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Posted November 09, 2023

FDA Warns Biorica International for Cholesterol, Kidney & Cancer Claims

On August 4, 2023, the FDA issued a Warning Letter to Biorica International Corp. following review of the company’s websites and social media, which found statements about the company’s Plaquex Oral Supplements to be drug claims, which are not permitted for dietary supplements.

For example, Plaquex Oral Supplement was promoted with statements such as, “Plaquex Oral is indicated for lowering cholesterol levels, triglyceride levels and to improve liver function but also as a[n] additional treatment to Plaquex infusions to prevent re-formation of plaque in the blood vessels after removal. Plaquex Oral is also used in kidney disease as studies show that it increases creatinine and urea clearance in conjunction with Plaquex infusions. Studies in patients with Psoriasis and Neurodermitis show that skin manifestations recede faster and stay in remission longer than with placebo.” and “Can Plaquex® help prevent cancer?...When I linked the facts of these three independent information sources, the thought came to me, that Plaquex® – Phosphatidylcholine – may be able to prevent cancer.”

The FDA stated that it considers these products to be “new drugs” because they are not recognized as safe and effective for their intended use. The FDA also found some of Biorica’s products to be misbranded because product labeling failed to bear adequate directions for their intended uses.

Biorica International Corp. must respond to the agency within 15 days of receipt of the warning explaining the specific steps taken to address any violations.

For more information about related products, see ConsumerLab’s Review of Cholesterol-Lowering Supplements.

Also see:

Are there vitamins or supplements that can reduce my risk of breast cancer? Do any increase cancer risk?

For more information, use the link below.

Warning: Biorica International Corp.

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