Sean Moloughney, Editor04.02.15
Claiming the safety and efficacy of dietary supplements is a matter of “deep public concern across the country,” 14 state attorneys general have sent a letter to Congress urging leadership to investigate the industry and to consider “a more robust oversight role” for FDA.
The April 2 letter stated in part: “The FDA has long been aware of problems in the dietary and herbal supplement supply chain, from dubious ingredient sourcing to a failure to carry out proper testing on finished products."
The action is the latest step in a series of developments sparked by cease-and-desist letters New York AG Eric Schneiderman issued on Feb. 2 to GNC, Target, Walgreens and Walmart, which were based on DNA barcode testing that allegedly found many herbal extract products evaluated didn’t actually contain ingredients listed on labels. However, Mr. Schneiderman has not released his study data despite calls for transparency.
Experts have said test methods were inappropriate because botanical extracts and highly processed finished products are not expected to have enough DNA intact to isolate a barcode. FDA itself recently stated that DNA barcoding tests should only be used in combination with established methodologies historically used to verify identity.
The coalition’s letter requests that Congress act in concert with the FDA to explore and address the following:
1. The adequacy and effectiveness of existing quality assurance measures for verifying the source, identity, purity, potency, and quality of ingredients and fillers;
2. The adequacy and effectiveness of existing regimes for verifying the identity, composition, purity, potency, and quality of the finished products sold by domestic manufacturers and retailers;
3. The degree to which product labels and marketing, including use of the terms “natural,” “herbal,” and “extract,” mislead consumers about the contents of herbal and dietary supplements and whether the FDA should develop standards and restrictions governing their use;
4. The extent to which Congress should mandate, or direct the FDA to develop, enhanced, uniform, industry-wide quality assurance and verification regimes to guarantee the source, identity, purity, and potency of materials incorporated into herbal and dietary supplements; and,
5. The extent to which Congress should mandate, or direct, the FDA to develop enhanced manufacturing and supply chain management requirements for the industry to guarantee the safety and efficacy of the finished herbal and dietary supplements.
‘Added Harassment Based on Science Fiction’
Natural Products Association CEO and Executive Director Daniel Fabricant, PhD, said the latest action from Mr. Schneiderman demonstrates “complete misunderstanding” of FDA’s regulatory authority. “The Natural Products Association regards this most recent action by Attorney General Schneiderman as added harassment based on science fiction. For the past two months, the attorney general has continued to escalate his attack on the supplement industry without any legitimate data to back up his arguments.”
As the former head of FDA’s Division of Dietary Supplement Programs, Dr. Fabricant said he has seen first-hand how the agency can take swift and forceful action when dietary supplement companies violate federal regulations.
“The FDA is properly equipped to identify and go after firms that pose a threat to public health. Attorney General Schneiderman’s claims that the FDA doesn’t have ample authority in this area show a complete misunderstanding of the regulatory structure in place to protect consumers and remove products from the market.” He further called the coalition’s request “an unnecessary distraction for our legislative branch.”
Actions Based on ‘Discredited Investigation’
Steve Mister, president and CEO of the Council for Responsible Nutrition, said the industry is already amply regulated on a federal level by FDA and FTC, that post-market surveillance has demonstrated few safety issues for these products and that concerns raised in the coalition’s letter are based on a discredited investigation.
He noted that GNC’s recent agreement with the NY AG “explicitly stated that there were no issues with the herbal supplements being investigated, and because of this, the products were returned to the store shelves.”
Over the past month, CRN has met with a number of state AGs around the country, he added, “and we are gratified that the concerns go away once we’re given the opportunity to fully explain the issue.”
The bottom line, Mr. Mister said, is that supplements are regulated by FDA and regulations are in place for pre-market notification of new ingredients, good manufacturing practices (including identity testing of both raw materials and finished products), product labeling and post-market surveillance (i.e., mandatory reporting of any serious adverse events).
However, he acknowledged there are problems in the industry that demand attention. “We wish that the state AGs had focused their efforts on helping solve the serious problem of criminals who spike products with illegal drugs and market them illegally as dietary supplements.”
The April 2 letter stated in part: “The FDA has long been aware of problems in the dietary and herbal supplement supply chain, from dubious ingredient sourcing to a failure to carry out proper testing on finished products."
The action is the latest step in a series of developments sparked by cease-and-desist letters New York AG Eric Schneiderman issued on Feb. 2 to GNC, Target, Walgreens and Walmart, which were based on DNA barcode testing that allegedly found many herbal extract products evaluated didn’t actually contain ingredients listed on labels. However, Mr. Schneiderman has not released his study data despite calls for transparency.
Experts have said test methods were inappropriate because botanical extracts and highly processed finished products are not expected to have enough DNA intact to isolate a barcode. FDA itself recently stated that DNA barcoding tests should only be used in combination with established methodologies historically used to verify identity.
The coalition’s letter requests that Congress act in concert with the FDA to explore and address the following:
1. The adequacy and effectiveness of existing quality assurance measures for verifying the source, identity, purity, potency, and quality of ingredients and fillers;
2. The adequacy and effectiveness of existing regimes for verifying the identity, composition, purity, potency, and quality of the finished products sold by domestic manufacturers and retailers;
3. The degree to which product labels and marketing, including use of the terms “natural,” “herbal,” and “extract,” mislead consumers about the contents of herbal and dietary supplements and whether the FDA should develop standards and restrictions governing their use;
4. The extent to which Congress should mandate, or direct the FDA to develop, enhanced, uniform, industry-wide quality assurance and verification regimes to guarantee the source, identity, purity, and potency of materials incorporated into herbal and dietary supplements; and,
5. The extent to which Congress should mandate, or direct, the FDA to develop enhanced manufacturing and supply chain management requirements for the industry to guarantee the safety and efficacy of the finished herbal and dietary supplements.
‘Added Harassment Based on Science Fiction’
Natural Products Association CEO and Executive Director Daniel Fabricant, PhD, said the latest action from Mr. Schneiderman demonstrates “complete misunderstanding” of FDA’s regulatory authority. “The Natural Products Association regards this most recent action by Attorney General Schneiderman as added harassment based on science fiction. For the past two months, the attorney general has continued to escalate his attack on the supplement industry without any legitimate data to back up his arguments.”
As the former head of FDA’s Division of Dietary Supplement Programs, Dr. Fabricant said he has seen first-hand how the agency can take swift and forceful action when dietary supplement companies violate federal regulations.
“The FDA is properly equipped to identify and go after firms that pose a threat to public health. Attorney General Schneiderman’s claims that the FDA doesn’t have ample authority in this area show a complete misunderstanding of the regulatory structure in place to protect consumers and remove products from the market.” He further called the coalition’s request “an unnecessary distraction for our legislative branch.”
Actions Based on ‘Discredited Investigation’
Steve Mister, president and CEO of the Council for Responsible Nutrition, said the industry is already amply regulated on a federal level by FDA and FTC, that post-market surveillance has demonstrated few safety issues for these products and that concerns raised in the coalition’s letter are based on a discredited investigation.
He noted that GNC’s recent agreement with the NY AG “explicitly stated that there were no issues with the herbal supplements being investigated, and because of this, the products were returned to the store shelves.”
Over the past month, CRN has met with a number of state AGs around the country, he added, “and we are gratified that the concerns go away once we’re given the opportunity to fully explain the issue.”
The bottom line, Mr. Mister said, is that supplements are regulated by FDA and regulations are in place for pre-market notification of new ingredients, good manufacturing practices (including identity testing of both raw materials and finished products), product labeling and post-market surveillance (i.e., mandatory reporting of any serious adverse events).
However, he acknowledged there are problems in the industry that demand attention. “We wish that the state AGs had focused their efforts on helping solve the serious problem of criminals who spike products with illegal drugs and market them illegally as dietary supplements.”
