Following President Donald Trump’s nomination of Scott Gottlieb, MD, for FDA Commissioner last week, Steve Mister, president and CEO of dietary supplements association the Council for Responsible Nutrition (CRN; Washington, DC), told Nutritional Outlook that his organization is “optimistic” that Gottlieb will walk a “middle ground” on regulating the supplements industry.
Gottlieb served as FDA Deputy Commissioner in 2005–2007 during the George W. Bush administration. Prior to that, he served as senior advisor to FDA Commissioner Mark McClellan, MD, and as the FDA Director of Medical Policy Development. He is a practicing physician and a Resident Fellow at the American Enterprise Institute, a nonprofit, nonpartisan think tank for issues including economics, education, and health care.
“If confirmed by the Senate, Gottlieb would be in charge of implementing Trump’s plan to dramatically cut regulations governing food, drugs, cosmetics, dietary supplements, and tobacco,” Reuters’ Toni Clarke wrote.
Not much is known yet about Gottlieb’s past stance, if any, on dietary supplements and whether he thinks the industry needs more, or less, regulatory oversight. According to Mister, CRN’s hope is that Gottlieb's impression from his time at FDA is that the supplements industry is interested in cooperating with the agency and abiding by regulations. Gottlieb was working for FDA during the time when both the supplement industry’s adverse-event reporting law, the Dietary Supplement and Nonprescription Drug Consumer Protection Act, was signed into law (2006) and when the industry’s Good Manufacturing Practices regulation went into effect (2007). “I think he understands that the industry has tried to cooperate with the agency based on those kinds of experiences when he was there,” Mister told Nutritional Outlook at this weekend’s Natural Products Expo West trade show in Anaheim, CA.
“We certainly know about his sort of general, conservative philosophy,” Mister added. “He wants government to get out of the way and let businesses do business when there’s not a public health need to be involved, but I think from his time at the agency, he understands that the agency is a public health organization and they have a job to protect safety. I think we will see him balancing those two.”
As such, Mister said, “we’re optimistic that Dr. Gottlieb will see both sides of it, and he will walk that middle ground."
Of note, the Reuters article noted Gottlieb's “deep ties to the pharmaceutical industry,” with Reuters source Michael Carome, director of Public Citizen's Health Research Group, stating that Gottlieb "has spent most of his career dedicated to promoting the financial interests of the pharmaceutical industry."
Mister said that as Gottlieb’s nomination heads to the Senate, CRN will be “reaching out to our friends in the Senate” to ensure that industry representatives have an opportunity during Senate hearings to present some of the questions at the top of industry’s mind now. “We’ll want to ask questions like, ‘Do you believe that DSHEA [the Dietary Supplement Health & Education Act] is sufficient regulation for this industry?’” Mister said. “That’s a good way to get them on the record saying, ‘Yes, I believe if this law is fully enforced that this adequately regulates the industry and protects consumer safety.”
A “Post-Regulatory” Era
Gottlieb’s nomination also brought up the subject of a “post-regulatory era,” a term discussed by speakers during a panel at the Natural Products Expo West trade show on March 11 called “Supplements Today: Why the Future Looks Bright.” Namely, said the speakers, industry should be cautious about promoting the notion of loosening regulations under a Trump administration.
One of the speakers on the panel, Senator Martin Heinrich (D-NM), said, “I know there’s a lot of people talking about the ‘post-regulatory era’ in Washington, DC. I would really caution anyone from buying into that mindset, because if that is the case within the FDA and the federal government, you will see someone fill that vacuum—and often times, the risk that you have there is someone filling that vacuum based on the individual bad actor that should be dealt with and applying a broad-brush application of that to the entire industry instead of it being a more targeted sort of approach.”
Mister, who also spoke at the panel, told Nutritional Outlook, “I don’t think this is a post-regulatory era. Because what may happen is who is the regulator will just shift. If the states believe that FDA has been rendered ineffective or they believe that FDA is not being aggressive, the state attorneys general, for one, but even the state legislatures, will be more than happy to fill that vacuum, and so they will step in.”
“Let’s use this time. If this indeed turns out to be a time when we have a little bit lighter touch on regulation, let’s as an industry use this to be proactive on some of the voluntary things you can do and show that we’re out there ahead of it,” Mister said.