Responding to a now-closed call for comment from the Food and Drug Administration (FDA), CRN highlighted new GMP regulations as being a step in the right direction, but noted ingredient suppliers remained under the rule of food GMPs, not the GMPs that came into force two years ago.
“Inadequate ingredient supplier qualification, especially among the smaller and less experienced dietary supplement manufacturers, coupled with the fact that ingredient suppliers are not subject to the dietary supplement GMPs, can be a contributor to sustaining a climate of EMA,” CRN’s vice president of scientific and regulatory affairs, Dr Andrew Shao, wrote to the FDA in an eight-page submission.
The 2007 GMP regulations place the onus on product manufacturers to ensure the quality of their raw materials is sufficient, but Shao wrote this concept of “quality” remained unclear.
Unknown adulterants
Dr Shao also observed the rapid development of adulteration science, and that many cases of adulteration occur in totally innocent circumstances – at lest on the part of the product manufacturer, who is blind to the adulteration at the time.
“Manufacturers face the same challenges as FDA when it comes to the awareness of an ability to test for known and potential adulterants,” he wrote.
“In many cases, there is inadequate dissemination to and application of these methods by manufacturers to ensure their products are free of such adulterants. With the efforts of perpetrators evolving so rapidly, consumer products companies are frequently faced with new, previously unknown adulterants. Furthermore, one cannot test for adulterants that one does not know exist. Finally, one cannot ‘test quality into products’.”
Dr Shao noted that while the Standardized Information on Dietary Ingredients (SIDI) protocol helped promote quality, it alone could not guarantee safety, and further tools needed to be developed. The FDA was urged to work with industry to achieve this goal and to increase the intensity of its inspections of food manufacturer’s facilities.
Punitive action must increase also. “Without the threat of adequate enforcement or perceived consequences for criminal behavior, the current climate of EMA will continue.”
Delivering EMA information to the FDA was questioned by Dr Shao, especially as it was not certain how the information would be used and publicized by the agency, with potentially devastating commercial results.
CRN suggested an anonymous web-based system would gather more, if less detailed, information, “and perhaps even erroneous leads” but it could be useful in identifying areas of concern.