Posted 26 September 2016
The Oregon Attorney General has expanded its lawsuit that charged General Nutrition Corporation (GNC) with selling dietary supplements that contain illegal ingredients.
The original complaint, filed in October 2015, concerned picamilon and BMPEA.
Picamilon is a synthetic chemical that is not approved in the United States, but is used as a prescription drug in some countries to treat neurological conditions. BMPEA is a powerful stimulant and amphetamine-like substance that is sometimes sold as a weight-loss or performance-enhancing supplement.
The original complaint alleges that GNC violated the Oregon Unlawful Trade Practices Act (UTPA) by misrepresenting the products as lawful when they are not legal to sell as dietary supplements in the United States.
The complaint also charged that some products labeled as containing botanical acacia rigidula had been spiked with unlabeled BMPEA.
In a response to the suit, GNC claimed that (a) consistent with “retail standard practice,” it “appropriately” relied on the guarantees of suppliers that their products are lawful, and (b) there is no basis for the Oregon Attorney General’s assertion that GNC or any other retailer knew or should have known that picamilon and BMPEA were illegal for use in dietary supplements.
On September 19, the complaint was amended to add products containing the purported stimulants DMAA and oxilofrine (methylsynephrine). The amended complaint charges GNC with knowingly selling products adulterated with DMAA at the same time federal regulators were moving to seize the products and failing to disclose FDA’s determination that the ingredient was illegal.
The complaint also noted that oxilofrine had been linked to serious adverse events—nausea, vomiting, agitation, tachycardia, chest pain, and cardiac arrest—when consumed at far lower dose levels than the maximum recommended in a product GNC had sold from early 2013 to mid-2015.[Meyers S. Oregon AG Adds DMAA, oxilofrine to GNC complaint. Natural Products Insider, Sept 20, 2016]
The FDA issued warning letters in 2012 to ten companies selling DMAA products and in March 2016 to seven companies selling products that contained methylsynephrine.
Source: Consumer Health Digest #16-36, September 25, 2016