In a letter dated October 5, 2012 , the FDA alleges that the company made claims on its website and product labels that the Agency to determine that the company’s Activz Control product “is promoted for conditions that cause the product to be a drug”.
In addition, during an inspection of the company’s facilities, FDA investigators found “a number of violations of the Current Good manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111)”.
GMP violations included, but were not limited to:
- Failure to produce master manufacturing records (MMR) for each dietary supplement formulation,
- Failure to include required information in its batch production records (BPR) for the Activz VMA and Control products,
- Failure to establish written procedures for manufacturing operations, and
- Failure to establish written procedures for packaging and labeling operations.
For a full list of the alleged violations, and to read the warning letter, please click here .
To read Food for Health International's response, please click here .