FDA's Jim Jones engages with dietary supplement leaders on proposed reorg

Five trade organizations representing manufacturers, online marketers and brick-and-mortar retailers of dietary supplement products met last month as a collective group for the first time with Jim Jones, FDA’s first deputy commissioner for human foods.

The meeting reflected an opportunity for Jones to learn more about the sprawling supplement sector while discussing a planned reorganization of FDA’s food programs.

Jones, a former employee of the Environmental Protection Agency, joined FDA in September and is charged with advancing priorities for a proposed, unified Human Foods Program (HFP). As part of the unified HFP, FDA has proposed the creation of an Office of Food Chemical Safety, Dietary Supplements and Innovation.

On Nov. 29, Jones met virtually with representatives from the American Herbal Products Association (AHPA), Council for Responsible Nutrition (CRN), Consumer Healthcare Products Association (CHPA), Natural Products Association (NPA) and United Natural Products Alliance (UNPA).

“Since joining the FDA, I have met with dozens of stakeholders across the gamut, both those representing industry as well as the consumer, health, research and academic sectors,” Jones said in an emailed statement to Natural Products Insider. “Hearing perspectives from across our network of stakeholders is essential to getting the full picture and to finding optimal solutions to the myriad of food safety and nutrition issues FDA faces on a daily basis. This is also true for dietary supplements—an area that will have increased attention and visibility under the proposed Human Foods Program reorganization.”

Related:FDA gives update on dietary supplement office status in new Human Foods Program

He added, “I am committed to ongoing stakeholder engagement and to finding opportunities to leverage the different tools and expertise across our stakeholders and regulatory partners so that we, at the FDA, more efficiently and effectively carry our mission to protect public health.”

UNPA’s Israelsen highlights foundation of DSHEA

Loren Israelsen is president of UNPA and among those trade group executives who met recently with Jones and other FDA staff, including top officials within the Office of Dietary Supplement Programs (ODSP). During the meeting, Israelsen delivered a brief presentation on the Dietary Supplement Health and Education Act (DSHEA) and the events leading to passage of the 1994 law.

Israelsen emphasized to FDA officials a purported history of misuse of food additive and new drug provisions to unfairly attack the supplement industry before DSHEA.

“The foundational principal of DSHEA is to create a subcategory of foods that are explicitly not food additives or drugs in statutory language—to pound that point home,” he said in an interview. “It’s one of those things one cannot say too many times.”

Related:FDA commissioner says reorg will not diminish resources for supplement regulations

Israelsen suggested a shift at FDA pivoting from risk management to a focus on food itself and the chemicals in them, underscoring the need to focus on what he has described as the “Q-suite,” quality, regulatory and analytical.

He said the Q-suite today is underfunded and a benchmark should be developed to ensure that proper investments are being made in these areas.

“The Q-suite is emerging as the most important function within our industry and the C-suite needs to understand that and engage, support [and] budget accordingly and get ahead of the game,” he said in the interview.

If FDA pivots to focusing on scrutinizing foods and dietary ingredients themselves—including adulterants, contaminants, additives, colors and flavors—and industry fails to “keep pace, complex new issues will arise,” he concluded by email.

CRN execs explain self-regulatory initiatives

CRN President and CEO Steve Mister has met with Jones twice, first in an in-person meeting on Nov. 20 in College Park, Maryland, then later in the gathering of trade association executives, where Jones appeared virtually. In the first meeting, which ODSP Director Cara Welch also attended, three other CRN executives were present as well, FDA’s public calendar shows.

In the initial meeting with Jones, CRN discussed a number of the industry’s voluntary programs, such as the Supplement OWL (Online Wellness Library), a dietary supplement product registry. This meeting followed a fireside chat Mister held with FDA Commissioner Dr. Robert Califf at CRN’s annual conference in early October.

Based on some of Califf’s remarks during the fireside chat, CRN concluded FDA perhaps “didn’t appreciate the work that the industry, and particularly CRN does, to foster self-regulation,” Mister said.

He said he wanted to be sure that Jones understood CRN members commit to best practices and an ethics code, are vetted before they become members and must place their labels in the Supplement OWL as a condition of membership.

CRN is “doing these things to foster accountability and transparency within the industry,” Mister said.

In the same meeting, the trade association highlighted a Supplements to Savings study from the CRN Foundation that describes billions in potential health care cost savings from the targeted use of supplements.

Mister described the meeting as “very productive” and said Jones “left with a more favorable view of the industry.”

“And we certainly had the chance to talk to him about the reorg and some of his plans and priorities within this new Human Foods Program at FDA,” he added.

During the subsequent meeting with all the trade associations, Jones shared he anticipated the HFP reorganization to be completed in about six months, Mister said, adding the reorg is subject to review by the Department of Health and Human Services and the Biden administration. Industry sources who attended the meeting with Jones said congressional committees would have an opportunity to object to the reorganization.

NPA’s Fabricant questions FDA ‘efficiencies’ narrative

NPA President and CEO Dan Fabricant remains concerned about FDA’s planned reorganization and its effect on the agency’s regulation and oversight of dietary supplement products.

During the recent meeting between FDA officials and trade associations, “everyone kind of danced around the reorg and wanted to make nice,” he said in an interview. “I think people are … starstruck that, ‘Oh wow, we’re meeting with the principal deputy commissioner of FDA,’ versus actually dealing with the matter at hand, which is a significant threat.”

Fabricant suggested that he raised questions at the meeting about allocation of resources “in a super office with food additives on top and dietary supplements on bottom or in a subservient role.”

FDA officials, on the other hand, have maintained supplements will remain a critical priority under the reorganization, a reorg will not diminish resources for the commodity, and implementation of a proposed Human Foods Program will strengthen the oversight of dietary supplements and the effectiveness of the Office of Dietary Supplement Programs.

Fabricant, a former FDA official during the Obama administration who oversaw the Division of Dietary Supplement Programs, is not persuaded by the above statements or convinced a reorganization will make the agency more efficient.

“FDA keeps talking about efficiencies. Who the hell looks to FDA for efficiencies?” he asked. “FDA’s always going to be inefficient. On the drug side, they’re inefficient. So I think this whole concept is just flawed from the start. And again … what is the efficiency [FDA officials] are trying to get at? They get X number of NDI [new dietary ingredient] reviews a year. The issue with NDIs has always been enforcement. So now somebody who doesn’t understand NDI enforcement even more is going to be helping out or leading on NDI enforcement?”

According to NPA Director of Government Affairs Kyle Turk, Jones suggested in the meeting that he only agreed to meet with the five trade organizations “because the five trades were somehow in agreement” on FDA’s planned reorganization.

Turk said he’s not sure how FDA reached such a conclusion.

“If we look at several issues impacting the industry such as mandatory product listing, and rewriting DSHEA, I’m not sure that’s entirely accurate,” Turk said in a follow-up email. “And then, two … am I to expect that we’re only going to get a meeting with you if the five trades are in alignment?”

An assumption about a consensus within the trade groups on an FDA reorganization “shows a real ignorance about the industry and … how it is fragmented,” Fabricant added. “It’s vast, there’s different sectors and diversity of thought.”

AHPA’s McGuffin: Access to FDA commissioner won’t be diminished

During the meeting with trade associations, Jones stressed that moving ODSP into a larger office—the Office of Food Chemical Safety, Supplements and Innovation—will not move the dietary supplement component of the new office further from communications with the FDA commissioner, according to AHPA President Michael McGuffin.

Jones discussed “the different tiers and just wants us to know that to the degree that the Office of Dietary Supplements senior management needs access to the commissioner, that has not been diminished in any way,” McGuffin said in an interview.

Jones also discussed the budget, full-time employees and FDA’s clear commitment “to maintaining the current status,” McGuffin added. That’s consistent with statements by Califf that a reorg will not diminish FDA resources for supplements.

“There are going to be absolutely no resources taken away from dietary supplements,” Califf said during the industry conference in October hosted by CRN. “What we need is more.”

The commissioner added, “For a $60 billion industry, the allocation from Congress related to dietary supplements is woefully inadequate.”

During the more recent meeting with industry trade groups, Jones “strongly emphasized transparency,” McGuffin said. “It wasn’t a question, ‘Will you be transparent?’ It’s thematic and we’ve heard this in previous meetings with senior FDA officials since the reorganization was announced. And it’s clearly something that the agency wants us to believe, accept, acknowledge or at least be aware of that the agency intends to be transparent.”

McGuffin said he believes FDA is trying to convey “an openness to engagement in kind of a two-way street, both increasing flow of information from the agency and seeking industry insights.”

“In AHPA’s view, that would represent a significant shift,” he added later in the interview. “FDA has historically not exhibited much transparency. We think that they prefer to keep everything close to the vest and then announce it.”

McGuffin cited as examples FDA’s introduction this year of a dietary supplement ingredient directory before soliciting input from industry, as well as determinations that certain ingredients—including NAC, an ingredient marketed in supplements for decades—are unlawful in supplements due to either being first investigated or approved as drugs.

“Transparency would involve some kind of advance discussion, and I don’t mean secret meetings at all,” McGuffin said. “If the advance discussion should have also included other stakeholders, that’s fine. But the fact that we’ve been selling NAC for decades and all of a sudden there’s a different communication, to me it’s not transparent for that to happen in the manner that it did.”

Asked for his perspective on FDA’s planned reorganization of its food programs, McGuffin responded, “It starts with, ‘They are going to do it anyway,’ so I think we’ve already moved to, ‘How do we live with that?’”

As for the proposed Office of Food Chemical Safety, Dietary Supplements and Innovation, McGuffin said he doesn’t think FDA will “start treating us like chemicals just because the word ‘chemical’ is in the name of that office.” Finally, neither does he believe FDA will “drift back to the early ‘90s and start trying to regulate herbs as food additives.”

CHPA’s Melville: FDA must prioritize ‘appropriate regulation’ of category

CHPA CEO Scott Melville said his organization welcomed the recent meeting with Jones “to discuss stakeholder concerns and to ensure that the proposed restructuring will in no way dilute the prioritization of dietary supplements within FDA.”

“Members of the dietary supplement industry are specifically requesting additional insights from FDA to confirm that the dietary supplement program, budget, and application of appropriate statutory authorities following a safety review all remain top priorities,” Melville added by email. “It’s imperative FDA prioritizes appropriate regulation of this growing category to provide consumers with continued access to safe and beneficial products, and we look forward to continuing to actively collaborate with FDA during its reorganization process.”