Posted December 26, 2017

Seller of BrainAlert Warned for Manufacturing Violations, Drug Claims

On December 14, 2017, the FDA issued a warning letter to BrainAlert, LLC., following a facility inspection which found the company's product,  BrainAlert, to be adulterated because it was 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 to make and keep written procedures for the responsibilities of the quality control operations, as required for federal regulations.

In addition, statements made about BrainAlert on the company's website, such as "Are you struggling with ... Seasonal depression? ... Then BrainAlert is the solution for you!" and "DMAE was used to help ADD children in the 1980's, which studies showing improvement in memory, concentration, and the ability to focus," were found to be drug claims. 

BrainAlert contains ingredients including DMAE, gotu kola, huperzine A, and vitamin B3 (niacinamide).

See ConsumerLab.com's Reviews of Huperzine A Supplements, and B Vitamin Supplements for tests of related products.

Also see ConsumerLab.com's answers to the following questions: 

Do any supplements really help with brain function, like memory and cognition?

Does Prevagen really improve memory?

What is Brain Bright and can it really improve memory or cognition?

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.