Despite widespread industry approval of the recently released GMP rule, New York-based product tester, Consumerlab.com (CL) has criticised the regulation for a "lack of quality standards" which it says may lead to "bad" products being produced under "good" practices. "The GMPs require manufacturers to test all ingredients going into supplements, but fail to specify the methods and standards by which ingredients are to be judged," said ConsumerLab president, Tod Cooperman, MD.
For example, lead and other contaminant levels in supplements are not specified in the ruling — it is instead left up to individual manufacturers to determine their own limits.
"The GMPs require manufacturers to test all ingredients going into supplements, but fail to specify the methods and standards by which ingredients are to be judged," he said, noting that manufacturers were free to judge the identity of ingredients, which it believes could open a Pandora's Box of "supplements of low quality or with very little real ingredient."
Marc Ullman, partner at New York law firm Ullman, Shapiro, Ullman and FDA regulatory expert, responded to Consumerlab in a blog on NPICenter.com saying Consumerlab was misinterpreting the GMP mandate.
"CL's misguided attack on the supplement GMPs is based on the very flawed concept that it is possible to test quality into products," Ullman wrote. "The original draft GMPs published by FDA represented an effort to do just that. The draft GMPs required repeated testing at almost every level of the manufacturing process while de-emphasizing the notion that true quality comes from understanding what you are doing, development of reliable methodologies to make the same thing every time and execution of processes in a consistent manner."
He added: "GMPs require companies to set up process controls. They are not intended to set limits on things like lead." The final regulation reflected this idea, he said, rather than making repeat testing mandatory.
Steve Mister, Council for Responsible Nutrition (CRN), President and CEO said Consumerlab.com's comments about the GMPs were self-serving and disingenuous. "Consumerlab.com's reaction to the GMPs is not surprising as it is a for-profit business that makes money from supplement companies who pay for CL's passing grades. The GMPs are an important step forward for this industry and will tremendously advance quality in this industry, whether manufacturers choose to participate in the CL programs or not." He added: "As for its ingredient verification program, CL joins many other respected private laboratories and consultants who perform these services. What the final GMPs make clear though is that manufacturers must be accountable for their supplements — reliance on suppliers, third party labs, or private testing services will not relieve companies who don't produce quality product for consumers. That is the central tenet of the GMPs."
In a statement, Cooperman accused CRN of spreading myths, saying companies can voluntarily have CL test their products, but none can pay for "passing grades. "In fact, companies can not send even send us marketed products — we have to buy them on the market — and these are tested on a blinded basis by one or more independent laboratories," he insisted.