Two Attorneys General Push For Reform On Supplement Industry Regulations

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New York—Only a few months after GNC, one of the nation’s largest supplement stores, made an agreement with New York Attorney General Eric T. Schneiderman to change its manufacturing process, Schneiderman and Indiana Attorney General Greg Zoeller have sent a letter to the Acting Commissioner of the Food and Drug Administration (FDA) urging for the reformation of its Dietary Supplements 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 statement. “The FDA has the authority to rewrite the rules that govern the multibillion-dollar dietary supplement industry today.”

According to the press release, the letter sent to FDA singles out four “flaws” in the cGMPs:

* Ingredient suppliers: The guidelines do not cover ingredient suppliers, which may be located overseas; therefore, the letter asserts that some ingredients arrive at manufacturers untested and these firms cannot adequately detect frauds. This point was made in reaction to a citizen petition submitted by the Organic and Natural Health Association. Karen Howard, the group’s CEO and executive director, stated that “many quality raw ingredient suppliers who already meet or exceed the FDA’s cGMP standards.” She adds that the problem are those that refuse to voluntarily adopt cGMPs, since they “compromise the integrity of their supply chains and create opportunity for a proliferation of substandard products in this highly price sensitive environment.”

* Testing of label claims: Companies can choose their own testing methodology to confirm claims made on product labels, the attorney generals say. FDA has acknowledged that multiple tests would be ideal, but the current cGMPs make only one test mandatory.

* Testing for Allergens: Products are not required to be tested for allergens even if the product is labeled to have none.

* Labeling Ambiguity: There is no common definition for words commonly used on labels, such as “extract” or “natural.”

“I urge the FDA to use every tool at its disposal to protect consumers in New York and across the country from the unnecessary risk of tainted supplements,” said Schneiderman.

While the American Herbal Products Association (AHPA) supports the Attorneys General of New York and Indiana, the organization also shows some hesitance regarding the affect of the reform in today’s market.

“AHPA and its members support the New York and Indiana attorneys general expressed call for more resources to strengthen enforcement of the numerous FDA regulations that govern the dietary supplement marketplace,” AHPA president Michael McGuffin said in a statement. “But AHPA does not believe there would be any increased product quality or benefit to consumers to required ingredient companies to comply with the dietary supplement CGMP rule at this last date.”

AHPA also makes the point that there are several inaccuracies in the letter. Regarding food allergen testing, for instance, the group says compliance with the “food allergen law is not voluntary but is compulsory. 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 food allergen labeling as is required for conventional foods.”

Published in WholeFoods Magazine, July 2015, (Posted 6/3/2015, updated 6/5/15)