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The American Herbal Products Association held its Congress on Regulatory Priorities in the Natural Products Market on Tuesday, November 15, 2022.
The American Herbal Products Association (AHPA; Silver Spring, MD) held its Congress on Regulatory Priorities in the Natural Products Market on Tuesday, November 15, 2022. Held in the shadow of the 2022 Midterm elections, the Regulatory Congress closed on a discussion between AHPA president Michael McGuffin and Pete Evich, vice president of Van Scoyoc Associates about how the upcoming 118th Congress may impact legislative priorities for the natural products industry. Results show that Democrats have retained control of the Senate but Republicans have won a slim majority in the House of Representatives.
Among the legislative priorities important for industry is a federal regulatory pathway for hemp-derived CBD as well as reforms to dietary supplement regulation, dubbed DSHEA 1.4, which includes amending the drug preclusion clause. Additionally, the potential for mandatory product listing (MPL) legislation still looms large. While MPL failed to pass as a so-called “super-rider” of FDA use fee reauthorization in the recent appropriations bill, there is still the potential that Democratic members of the “lame-duck” Congress may still try to attach the measure onto the upcoming omnibus spending bill, says Evich.
Democratic Senators such as Dick Durbin (D-Illinois), Patty Murray (D-Washington), and Richard Blumenthal (D-Connecticut) may put pressure on the primary committees of jurisdiction – namely the Senate Committee on Health, Education, Labor, and Pension (HELP) and House Committee on Energy and Commerce – to find a way to include MPL and other “super-riders” from FDA user fee reauthorization into the omnibus spending bill. Because the Democrats are losing control of the House in the upcoming Congress, they may view this as their last chance to take advantage of their majority in both the House and Senate. Therefore, opponents to MPL should remain vocal during this timeframe if they want to prevent its passage. Similarly, supporters of MPL may want to keep pressure on lawmakers if they want to see its passage. Whether MPL is enough of a legislative priority in Congress to make it into the final draft of the omnibus spending bill, however, remains to be seen.
If MPL passes into law as part of the omnibus bill, says Evich, then other provisions to reform dietary supplements regulation (ie. DSHEA 1.4) will likely become a low priority for lawmakers, with the exception of hemp-derived CBD, which will continue to be an active issue. When it comes to hemp-derived CBD, the leadership of the committees of jurisdiction over FDA may change in its favor. For example, the current chair of the Senate HELP Committee, Senator Patty Murray may leave her position to be chair of Senate Appropriations Committee after the retirement of Senator Patrick Leahy (D-Vermont). Next in line for Chair of the Committee would be Senator Bernie Sanders. On the Republican side, with the retirement of ranking member Senator Richard Burr (R-North Carolina), next in line would be Senator Rand Paul (R-Kentucky). Both Sanders and Paul are likely to be sympathetic toward hemp-derived CBD.
In the House Committee on Energy and Commerce, the leadership will remain the same, but the majority switches, which means that Representative Frank Pallone (D-New Jersey, 6th District) will remain the Democratic leader as ranking member and Senator Cathy McMorris-Rodgers (R-Washington, 5th District) will lead the Republicans as Chair. Pallone has a close and friendly relationship with the dietary supplement industry. According to McGuffin, Pallone is sympathetic to proposals to establish MPL. McMorris-Rodgers’ position on dietary supplements is less certain but in a recent article, but McGuffin stated that she is more critical of legislation that would add to FDA’ regulatory authority.
MPL remains a major point of contention within the industry, with some advocates passionately supporting the idea and other passionately opposing the idea. Looking ahead at the 118th Congress, there needs to be broader consensus within the industry on where to focus advocacy. With narrow majorities on each side of the aisle in the House and Senate, there is likely to be even more gridlock ahead. Drug preclusion may be a point of agreement across industry stakeholders.
Updated on 11/17/22 at 4:45 PM Eastern