AHPA Says HHS Secretary Could Rescue Vinpocetine as Dietary Supplement

Even if vinpocetine was first studied as a drug, the substance could still meet the definition of a dietary supplement under a narrow exception in the law that has never been invoked by the Secretary of Health and Human Services.

Josh Long, Associate editorial director, Natural Products Insider

November 9, 2016

3 Min Read
AHPA Says HHS Secretary Could Rescue Vinpocetine as Dietary Supplement

In 1981, vinpocetine was authorized for investigation as a new drug by FDA. Later in the mid- and late-1980s, trade, medical and newspaper articles reported on clinical studies of vinpocetine for the treatment of such conditions as dementia and central nervous system degenerative disorders, according to FDA.

The agency relied on the facts above—and a drug clause in federal law—to support its tentative conclusion announced in September that an ingredient sold in hundreds of supplement brands—vinpocetine—is excluded from the definition of a dietary supplement.

But in comments filed Monday with FDA, the American Herbal Products Association (AHPA) pointed out the law grants the Secretary of Health and Human Services (HHS) authority to create an exception to the drug-related exclusion.

“Given the present circumstances—that vinpocetine has been the subject of five NDI [new dietary ingredient] notifications on which FDA expressed no significant concerns or objections and that the ingredient is currently broadly sold—AHPA believes that vinpocetine should be recognized as a reasonable subject for the exception allowed for under the law," the trade association said in comments submitted by its president, Michael McGuffin, and Anthony Young, general counsel to AHPA and a partner with the law firm Kleinfeld, Kaplan and Becker LLP.

The 1994 Dietary Supplement Health and Education Act (DSHEA) generally excludes an article from the definition of a dietary supplement if the following elements have been satisfied:

·         Before it was marketed as a supplement or food, the article was first “authorized for investigation as a new drug;"

·         Pursuant to such authorization, “substantial clinical investigations have been instituted;"

·          And “the existence of such investigations has been made public."

FDA tentatively determined vinpocetine meets the criteria above. The ingredient was the subject of five NDI notifications in the 1990s, several years after vinpocetine was authorized for investigation as a new drug in 1981.

Still, vinpocetine could meet the definition of a dietary supplement under a narrow exception in the law: if HHS Secretary Sylvia Mathews Burwell, in her discretion, “issued a regulation, after notice and comment, finding that the article would be lawful under this chapter."

The HHS Secretary has never used such authority in DSHEA’s 22-year history, AHPA observed.

AHPA recommended FDA encourage the HHS Secretary to commence a rulemaking to declare vinpocetine lawful if vinpocetine is otherwise found to have met the definition of a dietary ingredient. But FDA has tentatively concluded otherwise—potentially spoiling the slim chance that Burwell would consider a rulemaking to keep vinpocetine supplements on the market.

In its Sept. 7, 2016 Federal Register notice, FDA described vinpocetine as “a synthetic compound, derived from vincamine, an alkaloid found in the Vinca minor plant, or tabersonine, an alkaloid found in Voacanga seeds."

However, AHPA encouraged FDA to explain that vinpocetine would qualify as a dietary ingredient if it is marketed as a food ingredient today or included as one in the future. The trade association requested FDA clarify that while the agency did not find evidence vinpocetine was used as a food, “such use was possibly overlooked or could come into use in the future."

About the Author(s)

Josh Long

Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition

Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Education and previous experience

Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.

Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.

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