The QMN Weekly Bulletin
Pharmaceuticals / Quality / Regulatory Affairs

FDA Warns Dietary Supplement Companies on Ingredients, Product Claims

Aug. 4, 2017
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A California company violated federal law by making and selling as a dietary supplement a product containing prescription drugs used to treat erectile dysfunction, the FDA said.

MS Bionic of Glendale also made claims about its supplements that led them to be categorized as unapproved new drugs.

The FDA made similar category allegations in July letters to two other supplement firms: Vendame Oils, of Beverly Hills, Calif., and Absonutrix, of Greensboro, N.C.

The MS Bionic product Megajex, marketed as an herbal supplement, contained sildenafil and tadalafil, the FDA said. Sildenafil is the active pharmaceutical ingredient in Viagra, and tadalafil is the active ingredient in Cialis, both prescribed for erectile dysfunction.

MS Bionic voluntarily recalled Megajex nationwide in November 2016, the letter said.

Megajex is claimed to “increase stamina,” and a second MS Bionic product, Casanova Plus, was marketed with the claim “free from premature ejaculation.” MS Bionix did not seek approval for the drug claims approval by the FDA as new drugs, the letter said.

Vendame Oils claimed its products could combat eczema, destroy acne-causing bacteria and prevent skin blemishes and blackheads, the FDA said.

Absonutrix claimed that its products could inhibit the growth of colon cancer cells, control high blood pressure, treat urinary tract infections, regulate cholesterol and blood sugar, help prevent osteoarthritis and deter viruses, bacteria, parasites and fungi. Vendame also improperly displayed the FDA logo on its web site, the agency said.

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