Despite the recent departure of Scott Gottlieb from FDA, the dietary supplement initiatives he set in motion are expected to continue under his successor. But it remains to be seen whether any substantive changes to supplement regulations or policies will be adopted under the current interim FDA commissioner.
Gottlieb, a physician who served as commissioner of FDA for two years and left the agency in early April, was widely regarded as a competent leader who spearheaded myriad initiatives and worked collaboratively.
National media reported the 46-year-old Gottlieb wanted to spend more time with his family after commuting weekly to Washington from his home in Connecticut. Gottlieb is currently listed as a resident fellow at the American Enterprise Institute (AEI), a conservative think tank, where he focuses on pharmaceutical policy, the cost of prescription drugs, FDA and other issues.
Under Gottlieb’s tenure in recent months, the agency announced plans to strengthen its regulation of dietary supplements and examine a potential legal pathway for the use of cannabidiol (CBD) in conventional food and dietary supplements. He also recently revealed the agency’s enforcement strategy related to CBD, which is widely sold in dietary supplements, cosmetics and other products.
“For supplements, Dr. Gottlieb's tenure represents an era of FDA-industry collaboration that has never been observed before,” said Andrew Shao, interim senior vice president of scientific and regulatory affairs with the Council for Responsible Nutrition (CRN), in an email. “Under Dr. Gottlieb's leadership, the agency recognized for the first time the importance of dietary supplements for public health and the great impact the industry has had.”
Outside the dietary supplement industry, the physician and former venture capitalist built a reputation for leading many initiatives focused on tackling high drug prices, strengthening food safety, preventing the use of e-cigarettes by minors and other public health issues.
“Commissioner Gottlieb’s resignation is a loss for the consumer products industry because he has shown a willingness to give industry guidance in areas that you often don’t see from agencies,” Raqiyyah Pippins, a lawyer in Washington with Arnold & Porter Kaye Scholer LLP, who focuses on FDA regulatory issues, said in an email.
Geoff Freeman, president and CEO of the Grocery Manufacturers Association (GMA), a trade group in Arlington, Virginia, representing food, beverage and consumer products companies, described Gottlieb as “a strong and effective champion of public health.”
“His candor, transparency and willingness to work together was a welcomed approach in the regulatory environment,” Freeman said in a statement. “The consumer packaged goods [CPG] industry believes in smart, uniform regulation, and a strong FDA is a critical partner in building trust in the products Americans use every day.”
Dietary Supplement Initiatives
On Feb. 11, Gottlieb revealed plans to strengthen FDA’s regulation of dietary supplements. He expressed concern that changes in the supplement market may have outpaced the evolution of the agency’s policies and capacity to manage emerging risks.
“To continue to fulfill our public health obligations, we need to modernize and strengthen our overall approach to these products,” Gottlieb said in a comprehensive statement at the time. “Toward these goals, the FDA is committing to new priorities when it comes to our oversight of dietary supplements at the same time that we carefully evaluate what more we can do to meet the challenge of effectively overseeing the dietary supplement market while still preserving the balance struck by” the Dietary Supplement Health and Education Act of 1994 (DSHEA).
The then-FDA Commissioner announced several steps to advance FDA’s policy goals, including novel ways to communicate more readily when the agency is concerned that an ingredient marketed in supplements is unlawful and potentially dangerous. Gottlieb suggested FDA is working to encourage the submission of new dietary ingredient (NDI) notifications, and he revealed plans to issue more guidance and modernize its approach to such notices.
Gottlieb also announced plans to start a public dialogue over modernizing DSHEA a quarter century after its passage. In FDA’s fiscal year 2020 budget request to Congress, the agency proposed legislation that would require dietary supplements register with FDA. According to the agency, an estimated 50,000 to 80,000 dietary supplement products are on the market.
“Under current law, FDA is not clearly authorized to require listing of individual dietary supplement products on the market, and the agency has no convenient mechanism for compiling basic information about those products,” FDA noted in its budget request. “This proposal would require all products marketed as ‘dietary supplements’ to be listed with FDA and give FDA authority to act against non-compliant products and the manufacturers and/or distributors of such products. This would allow FDA to know when new products are introduced, quickly identify and act against dangerous or otherwise illegal products, and improve transparency and promote risk-based regulation.”
Steven Tave, Director of FDA’s Office of Dietary Supplement Programs, addressed the significance of Gottlieb’s statements. “Maybe the most significant thing is we have an FDA Commissioner for the first time in recent history, and probably longer, addressing dietary supplements and saying, ‘This is an agency priority and an area where we want to do more,’” Tave said in an interview in February with Natural Products INSIDER.
Under Gottlieb's tenure, FDA also announced the formation of a working group within the agency to improve oversight of the dietary supplement industry. The internal working group, Tave explained in the interview, is focused on improving the agency’s internal processes and procedures, and he emphasized FDA would continue to solicit input from stakeholders on substantive policy changes.
Public Meetings on Innovation, CBD
In a March 5 statement at the time Gottlieb's impending retirement came to light, the leader of the Natural Products Association (NPA) urged President Donald Trump to consider a new FDA Commissioner "that will use the agency’s enforcement powers to get tough on bad actors and lead on new areas like [CBD] and other promising natural products." NPA CEO Daniel Fabricant, Ph.D., also suggested it was important that a new FDA Commissioner lead on such issues as trade and protection of NDI intellectual property.
Under the interim FDA Commissioner, Norman “Ned” Sharpless, M.D., the agenda Gottlieb started for dietary supplements will continue, Shao said.
A public meeting is scheduled for May 16 to discuss innovation in supplements, and a public hearing is scheduled for May 31 to examine a potential rulemaking that would allow CBD to be sold in food and supplements. The agency also has formed a high-level working group to examine issues related to CBD.
But it’s unclear how Sharpless will view FDA’s role over dietary supplements. According to his FDA biography, Sharpless previously served as director of the National Cancer Institute (NCI). Prior to his appointment with NCI, Sharpless worked as the director of the University of North Carolina Lineberger Comprehensive Cancer Center.
“Time will tell if the foundation Dr. Gottlieb established and the objectives he set forth will come to fruition,” Shao acknowledged in an email. But he said CRN remained “optimistic” and looked forward to working with Sharpless.