NY Attorney's Supplement Lab Tests: The REAL False Claims?

NY Attorney's Supplement Lab Tests: The REAL False Claims?
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Post Updated March 30 with an extremely questionable agreement between GNC and NY. The White House had Watergate, the NFL had Deflategate, and now the supplement industry has its own scandal… FILLER-Gate. With the new year comes a fresh set of accusations in the ever-evolving world of supplementation. 2014 was …
(Read More on the PricePlow Blog)


Excellent article and spot on which is the reason I haven’t jumped on the bandwagon to attack these vendors. DNA bar coding is not an acceptable test method for dietary supplements. My manufacturing facility has been audited 3 times by the FDA. We can't use DNA Bar coding for raw ingredient validation or final product testing, we use only USP testing methods. During a GMP audit, we not only have to provide scientific test results, we have to prove out the test methods. The NYAG was negligent in using a non-validated test method and not backing it up with UPS test methods proven out for each of the specific ingredients.

Federal regulation CFR 21 Part 111 requires scientific testing to ensure specifications are met for identity, purity, strength and composition of every dietary ingredient. In my facility, every individual lot of every dietary ingredient we purchase is quarantined until tested by independent labs before it is released into production. After the lot is tested quantitatively for purity and strength and composition, the individual barrels have to be identified. Each barrel within the lot undergoes FTNIR analysis to prove out identity. We’ve spent over a half a million dollars to build our identity lab for this singular purpose. CFR 111 also requires testing to prove label claim of finished product prior to release to the consumer. These are standard GMP procedures under CFR 111 regulations. I cannot imagine any of these four big box chains not using GMP manufacturing facilities. A GMP facility would have tested the ingredient coming in to the factory and the finished product prior to shipping to the consumer.

Most of the big box stores like Walmart, Target and so on, do sell pretty cheap products, however, they are usually amongst the strictest when it comes to ensuring that their contract manufacturers meet GMP specifications. Most won't rely on 3rd party certs like NSF, they send their own auditors, which in my experience have been stricter than FDA auditors. They might be price conscious and not concerned with making the best product, but they are extremely strict about compliance for regs to protect themselves against claims as the NYAG just hit them with.

It seems the AG is starting to realize his possible error, and has started to change his tune and is now issuing subpoenas for their research validating structure and function claims on the labels. If he can’t get them one way, he will go after them another way to divert attention.

What is just as interesting is how the media and politicians have responded; all condemning the industry and blaming it on deregulation by DHSEA act in 1994 and now claiming the industry is completed unregulated. This is completely untrue, every aspect of dietary supplement manufacturing, labeling, packaging and storage is completely regulated, almost to extent of pharmaceutical drug manufacturing. The federal regulation is 21 CFR Part 111: CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS.

Mark Glazier
Founder & CEO
NutraBio Labs