Sharpless On FDA's Dietary Supplement Regulation Reform: It's 'Complicated'
Executive Summary
"I look forward to beginning a productive dialogue about reshaping our oversight of these products," acting FDA Commissioner Norman Sharpless said recently about agency's public meeting on May 16. Access to meeting at CFSAN headquarters opens at 8 a.m. and irst of four sessions on questions center stated in meeting notice begins at 9 a.m. Each discussion followed by question and answer sessions and public comments scheduled for 3 p.m.
Opening remarks at the US Food and Drug Administration's May 16 public meeting on regulating the dietary supplement industry will come from Acting Commissioner Norman Sharpless, who says he's "seen first-hand" how false claims harm consumers.
"I look forward to beginning a productive dialogue about reshaping our oversight of these products," Sharpless said when he mentioned the meeting during his remarks at the Food and Drug Law Institute conference in Washington on May 2.
Sharpless framed the FDA's regulation of vitamin, mineral and supplement product manufacturing and marketing as a challenge due to not only the industry's tremendous growth since the agency's regulatory framework was established in 1994, but also the prevalence of products marketed as supplements but promoted with disease claims or containing undisclosed drug ingredients.
"As supplements have grown in popularity, so have the number of products on the market that are potentially dangerous or that have misleading health benefit claims," said Sharpless, who moved from heading the National Cancer Institute to acting FDA chief with the resignation of Scott Gottlieb in April. (Also see "Acting FDA Chief Sharpless Pledges 'Full Speed Ahead' On Current Agenda" - HBW Insight, 17 Apr, 2019.)
Like Gottlieb, Sharpless is a physician; unlike Gottlieb, though, he didn't preface his criticism of the VMS industry with acknowledgments that he uses some products and recognizes their value to public health. Instead, Sharpless recalled patients' experiences during his years in practice.
"As an oncologist, I have seen first-hand how Charlatans will sell false hope to prey upon desperate patients with cancer and other diseases," he said.
'Enormous Challenges' For FDA
Sharpless noted the extent of the FDA's responsibilities under the Dietary Supplement Health and Act, Public Law 103-417, which Congress passed in 1994 to establish the framework for the FDA's regulation of the industry.
"Our work to modernize and reform our oversight and strength of our enforcement strategy in this area is complicated," he said at the FDLI conference.
But the agency's focus concerning VMS products isn't complicated. "Even as the FDA works to modernize our oversight structure, we'll continue to protect consumers by cracking down on false, misleading and potentially harmful claims by some of these manufacturers," Sharpless said.
Additionally, while the FDA raised the profile of CFSAN's VMS product division by making it an office in 2015 and the office's staff has reached nearly 12, the US industry it regulates has around $40bn in sales from more than 80,000 in products.
"This office faces frankly enormous challenges in regulating an industry that has grown 10-fold in the last 25 years since [DSHEA] was enacted," Sharpless said.
NDI Notifications Top FDA's List
The FDA didn't identify compliance with its new dietary ingredient notification requirement when it announced it would consider changes to strengthen its regulation of the VMS industry in February. NDI notifications, though, are the only focus of the public meeting at the agency's Center for Food Safety and Applied Nutrition headquarters in College Park, Md. (Also see "NDI Notifications Take Center Stage In FDA's Evaluation Of DSHEA" - HBW Insight, 10 Apr, 2019.)
Compliance with the NDI notification requirement is a volatile topic of disagreement between industry stakeholders, joined by its Capitol Hill allies, and the FDA. Two draft guidances on NDI notifications have provided little in the way of bringing the industry more in line with CFSAN officials' thinking on the requirement. (Also see "FDA Could Stick With Current Advice On NDI Notifications, Old Ingredient Evidence" - HBW Insight, 26 Jun, 2018.)
The number of NDI notifications is well below the FDA's expectations for reasons including manufacturers, ingredient suppliers and other firms not investing in research to support notifications because they gain no market exclusivity as other firms also can use the same ingredient in products.
Stakeholders also contend the FDA has not made clear what is needed in a notification that will convince the agency of an ingredient's safety for its intended use. Similarly, stakeholders and the agency disagree on proof needed to show an ingredient was available in the US food supply before Congress passed DSHEA.
The notification numbers trail the FDA's expectations also because some firms simply ignore the requirement by using ingredients they know were not available pre-DSHEA and have not been notified to the agency with a no-objection result.
Still, a more common problem for the FDA and the industry is labeling violations found for products that are marketed as VMS products but contain undeclared drugs, most often active ingredients for erectile dysfunction and weight loss. Those violations not only cross DSHEA regulation lines, but also make the products noncompliant with the agency's drug regulations as unapproved and misbranded products. (Also see "DoJ Prosecutions: USPlabs Guilty, DMBA Firm Indicted From FDA Investigations" - HBW Insight, 14 Mar, 2019.)
Four Discussions Followed By Public Comments
In addition to Sharpless, the FDA officials participating in the public meeting are Steve Tave, Office of Dietary Supplement Programs director, and Cara Welch, a former ODSP executive who currently is working in the Office of the Commissioner as acting special assistant to the deputy commissioner for Policy, Legislation, and International Affairs.
Access to the meeting at CFSAN opens at 8 a.m. and the first of four sessions on questions the center stated in its meeting notice begins at 9 a.m., according to the agenda. Each discussion will be followed by question and answer sessions and public comments are scheduled for 3 p.m., the final agenda item before the meeting ends at 4:30 p.m.
The first session will feature a panel discussing the scope of permissible dietary ingredients allowed under DSHEA, "including issues such as synthetic copies of botanical constituents and the phrase 'dietary substance for use by man to supplement the diet by increasing the total dietary intake',” according to the agenda.
In the second session, the panel will discuss issues related to when an NDI notification is not required and "whether evolution in the dietary supplement marketplace has altered the impact of this provision."
The third session's topic is comparative perspectives from other regulatory systems. The fourth panel will discuss challenges and opportunities associated with promoting overall compliance with the NDI notification requirement through avenues such as marketing advantages and enforcement.
Scheduled to participate on the panels are representatives from supplement and consumer health product trade groups; International Probiotics Association; Center for Science in the Public Interest; and Pew Charitable Trusts. Also on the panels are food and drug law attorneys Scott Bass of Sidley Austin LLP; Ashish Talati of Amin Talati & Upadhye; and Wes Siegner of Hyman Phelps & McNamara P.C.; and public health advocate and researcher Pieter Cohen of Harvard Medical School and Cambridge Health Alliance.