Will the dietary supplement industry benefit from the new political landscape in the nation’s capital?
Executives of industry trade associations expressed optimism when asked to comment on the potential ramifications of a GOP-controlled Congress and White House inhabited by a New York billionaire, Donald J. Trump.
The Trump administration, as well as Republicans in the House and Senate, will aim to eradicate regulations that “hamper business and innovation," remarked Mike Greene, vice president of government relations at the Council for Responsible Nutrition (CRN). “I don’t know that our federal government can be run like a business, but it certainly is going to be more focused on doing more with less and being more efficient streamlining," Greene said in an interview.
Daniel Fabricant, Ph.D., executive director and CEO of the Natural Products Association (NPA), indicated the pending arrival of Trump to 1600 Pennsylvania Avenue could be reassuring for the supplement industry. “We’re a growth industry," he said in an interview. “I think that’s a story that Mr. Trump can appreciate."
Trump nominated Rep. Tom Price (R-Georgia) to lead the Department of Health and Human Services (HHS), which oversees FDA. Price, an orthopedic surgeon whose HHS appointment must be confirmed by the Senate, is expected to concentrate his efforts on repeal or significant reform of the Affordable Care Act, or Obamacare. FDA Commissioner Robert Califf., M.D., is likely to step down to make room for a yet-to-be-named successor under a Republican administration.
The extent to which Trump’s HHS will influence FDA’s priorities in regulating dietary supplements, if at all, remains to be seen. Steven Tave, a long-time FDA official and lawyer, was recently named permanent director of the agency’s Office of Dietary Supplement Programs (ODSP).
On regulations, Trump has pledged the following on his website: “Ask all Department heads to submit a list of every wasteful and unnecessary regulation which kills jobs, and which does not improve public safety, and eliminate them." He also has advocated for “a temporary moratorium on new agency regulations that are not compelled by Congress or public safety in order to give our American companies the certainty they need to reinvest in our community, get cash off of the sidelines, start hiring again, and expanding businesses."
Industry trade associations didn’t rule out the prospect that Trump’s administration would frown upon FDA’s draft new dietary ingredient (NDI) guidance. Some trade groups have argued the 102-page document is burdensome, complex and contrary to the law. Before the document is finalized, it must be reviewed by the White House’s Office of Management and Budget (OMB), industry sources said.
“OMB could stop it," Greene acknowledged. “They’ve sat on and slowed a lot of regulation in the past because of its concerns with small business. I believe because we’re still in the middle of the draft guidance, we’re still really working through the process. I suspect after comments are submitted … you’ll probably see FDA take it back, and we may not see the guidance for a while."
Asked whether the draft guidance was in jeopardy, United Natural Products Alliance (UNPA) President Loren Israelsen observed, “We’re aware that some have asked that it be stopped fully or that there be some moratorium or a full withdrawal.
“I’m not aware that there is anything more than … a talking circle about that," he cautioned, without further elaboration.
However, Israelsen predicted OMB will critically examine the economic effect of a regulation or guidance document.
“I am guessing that the new administration will really look at … economic impact on business, and they will likely have a much more critical eye if it seems that a regulation, a guidance or something else would act as a significant impediment to business growth," he said in an interview. “Does this [NDI] guidance fit that definition? Yah … it does."
Meanwhile on Capitol Hill, critics of the industry in the Democratic Party may have few opportunities to advance bills that would further regulate supplements because Republicans control both chambers of Congress.
Industry executives griped that a 2016 amendment to a military authorization bill would have limited access to supplements by military personnel and their families. The amendment was ultimately withdrawn by Sen. Richard Blumenthal (D-Connecticut). Even if such legislation is reintroduced in 2017, it appears to have little chance of being passed into law in the 115th Congress.
Said Greene: “I truly believe we’re going to be seeing a Congress, a government in general, that’s going to be focused on streamlining the bureaucracy that we have here in our government, and doing our best to remove obstacles from businessnot necessarily put up new obstacles."