A new critic of FDA’s oversight of new dietary ingredients for nutritional supplements joins a known critic in questioning the agency on allowing sales of supplements that contain an ingredient prescribed as a drug in other countries.

Sen. Claire McCaskill, ranking member on the Special Committee on Aging, sent a letter Oct. 6 asking FDA to order a halt to sales of supplements containing vinpocetine and picamilion. She also asked for NDI and adverse event report information on the ingredients, which currently are available in the US in numerous supplements, many promoted for cognitive benefit.

Sen. McCaskill’s concerns could put front and center on the NDI stage the question of whether FDA should allow sales of supplements that contain an ingredient used in drugs available in other countries but accepted as a dietary ingredient in the US.

The Missouri Democrat contacted FDA after the publication of research, led by Pieter Cohen, a staunch advocate for tightening US regulation of supplement manufacturing and marketing, showing that some supplements labeled as containing vinpocetine or picamilon did not contain either ingredient. The researchers also said neither ingredient is derived from natural sources but both are synthetics used as drugs in other countries (see story this issue, [A#05151012008]).

In the US, vinpocetine is recognized as a semisynthetic derivative of the vinca alkaloid vincamine, an extract from the lesser periwinkle plant, and picamilon as a combination of niacin, or vitamin B3, and nicotinoyl-gamma-aminobutyric acid.

McCaskill, who earlier in 2015 questioned why FDA allowed supplements to make cognitive benefit claims, pointed out in her latest letter that the ingredient already was used in drugs marketed in other countries before the agency accepted an NDI notification for vinpocetine in 1997 ([A#05150622013]).

The notification, she said, “seems to have met little scrutiny from FDA as to the product’s allegedly synthesized origins, as it has been on US shelves for several years.”

McCaskill, who also was highly critical of weight loss supplement marketing during a hearing in 2014 when she was Consumer Protection Subcommittee chairwoman, asked FDA to provide by Oct. 12 copies of NDI notification materials the agency received concerning supplements containing vinpocetine or picamilon and for AERs linked to either ingredient ([A#05140623002]).

CFSAN said it would respond to the senator’s questions but declined to elaborate on whether it will enforce against vinpocetine- and picamilon-containing supplements.

Just Synthetic, Or Pharmaceutical Too?

While McCaskill is not the first to question FDA on the presence of pharmaceutical ingredients in supplements, she raises an additional area of concern in asking the agency about NDI notifications for substances that are considered pharmaceutical ingredients in other countries.

Members of Congress and critics of FDA’s supplement industry oversight long have pointed out products spiked with drug or other violative ingredients, most marketed for weight loss, strength training or sexual enhancement. The agency’s enforcement against those products generally entails informing the marketers that their products are unapproved new drugs and, in some cases, rejecting firms’ arguments that the disputed ingredients are not pharmaceutical but dietary.

McCaskill’s letter, though, could put front and center on the NDI stage the question of whether FDA should allow sales of supplements that contain an ingredient used in drugs available in other countries but already marketed as a dietary ingredient in the US.

“As you know, the law governing dietary supplements prohibits the inclusion of synthesized ingredients like those found in prescription drugs,” the senator stated in the letter.

The Dietary Supplement Health and Education Act enacted in 1994 allows firms to market dietary supplements that contain dietary ingredients available in the US food supply before Congress passed the act.

FDA explains that under DSHEA, a dietary ingredient allowed for use in a supplement is a vitamin, mineral, herb or other botanical, amino acid, “a dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands,)” or a concentrate, metabolite, constituent or extract.

For NDIs – ingredients not available in the US before Oct. 15, 1994 – DSHEA requires firms to submit to FDA, at least 75 days before marketing a product, a notification with information supporting that a substance is a dietary ingredient and that it is safe for its intended use. The agency does not approve NDI notifications, but informs firms either that their submissions have been filed, indicating FDA officials do not question the information, or that their information was insufficient to support a substance as an NDI.

An NDI notification for a pharmaceutical ingredient – marketed in or outside the US – is not likely. However, ingredients derived from natural sources, or their synthetic analogs, that are similar to but chemically distinctive from substances used as drug ingredients and that are not intended to treat a disease already were used in dietary supplements pre-DSHEA and have been NDI notification subjects since then.

FDA and the supplement industry have been at odds over the NDI notification process since DSHEA’s passage. In addition to arguing about whether certain ingredients were available in the US pre-DSHEA, FDA and manufacturers, as well as industry trade groups, are far from agreement on issues including the type of information the agency should require in NDI notifications, whether differences in manufacturing processes render an ingredient an NDI and whether synthetics of dietary ingredients should be considered NDIs Also see "Supplement NDI Draft Guidance Discussions Snagged On Basic Criteria" - Pink Sheet, 12 July, 2013..

A draft guidance on NDI notifications FDA published in 2012 only heightened the disagreement and the agency began a revision in 2013 after widespread industry protest and a request from the industry’s chief allies in Congress Also see "FDA Revision Of NDI Draft Guidance Starts With Grandfathered List" - Pink Sheet, 25 June, 2012..

New Wrinkle In NDI Debate: Supplement Ingredients Used As Drugs Outside US

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