He rides into town again…

Senator Orrin Hatch Urges FDA to Withdraw

W ithout the involvement of Sen. Orrin Hatch, it is unlikely that the Dietary Supplement Health and Education Act (DSHEA) would ever have passed back in 1994. But instead, it was made into law without a single objection by the House and the Senate. It was unanimous! Consequently, Americans have had 26 years of peaceful progress in nutritional supplements brought to the market place for the benefit of all who choose to take their health into their own hands.

So it was good to hear from Sen. Orrin Hatch, a Republican from Utah, who during the last week of October urged Commissioner Robert Califf, M.D., in a letter, to withdraw the federal register notice for Vinpocetine, a dietary ingredient that has five acknowledgements in the U.S. Food and Drug Administration (FDA) New Dietary Ingredients Database.

Wrote Hatch in his letter, “the Dietary Supplement Health and Education Act of 1994 (DSHEA) provides pathways for withdrawing dietary ingredients based on safety concerns.” However, in the FDA notice, no “risk of illness or hazard to public health” was cited for the ingredient vinpocetine to be excluded from the definition of a dietary supplement in the Federal Food, Drug and Cosmetic Act.

Vinpocetine, which is commonly marketed as a supplement for improvement of brain function, weight loss, and energy, was instead excluded on September 6, 2016 (the date of the FDA’s notice) because vinpocetine is synthetically produced instead of being a constituent of a natural substance. Thus, in FDA’s opinion, it is ineligible to be a dietary ingredient because it did not fit the definition.

Hatch’s letter went on to state that in 1997, 1998, and three times in 1999, FDA pulled five New Dietary Ingredient notifications for vinpocetine for 75 days and conducted safety and regulatory checks. For each review FDA saw there were no concerns with the ingredient or data provided and allowed each product to go to market.

Because vinpocetine is present in more than 300 products, Hatch believes a cost-benefit analyses should instead be conducted when FDA considers withdrawing a dietary supplement product “when safety is not the predicating reason for withdrawal.”

As of yet, vinpocetine has not been banned from the market. FDA will continue accepting comments from the public regarding the regulatory status of vinpocetine until November 7th, 2016. Welcome back, Sen. Hatch.

In our editorial last month concerning the FDA’s attempt to impose a Spartan-like rule on “New Dietary Ingredients”—the consequence of which would do serious harm to the public health—there has been a slight reprieve with the extension of the comment period by 60 days until December 12, 2016. So if you haven’t already written in, please do so now, and welcome Marshal Hatch back!.

Highest-Level Action Alert!

Action Alert! Write to Congress and the FDA to protest this revised guidance that threatens our access to supplements. Please send your message immediately. Go to http://www.anh-usa.org/action-alert-stop-the-massive-attack-on-supplements/ and here: http://www.anh-usa.org/action-alert-extend-ndi-comment-period/

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