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Posted December 26, 2017

Seller of Fish Oil, Vitamin D, Whey Protein and More Warned for Manufacturing Violations

On December 19, 2017, the FDA issued a warning letter to Maine Natural Health, Inc., following a facility inspection which found some of the company's products, including its Peppermint SO3 + D3 Fish Oil and Vanilla Recovery Whey Protein products 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 establish specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, and failure of finished product specifications to include all of the ingredients used in the products, including rebaudioside A, natural vanilla flavor, and sunflower lecithin that are used in Vanilla Recovery Whey Protein and natural peppermint flavor and mixed natural tocopherols used in Peppermint SO3 + D3 , as required for federal regulations.

In addition, statements made about certain products on the company's website were found to be drug claims. For example, SO3 + D3 Fish Oil was promoted with statements such as " [Vitamin D [an ingredient in the product] may improve heart health... heart disease is the leading cause of death in the US, which makes vitamin D an important nutrient." and " Benefits of fish oil [an ingredient in the product] include: reduced inflammation." Recovery Whey Protein was promoted with statements such as " [G]rass fed whey [an ingredient in the products]... naturally higher in Omega-3... benefits include: reduces inflammation... reduces risk of irregular heartbeats...reduce risk of plaque buildup in arteries " 

See's Reviews of Fish Oil and Omega-3 Fatty Acid Supplements, Vitamin D Supplements and Protein Powders and Drinks for tests of related products.

See related warnings:

Seller of Meal Replacement, Protein Drinks, Cranberry and More Warned for Manufacturing Violations

Seller of Supplements for Pain and Allergies Warned for Manufacturing Violations, Drug Claims

Seller of 5-HTP, Chromium, Curcumin and More Warned for Drug Claims

Seller of Muscle Supplements and More Warned for Manufacturing Violations

Creatine Powder Containing DMAA Recalled

FDA Warns Seller of Acai, Garcinia & More for Drug Claims

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