Sean Moloughney, Editor10.27.15
Oregon Attorney General Ellen Rosenblum filed a lawsuit against GNC (General Nutrition Corporation) on Oct. 22, alleging the retailer sold dietary supplements containing “illegal ingredients” picamilon and BMPEA.
The lawsuit claims the company violated the Oregon Unlawful Trade Practices Act (UTPA) by misrepresenting certain products as lawful dietary supplements when they are actually unapproved drugs. The complaint also alleges that GNC sold products labeled as containing the botanical Acacia rigidula that had been spiked with unlabeled BMPEA.
GNC subsequently filed a motion to have the the case moved to Federal Court, issuing a statement saying the lawsuit is “without merit” and that the company “intends to defend itself vigorously against this unfair action.”
“When Oregonians buy a dietary supplement, they deserve to know that the ingredients in the products are safe and comply with the law,” said Ms. Rosenblum. “There are 25 GNC stores in Oregon that sold thousands of these products over the span of a couple of years.”
In its statement, GNC said it takes the quality of its products and compliance by third parties seriously, and takes responsible measures to review concerns raised by FDA or other regulatory bodies.
“With respect to the two ingredients at issue in the Oregon Attorney General's lawsuit, picamilon was included as an ingredient in dietary supplements widely sold by major retailers up to the time of the filing of Oregon's lawsuit on October 22, 2015, and products containing BMPEA were also widely available until the FDA issued a warning letter in April 2015. There is no basis for the Oregon Attorney General's assertion that GNC or any other retailer ‘knew or should have known’ that these ingredients were not legal for use in dietary supplements. As a matter of law, this critical legal issue remains undetermined as neither FDA nor any court has issued a legally binding determination of the status of these ingredients.”
FDA’s Declaration on Picamilon & Delegation of Authority
Cara Welch, acting deputy director of the Dietary Supplement Programs at FDA wrote in a signed affidavit on Sep. 28 that picamilon, which is formed by combining niacin with GABA, “does not fit any of the dietary ingredient categories” under the law. Despite this assertion, FDA has yet to use its enforcement power to restrict the ingredient, noted Dan fabricant, PhD, executive director and CEO of the Natural Products Association, who criticized the agency for its failure to take action in this case and for its decision to delegate authority to the state level.
“The FDA has both the authorities and tools in place to take action against harmful ingredients,” he said. “It is concerning to us that the FDA is delegating its responsibilities to the states instead of using its own enforcement authority. If the FDA finds an ingredient to violate the law, then it should take immediate administrative action, not use taxpayer dollars to fund a state priority.”
Steve Mister, president and CEO of the Council for Responsible Nutrition, sent a letter to FDA on Oct. 27—addressed to Ted Elkin, deputy director for regulatory affairs, Center for Food Safety and Applied Nutrition (CFSAN)—expressing concern about Dr. Welch’s declaration on picamilon.
“FDA has never made any public statements with regard to picamilon: it has not released any warning letters to the companies marketing picamilon, issued any recall on this ingredient, or announced any consumer advisories on it. In fact, we are not aware that FDA has ever communicated publicly about picamilon in any regard. Moreover, we are not aware that picamilon has been the source of any significant number of adverse event reports or any other signals that it may present a public health or safety concern. Rather, the matter of picamilon’s status as a new dietary ingredient, or even as a dietary ingredient at all, is purely a matter of legal interpretation deserving of due notice to industry. Given FDA’s position on so many other issues—that the public interest and FD&CA are best served by providing adequate notice to industry prior to beginning an enforcement action—it is difficult to understand how that interest is served here. Certainly FDA’s long history of slow, deliberate action on such actual safety issues as DMAA, pure powdered caffeine, and numerous products tainted with illegal prescription drugs would counsel for thoughtful action from the FDA with an opportunity for industry input prior to issuing a Declaration to be used in a state action.”
Moreover, Mr. Mister said CRN was deeply troubled by an apparent “abdication of federal authority under the FD&CA by FDA to state law enforcement.”
“As the recent New York AG allegations regarding devil’s claw illustrate, not all technical violations of the statute are matters of public safety, or even consumer protection. Such may be the case with picamilon as well. The FDA has an obligation to evaluate the interests of the agency in preserving its supremacy over the regulation of products under its jurisdiction. Providing testimony to a state agency on a matter in which the agency has not spoken undermines the interests of the FDA rather than promoting it.”
FDA should have issued a warning letter that explained why picamilon (also referred to as pikatropin) is not a legal dietary ingredient, or perhaps more appropriately, “the agency also could have declared the products containing this ingredient adulterated under Section 402(f)(1)(B) as a new dietary ingredient (NDI) which requires notification.”
The Oregon Attorney General’s lawsuit also accuses the retailer of selling BMPEA, which the FDA did in fact take action to remove from store shelves earlier this year. “In the case of BMPEA, the agency took the necessary steps to shield consumers against a product that it has found to contain an illegal, adulterated dietary ingredient,” said Dr. Fabricant. “NPA encourages this type of action in response to picamilon, instead of delegating its regulatory and enforcement authority to states.”
GNC said it stopped selling products with BMPEA and picamilon immediately upon learning indirectly, rather than from notice directed at GNC, that FDA did not view BMPEA and picamilon as legal dietary ingredients. “Neither picamilon nor BMPEA were included in a previous FDA warning letter or other FDA notification,” GNC said in its statement. “Further, GNC took action to remove BMPEA and picamilon products even though the FDA did not raise any safety concerns with respect to these ingredients, and neither notice constituted a legally binding FDA action on the legal status of these ingredients. Products containing BMPEA and picamilon were produced by third parties and accounted for less than one percent of the Company's sales.”
GNC said it will continue to play a leading role in setting industry quality and compliance standards. “We are committed to providing our customers with the highest quality supplements available, using the purest and most effective ingredients, to help them live healthier lives."
GNC Holdings stock closed down 14.24% to $34.50 on Oct. 22 following news of the lawsuit.
The lawsuit claims the company violated the Oregon Unlawful Trade Practices Act (UTPA) by misrepresenting certain products as lawful dietary supplements when they are actually unapproved drugs. The complaint also alleges that GNC sold products labeled as containing the botanical Acacia rigidula that had been spiked with unlabeled BMPEA.
GNC subsequently filed a motion to have the the case moved to Federal Court, issuing a statement saying the lawsuit is “without merit” and that the company “intends to defend itself vigorously against this unfair action.”
“When Oregonians buy a dietary supplement, they deserve to know that the ingredients in the products are safe and comply with the law,” said Ms. Rosenblum. “There are 25 GNC stores in Oregon that sold thousands of these products over the span of a couple of years.”
In its statement, GNC said it takes the quality of its products and compliance by third parties seriously, and takes responsible measures to review concerns raised by FDA or other regulatory bodies.
“With respect to the two ingredients at issue in the Oregon Attorney General's lawsuit, picamilon was included as an ingredient in dietary supplements widely sold by major retailers up to the time of the filing of Oregon's lawsuit on October 22, 2015, and products containing BMPEA were also widely available until the FDA issued a warning letter in April 2015. There is no basis for the Oregon Attorney General's assertion that GNC or any other retailer ‘knew or should have known’ that these ingredients were not legal for use in dietary supplements. As a matter of law, this critical legal issue remains undetermined as neither FDA nor any court has issued a legally binding determination of the status of these ingredients.”
FDA’s Declaration on Picamilon & Delegation of Authority
Cara Welch, acting deputy director of the Dietary Supplement Programs at FDA wrote in a signed affidavit on Sep. 28 that picamilon, which is formed by combining niacin with GABA, “does not fit any of the dietary ingredient categories” under the law. Despite this assertion, FDA has yet to use its enforcement power to restrict the ingredient, noted Dan fabricant, PhD, executive director and CEO of the Natural Products Association, who criticized the agency for its failure to take action in this case and for its decision to delegate authority to the state level.
“The FDA has both the authorities and tools in place to take action against harmful ingredients,” he said. “It is concerning to us that the FDA is delegating its responsibilities to the states instead of using its own enforcement authority. If the FDA finds an ingredient to violate the law, then it should take immediate administrative action, not use taxpayer dollars to fund a state priority.”
Steve Mister, president and CEO of the Council for Responsible Nutrition, sent a letter to FDA on Oct. 27—addressed to Ted Elkin, deputy director for regulatory affairs, Center for Food Safety and Applied Nutrition (CFSAN)—expressing concern about Dr. Welch’s declaration on picamilon.
“FDA has never made any public statements with regard to picamilon: it has not released any warning letters to the companies marketing picamilon, issued any recall on this ingredient, or announced any consumer advisories on it. In fact, we are not aware that FDA has ever communicated publicly about picamilon in any regard. Moreover, we are not aware that picamilon has been the source of any significant number of adverse event reports or any other signals that it may present a public health or safety concern. Rather, the matter of picamilon’s status as a new dietary ingredient, or even as a dietary ingredient at all, is purely a matter of legal interpretation deserving of due notice to industry. Given FDA’s position on so many other issues—that the public interest and FD&CA are best served by providing adequate notice to industry prior to beginning an enforcement action—it is difficult to understand how that interest is served here. Certainly FDA’s long history of slow, deliberate action on such actual safety issues as DMAA, pure powdered caffeine, and numerous products tainted with illegal prescription drugs would counsel for thoughtful action from the FDA with an opportunity for industry input prior to issuing a Declaration to be used in a state action.”
Moreover, Mr. Mister said CRN was deeply troubled by an apparent “abdication of federal authority under the FD&CA by FDA to state law enforcement.”
“As the recent New York AG allegations regarding devil’s claw illustrate, not all technical violations of the statute are matters of public safety, or even consumer protection. Such may be the case with picamilon as well. The FDA has an obligation to evaluate the interests of the agency in preserving its supremacy over the regulation of products under its jurisdiction. Providing testimony to a state agency on a matter in which the agency has not spoken undermines the interests of the FDA rather than promoting it.”
FDA should have issued a warning letter that explained why picamilon (also referred to as pikatropin) is not a legal dietary ingredient, or perhaps more appropriately, “the agency also could have declared the products containing this ingredient adulterated under Section 402(f)(1)(B) as a new dietary ingredient (NDI) which requires notification.”
The Oregon Attorney General’s lawsuit also accuses the retailer of selling BMPEA, which the FDA did in fact take action to remove from store shelves earlier this year. “In the case of BMPEA, the agency took the necessary steps to shield consumers against a product that it has found to contain an illegal, adulterated dietary ingredient,” said Dr. Fabricant. “NPA encourages this type of action in response to picamilon, instead of delegating its regulatory and enforcement authority to states.”
GNC said it stopped selling products with BMPEA and picamilon immediately upon learning indirectly, rather than from notice directed at GNC, that FDA did not view BMPEA and picamilon as legal dietary ingredients. “Neither picamilon nor BMPEA were included in a previous FDA warning letter or other FDA notification,” GNC said in its statement. “Further, GNC took action to remove BMPEA and picamilon products even though the FDA did not raise any safety concerns with respect to these ingredients, and neither notice constituted a legally binding FDA action on the legal status of these ingredients. Products containing BMPEA and picamilon were produced by third parties and accounted for less than one percent of the Company's sales.”
GNC said it will continue to play a leading role in setting industry quality and compliance standards. “We are committed to providing our customers with the highest quality supplements available, using the purest and most effective ingredients, to help them live healthier lives."
GNC Holdings stock closed down 14.24% to $34.50 on Oct. 22 following news of the lawsuit.
