04.29.15
FDA has issued warning letters to 14 companies regarding a total of 17 products that contain DMBA, claiming the products are adulterated under the law because DMBA is not a dietary ingredient.
The action follows similar letters the agency sent to five companies over the use of BMPEA in eight products.
Under the Dietary Supplement Health and Education Act (DSHEA), FDA can take action to remove products from the market, but the agency must first establish that such products are adulterated or misbranded.
The companies have 15 business days from the date of receipt of the letter to communicate to the agency the specific steps they will take to bring their products into compliance with the law. The warning letters also caution the companies that FDA may take further enforcement action without warning if they do not immediately cease distribution of the products.
The Warning Letters can be found here:
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)
The action follows similar letters the agency sent to five companies over the use of BMPEA in eight products.
Under the Dietary Supplement Health and Education Act (DSHEA), FDA can take action to remove products from the market, but the agency must first establish that such products are adulterated or misbranded.
The companies have 15 business days from the date of receipt of the letter to communicate to the agency the specific steps they will take to bring their products into compliance with the law. The warning letters also caution the companies that FDA may take further enforcement action without warning if they do not immediately cease distribution of the products.
The Warning Letters can be found here:
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)