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Posted April 29, 2014

Seller of B Vitamins, CoQ10, Amino Acids and Other Supplements Warned for Manufacturing Violations and Drug Claims

On April 1, 2014, the FDA issued a warning letter to Bio-Recovery, Inc., following a facility inspection which found products distributed by the company, including Bio-Lithium, Niacinamide, Bio-Aminos, and CoQ-10, to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to identify personnel to be responsible for quality control operations and failure to establish and follow written procedures for returned dietary supplements and product complaints.

Statements made about Bio-Lithium, Niacinamide, Bio-Aminos, and CoQ-10 on Bio-Recovery's website were also found to be drug claims.

Bio-Lithium contains lithium orotate and was promoted with statements such as "[w]e've seen many positive benefits... particularly for alcoholics" and "Lithium treatment shows promise for ...Cluster Headaches; Hyperthyroidism/Graves Disease; Gout; Fibromyalgia; Herpes Simplex and other Viruses."

Niacinamide was promoted with statements such as "B3 treatment has been used successfully to treat some forms of schizophrenia" and "Niacin has been shown effective in: Lowering of high cholesterol."

(See's Review of B Vitamin Supplements for tests of related products.)

Bio-Aminos contains a blend of amino acids including cysteine, histidine, glycine, proline, taurine, tyrosine, glutamine, leucine, isoleucine, phenylalanine, lysine, arginine, alanine, methionine, valine, aspartic acid, serine and threonine. It was promoted with statements such as "amino acids ...Promote wound healing...[;]Reduce blood pressure[;] Lowering cholesterol...[;] Relieve pain[;] Provide relief for ailing gall bladders[;] Fight drug addiction[;] Control Parkinson's disease[;] Prevent insomnia."

(See's Review of Muscle Enhancers for tests of related products.)

CoQ-10 was promoted with statements such as "Co-Q 10 supplementation... improves a variety of heart conditions such as cardiomyopathy, congestive heart failure, valve problems, unstable angina and high blood pressure" and "Supplementation ...may even slow down or possibly reverse some age related brain disorders, such as Alzheimer's, Huntington's and Parkinson's."

(See's Review of CoQ10 Supplements for tests of related products.)

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