Utah-based Food for Health International, LLC, says it is ‘much stronger’ following a recent FDA audit and the changes necessitated by a subsequent warning letter.
In a warning letter dated October 5, 2012 , the Food and Drug Administration (FDA) alleged that the company made disease claims on its website and product labels, and that an earlier audit revealed GMP violations.
In response to the audit’s findings and the subsequent warning letter, Food for Health International (FFH) issued a statement to NutraIngredients-USA saying it “takes FDA audits and regulations very seriously, and sent a response to the FDA within the required 15 days after the audit was performed. The FDA confirmed receipt of this letter, and all audit agenda items were fully satisfied and addressed by the time the warning letter was received five months later.”
“According to the FDA, the warning letter was issued because proof of corrective implementations must be continually sent to their offices after the initial audit. The Compliance Safety Officer never stated this policy to FFH representatives, and it was not documented in any clause numbers on the audit. As soon as this policy was explained, FFH provided the necessary proof within three days.
“For example, FFH’s Activz Control dietary supplement was cited for labels that did not conform to FDA regulations. Immediate action was taken to remove Activz Control from the company website, and the remaining inventory was placed on QA Hold. Proper revisions to meet FDA regulations for the labels and packaging are nearing completion, and the product will not become available again until this process is complete.
“Food for Health manufacturing is much stronger due to the changes made in response to the audit findings. We are now confident that our facility is 100% compliant with all FDA guidelines and regulations.”
A spokesperson for the company told use that, despite the activznutrition.com website still being accessible, the product is no longer available. The website is operated by a third party vendor and FFH is "working with this vendor to get the functional claims and other outdated copy removed, but we are beholden to their timeline, not ours".