Industry stakeholders look forward to working with Biden Administration even as pandemic, Kessler add cause for concern

By Hank Schultz contact

- Last updated on GMT

©Getty Images - YayaErnst
©Getty Images - YayaErnst

Related tags: Regulation, Dietary supplement industry, Dietary supplement caucus, Dietary supplement companies

Industry stakeholders anticipated a smooth working relationship with a new Biden Administration, but said this year’s highly unusual circumstances makes this transition more uncertain than most.

President Trump has so far refused to accept the electoral results and is pursuing court challenges of vote counts in several states.  While most observers believe the strategy has no hope of overturning the result, it does complicate the matter of laying plans for how to deal with a new administration.

Pandemic, transition interregnum add uncertainty

“At the first level we have to say we really don’t know what working with the new Administration will be like, given the highly unusual circumstances of the transition,”​ said Loren Israelsen, president of the United Natural Products Alliance (UNPA).

“We have been given some of the names being considered for cabinet positions, and we think there are opportunities that will open up for the industry there, such as with the Department of Agriculture,” ​he said.

Israelsen said new leadership at USDA could see a renewed emphasis on progressive farming practices, more attention paid to foster organic production, and other policy areas where the supplement industry might have an interest.

As for the Department of Health and Human Services, which houses the Food and Drug Administration, Israelsen said the leadership picture is less clear, but some ideas seem to be givens during times of Democratic control of the executive branch.

“We’d anticipate from FDA a more rigorous regulatory oversight posture as compared to the past four years,”​ Israelsen said.

CRN looking forward to receptive ears for CBD, product listing

Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN) said his organization’s membership was looking forward to working with the new leadership.

“I think there is a lot of optimism actually when you look at some of the things we are trying to accomplish.  We think there will be a receptive voice on CBD.  And we think there will a receptive voice on getting a mandatory product listing,”​ Mister said.

Makeup of Congress key to new policy initiatives

Dan Fabricant, PhD, president and CEO of the Natural Products Association (NPA), said of more import than the presidential race outcome will be the final makeup of the Senate and the House of Representatives.  Republicans picked up seats in the House, narrowing the Democrats’ majority.  And in the Senate, control hangs in the balance, with the races for the two seats in Georgia both heading to January runoff elections.  Georgia’s election rules call for a Senator to get at least 50% of the votes cast to be called an outright winner in the initial election, something that no candidate managed to do. Democratic candidates would need to win both races to get to an even 50-50 split in the Senate.

“If the Senate stays Republican controlled and with the gap narrowing in the House we will see more gridlock,”​ Fabricant said.

Pandemic taking center stage

Israelsen said that the pandemic adds an additional layer of uncertainty onto the process to go with the Trump team’s machinations. The concern among some industry stakeholders is that dealing with the disease crisis will divert so much attention that FDA will have no bandwidth to move forward on questions such as a solution for CBD and the ‘DSHEA 2.0’ discussions.

“The dietary supplement industry has not been a priority, I would say,” ​Israelsen observed.

"If I had any concern going forward it's the coronavirus pandemic taking all of the energy at the Agency away from everything else. We want to make sure that ODSP (the Office of Dietary Supplement Programs) does not get lost because of the coronavirus,"​ Mister said.

Fabricant noted that the portions of FDA that are supported by user fees, such as on the drug development side, have always garnered more attention.

“We ​[the supplement industry] are all appropriated money and FDA pays more attention to its user fee funding,”​ he said.

Concerns about Kessler

Some concern within industry was raised at seeing Dr David Kessler’s name pop up on the roster of President Elect Biden’s Coronavirus Task Force.  Kessler was FDA Commissioner when the Dietary Supplement Health and Education Act (DHSEA) was passed in 1994 and was known to oppose the law.  Subsequent to DSHEA’s passage FDA, under Kessler’s leadership, did very little to enforce the new law’s provisions.  Stakeholders were concerned that such a well known opponent of the industry might again be in a position to influence policy.

Israelsen noted that Kessler had pursued a regulatory course in the early 1990s that would have seen many ingredients used in supplements today be classified as illegal food additives.

“It’s quite likely he’ll become very well known to the American public as part of his work on the task force.  While his role there would really be to advise and make policies with the goal of really getting a grip on this pandemic, there would also be opportunities for him to express his long held views that DSHEA was a piece of legislation he actively disagreed with,”​ Israelsen said.

“There has been some concern about Dr Kessler being apart of Biden’s coronavirus team.  We certainly remember what FDA was like under Dr Kessler.  But the fact that he is on the transition team and the coronavirus team does not mean a new direction at FDA.  We have seen some other names on the shortlist for FDA that gives us hope for the future,”​ Mister said.

Educating new members of Congress

Fabricant said with all of the new faces coming into the House and the Senate there is a big opportunity for the supplement industry to tell its story, especially in light of the evidence that is coming out on some ingredients and their helpful role in the pandemic.

“For example, you can’t go a day without seeing some new study on people’s vitamin D status and COVID-19 outcomes,” ​Fabricant said. “We will work with whoever.  There are a lot of new faces coming in, and we can make the case with them that this information about supplements is information the American public wants.  Why can’t we get that into their hands?” ​Fabricant said.

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