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."