Recalls & Warnings
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Posted January 26, 2016
Seller of CoQ10, SAM-e, Vitamin D, and More Warned for Manufacturing Violations, Drug Claims
These violations include failure to establish specifications for identity and purity of each finished dietary supplement product, and failure to investigate product complaints (including three complaints of adverse events such as flushing, hives, heart palpitation, and GI distress, resulting in two individuals going to the emergency room for treatment) as required by federal regulations.
In addition, statements about these products in marketing materials and on the company's website were found to be drug claims. For example, SAMe-200 (Progressive Labs brand) was promoted with statements such as "[T]hese vitamins result in low concentrations of SAMe in the central nervous system (CNS). Low blood or CNS levels have been detected in people with cirrhosis of the liver, coronary heart disease, Alzheimer's disease, and depression. SAMe has been effectively used as an antidepressant; it is beneficial for disorders of the joints and connective tissues, such as osteoarthritis and fibromyalgia... it may lower homocysteine levels, an amino acid associated with cardiovascular disease". Nutri-Dyn brand: D3 5000 was promoted with statements such as "Helps in cancer prevention."
See Related Warnings:
To read the FDA's warning letter, use the link below