Important Read Regarding NSP Products
We share the following information with you because of a recent development within the FDA that could possibly affect one of our NSP products, GABA Plus. Our GABA Plus doesn’t contain niacin, as does Picamilon. However, NSP works within the safe borders of using a conservative approach on products that might get the FDA’s attention so as not to be challenged by them in any way that could disrupt our availability to the products we depend upon. Please read the article and form your own conclusions. To be safe, Dick & Joy have chosen to order additional GABA Plus.
FDA Set to Yank Brain Health Herb
By ANH-USA on September 13, 2016
A number of months ago 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. Picailon 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. 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