The Council for Responsible Nutrition (CRN), Washington, D.C., has offered comments to FDA regarding economically motivated adulteration (EMA), saying the problem is “a serious and growing concern for all consumer products industries.”

“The combination of key ingredients or raw materials that are in relatively high‐demand but relatively low‐supply has helped to fuel EMA for a whole host of consumer products,” Andrew Shao, PhD, vice president, scientific and regulatory affairs, CRN, said in his statement. “The inappropriate reliance (intentional or not) on outdated or nonspecific test methods for identity also allows EMA to go unabated. The absence of adequate enforcement and the perception by some that there are few, if any, consequences for committing EMA is also a major contributor to this problem.”

Dr. Shao stressed the importance of ingredient supplier qualification, including high standards for manufacturing practices as well as routine and thorough facility inspections.

“The dietary supplement good manufacturing practices (GMPs), promulgated in June 2007 are now in effect for the majority of the dietary supplement industry. This comprehensive set of regulations establishes high standards for the manufacturing, packaging and holding of dietary supplements. Holding dietary supplement manufacturers to these standards through rigorous enforcement will help to ensure that consumers have access to well made, high quality, unadulterated dietary supplements.”

However, GMPs alone—even when thoroughly implemented—are not enough to defend against EMA, he added, noting that suppliers of dietary ingredients are only held to GMP standards for food, which are far less stringent. “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. “

The industry faces a significant challenge in developing, disseminating and implementing the tools to detect economic adulterants, Dr. Shao said. Thus again demonstrating the importance of supplier qualification. “Analytical methods to detect specific economic adulterants may or may not be developed and available for use. 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’.”

To assist with the qualification of ingredient suppliers the dietary supplement industry developed the Standardized Information on Dietary Ingredients (SIDI) protocol. SIDI assists in the exchange of raw material information between ingredient suppliers and manufacturers. “While it is an effective tool, it represents only one small component of the ingredient supplier qualification process,” Dr. Shao said. “Additional effective tools and guidelines need to be developed to assist manufacturers with ingredient supplier qualification and to help ingredient suppliers assist their customers with proper GMP compliance.

Given CRN’s comments, Dr. Shao noted that FDA should reprimand manufacturers who knowingly accept economically adulterated raw materials. Still, many in the industry have expressed concern about reporting instances of EMA to FDA. “Concerns remain about FDA’s recent requests for information from the industry regarding instances of EMA. It is uncertain exactly how FDA would use information pertaining to, for example, a specific case of EMA regarding a dietary supplement raw material reported to them by a manufacturer.” CRN recommends that FDA establish a system of EMA information gathering and maintenance that would alleviate such concerns.