FDA Warning Letters: cleansers, creams, moisturizers deemed drugs by FDA

Under the Food, Drug, and Cosmetic Act, cosmetic products and ingredients do not need FDA pre-market approval, with the exception of color additives. As a result, FDA’s enforcement of the FDCA are taken against products already on the market.  One such enforcement mechanism is the issuance of Warning Letters.  As Warning Letters are posted, available here, I will post a summary of those letters involving cosmetic products and topical over-the-counter drug products that are often marketed by traditionally cosmetic companies (e.g., acne products, sunscreens, topical analgesics, and skin protectants).  In October and November 2014, the FDA issued 3 such letters…

The letters were issued to PI Pharma, Inc. dba Nature’s Extra; Jansen Enterprises, LLC dba HealthWorksUSA; and  Cell Vitals.  In each, the products were identified as being marketed in a manner that indicates the products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or articles intended to affect the structure or any function of the human body, rendering them drugs under the Act– in other words, as drugs.

In the letter addressed to Cell Vitals, involving a facial moisturizercleanser, and eye cream, FDA addressed the manner in which the manufacturer identified the purported benefits of specific ingredients. For example, the products were marketed with claims such as:

“Calendula Extract [an ingredient in your product] -Anti-inflammatory/itching herb, assists in strengthening capillaries, anti-inflammatory/itching [sic], helps heal, contains L-Beta-Sitosterol (anti-inflammatory and anti-cancer); D-Lupeol (anti-peroxidant and anti-inflammatory); and L-Rutin (anti-capillary-fragility factor)”

“Tetrahexyldecyl Ascorbate: [an ingredient in your product] …protect cells from …inflammation.”

In addition, the eye cream contained claims that it caused the “activation of collagen synthesis.”

The letters addressed to PI Pharma and Jansen’s Enterprises involved topical creams that appear to be topical analgesics, skin protectants, and perhaps sunscreen.  Over-the-counter (OTC) drugs must comply with an applicable OTC drug monograph issued by the FDA.  Among other things, each OTC monograph lists the only active ingredients that may legally be included in a drug product.  Although pre-approval by FDA for OTC drugs under a drug monograph is not required, if a drug cannot comply with the drug monograph, an IND or approved NDA is necessary before the drug may be marketed in the US.

In these letters, the FDA flagged the following marketing claims associated with the products:

“Wound Healing… Pain Relief & Burn Therapy…”

“Directions: apply topically as needed to open wounds, scratches, bites, burns, abrasions, or inflamed areas of the skin.”


“Helps relieve insect bites and other skin problems”

“Cuts and scratches love the feel of our healing gel”

“Natural NutraGel helps prevent and heal inflammation due to sun exposure”

“Now children and fair-skinned people can safely avoid burning!”

“NutraGel allows you to enjoy the sun longer without damaging your skin.”

“Helps relieve joint and muscle pain!”

“Childhood injury visibly improved after only 5 months of applying the gel twice daily” (with a picture of a scarred arm with the scar diminishing).”

“Takes the sting out of bug bites!”

In addition, in each of the 3 letters, not only did the claims cause the various products to be considered drugs, but also, the FDA asserted that the conditions identified in the marketing claims are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. As a result, the FDA considered the drugs misbranded within the meaning of section 502(f)(1) of the Act for failing to bear adequate directions.

For additional posts regarding marketing claims turning a cosmetic into a drug and the distinction between cosmetics and drugs see here.

Take away while the definitions for cosmetics and drugs result in a clearly delineated line, cosmetic marketing claims often cause the line to become blurred. Semantics…semantics…semantics.  Audit marketing and labeling claims, including legal review, before going to market to be sure your companies’ claims fall on the proper side of the line.


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