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:
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McCaskill is absolute p.o.s. and confirms that fact on very regular basis.
Who votes for that woman? BTW, before voting for Paul Ryan (he won his primary) please remember that he wants to do away with Social Security/Medicare. Used his own mother to make that point when on the Romney ticket as VP.
The Organic Laws of The United States of America, The Common Law (specifically The Herbalist Charter), The Food, Drug and Cosmetic Act of 1938, which limits the FDA’s jurisdiction/authority to Washington, DC and the territories (supported by the 18th and 21st Amendments) except in the regulating (organizing for efficient flow) of interstate commerce (transportation across State lines – there is no FDA authority to control the sale and manufacturing of anything that I can find.), the case of Lopez v. United States, Dun & Bradstreet documents showing that the Texas Courts and government ‘agencies’ are “corporations for profit”, the United States Code 28 Sec. 3002 showing that the “United States” is a federal corporation (which is a fictitious rather than an organic entity- our God-given Rights are recognized only by the organic United States of America) and numerous other Supreme cases that establish that God-given Rights cannot be statutorily converted into privileges.”
This may be true but who will fight it and succeed? It would be like claiming income tax is unconstitutional. Doesn’t work.
please learn to read Title 21, they have limited jurisdiction, and Title 21 is not positive law. If you contract with the FDA then you hang yourself because they don’t have the jurisdiction.
The first step to reforming FDA is to split the food part and the drug part into separate agencies – being sure to assign responsibility for dietary supplements to the food agency, NOT the drug agency. The new Food Agency will then have a vested interest in keeping the Drug Agency’s nose out of its business.
Whenever certain companies realize the value and effectiveness of various supplements they try to get them banned. After the FDA does their work the companies can use their large capital reserves to patent and profit off of the former supplement.