FDA Attacks Brain Health Supplements

We think this is to pave the way for a new blockbuster drug. Action Alert!

In October we told you about a potential new blockbuster drug for Alzheimer’s from drug giant Eli Lilly. Solanezumab is in the third and final phase of FDA drug trials, and if approved, could bring in at least $7.6 billion in sales by 2024 and probably much more. Other drug companies also have “big” Alzheimer’s drugs in the works.

Now the FDA has sent warning letters to five supplement companies targeting the supplement picamilon, which may help with Alzheimer’s, anxiety, and general brain health. It is a combination of natural ingredients niacin (vitamin B3) and GABA, a substance our body makes from the amino acid glutamine. This particular combination crosses the blood–brain barrier more effectively than GABA alone. The FDA, however, claims that picamilon does not meet the statutory definition of a dietary supplement because it is neither a vitamin, nor (in its combined form) a completely organic substance, nor a minor component of foods. The agency says that although picamilon can be synthesized from niacin, it is a different chemical entity, and is therefore “adulterated.”

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