Sean Moloughney, Editor06.09.15
New York Attorney General Eric Schneiderman and Indiana Attorney General Greg Zoeller sent a letter to FDA dated May 26 calling for an overhaul to federal oversight of the dietary supplement industry.
In February Mr. Schneiderman launched an investigation into the herbal dietary supplement market, claiming DNA tests failed to show certain products from major retailers actually contained ingredients listed on labels.
While the testing method for this case was widely discredited, GNC reached an agreement with the AG in March whereby the retailer said it will perform DNA barcode testing to authenticate botanical ingredients used in its brand of supplements.
The retailer also agreed to conduct allergen testing, to purchase ingredients only from third-party certified suppliers and to educate consumers about the processing of its extracts.
Extending GMPs to Suppliers
The letter referenced a recent citizen petition submitted by the Organic and Natural Health Association that requested FDA extend cGMP rules to cover dietary ingredient suppliers.
“Not only should FDA swiftly act on this request, the agency should view the petition as an opportunity to broadly revisit and strengthen the existing supplement regulations and their enforcement,” the AGs’ letter stated.
“Excluding suppliers from existing regulations is all the more concerning given that manufacturers typically receive ingredients as unrecognizable vats of powder, analytic testing at this stage cannot adequately detect frauds, and the ingredient suppliers are often overseas and beyond the reach of effective enforcement actions.”
American Herbal Products Association (AHPA) President Michael McGuffin responded to the letter, saying the association and its members support the New York and Indiana attorneys general call for more resources to strengthen enforcement of FDA regulations that govern the dietary supplement marketplace.
"But AHPA does not believe there would be any increased product quality or benefit to consumers to require ingredient companies to comply with the dietary supplement cGMP rule at this late date. AHPA supported FDA in 2003 when it proposed to include ingredient companies in the proposed cGMP rules. FDA then chose not to do so. But it is neither feasible nor necessary to roll back the clock.
“Since the passage of the Food Safety Modernization Act (FSMA) in early 2011,” he continued, “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.”
‘Grave Public Concern’
The AGs’ May 26 letter to FDA went on to suggest that quality and safety issues facing the supplement industry are a matter of “grave public concern.”
“Scientists and consumer advocates have repeatedly discovered dangerous natural and synthetic compounds, including powerful stimulants, anabolic steroids, and prescription drugs, in commercially available dietary supplements.”
The letter also pointed to adulteration and substitution of herbal supplement ingredients, suggesting a lack of validated and standardized testing methods is to blame.
In its response, AHPA noted the AGs’ letter indicates some misunderstanding of the current responsibilities of dietary supplement manufacturers. “Compliance with the dietary supplement cGMP regulation and with the food allergen law is not voluntary but is compulsory,” said Mr. 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 food allergen labeling as is required for conventional foods.”
According to the AGs, cGMPs “fail to define the key terms applied to dietary supplements or require manufacturers to disclose to consumers how those terms apply to a given product. There terms are poorly understood and manufacturers use them in ambiguous and conflicting ways.” The letter cited broad use of the term “extract” to refer to a range of products, including highly processed chemical constituents.
"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. Extraction of botanical ingredients is intended, just as with flavor extracts, to provide herbal products in a useful form to consumers."
The AGs concluded, “Congress should act swiftly to expand FDA’s powers to regulate the industry and substantially increase resources for enforcement.”
In February Mr. Schneiderman launched an investigation into the herbal dietary supplement market, claiming DNA tests failed to show certain products from major retailers actually contained ingredients listed on labels.
While the testing method for this case was widely discredited, GNC reached an agreement with the AG in March whereby the retailer said it will perform DNA barcode testing to authenticate botanical ingredients used in its brand of supplements.
The retailer also agreed to conduct allergen testing, to purchase ingredients only from third-party certified suppliers and to educate consumers about the processing of its extracts.
Extending GMPs to Suppliers
The letter referenced a recent citizen petition submitted by the Organic and Natural Health Association that requested FDA extend cGMP rules to cover dietary ingredient suppliers.
“Not only should FDA swiftly act on this request, the agency should view the petition as an opportunity to broadly revisit and strengthen the existing supplement regulations and their enforcement,” the AGs’ letter stated.
“Excluding suppliers from existing regulations is all the more concerning given that manufacturers typically receive ingredients as unrecognizable vats of powder, analytic testing at this stage cannot adequately detect frauds, and the ingredient suppliers are often overseas and beyond the reach of effective enforcement actions.”
American Herbal Products Association (AHPA) President Michael McGuffin responded to the letter, saying the association and its members support the New York and Indiana attorneys general call for more resources to strengthen enforcement of FDA regulations that govern the dietary supplement marketplace.
"But AHPA does not believe there would be any increased product quality or benefit to consumers to require ingredient companies to comply with the dietary supplement cGMP rule at this late date. AHPA supported FDA in 2003 when it proposed to include ingredient companies in the proposed cGMP rules. FDA then chose not to do so. But it is neither feasible nor necessary to roll back the clock.
“Since the passage of the Food Safety Modernization Act (FSMA) in early 2011,” he continued, “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.”
‘Grave Public Concern’
The AGs’ May 26 letter to FDA went on to suggest that quality and safety issues facing the supplement industry are a matter of “grave public concern.”
“Scientists and consumer advocates have repeatedly discovered dangerous natural and synthetic compounds, including powerful stimulants, anabolic steroids, and prescription drugs, in commercially available dietary supplements.”
The letter also pointed to adulteration and substitution of herbal supplement ingredients, suggesting a lack of validated and standardized testing methods is to blame.
In its response, AHPA noted the AGs’ letter indicates some misunderstanding of the current responsibilities of dietary supplement manufacturers. “Compliance with the dietary supplement cGMP regulation and with the food allergen law is not voluntary but is compulsory,” said Mr. 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 food allergen labeling as is required for conventional foods.”
According to the AGs, cGMPs “fail to define the key terms applied to dietary supplements or require manufacturers to disclose to consumers how those terms apply to a given product. There terms are poorly understood and manufacturers use them in ambiguous and conflicting ways.” The letter cited broad use of the term “extract” to refer to a range of products, including highly processed chemical constituents.
"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. Extraction of botanical ingredients is intended, just as with flavor extracts, to provide herbal products in a useful form to consumers."
The AGs concluded, “Congress should act swiftly to expand FDA’s powers to regulate the industry and substantially increase resources for enforcement.”
