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NY AG Schneiderman and IN AG Zoeller identified four "major flaws" in FDA's cGMPs for dietary supplements.
New York State Attorney General Eric T. Schneiderman is expanding his campaign to combat the “lax regulations” of the dietary supplement industry-this time in partnership with fellow State Attorney General Greg Zoeller of Indiana.
On May 26, Zoeller and Schneiderman sent a letter to FDA, calling for the agency to “overhaul federal oversight of the dietary supplement industry,” including an immediate enhancement to the industry’s current Good Manufacturing Practices (cGMPs).
“There’s no need to wait for congressional action to drastically improve federal oversight of the dietary supplement industry,” said Schneiderman, in a press release. He added that “the health and safety of the tens of millions of American who take supplements every single day will continue to be jeopardized until these lax regulations are improved.”
The attorneys general identified four “major flaws” in FDA’s current cGMPs for the dietary supplement industry, such as failing to cover ingredient suppliers, allowing manufacturers to decide on their own testing methods for confirming label claims, not requiring manufacturers to perform confirmatory testing of common allergens, and allowing ambiguous terms to be used in supplement labeling, such as “extract” or “natural.”
However, Michael McGuffin, president of the American Herbal Products Association (AHPA; Silver Spring, MD) challenged the idea that overhauling the cGMPs is necessary at this time, especially with the impending announcement of related regulations from the Food Safety Modernization Act (FSMA) to come later this year.
“Since the passage of the Food Safety Modernization Act (FSMA) in early 2011, ingredient suppliers have prepared for the cGMP and Preventive Controls regulations that will be issued later this year to implement this new law, and these regulations-which will apply to all domestic and international suppliers of food and food ingredients-will be more than adequate to ensure the accurate identity and quality of all food ingredients, including those used in supplements.”
McGuffin also noted “some misunderstanding of the current responsibilities of all dietary supplement manufacturers” on the part of the attorneys general, especially regarding food allergens.
“Compliance with the dietary supplement cGMP regulations and with the food allergen law is not voluntary but is compulsory,” said McGuffin. “Compliant companies may not include undeclared or substitute ingredients or contaminants that would adulterate a supplement product, and must meet the same FDA standard for ‘gluten-free’ and major allergen labeling as is required for conventional foods.”
Additionally, McGuffin contested the notion that consumers are misled by words like “extracts.”
“AHPA does not believe that consumers of vanilla extract believe they will find vanilla beans in each 2 ounce bottle, or vanilla flowers in the several prominent national brands that bear pictures of flowers on their labels,” said McGuffin. “Extraction of botanical ingredients is intended, just as with flavor extracts, to provide herbal products in a useful form to consumers.”
In the words of the attorneys general, the alleged shortcomings of current cGMPs for dietary supplements include:
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