Tell FDA to Protect Brain Health Supplements

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.

Write to Congress and the FDA, telling them to preserve consumer access to these important supplements!

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Please protect piracetam and other brain health supplements

Dear [Decision Maker],

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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.

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 that can kill brain cells and eventually lead to senility.

In 2004, the FDA rejected a NDI (new dietary ingredient) notification for piracetam, saying the submission was incomplete. This is understandable, given that requirements for complying with NDI notification rules have not been completed by the FDA. The agency published its first draft guidance for NDI notifications in 2011, almost 20 years after the law was passed. This draft was withdrawn after stakeholders pointed out glaring problems in the guidance, and a revised draft wasn't released until 2016--and still has not been completed. For all this time, companies have been in the dark about how to comply with the FDA's NDI policies--but the drug industry can still start researching these compounds to corner the market and prevent supplement versions from being legally marketed.

This is likely what will happen with piracetam. In a 2012 warning letter, the FDA stated that piracetam was being investigated as a new drug, and since there is no evidence that it was marketed as a supplement before that, it cannot be a supplement.

Clearly the deck is stacked against the natural products industry.

The FDA has also moved against vinpocetine and picamilon, two other brain health supplements. At the same time, major trials for Alzheimer's drugs keep failing.

Please preserve consumer access to important brain health supplements like piracetam!

Sincerely,
[Your Name]
[Your Address]
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[Your Email]