Sen. Orrin Hatch, the Republican from Utah, has urged FDA to withdraw a notice in the Federal Register regarding an ingredient that has been sold as a dietary supplement since the 1990s: vinpocetine.
The senator this week called on FDA Commissioner Robert Califf, M.D., to backpedal from what Hatch described as an attempt by FDA to withdraw a product from the market for a reason other than concerns over public health. Hatch helped craft and negotiate the 1994 Dietary Supplement Health and Education Act (DSHEA).
“By removing a product from [the] market without safety concerns, FDA would be taking a precedential step that could shake the confidence that manufacturers maintain in the FDA process," Hatch wrote to Califf in the letter dated Oct. 25. “Given that FDA has had five opportunities to make this change, yet returned the product to market, the agency signaled that the product could be sold in the U.S. As such, I urge you to withdraw this notice and conduct cost-benefit analyses when considering the merits of withdrawing dietary and nutritional supplement products when safety is not the predicating reason for withdrawal."
INSIDER obtained the letter Wednesday, which had been distributed by the board of directors of the Natural Products Association (NPA). NPA is led by Daniel Fabricant, Ph.D., a former head of FDA’s Division of Dietary Supplement Programs.
Fabricant welcomed Hatch’s letter and indicated NPA planned to start a grassroots campaign asking members to write to their representatives in Congress, requesting the lawmakers contact FDA regarding the vinpocetine issue.
In a Federal Register notice in September that drew scrutiny from the industry, FDA tentatively concluded vinpocetine doesn’t qualify as a dietary ingredient and is excluded under DSHEA from the definition of a dietary supplement because it was authorized for investigation as a new drug and had been subject to substantial clinical investigations that had been instituted and publicized.
While vinpocetine is present in more than 340 dietary supplement brands, the ingredient has been marketed as a drug in countries outside the United States, according to researchers from Harvard Medical School and the University of Mississippi.
In the late 1990s, the supplement industry submitted to FDA five safety-related premarket NDI (new dietary ingredient) notifications concerning vinpocetine. FDA did not object to any of the notifications by Amrion Inc., General Nutrition Corp. (GNC), Leiner Health Products and Pharmavite Corp.
An FDA spokeswoman, Marianna Naum, said the agency would respond directly to Hatch.
“You have an ingredient not once, not twice, but five times the agency has said is OK and now all of a sudden we’re going to have a sea change," Fabricant said in a phone interview. “Where is the authority for that?"
Last year in a letter to FDA, Sen. Claire McCaskill (D-Missouri) described the ingredients vinpocetine and picamilon as “synthetic or semisynthetic substances." Drew Pusateri, a spokesman for McCaskill, did not immediately respond Wednesday to a request for comment on Hatch’s letter.
Researchers who were referenced in McCaskill’s letter examined the sale of vinpocetine in dietary supplements. They described the ingredient as a pharmaceutical drug in a number of countries, but the researchers noted vinpocetine has never been approved by FDA in the United States. Pieter Cohen, M.D., an assistant professor of medicine at Harvard Medical School and one of the researchers who studied the ingredient, supports FDA's tentative determination that vinpocetine should not be sold as a dietary supplement.
“Senator Hatch's legislation [DSHEA] was clearly not meant to create a backdoor to permit unapproved pharmaceuticals to be marketed directly to consumers without FDA approval," Cohen said in an emailed statement. “By closing the loophole through which vinpocetine slipped into the supplement supply chain, the FDA would confirm that investigational drugs are not permitted to be sold as dietary supplements. This would provide needed clarity to the industry and consumers that drugs cannot be introduced directly to consumers without FDA approval."
It’s not a foregone conclusion FDA will eventually ban vinpocetine from the market. The agency is requesting comments in an administrative proceeding on its tentative conclusions, and FDA isn’t taking enforcement action against companies selling vinpocetine, Cara Welch, Ph.D., senior advisor to FDA's Office of Dietary Supplement Programs, confirmed during an interview earlier this month at SupplySide West in Las Vegas. She also said FDA didn’t act “based on an acute safety concern with vinpocetine."
“This was more ensuring the integrity of the products that are on the market," she said.