FDA warns against diet, sports, and sleep supplements

Companies warned to stop distributing products
Tuesday, April 16, 2019
WASHINGTON, D.C. (WPVI) -- The FDA has issued nearly a dozen warning letters to maker of dietary supplements with 2 unapproved ingredients.

8 letters went to makers with products containing the stimulant DMHA.
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They're often marketed for sports performance or weight loss.

DMHA may also appear on the ingredient panel as:

1,5-Dimethylhexylamine

1,5-DMHA



2-amino-5-methylheptane

2-amino-6-methylheptane

2-aminoisoheptane

2-Heptylamine, 6-methyl-

2-Isooctyl amine



2-Metil-6-amino-eptano
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6-Amino-2-methylheptane

Amidrine

Octodrine

Vaporpac

DMHA can cause nausea, heart palpitations, or increased blood pressure.



The other warning letters were for products with Phenibut, sometimes sold as a sleep aid.

Phenibut may also be sold as:

fenibut

phenigam
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PhGaba

Phenigamma



Phenygam

4-Amino-3-phenylbutanoic acid

-(aminomethyl)benzenepropanoic acid

beta-(Aminomethyl)hydrocinnamic acid

-phenyl--aminobutyric acid

The FDA has given the companies 15 business days from receiving the letter to inform the agency on what they'll do to comply.

The FDA can take enforcement action without further notice if the companies don't immediately cease distribution of the products.
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