Editor's Note: Healthcare professionals attending an FDA webinar yesterday were reminded that FDA regulates both finished dietary supplements and dietary ingredients and products tainted with active pharmaceutical ingredients (APIs) are not dietary supplements. Capt. Jason Humbert, R.N., national health fraud coordinator in FDA's Office of Regulatory Affairs, noted that when FDA catches up with a company peddling tainted products, a class 1 recall is almost always issued. If the company does not accept FDA's request to recall the products, the agency can take further action such as issuing warning letters, conducting product seizures and/or taking the company to court. Nicole Kornspan, M.Ph., consumer safety officer at FDA, noted that while tainted products often masquerade as supplements, FDA also has found such products marketed as foods and cosmetics. AHPA actively works to inform consumers about tainted products at KeepSupplementsClean.org.

Natural Products INSIDER
November 21, 2017


In the most recent installment of FDA's Division of Drug Information (DDI) Webinar Series, speakers from the agency stressed dietary supplements are regulated and products tainted with drugs are not dietary supplements.

In the webinar sponsored by FDA's DDI, Center for Drug Evaluation and Research (CDER) and Office of Communications, Capt. Jason Humbert, R.N., national health fraud coordinator in FDA's Office of Regulatory Affairs, said "tainted supplements" is not the correct term for products adulterated with active pharmaceutical ingredients (APIs). ...

"The agency does not issue gold stars," Humbert assured, referring to GMP compliance. However, he debunked the common misconception in the healthcare community that supplements are not regulated. "FDA regulates both finished dietary supplements and dietary ingredients," he confirmed.

In reviewing the history of dietary supplement GMP regulations, Humbert noted FDA inspectors typically do not find adulteration during GMP inspections. "Many of the offenders are not registered with the agency, like responsible companies are," he explained.


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