Posted November 29, 2016

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

On July 1, 2016, the FDA issued a warning letter to BioGenyx-Basic Reset, following a facility inspection which found the company's products, including Ionyte, Aqualyte, Beta Factor, Bee Gold and Primo Java 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 dietary supplement labels, and for packaging that may come in contact with dietary supplements, and failure to establish and follow written procedures for the responsibilities of the quality control operations, as required by federal regulations.

In addition, statements made about the products on labels and in marketing materials were found to be drug claims. For example, AquaLyte was promoted with statements such as "reduce, or eliminate aches and pains in joints and muscles... prevent bone loss associated with osteoporosis ". Ionyte was promoted with statements such as "eliminate aches and pains in muscles and joints... Speeds healing of cuts, burns, bruises, insect bites/stings... rheumatoid arthritis... irritable bowl [sic] syndrome... diabetes... psoriasis... it stops arthritis".

(See ConsumerLab.com's Reviews of Calcium Supplements and Joint Health Supplements for tests of related products).

See Related Warnings:

Seller of B Vitamins, Omega-3s and More Warned for Manufacturing Violations, Drug Claims

Seller on Noni Juice Warned for Manufacturing Violations, Drug Claims

Seller of Whey Protein Warned for Manufacturing Violations, Drug Claims

Seller of Joint Health, Omega-3 Supplements & More Warned for Manufacturing Violations, Drug Claims

Seller of Turmeric, Milk Thistle and More Warned for Manufacturing Violations, Drug Claims

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