Vitality Products Company Inc. – FDA Warning Letter, Jul 7, 2010
The FDA conducted inspections at Vitality Products Company, Inc. from April 13-14, 2010, and June 30-July 7, 2010, and reviewed their website in October 2010. The review revealed serious violations of the Federal Food, Drug and Cosmetic Act.
Multiple products, including "Arthritis Nutritional Support with Glucosamine Sulphate," "Oral Chelation with EDTA," and "Natural Relaxation Magnesium Glycinate," were deemed unapproved new drugs under section 201(g)(1)(B) and 201(p) of the Act due to therapeutic claims on labels, literature, and the website, indicating intent for disease cure, mitigation, treatment, or prevention. These products are not generally recognized as safe and effective and lack FDA approval. Additionally, several of these products were misbranded under section 502(f)(1) for failing to bear adequate directions for use.
Even if not unapproved drugs, all listed products, plus "Liver Health Complex," "Thyroid Complex," and others, were misbranded dietary supplements under section 403 of the Act for non-compliance with 21 CFR Part 101 food labeling requirements. Specific misbranding issues included: - Failure to present nutrition information in a "Supplement Facts" panel (21 CFR 101.36(e)(1)). - Incorrect
ID · 171f1c29-a7dd-49c8-99ba-3bb119b5afe1
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