Posted July 18, 2018

Maker of Vitamin B12 and Multimineral Supplements Warned by FDA

On July 6, 2018, the FDA issued a warning letter to Aegle Nutrition, LLC, following a facility inspection which found some of the company's products, including Tropical Oasis Ionized Trace Minerals, Tropical Oasis Ultra Methyl B12, and Tropical Oasis Premium Vitamin B12 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 batch of dietary supplements to ensure the quality of the dietary supplement and failure to prepare and follow a master manufacturing record (MMR) for the dietary supplement products that the company packages and labels, as required by federal regulations.

In addition, some of the products were found to be misbranded. For example, the product label for Tropical Oasis Ionized Trace Minerals declares calcium, iron, zinc, iodine, phosphorus, magnesium, potassium, selenium, copper, manganese, chromium, molybdenum, and sodium as components of the Colloidal Minerals blend, but the amounts of these ingredients are not properly listed.

(See ConsumerLab.com's Multivitamin and Multimineral Supplements Review for tests of related products.)

Tropical Oasis Ionized Trace Minerals, Tropical Oasis Ultra Methyl B12, and Tropical Oasis Premium Vitamin B12 were found to be misbranded because the labels fail to identify the part of the plant from which each botanical dietary ingredient in the products are derived, as required by federal regulations. 

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

See related warnings:

Seller of B Vitamins, Vitamin C, Potassium & More Warned for Manufacturing Violations

Maker of Magnesium, Calcium, Zinc, B Vitamins and More Warned for Manufacturing Violations, Drug Claims

Seller of B-12, Zinc, Echinacea and More Warned for Manufacturing Violations and Drug Claims

B Vitamin Supplement Found To Contain Anabolic Steroids

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