Recalls & Warnings
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Posted January 19, 2022
FDA Warns Seller of Carnitine and Alpha Lipoic Acid Supplements
On November 18, 2021, the FDA issued a warning letter to GeroNova Research Inc. following a review of the company's website, social media, and Amazon listing, which found statements about the company's products, including CARNITINE PLUS Vegacaps, GeroNova Beauté Infine Elixir (also referred to as Liquid L-Carnitine and Liquid CARNITINE-PLUS,) and R-Lipoic Acid Vegacaps (both 300 mg and 100 mg), to be drug claims.
For example, the company's Amazon, website, and social media promotes CARNITINE PLUS Vegacaps and GeroNova Beauté Infine Elixir with statements such as "…supplemental Acetyl-L-Carnitine ‘significantly decreases depressive symptoms compared with placebo/no intervention…'" and "…slows signs of…cardiovascular and neurological disorders." R-Lipoic Acid Vegacaps were promoted with statements such as, "‘Possess anti-diabetic and anti-obesity properties,'...as it both increases insulin sensitivity through AMPK activation...and reduces insulin in pancreatic beta cells..."
The agency warned that the products are considered to be "new drugs" because "they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling." The products were also found to be misbranded because the labels did not provide bear adequate directions for its intended use.
The company has 15 days to respond to the FDA in writing, explaining the steps it has taken to correct these violations.
For more information, use the link below.
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