infection was present. Within 48 hours significant healing has occurred with no sign of infection.”

“We have treated thousands of patients and have seen this medicine work!”

Four Elements Organic Herbals, LLC, Dated March 4, 2015. Products: Self Heal Cream, Sweet Violet Moisture Cream; Lemon Lip Balm; Rose Comfrey Moisture Cream; & Unscented Comfrey Moisture Cream

“Heals the wound…”

“[Comfrey can be] used…to heal a wound or a bone break…”

“[Comfrey] is effective for joint pain, sprains, bruising, pulled muscles and ligaments.”


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