Compiling Pre-DSHEA Ingredient List Relies On Bridging FDA-Industry Gap

"Nobody said these are easy questions, if they were they would have been answered a long time ago," says Steve Tave, director of FDA's Office of Dietary Supplement Programs. Industry stakeholders at a public meeting recommend a reasonable threshold for evidence that verifies a dietary ingredient was available in the US before Congress passed DSHEA.

FDA and dietary supplement industry stakeholders aren't on the same page about compiling an authoritative list of dietary ingredients that were eligible for use in supplements when Congress established the regulatory framework for the industry, comments at an Oct. 3 public meeting indicate.

Representatives of industry trade groups and other stakeholders recommend that FDA set a reasonable threshold for evidence that verifies a dietary ingredient was available in the US before Congress passed the Dietary Supplement Health and Education Act, with Oct. 15, 1994, as the grandfather date for ingredients eligible for use in supplements without first being notified to the agency with substantiation of reasonable expectation of safety for their intended use.

"Nobody said these are easy questions, if they were they would have been answered a long time ago," said Steve Tave, director of CFSAN's Office of Dietary Supplement Programs, in his closing remarks at the day-long meeting in College Park, Md. (Also see "Road To 'New' From FDA 'Old' Dietary Ingredient Discussion Has Doubters" - HBW Insight, 2 Oct, 2017.)

Tave noted in his opening remarks that comments on ODSP's July 2016 revised draft guidance on new dietary ingredient notifications indicated a variety of preferences for developing an authoritative list of ODIs, but showed a "broad consensus that this was a useful task for us to undertake."

It's a task, though, that ODSP is aware has become more complicated and difficult with each passing year since DSHEA's passage framed FDA's oversight of vitamin, mineral and supplement product manufacturing and marketing.

"'ll be blunt. This would have been a completely different undertaking if today were Oct. 16, 1994," Tave said.

Stephen Ostroff, FDA deputy commissioner for foods and veterinary medicine, pointed out that ODSP is looking at whether an authoritative list of ODIs is feasible as the office approaches its two-year anniversary of being established, which Ostroff "very strongly championed" while serving as acting commissioner.

Determining whether a dietary ingredient already is eligible for use in supplements is "burdensome to industry especially without an authoritative list of ingredients that were marketed" pre-DSHEA, Ostroff said. "I assure you it can also be burdensome to us."

Look for additional coverage of comments and other information in the Rose Sheet from CFSAN's public meeting on developing a pre-DSHEA list of dietary ingredients.

The burden on manufacturers and industry suppliers, said United Natural Products Alliance President Loren Israelsen, was shown in February when 71% of the participants in an UNPA conference said they are not filing NDI notifications because they are unsure of FDA's evaluation criteria.

Stakeholders are "too uncertain," Israelsen said. "We don't know what to do. We simply don't know what to do."

The industry should don't expect answers to arrive soon after 23 years of DSHEA, said Cara Welch, ODSP senior advisor. "We are not exactly looking at ticking clock on this," she said from the dais during the meeting.

Industry Lists Have History

Industry stakeholders speaking on panels at the meeting focused some comments on the types and amounts of evidence FDA should accept as verifying an ingredient as pre-DSHEA.

Israelsen said UNPA, as have other trade groups, has compiled an ODI list. "FDA has never regarded this or other lists as authoritative and that's what is really a clear problem," he said.

ODSP in the 2016 NDI notification draft guidance stated it would rely on an industry-compiled list. (Also see "Revised NDI Notification Draft Guidance Shrinks Divide Between FDA And Industry" - HBW Insight, 11 Aug, 2016.)

However, American Herbal Products Association President Michael McGuffin pointed out, the document identified as acceptable proof information such as sales records or contracts, bills of lading, manufacturing logs and commercial invoices, "most of which does not exist anymore,"

"Some pack rats might have a box or two of those," McGuffin said, adding, "FDA should move away from any position of absolute proof of pre-DSHEA marketing."

Instead, information from other materials not sourced from product sales or manufacturing, such as scientific, reference texts, guides to edible plants and herbal food menus, should be accepted as showing whether a dietary ingredient was used pre-DSHEA, AHPA suggests.

Those materials show "ingredients that were in the marketplace even though there wasn’t a dollar sign" included with the references and "clearly at least strongly suggest that these products were marketed prior" to DSHEA, McGuffin said.

"Each of these should be considered as implicit evidence of pre-DSHEA marketing, which AHPA believes a court of law would accept," he said. But, FDA's "limited view of what constitutes marketing in the US is unnecessarily narrow and is inconsistent with the actual language of DSHEA."

Israelsen, who worked on drafting DSHEA as a congressional staff member, pointed out the act anticipates the introduction of NDIs by requiring notifications to FDA, but whether other ingredients more than 20 years later could be shown as available before October 1994 wasn't a topic of concern.

"The passage of time has changed tech and it also has changed our ability to access the little information that was available" about dietary ingredients available in the US pre-DSHEA, he said. "Now we're at DSHEA plus 23 years ... if we had been able to do this on day plus 1, it would have been really easy."

Sources From Arcane To Agency

An official from the National Institute of Health's dietary supplement program, Joe Betz, also suggested that proof of some botanicals' use as food before October 1994 far more likely will be found in materials other than sales receipts.

Betz pointed out materials including the 1965 Boy Scouts of America Handbook and the 1918 US Dispensatory as showing that plants and other botanicals were used as food at those times.

"This is certainly evidence that they were in the food supply, but good luck trying to figure out if they were marketed," said Betz, Office of Dietary Supplements and Analytical Methods & Reference Materials Program director at NIH.

The Council for Responsible Nutrition recommends looking not only for evidence that is not "extremely limited" by FDA, but also closer to home for sources for an authoritative list of eligible dietary ingredients, said Duffy MacKay, the groups senior vice president, scientific and regulatory affairs.

In addition to ingredients that FDA acknowledges are documented as pre-DSHEA, CRN suggests an authoritative list include NDIs that receive "no objection" responses from the agency and ingredients already listed on the agency's multiple food supply databases.

MacKay said rather than pointing in the direction of resolving the impasse between the industry and FDA, stakeholders' disparate arguments on how pre-DSHEA evidence should be verified precludes reaching an agreement.

"We are 20-plus years later and I would argue we are starting from scratch," he said. "We continue to play this tug of war but it's time to map out a path for what makes sense," he added.

From the editors of The Tan Sheet. Our dietary supplement industry coverage now is published in the Rose Sheet, with articles emailed to readers daily and available on this page of the Rose Sheet website.