Attorneys General Urge FDA to “Overhaul” Regulation of Supplements


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:

  • Ingredient Suppliers: The CGMPs do not cover ingredient suppliers, which are often located overseas and beyond the reach of effective enforcement actions. Since manufacturers typically receive ingredients from suppliers as unrecognizable vats of powder, analytic testing at this stage cannot adequately detect frauds.
  • Testing of Label Claims: The CGMPS allow manufacturers to set their own label specifications and then choose their own tests for confirming label claims. The tests used by most manufacturers often cannot distinguish genuine products from chemically similar natural and synthetic compounds. Manufacturers largely judge for themselves whether to test for known substitutes and contaminants. The FDA acknowledges that a combination of testing methods is preferable, but the CGMPs expressly mandate the use of only one test-leaving the use of additional tests to the discretion of manufacturers.
  • Testing for Allergens: The CGMPs do not require manufacturers to engage in any confirmatory testing to ensure that supplements are free of common allergens, even where products are marketed as containing no allergens (e.g. “Gluten-Free”).
  • Labeling Ambiguity: The CGMPs fail to define key terms commonly used by manufacturers on labeling of dietary supplements. These terms are poorly understood and manufacturers use them in ambiguous and conflicting ways. For example, with herbal supplements, the industry applies the term “extract” to a spectrum of products-from minimally processed plants to highly purified chemicals. When consumers buy a “natural” product-which typically features a root, a leaf, a flower, or a piece of bark on the label-they do not reasonably expect to receive a heavily processed chemical. Yet, more often than not, this is what they get. 


Read more:

NY AG Takes Dietary Supplements Fight to Congress

NY AG, GNC Reach Agreement. But Is It a Mistake?


Michael Crane
Associate Editor
Nutritional Outlook Magazine


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