09.01.09
The Council for Responsible Nutrition (CRN), Washington, D.C., and the American Herbal Products Association (AHPA), Silver Spring, MD, have submitted comments to FDA regarding economically motivated adulteration (EMA). CRN called the problem “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,” said Andrew Shao, PhD, vice president, scientific and regulatory affairs, CRN. “The inappropriate reliance (intentional or not) on outdated or nonspecific test methods for identity also allows EMA to go unabated.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. 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.
In its comments, AHPA suggested that FDA consider including language in its proposed definition of EMA to ensure it encompasses products marketed as dietary supplements that are “spiked” with undeclared drug ingredients. “It is obvious that enforcement action is needed against these bad actors, and it is also clear that these products are intentionally adulterated for financial gain,” said Michael McGuffin, AHPA president. In addition, AHPA encouraged FDA to revisit a July 2007 petition suggesting FDA require companies receiving product in manufactured form to conduct examinations or tests to verify that identity and other specifications were met.
“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,” said Andrew Shao, PhD, vice president, scientific and regulatory affairs, CRN. “The inappropriate reliance (intentional or not) on outdated or nonspecific test methods for identity also allows EMA to go unabated.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. 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.
In its comments, AHPA suggested that FDA consider including language in its proposed definition of EMA to ensure it encompasses products marketed as dietary supplements that are “spiked” with undeclared drug ingredients. “It is obvious that enforcement action is needed against these bad actors, and it is also clear that these products are intentionally adulterated for financial gain,” said Michael McGuffin, AHPA president. In addition, AHPA encouraged FDA to revisit a July 2007 petition suggesting FDA require companies receiving product in manufactured form to conduct examinations or tests to verify that identity and other specifications were met.