By Mike Montemarano, Associate Editor11.12.20
On Nov. 10, just a few days after Joe Biden was projected to become the 46th President of the United States, the American Herbal Products Association (AHPA) hosted a discussion with Shannon Campagna, Ross Kyle, and Pete Evich from the Washington, D.C.-based lobbying firm Van Scoyoc Associates. These experts parsed the results of the 2020 election—which saw the highest voter turnout since 1908—and how the 117th Congress may influence dietary supplement regulations.
While Democrats held onto a slim majority in the House of Representatives, control of the Senate will hinge on a Jan. 5 runoff election in Georgia for both seats.
Overall, the Democratic party under-performed significantly compared to projections made by most pollsters in this election cycle, which was a significant blow to public trust in political polling, Campagna said. “There are even more limitations on the efficacy of polling than we thought previously. We’re learning that we should perhaps save ourselves some time and stop watching polls so closely,” she said. “Pollsters had a rough night, and we all need to take a hard look at how polling is conducted, and how we should utilize it both as consumers and as people interested in political outcomes.”
Based on election results, some broad trends for agendas in the House and Senate can be projected, Campagna said. Ultimately, moderacy is likely to prevail. Recent headlines suggest, for example, the U.S. Supreme Court may not overturn the Affordable Care Act in its entirety, but will instead reach a more provisional ruling, Campagna said. Additionally, the lack of a “blue wave” will likely mean that both political parties will operate in an environment ruled by moderation, with specific urgency being placed on healthcare access (largely fueled by the COVID-19 pandemic) and infrastructure expansion. The ratios of legislative committees, including those which oversee the FDA and other agencies whose auspices include the dietary supplements industry, will be very bipartisan.
Key Players for Industry to Watch
Evich highlighted a number of key players and regulatory objectives which he projected will be the most important to focus on for the industry.
“There are many implications for the dietary supplement trade, based upon the makeup of committees with jurisdiction over the FDA,” Evich said. “Congressman Frank Pallone of New Jersey, a proponent of DSHEA (The Dietary Supplement Health and Education Act of 1994) and member of the Dietary Supplement Caucus will remain, and he’s a friendly ear who we anticipate will be receptive to the supplement trade as he has been over the years.” This year, the membership ratio of the House Energy and Commerce Committee will be 27 Democrats to 17 Republicans, which is a slightly adjusted ratio compared to the previous Congress, as the Committee will see six vacated seats.
The Senate HELP (Health, Education, Labor and Pensions) Committee, another legislative wing with jurisdiction over the FDA, will see a new chairman, as Sen. Lamar Alexander (R-TN) announced his intent to retire after his term ends in 2020. However, Sen. Richard Burr (R-NC) announced that he is retiring in 2022, and would tentatively be replaced by Sen. Patty Murray (D-WA) if the Democratic Party prevails in the runoff elections taking place in Georgia. Within the HELP committee are some other representatives likely to be receptive to input from dietary supplement trade lobbying, such as Sen. Tim Scott (R-SC), a Dietary Supplements Committee co-chair, and Sen. Mitt Romney (R-UT), who Evich said would likely be receptive to input from the industry due to Utah’s prominence in the dietary supplements space.
While Evich’s projections on who might be the next FDA Commissioner under a Biden administration are what he would characterize as “highly preliminary” speculations, he did identify a few likely candidates. He believes that former FDA Commissioner David Kessler may be tapped to take the reins.
“Folks who’ve been in the industry for a long time know that he’s not a fan of the DSHEA construct, and he is currently the board chair of the CSPI (Center for Science in the Public Interest),” Evich said. The group is well-known for being highly critical of the current regulatory structure by which the dietary supplement trade navigates, calling for much more stringent regulations in many domains. During a mid-July hearing held by FDA on updating its regulatory framework, testimony from the organization characterized dietary supplements as “among the most poorly regulated consumer products.” Former FDA Deputy Commissioner Joshua Sharfstein may also generate interest for the future administration when it seeks to fill the position, too, Evich said.
Mandatory Product Registration
Under a new administration, one of FDA’s utmost priorities will likely be its proposed new rule to establish mandatory product registration (MPR) for all products being marketed as dietary supplements. Having already garnered support from some major trade associations representing the dietary supplements industry, in addition to CSPI and the PEW research center, Evich believes that mandatory product registration will be enacted within the next four years. Despite opposition from other trade groups to the measure, including AHPA and the Natural Products Association, it does appear that FDA will be open to deliberations in the days ahead, AHPA President Michael McGuffin said.
“While the FDA will be the main negotiator of the MPR, AHPA will be given a significant stake in the deliberations,” McGuffin said. “FDA really wants it, and most trade groups want it, so we know it’s going to move forward. FDA wants engagement from us, and wants us to point out the perceived drawbacks of it and other tactics for good policy reasons. They want to create a policy that brings everyone on board, because, tactically, it will help them with negotiations on other supposed DSHEA shortcomings moving forward; so there’s merit to differences of opinion.”
Eyes on Enforcement
In general, experts anticipated more robust regulatory enforcement, even more aggressive than the four years prior. Some detractors may challenge the self-GRAS affirmation structure that is currently in place, which they consider to be a “loophole,” Evich warned. Other possible pushes may include more in-depth labeling requirements for supplements that interact with drugs, and stronger enforcement of mandatory reporting for non-serious adverse events. Furthermore, he believes it isn’t out of the question to anticipate conversations about DSHEA detractors seeking to grant state attorneys general authority in enforcing federal dietary supplement laws. Furthermore, he said to anticipate harsher regulatory scrutiny toward supplements in certain health categories known to be “high risk,” such as weight management and brain health.
Evich went on to name who he anticipates will be some of the most active legislators in the 117thCongress who are opponents to DSHEA and in strong support of revising the regulatory structure surrounding dietary supplements. Specifically, he believes that Rep. Rosa DeLauro (D-CT) will be a leading voice on behalf of CSPI’s objectives in the realm of dietary supplements, alongside Sen. Richard Blumenthal (D-CT), who will likely be a leading “antagonist” of the dietary supplements industry in the Senate. Other Senators likely to voice scrutiny toward the dietary supplements industry include Sen. Edward Markey (D-MA), Sen. Elizabeth Warren (D-MA), and Sen. Dick Durbin (D-IL).
While Democrats held onto a slim majority in the House of Representatives, control of the Senate will hinge on a Jan. 5 runoff election in Georgia for both seats.
Overall, the Democratic party under-performed significantly compared to projections made by most pollsters in this election cycle, which was a significant blow to public trust in political polling, Campagna said. “There are even more limitations on the efficacy of polling than we thought previously. We’re learning that we should perhaps save ourselves some time and stop watching polls so closely,” she said. “Pollsters had a rough night, and we all need to take a hard look at how polling is conducted, and how we should utilize it both as consumers and as people interested in political outcomes.”
Based on election results, some broad trends for agendas in the House and Senate can be projected, Campagna said. Ultimately, moderacy is likely to prevail. Recent headlines suggest, for example, the U.S. Supreme Court may not overturn the Affordable Care Act in its entirety, but will instead reach a more provisional ruling, Campagna said. Additionally, the lack of a “blue wave” will likely mean that both political parties will operate in an environment ruled by moderation, with specific urgency being placed on healthcare access (largely fueled by the COVID-19 pandemic) and infrastructure expansion. The ratios of legislative committees, including those which oversee the FDA and other agencies whose auspices include the dietary supplements industry, will be very bipartisan.
Key Players for Industry to Watch
Evich highlighted a number of key players and regulatory objectives which he projected will be the most important to focus on for the industry.
“There are many implications for the dietary supplement trade, based upon the makeup of committees with jurisdiction over the FDA,” Evich said. “Congressman Frank Pallone of New Jersey, a proponent of DSHEA (The Dietary Supplement Health and Education Act of 1994) and member of the Dietary Supplement Caucus will remain, and he’s a friendly ear who we anticipate will be receptive to the supplement trade as he has been over the years.” This year, the membership ratio of the House Energy and Commerce Committee will be 27 Democrats to 17 Republicans, which is a slightly adjusted ratio compared to the previous Congress, as the Committee will see six vacated seats.
The Senate HELP (Health, Education, Labor and Pensions) Committee, another legislative wing with jurisdiction over the FDA, will see a new chairman, as Sen. Lamar Alexander (R-TN) announced his intent to retire after his term ends in 2020. However, Sen. Richard Burr (R-NC) announced that he is retiring in 2022, and would tentatively be replaced by Sen. Patty Murray (D-WA) if the Democratic Party prevails in the runoff elections taking place in Georgia. Within the HELP committee are some other representatives likely to be receptive to input from dietary supplement trade lobbying, such as Sen. Tim Scott (R-SC), a Dietary Supplements Committee co-chair, and Sen. Mitt Romney (R-UT), who Evich said would likely be receptive to input from the industry due to Utah’s prominence in the dietary supplements space.
While Evich’s projections on who might be the next FDA Commissioner under a Biden administration are what he would characterize as “highly preliminary” speculations, he did identify a few likely candidates. He believes that former FDA Commissioner David Kessler may be tapped to take the reins.
“Folks who’ve been in the industry for a long time know that he’s not a fan of the DSHEA construct, and he is currently the board chair of the CSPI (Center for Science in the Public Interest),” Evich said. The group is well-known for being highly critical of the current regulatory structure by which the dietary supplement trade navigates, calling for much more stringent regulations in many domains. During a mid-July hearing held by FDA on updating its regulatory framework, testimony from the organization characterized dietary supplements as “among the most poorly regulated consumer products.” Former FDA Deputy Commissioner Joshua Sharfstein may also generate interest for the future administration when it seeks to fill the position, too, Evich said.
Mandatory Product Registration
Under a new administration, one of FDA’s utmost priorities will likely be its proposed new rule to establish mandatory product registration (MPR) for all products being marketed as dietary supplements. Having already garnered support from some major trade associations representing the dietary supplements industry, in addition to CSPI and the PEW research center, Evich believes that mandatory product registration will be enacted within the next four years. Despite opposition from other trade groups to the measure, including AHPA and the Natural Products Association, it does appear that FDA will be open to deliberations in the days ahead, AHPA President Michael McGuffin said.
“While the FDA will be the main negotiator of the MPR, AHPA will be given a significant stake in the deliberations,” McGuffin said. “FDA really wants it, and most trade groups want it, so we know it’s going to move forward. FDA wants engagement from us, and wants us to point out the perceived drawbacks of it and other tactics for good policy reasons. They want to create a policy that brings everyone on board, because, tactically, it will help them with negotiations on other supposed DSHEA shortcomings moving forward; so there’s merit to differences of opinion.”
Eyes on Enforcement
In general, experts anticipated more robust regulatory enforcement, even more aggressive than the four years prior. Some detractors may challenge the self-GRAS affirmation structure that is currently in place, which they consider to be a “loophole,” Evich warned. Other possible pushes may include more in-depth labeling requirements for supplements that interact with drugs, and stronger enforcement of mandatory reporting for non-serious adverse events. Furthermore, he believes it isn’t out of the question to anticipate conversations about DSHEA detractors seeking to grant state attorneys general authority in enforcing federal dietary supplement laws. Furthermore, he said to anticipate harsher regulatory scrutiny toward supplements in certain health categories known to be “high risk,” such as weight management and brain health.
Evich went on to name who he anticipates will be some of the most active legislators in the 117thCongress who are opponents to DSHEA and in strong support of revising the regulatory structure surrounding dietary supplements. Specifically, he believes that Rep. Rosa DeLauro (D-CT) will be a leading voice on behalf of CSPI’s objectives in the realm of dietary supplements, alongside Sen. Richard Blumenthal (D-CT), who will likely be a leading “antagonist” of the dietary supplements industry in the Senate. Other Senators likely to voice scrutiny toward the dietary supplements industry include Sen. Edward Markey (D-MA), Sen. Elizabeth Warren (D-MA), and Sen. Dick Durbin (D-IL).
