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Posted October 30, 2014

Supplement Maker Warned for Manufacturing Violations

On October 21, 2014, the FDA issued a warning letter to DNG Trading & Milling, LLC, following a facility inspection which found the company's 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 product specifications for the identity, purity, strength, and composition of the finished batches of dietary supplements to ensure quality, and failure to conduct at least one appropriate, scientifically valid test or examination to verify the identity of a component that is a dietary ingredient prior to its use. For example, the company performed a visual inspection of the raw material Tribulus terrestris, but did not perform any scientifically valid tests to ensure the identity of the ingredient.

(See the Sexual Enhancers Review for tests of related products.)

In addition, one product (which was not named) was found to be misbranded, because the label failed to provide information required by federal regulations, including the presence of known allergens, and the place of business of the manufacturer.

See Related Warnings:

Maker of Herbal Supplements Warned for Manufacturing Violations and Drug Claims

Seller of Mineral and Joint Supplements Warned for Manufacturing Violations and Drug Claims

Vita Springs Health Warned for Manufacturing Violations and Drug Claims

Seller of Flaxseed, Ginkgo and More Warned for Manufacturing Violations and Drug Claims

Seller of Aloe, Thyroid and Other Supplements Warned for Manufacturing Violations and Drug Claims

Herbal Supplement Company Warned For Drug Claims, Manufacturing Violations

Maker of Digestive Health Supplement Warned For Manufacturing Violations, Drug Claims

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