On April 16, 2019, the FDA announced it has issued 11 warning letters to companies whose dietary supplement products contain the drugs DMHA or phenibut, and therefore are in violation of the law.

DMHA, is also known as 1,5-Dimethylhexylamine, 1,5-DMHA, or by names such as Amidrine, Octodrine or Vaporpac. It is a stimulant drug that is not permitted in dietary supplements. The FDA issued warning letters to eight companies selling products containing DMHA, which are often promoted as workout or weight loss supplements:

• Lean Pills (Line One Nutrition)


• Pre-Workout Relentless V1 (Iron Brothers Supplements)


• Enrage Extreme (eflow Nutrition LLC)


• Ultimate Orange, HydroxyElite, Lipodrene Elite, and Synadrene (Hi-Tech Pharmaceuticals, Inc.)


• Synedrex and E.S.P. Extreme (IQ Formulations, LLC / DBA Metabolic Nutrition Inc.)


• Simply Skinny Pollen (Down To Earth Solutions, LLC)


• Chaos Unleashed (Forbidden Labz)


• 1,3D NOX, Shredder, and Tummy Tuck (TBN Labs LLC)

The FDA also issued three warning letters to companies selling products containing phenibut, a drug that stimulates dopamine receptors and has anti-anxiety and cognitive-enhancing effects. Phenibut is also known as 4-Amino-3-phenylbutanoic acid, PhGaba or fenibut. The FDA issued the warning letters to companies selling the following products promoted to enhance cognition:

• Limitless (Atomixx)


• Sleep Walker and Red Dawn Liquid (Evol Nutrition Associates, Inc. d/b/a Red Dawn Energy)


• Kavinace (NeuroScience)

The warning letters are part of the FDA's new efforts to strengthen the regulation of dietary supplements. The Agency also recently established a Dietary Supplement Ingredient Advisory List which provides information about dangerous ingredients found in supplements.

See related recalls and warnings:

Dangerous Drug In Supplements for Pain and Anxiety

Higenamine -- A Potentially Dangerous Stimulant -- Found in Some Supplements

To read the FDA's full statement about products containing DMHA or phenibut, use the link below.