Posted January 26, 2016

Seller of CoQ10, SAM-e, Vitamin D, and More Warned for Manufacturing Violations, Drug Claims

On January 15, 2016, the FDA issued a warning letter to Nutri-Dyn Midwest, Inc., following a facility inspection which found the company's products, including Cardioauxin BP, Zinc Lozenge, Oliver, Pau D'Arco, Petadolex, Chondro Jointaide, Dynagesic, SAMe-200, Gugulipid. CaridoAuxin BP, Coenzyyme Q10, OmegaGenics, Mega 10, ArginCor, NutrihCG, NutrihCG Reset, Nutri DMSA, Metal Detox, D3 5000, Cardioauxin and Red Yeast Extract Extra Strength to be adulterated because they prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

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 ConsumerLab.com's Review of SAM-e Supplements and Vitamin D Supplements for tests of related products.

See Related Warnings:

Seller of Aloe, Moringa Supplements Warned for Manufacturing Violations, Drug Claims

Seller of Brain, Diabetes, Echinacea Supplements and More Warned for Drug Claims

Maker of Vitamin K, Vitamin A & More Warned for Manufacturing Violations, Drug Claims

Seller of "Hangover" Supplement Warned for Manufacturing Violations & Drug Claims

Seller of "Natural" Cough Syrup Warned for Manufacturing Violations, Drug Claims

Seller of Aloe, Sexual Enhancement Supplements and More Warned for Manufacturing Violations, Drug Claims

Maker of Aloe, Weight Loss Supplements and More Warned for Manufacturing Violations, Drug Claims

To read the FDA's warning letter, use the link below