The FDA regulations will affect supplements makers and be published in a few weeks, according to an article in Functional Foods and Nutraceuticals.
“GMPs [good manufacturing practices] are crucial because they assure the public that the products they are buying live up to their labels,” Senator Orin Hatch said.
Loren Israelsen, president of the United Natural Products Alliance, welcomed the document but expressed reservations about its likely content.
The Councel on Responsible Nutrition stated, “Consumers deserve supplement-specific good manufacturing practices for all supplement products.
The FDA traditionally considered dietary supplements to be composed only of essential nutrients, such as vitamins, minerals, and proteins. The Nutrition Labeling and Education Act of 1990 added “herbs, or similar nutritional substances,” to the term “dietary supplement.” As a result of the Dietary Supplement Health and Education Act of 1994 (DSHEA), Congress expanded the meaning of the term “dietary supplements” beyond essential nutrients to include such substances as ginseng, garlic, fish oils, psyllium, enzymes, glandulars, and mixtures of these.
John Russo, Jr., PharmD, is president of The MedCom Resource, Inc. Previously, he was senior vice president of medical communications at www.Vicus.com, a complementary and alternative medicine website.