In the latest attack on the supplements industry by state attorney generals (AGs), GNC is being sued by Oregon’s AG Ellen Rosenblum, for allegedly selling supplements spiked with unmarked illegal ingredients.
The two ingredients at issue are stimulants picamilon and BMPEA (beta-methylphenylethylamine), which were formulated in products such as “Jetfuel Superburn” and “Phenyl Core Weight Management.” Earlier this year, the U.S. Food and Drug Administration (FDA) warned companies that they should stop selling BMPEA because it has not been recognized for sale as supplement ingredients, and GNC complied. The suit alleges that GNC "knew or should have known" earlier that the ingredient should not be incorporated into supplements, and that it should not sell picamilon.
After being unable to reach an agreement, GNC filed a motion Friday to move the case to Federal Court.
GNC issued a statement in which the retailer said it “believes that the lawsuit filed by the Oregon Attorney General is without merit, and the Company intends to defend itself vigorously against this unfair action.”
GNC also stated that each product it sells is “regulated by the U.S. Food and Drug Administration” and its vendors “certify that they are in full compliance with the Food, Drug and Cosmetic Act.”
“Consistent with retail standard practice, GNC has appropriately relied on the guarantees of suppliers that their products are lawful. This is a basic tenet of retail sales and is recognized in federal law in the FDC Act and what is known nationally as the "FDA Guarantee,” GNC said.
This will be the second time this year that GNC has been involved with state AGs about the sale of supplements. In February, NYAG Eric T. Schneiderman filed a suit against GNC (and the two reached an agreement), basing his argument on the results of DNA barcoding. Schneiderman accused the retailer of fraud for selling products that supposedly did not contain DNA from certain herbs they should have contained.
Since this time, there has been a growing interest by AGs to "crack down" on the supplements industry, of which critics feel lacks oversight.
This lawsuit is the tip of the iceberg on a related issue. In late September, Cara Welch, Ph.D., acting deputy director for dietary supplements programs, provided a Declaration to several state AGs that wanted clarification about whether picamilon is legal for sale as a dietary supplement. Welch stated in the Declaration that picamilon does not fit any legal dietary supplement category. Her statement was not made public, and did not give industry a chance to offer its opinion on this issue or provide evidence for why it is legal, CRN's letter stated.
This information was the evidence used by several AGs to send cease-and-desist letters to several supplements retailers, according to a letter sent to FDA's Ted Elkin by the Council for Responsible Nutrition (CRN).
Said CRN's president and CEO Steve Mister in the letter, "CRN believes this sets a dangerous precedent regarding the cooperation between FDA and state law enforcement on matters of federal law not previously noticed to the industry."
Daniel Fabricant, Ph.D., CEO and executive director at the Natural Products Association, also contacted FDA with concerns about the appropriateness of Welch's actions. In an email to Stephen Ostroff, M.D., FDA's acting commissioner of food and drugs, Fabricant said Welch's document "should be available on the FDA FOIA page but it presently isn’t."
Fabricant was also concerned that FDA has not used its enforcement power to restrict the sale of picamilon, yet Welch told AGs that it is an illegal supplement ingredient.
Mister stated in his letter, "We believe that FDA, after being made aware of the presence of this ingredient in the marketplace, should have issued a warning letter stating the reasons why picamilon is not a legal dietary ingredient. Alternatively, and perhaps the more appropriate option, 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."
Published in WholeFoods Magazine, December 2015 (online 10/27/15)