Reverse FDA Position on Phenibut
The FDA has said Phenibut is no longer dietary ingredient. Phenibut had been a dietary ingredient for many years. It has helped many people. It is safe and well tolerated. We ask the FDA to reverse this because:
1. Phenibut is an amino acid and meets definition of dietary ingredient: GABA is an amino acid because it meets the definition, ie. having a primary amine and a carboxylic acid functional group. Adding a phenyl group to it does not exclude it from this designation anymore than phenylalanine (another naturally occurring amino acid) would be excluded for having a phenyl group.
2. Phenibut is safe: Phenibut has a far safer record than many other dietary supplements such as caffeine, yohimbe, and kratom for example.
3. Phenibut has helped hundreds of thousands of people: This ingredient has been on the market for over 20 years and has proven itself to confer a high amount of benefit to many people when used properly. Plus there is strong scientific evidence supporting many health benefits of Phenibut on stress and cognitive function.
4. Phenibuts classification in other nations has no bearing:
Designation of ‘medicine(pharmaceutical)’ or ‘dietary ingredient’ varies from nation to nation. The notion that Phenibut may be a medicine in other nations should not have weight in the decision process here. Indeed even in the USA, many supplements are also classified as drugs (and sold under prescription in the USA). For example:
DHEA (steroid, Rx drug)
L-Carnitine (amino acid, Rx drug)
Fish Oil (EFA, Rx drug) and Vitamin D (steroid, Rx drug).
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