Why? Because Alzheimer’s is a hot area, and Big Pharma wants it. Action Alert!
A number of months ago we wrote about how Sen. Claire McCaskill (D-MO) called for the removal of picamilon and vinpocetine from store shelves, pending a review of their status as dietary supplements. Sen. McCaskill, who is clearly doing industry’s bidding, claimed these supplements were synthetic and not natural, but that wasn’t true. Picamilon is a combination of GABA (a substance made from the amino acid glutamine) and niacin (vitamin B3). Vinpocetine is a derivative of the lesser periwinkle plant, making it akin to a botanical extract.
The FDA recently said that it has reached a “tentative” conclusion that vinpocetine is an illegal dietary ingredient because 1) it does not meet the legal definition of a dietary ingredient and 2) it is being investigated as a new drug. This FDA move could have serious consequences.
In the 1990s the agency accepted five New Dietary Ingredient (NDI) notifications on vinpocetine. (NDI essentially means “new supplement.”) Part of the NDI notification process is determining whether an ingredient meets the definition of a supplement. Why is the FDA all of a sudden reversing its decision?
According to the new draft NDI guidance, if a supplement is converted into a drug, but no new drug comes to market, the substance simply disappears. This is what happened to pyridoxamine, an important natural form of B6 which has, among many other things, anti-aging properties. Only one form of natural B6 remains available, and Big Pharma wants that too.
Remember too that in the new NDI guidance, the FDA has stated that it does not consider synthetic botanicals to fit the definition of a dietary ingredient (i.e., supplement)—a position that agency is apparently starting to enforce. We think it’s nonsense: nothing in the landmark Dietary Supplement Health and Education Act of 1994 states that synthetic and natural botanicals should be treated differently. The FDA is interpreting the statute as it wishes in order to hand as many of these substances to Big Pharma as possible. What’s next? Will bioidentical hormones be turned into drugs by the FDA?
Vinpocetine has a number of uses, including neuroprotective effects; it improves brain health and cognitive function, and has virtually no side effects. Dr. Russell Blaylock, in the February issue of his Blaylock Wellness Report, notes that other positive effects of vinpocetine include reducing cellular calcium (too much calcium in cells is very toxic), improving blood flow, reducing excitotoxicity, protecting mitochondria, reducing inflammation, reducing fat peroxidation, and exhibiting anti-cancer potential.
We must push back against this latest grab by the FDA as it once again shamelessly fronts for the pharmaceutical industry.
Action Alert! Tell the FDA to maintain consumer access to vinpocetine as a supplement—and urge the agency to extend the comment period on the NDI guidance, so consumers and stakeholders have ample time to respond to this document. Please send your message immediately.
Other articles in this week’s Pulse of Natural Health: