FDA steps up on warnings over drug claims

By Simon Pitman contact

- Last updated on GMT

FDA steps up on warnings over drug claims
The FDA has recently sent two letters out to companies marketing personal care products for topical use, underlining that any claims pertaining to physiological changes puts the products in the drugs category.

Warning letters categorized as unapproved drugs and misbranding have been sent out to two companies marketing products in the United States during the course of the past two months, pointing to a further tightening of the reigns.

The FDA warning letters were sent out to Innovative Biodefense, dated June 30th​ and to Pharmagel, dated May 22nd​, which are both categorized as new drugs/labeling/misbranded.

Pharmagel letter

The FDA warning letter addressed to Pharmagel International, which is headquartered in California, refers to the products Beta-C, Bio-A Concentrate, Eye Firmé, Pharma Clean Medicated Moisturizer and Slender Shaper.

According to the FDA, the claims on the company website about these products: are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are articles (other than food) intended to affect the structure or any function of the human body, rendering them drugs under the [Federal Food, Drug and Cosmetic] Act.”

The letter then goes on to explain how each of the cited topical products make claims that put provide evidence they are intended for use as drugs.

For Beta-C, the letter cites claims about stimulating collagen production and the regeneration of damaged skin, while for Eye Firmé, it makes reference to anti-inflammatory as well as collagen formation and production properties.

“We request that you take prompt action to correct all violations associated with your products, including the violations identified in this letter. Failure to do so may result in enforcement action without further notice,”​ the letter goes on to state.

Innovative Biodefense letter

The FDA letter concerning Innovative Biodefense refers to medicated personal care products for topical use, including Zylast XP Antiseptic,Zylast XP Antiseptic Foaming Soap, and Zylast XP Antiseptic Lotion.

Similar to the warning letter for Pharmagel, the FDA points to the fact that the company is defying the Federal Food, Drug and Cosmetic Act because of unapproved drug charges.

It specifies that the products listed and the claims made on the company’s website are intended to be effective against specific serious-disease-related pathogens such as Ebola, Methicillin-Resistant Staphylococcus aureus ​(MRSA), H1N1 flu virus, and norovirus.

The letter goes on to state that based on the labelling the products are drugs and the fact that they do not fulfill OTC monograph status, the company must take prompt action to change all such claims relating to the products mentioned, or face legal action.

Related topics: Regulation & Safety, Skin Care

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