FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Unsubstantiated Website Claims Draw FDA Warnings

Sept. 16, 2016
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Product claims on three companies’ websites led the FDA to issue warning letters declaring that the products have not been tested in human trials and cannot be advertised as bestowing health benefits.

Menscience Androceutical, based in Miami, sells its anti-aging cream through its website (www.menscience.com). The site featured claims that the cream is able to be “absorbed into fatty layers of skin to promote greater cell renewal and increases in collagen and elastin production.”

Other claims say the cream encourages collagen production and contains products that block the release of a neurotransmitter that causes facial muscles to tense and wrinkles to appear; reduce skin inflammation, irritation, itching and burning; facilitate quicker healing of wounds; and assist in increasing blood circulation and the creation of new skin cells.

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