FDA Demands 14 Dietary Supplement Cos. Remove DMBA From Supplements

By Greg Webb, May 8, 2015

supplements

Has the FDA has been slow to act in the case of DMBA, a synthetic stimulant used in many weight-loss and body building dietary supplements?   Some in Congress think so.  In October of 2014, Senators Durbin and Blumenthal pressed the FDA to deal with DMBA, an artificially produced ingredient with amphetamine-like qualities being sold in supplements. On April 24, 2015 the FDA finally issued letters to 14 companies demanding the removal of products containing DMBA from the market.

DMBA has been raising concerns for several years, with Dr. Pieter Cohen being the most vocal in calling for closer scrutiny and regulation of the dietary industry. “This is extremely welcome news,” Pieter Cohen, an assistant professor with Harvard Medical School who has researched a number of controversial supplements, said in an emailed statement. “Rather than waiting until heart attacks, strokes or deaths are definitely linked to this new designer stimulant, the FDA has now made it extremely clear to manufacturers: there is no justification to sell DMBA in supplements and it poses a potential health risk to consumers.”

Federal law states that any ingredients added to dietary supplements after October 15, 1994 must meet certain requirements. “The first is that the supplement only contains dietary ingredients present in the food supply as an article used for food in which the food has not been chemically altered. The second is that there is a history of use or other evidence of safety establishing that the dietary ingredient, when used as suggested on the label, “will reasonably be expected to be safe” and the manufacturer or distributor has provided FDA with adequate information supporting that conclusion.”

Research by Dr. Cohen and colleagues, published in October 2014,  found DMBA to be a synthetic stimulant, not found in the food supply and never tested on humans. The findings allowed the FDA to declare the dietary ingredient unsafe.

Senators Durbin and Blumenthal called out the FDA for taking so long to deal with the matter.  “…the FDA has finally heeded our call and taken steps to get this dangerous, mislabeled supplement off the shelves,” Blumenthal and Durbin said in a joint statement. “Consumers deserve to know what ingredients are in the products they’re taking and it is unacceptable that the health risks associated with supplements containing DMBA have been hidden for so long. The FDA was right to take action and demand these dangerous products be removed from shelves.”

The following companies received letters from the FDA prohibiting the sale of dietary supplements containing DMBA:

  • Vital Pharmaceuticals, Inc. d/b/a VPX Sports (Products: VPX Redline White Heat (strawberry, fruit punch, and watermelon) and MD2 Meltdown)
  • Powder City LLC (Product: AMP Citrate)
  • Prime Nutrition (Product: PWO/STIM)
  • Beta Labs (Product: Oxyphen XR Amp’d)
  • Genomyx LLC (Product: EVOL)
  • Lecheek Nutrition (Products: Ampilean and Ampitropin)
  • Iron Forged Nutrition d/b/a TGB Supplements (Product: Contraband)
  • Nutrex Research, Inc. (Product: Adipodex)
  • Blackstone Labs LLC (Product: Angel Dust)
  • 1ViZN LLC (Product: Velocity)
  • Core Nutritionals LLC (Product: AMP Citrate)
  • RPM Nutrition, LLC (Product: Red Rum SS)
  • Brand New Energy LLC (Product: Yellow Bullet AMP)
  • DSEO LLC (Products: HybriLean and PREAMP)