How far do people go to get the perfect physique? Some people go further and add dietary supplements to complement their gym routine and carefully measured food intake, but how healthy and natural are dietary supplements?
Fitness buffs, beware. Oregon's attorney general (AG) Ellen Rosenblum just sued General Nutrition Corporation (GNC), one of the world's biggest sellers of dietary supplements, for products laced with synthetic drugs not approved in the United States.
The lawsuit, filed on Oct. 21, said GNC is selling 22 types of all-natural dietary and fat-burning supplements that contain picamilon, a prescription drug used in Russia for neurological treatment. The lawsuit specified that a GNC official already knew back in 2007 that the drug was synthetic and couldn't be included in the 'all-natural' products the company is selling.
The second synthetic drug included in the lawsuit is Beta-methylphenethylamine (BMPEA), a chemical with amphetamine-like effects. Amphetamine is a mood-altering drug commonly used for treating attention deficit hyperactivity disorder (ADHD), obesity and narcolepsy. AG Rosenblum cites two emails dating back to the wake of USA TODAY's 2013 article about BMPEA-laced supplements. The said emails were disseminated among the top executives of GNC.
"GNC sells products obtained from third-party vendors that GNC knows or should know contain unlawful and potentially unsafe ingredients," said the lawsuit which highlights that GNC pre-approves all marketing and packaging materials and labels of items sold in their stores after reviewing the products made by third-party vendors.
The lawsuit accused GNC of over 4,000 violations of Oregon's Unlawful Trade Practices Act. Some of the violations include failure to reveal that the products sold contained synthetic materials and misinterpretation of products as 'all-natural' dietary supplements. Each violation has a $25,000 maximum fine.
The company stopped selling items laced with picamilon back in September, said the lawsuit. This ceased operation took place after the Oregon AG's office told GNC that the third-party vendor was involved in illegal trade activities. The lawsuit said Oregon officials had demanded that GNC present the AG office with sales documents following a speculation that picamilon might be an illegal dietary ingredient. Internal documents reviewed by a GNC official way back in May 2007 revealed "that picamilon was a synthetic drug created by Soviet investigators and was not a lawful dietary ingredient in the United States," alleged the lawsuit.
Internal documents secured by the Oregon AG's office revealed that GNC senior manager for technical research, Jennifer Jakel, studied picamilon. Jakel's review included an analysis of translated records that were originally Russian. In one of the documents, picamilon was described as "a new class of medicinal preparations" and "synthesized in 1969 by the All-Union Scientific Research Institute." The records from Russia said picamilon is used to treat learning, memory and attention issues.
The lawsuit accused GNC of having known that picamilon is an illegal dietary ingredient due to the May 2007 review by Jakel wherein she wrote, "No NDI that I could find." A New Dietary Ingredient (NDI) label requires the ingredient to be filed with U.S. Food and Drug Administration (FDA) before a pre-1994 natural dietary ingredient can be traded as a dietary supplement in the country. The lawsuit claimed that Jakel reviewed picamilon once more in April 2014 to check if an NDI has been filed. In her document, Jakel noted "still no NDI found."
In April, GNC stopped selling BMPEA-laced products in their stores, following a written warning from the FDA released to several manufacturers of supplements with BMPEA on the labels. An FDA research found nine dietary supplements that included a bushy plant called Acacia rigidula, which is said to contain BMPEA. The research did not find BMPEA compound in the plant samples and revealed the compound's safety in humans had never been verified.
Jakel knew about the FDA research as early as Nov. 2, 2013 from an alert provided by a catalogued scientific journal, however, it was the USA TODAY article published weeks later that finally caused an avalanche of concerns within the GNC headquarters. Jakel sent the USA TODAY article to GNC officials, which included Guru Ramanathan (Senior Vice President and Chief Innovation Officer) and David Sullivan (Vice President and General Counsel for Regulatory Affairs). Despite the flurry of actions within the GNC headquarters and the widespread knowledge of the high risk that the products could have been spiked with BMPEA, the company continued to sell products with Acacia Rigidula and BMPEA on the labels, said the lawsuit.
"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," said GNC in a press release published in the company website on Oct. 22.
