FDA Sends Warning Letters for DMHA and Phenibut

FDA Regulating Supplements

The Food and Drug Administration (FDA) has sent warning letters to several brands producing products containing DMHA and Phenibut. The letter were dated 4/10/19 and 4/11/19. Notable brands receiving letters include Hi-Tech Pharmaceuticals, eFlow and Iron Brother's Supplements. You can view the list of brands here

DMHA (also known as 2-Aminoisoheptane, Octodrine, 2-amino-6-methylheptane, 2-amino-5methylheptane and Dimethylhexylamine) has been the subject of debate since DMAA was banned by the FDA. DMHA carries out a variety of similar functions to other psychoactive central nervous system stimulants, including enhancing energy levels, enhancing cognitive function, decreasing appetite and improving bronchodilation. DMHA is typically found in many high stimulant pre-workout products, fat burners and nootropics.

Phenibut (also known as β-phenyl-γ-aminobutyric acid) is the other ingredient that the FDA targeted with these warning letters. Phenibut is a mushroom that is used in sleep aids. Phenibut can also be used in nootropics.

In all, 11 letters were sent. Eight of the letters targeted DMHA, while three targeted Phenibut.

The brands have 15-days to respond to the FDA warning letter with the following information:

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violation. Include an explanation of each step being taken to prevent the recurrence of the violation, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

It is unclear why these particular brands were selected by the FDA.

Fitness Informant's POV

I am not surprised the FDA is coming down on both of these ingredients. Candidly, I love them both. I prefer DMHA over DMAA any day of the week, but it resembled DMAA too closely and the government doesn't like those things. Not too mention we have so many idiotic brands (none that received letters) that misused these ingredients.

Phenibut has some crazy effects if you're not careful with it. I personally love it for sleep aids. I have never had better sleep than I have with products that contain Phenibut, but to that extent, it is those brands and consumers who misuse these ingredients that call them into question.

I would fully expect to see brands start to pull both DMHA and Phenibut from their products.

The silver lining to this is that this forces brands to reformulate products that could use some reformulation to include new, effective ingredients (although my favorite sleep aid currently uses Phenibut so I am devastated). 

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