Posted July 23, 2016

Maker of "Super Food" Warned for Manufacturing Violations

On July 12, 2016, the FDA issued a warning letter to TerraVare, Inc., following a facility inspection which found the company's product,  High Frequency Super Food Formula 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 identify who is responsible for quality control operations (specifically, no quality control personnel was employed during the inspection), failure to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to its use (specifically, phytoplankton and milled chia seed), and failure to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement manufactured, as required by federal regulations. 

In addition, High Frequency Super Food Formula was found to be misbranded because information listed on the label did not comply with federal regulations. 

(See ConsumerLab.com's Reviews of Greens and Whole Foods Powders and Pills for tests of related products.)

See Related Warnings:

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

Seller of Brain, Diabetes, Echinacea Supplements and More Warned for Drug Claims

Maker of Vitamin K, Vitamin A & More Warned for Manufacturing Violations, Drug Claims

Seller of "Hangover" Supplement Warned for Manufacturing Violations & Drug Claims

Seller of "Natural" Cough Syrup Warned for Manufacturing Violations, Drug Claims

Seller of Aloe, Sexual Enhancement Supplements and More Warned for Manufacturing Violations, Drug Claims

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