The FDA is complicit in turning another supplement into an expensive drug. Action Alert!
Earlier this year, the FDA fired off warning letters to seventeen companies that, in the agency’s view, were illegally marketing supplements to treat Alzheimer’s disease. One of the supplements targeted in the FDA’s action was piracetam, a derivative of GABA, continuing an FDA trend of attacking brain health supplements to protect drug industry profits.
Piracetam has been on the market as a supplement for years. It is approved as a drug in Europe and prescribed for cognitive impairment and dementia. Researchers think that piracetam helps the brain by boosting energy production in brain cells. As we age, our brain cells decline in their ability to generate energy; this decline in energy causes cellular “debris” to accumulate which can kill brain cells and eventually lead to senility.
The FDA’s treatment of piracetam highlights how broken our system is. This relates to the “new supplement” notification process we’ve discussed many times. Any supplement that came to the market after 1994 is considered a “new supplement.” Companies that want to sell new supplements must notify the FDA 75 days in advance of marketing the product. In implementing this provision of the law, though, the FDA has been trying to turn this notification process into a de facto pre-approval process. The agency has also adopted an expansive view of what constitutes a new supplement.
Additionally, if a compound is being investigated for use in a drug, and that process started before a “new supplement” notification was filed on that compound, then that substance cannot be sold as a supplement—even if the drug company abandons the research on that compound. This, remember, is what happened with pyridoxamine, a crucial form of vitamin B6. Additionally, L-glutamine and CBD have both been turned into drugs through this mechanism.