OK, so there's more than one news in here, but we had to dive into the warning letter pile. There have been numerous letters that offer free tutorials into the FDA approach to GMPs and product claims, so we’ve pulled a couple of the most important ones.
As the posting amounted to an unauthorized drug-claim and AMARC had effectively 'endorsed' it by 'liking' it on its Facebook page, the FDA included this as one of several examples of the company promoting PolyMVA “for conditions that cause the product to be a drug” rather than a dietary supplement.
Second is the letter sent to Pristine Bay, L.L.C., which showed the Agency’s stance on the obligations of private label distributors to “ensure that all phases of the production of [a] product are in compliance with dietary supplement CGMP requirements”.
Commenting on the letter, Justin Prochnow, shareholder at lawfirm Greenberg Traurig, LLP in Denver, said: “I have previously identified warning letters in which FDA has reiterated the obligations of private label distributors to ensure that the cGMPs are followed, even if the private label distributors do not perform any manufacturing duties.
“While other letters have pointed out the obligations of private label distributors, FDA, in an April 26, 2013 letter to Pristine Bay LLC dba Vianda, goes to greater lengths to emphasize the private label distributors’ obligations.”
Finally, a warning letter dated May 22, 2013 indicated that the FDA was continuing to deepen the scope of its Section 111-related investigation criteria, with the reaffirming FDA’s willingness and ability to test and verify nutrient content claims.
Commenting at the time, Aaron Secrist, Quality & Regulatory Manager for NOW Foods, told us: "I think the warning letter clearly demonstrates that the FDA is moving past some of the basic foundational GMP issues such as specifications, SOPs and master manufacturing records to address what companies are doing to ensure that their label claims are met through finished product testing. I expect there will be more warning letters to come in this area.”