GNC Lawsuit Brought Over Potentially Spiked Supplements
GNC Lawsuit Brought Over Potentially Spiked Supplements
A lawsuit has recently been filed that accuses dietary supplement giant, GNC, of selling products containing synthetic drugs. The lawsuit was filed by Oregon Attorney General (AG), Ellen Rosenblum, and alleges that GNC was aware that its dietary supplements contained synthetic drugs as far back as 2007, but continued selling the tainted products.
Our firm is investigating potential lawsuits on behalf of individuals who have been injured, or died, due to alleged GNC supplement products side effects.
Lawsuit Alleges Two Unapproved Drugs Hidden in GNC Products
GNC Holding Inc. sold dietary supplements that contained two illegal synthetic drugs in the United States, according to allegations by Oregon's attorney general (AG), Ellen Rosenblum, wrote Reuters. "It is scary to know that certain products sold by GNC contain an ingredient that is not even labeled-let alone approved in the United States," AG Rosenblum stated.
According to the lawsuit, as well as internal company records, GNC, knowingly sold products containing two synthetic drugs. The lawsuit accuses GNC of selling thousands of units of 22 workout and fat-burner supplement products containing picamilon or BMPEA (beta-methylphenylethylamine), according to USA Today.
Ingredients Used in Alleged Supplement Spiking
Picamilon is a prescription drug sold in Russia for the treatment of neurological conditions. Internal GNC company records reveal that a key GNC official was aware, since 2007, that the ingredient was not natural, according to lawsuit allegations. Because of this, the drug ingredient could not legally be included in dietary supplements, which may only contain natural ingredients, wrote USA Today. Reuters noted that, while not approved in the U.S. picamilon is a prescription drug used in some countries in the treatment of neurological conditions.
AG Rosenblum also accuses GNC of selling other workout and weight-loss supplements that contained BMPEA, a synthetic amphetamine-like chemical also known as Beta-methylphenethylamine, among other chemical names. According to the lawsuit, the AG's office cites emails that were distributed to top GNC executives in 2013 following a USA Today investigative article that same year regarding BMPEA in supplements. "The USA Today article stimulated significant concern and discussion within GNC," the lawsuit indicates; however, GNC continued selling BMPEA-containing products until earlier in 2015. "GNC sells products obtained from third-party vendors that GNC knows or should know contain unlawful and potentially unsafe ingredients," the lawsuit also allege, noting that GNC reviews and pre-approves all of the labeling, packaging, and marketing materials for the products it sells in its stores that are manufactured by other companies.
According to USA Today, although GNC had said it would not comment on the pending litigation; it issued a short statement on October 22, 2015 stating that, "The claims made by the Oregon Attorney General are without merit and GNC intends to vigorously defend against these allegations. In response to FDA statements regarding the regulatory status of BMPEA and picamilon, GNC promptly took action to remove from sale all products containing those ingredients." Despite the statement, GNC shares dropped nearly 15 percent in that day's late afternoon trading.
Reuters noted that the FDA previously asked companies to stop selling dietary supplements containing the stimulant DMBA. DMBA and BMPEA are similar to 1,3-dimethylamylamine, or DMAA. DMAA has been banned by the FDA.
Lawsuit Alleges Thousands of Violations, GNC Officials Aware for Years of BMPEA, Picamilon Spiking
Meanwhile, the lawsuit alleges more than 4,000 individual violations of Oregon's Unlawful Trade Practices Act. Violations include GNC's failure to disclose that its products contained BMPEA and picamilon, misrepresenting that the products were lawful dietary supplements. Each violation carries a maximum penalty of $25,000, noted USA Today.
The lawsuit also indicates that GNC stopped selling products containing picamilon in September 2015, according to USA Today; this following notification from the Oregon AG's office advising GNC that it was involved in unlawful trade practices. Prior, in June 2015, Oregon officials demanded GNC provide them with documents about GNC's supplement sales over the possibility that picamilon was not a lawful dietary ingredient, according to the lawsuit. In fact, the lawsuit indicates that, in May 2007, actions taken by a key official at GNC responsible for ensuring the accuracy of supplement labels and scientific claims reveals that "GNC knew that picamilon is not a lawful dietary ingredient." Documents this official reviewed at that time also indicate "that picamilon was a synthetic drug created by Soviet investigators and was not a lawful dietary ingredient in the United States," the suit also alleges.
Among the GNC documents the AG's office obtained were some that reveal that Jennifer Jakell, GNC's senior product manager for technical research, conducted a review of picamilon, including records translated from Russian describing picamilon as one of "a new class of medicinal preparations" that was "synthesized in 1969 by the All-Union Scientific Research Institute." Ms. Jakell underlined specific areas of the documents, the lawsuit indicates. Also, the Russian documents contained information on picamilon's efficacy treating memory, attention, and learning issues, the lawsuit also indicates. "GNC also knew that picamilon is not a lawful dietary ingredient because, as part of her May 2007 review, Ms. Jakell documented in the GNC library file on picamilon: ‘No NDI that I could find,'" according to the lawsuit. The lawsuit document spells Jakell's name differently than the way in which her email and LinkedIn account names are spelled.
A new dietary ingredient, or NDI, notification must be filed with the U.S. Food and Drug Administration (FDA) before a natural dietary ingredient that was not used prior to 1994 in the United States may be sold as a dietary supplement. In April 2014, Jakell allegedly checked to determine if an NDI was filed for picamilon. She noted in her file, at that time, "still no NDI found," USA Today reported.
BMPEA may be hidden in supplements containing the botanical ingredient, Acacia rigidula, noted Reuters. BMPEA, described as a powerful stimulant and amphetamine-like substance, is sometimes sold as weight loss or performance enhancing nutritional supplement, according to the statement.
Lawsuit documentation indicates that GNC ceased selling BMPEA products in April 2015; this after the agency issued warning letters that same month to numerous supplement manufacturers that listed BMPEA on its labels. The letters were issued 18 months after FDA scientists published research in what USA Today described as a "scientific journal" indicating that the research revealed "non-natural" BMPEA in nine dietary supplements and in which Acacia rigidula was one of the ingredients. FDA researchers wrote in their article that they were unable to locate BMPEA in verified samples of the plant and that the compound does not appear to have ever undergone safety testing in humans.
GNC was aware of this agency research as far back as November 2, 2013 and Jakell received an automated alert from a scientific journal cataloging service, according to the lawsuit, wrote USA Today. Several weeks later, a USA Today news article was published concerning the FDA study, which sparked significant concern; Jackell sent the article to some 100 staff at GNC's headquarters, including the Senior Vice President and Chief Innovation Officer, Guru Ramanathan, as well as GNC's Vice President and General Counsel for regulatory affairs, David Sullivan, according to the lawsuit.
"Please tell me we won't have to get rid of acacia now," a GNC merchandising manager wrote to GNC's director of merchandising "within minutes" after receiving the email. At around the same time, GNC's director of e-commerce learned of six "acacia rigidula" products sold by GNC; another high-level GNC official offered to conduct a database search to locate all affected products, all according to the lawsuit, USA Today reported. Meanwhile, the lawsuit indicates that GNC continued selling products that indicated acacia rigidula as an ingredient, despite "widespread knowledge" they were "at high risk of having been spiked with BMPEA." GNC continued to sell supplements specifically listing BMPEA on their labels, the AG also alleges.
Lawsuit allegations concerning the FDA study include that it is clear that BMPEA is a synthetic substance similar to amphetamine. "Thus, anyone aware of the 2013 FDA study would know that BMPEA is not a lawful dietary ingredient and that products labeled as containing acacia rigidula were at significant risk of being spiked with BMPEA," the lawsuit indicates, according to USA Today.
FDA Under Fire
The Oregon lawsuit originated at the state, not the federal level and, according to USA Today, raises concern regarding the agency's efficacy in how it regulates the $35 billion dietary supplement industry. More and more, weight loss, bodybuilding, and sexual enhancement supplements have been found to contain hidden, sometimes dangerous pharmaceutical ingredients. "Basically the FDA has delegated its authority to the states, which they can't do," said Daniel Fabricant, executive director of the Natural Products Association; Fabricant was the previous director of the FDA's supplement division. "If there was a problem with the product, they should have taken action," he told USA Today. The media outlet noted that GNC is a both a member of the association and one of its officials serves on the group's board of directors.
Fabricant was specifically concerned that the FDA was serving in a role in which it was acting as an expert witness for the Oregon AG, providing a written declaration that is an exhibit in the lawsuit. The document, signed by Cara Welch, acting deputy director of FDA's supplement division describes why picamilon "is not a dietary ingredient." USA Today notes that, prior to joining the agency, Welch was a senior vice president at the industry group, Natural Products Association.
Fabricant said that, the FDA could have issued a warning letter to companies concerning the issue, according to Fabricant. They didn't and, "There's got to be some due process here and there's not," he added.
While FDA supplement regulators were unavailable for comment on October 22, 2015, in a statement issued on October 23rd, the FDA wrote that it prioritizes enforcement actions based on its available and "limited" resources, as well as the identified safety level concerns, according to USA Today. "We are also working with our government partners-like the state's attorney generals, the Federal Trade Commission, and the Department of Justice-and with members of industry who have a vested interest in seeing bad actors held accountable," the FDA wrote.
According to the FDA, under current regulations, before it takes any action to remove the product from the market, it must show a product is not safe, its labeling is false or misleading, or that it was not made using good manufacturing practices. The agency indicated that it provided a declaration by Welch to Oregon investigators as it was in the public interest and because it furthered Federal Food, Drug, and Cosmetic Act and FDA objectives. Oregon AG David Hart said that, regulators at both the state and federal level similarly seek to protect consumers and collaborate. "If the FDA is unable to take action, and the health and safety of Oregonians are threatened, Oregon can move in quickly to fill the regulatory void," he said in a statement, according to USA Today. "Regardless of whether regulation of dietary supplements requires reform, more aggressive enforcement of existing laws will better protect consumers," Hart added.
| Legal Help for Individuals Allegedly Injured Due to Tainted Supplements
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