NOVEMBER 3, 2022 – UNLOCKED EDITION –
FDA responds to CRN’s comments on ‘Supplement Your Knowledge’ content
CRN staff met virtually with FDA officials last week following the agency’s receipt of written feedback on its “Supplement Your Knowledge” educational content, and other characterizations of dietary supplement on its website.
- CRN provided feedback in September to FDA on the agency's "Supplement Your Knowledge" educational content and other dietary supplement information on its website.
- An accompanying summary presentation highlighting key points is available, as well.
FDA Office of Dietary Supplement Programs Director Cara Welch, Ph.D., who previously met with CRN staff about the educational materials and recommended CRN submit written comments, convened additional staff for the follow-up meeting, including: Nichole Nolan, ODSP acting deputy director; Gerie Voss, director of ODSP’s division of policy and regulations implementation; and Jacqueline Woodard, division director for education, outreach and information, with FDA’s Office of Analytics and Outreach.
CRN’s team presented a summary deck highlighting examples of how FDA’s content does a disservice to consumers by over-emphasizing risk and ignoring the benefits dietary supplements provide, especially in addressing nutrient shortfalls identified by the U.S. government’s Dietary Guidelines for Americans.
FDA’s educational videos for health care professionals, developed with the American Medical Association, are especially egregious, CRN pointed out. One example presents an awkward and uncomfortable exchange with a physician as “best practices” when it, in reality, presents more of a “what not to do” while being part of a curriculum offering continuing education credits as a stamp of approval, CRN’s team explained.
Regarding regulation, CRN focused on how FDA’s materials mischaracterize the agency’s authority over dietary supplements as “less than” with emphasis placed on what the agency does not do, rather than what it does do.
FDA has inspection authority, the agency looks at labels, at adverse events, and more, and then says, “but we don't regulate them the same way we do as drugs because we don't have pre-market approval,” CRN President & CEO Steve Mister pointed out. “That may seem nuanced, but I think it transmits a very different message to consumers when they hear about what you don't do as the lead…I'm not necessarily looking for you to say you agree with that, but I want to be sure that you are hearing that perspective,” he added.
What they’re saying: “I'm hearing it and I think I actually do agree with it,” Dr. Welch affirmed, regarding CRN’s observations about how dietary supplement regulation is presented. She noted the agency does try to avoid leading with the statement that dietary supplements are not regulated the same as drugs “because honestly, that's the line that bothers me…of course, we don't regulate them like drugs. They're not drugs.”
FDA conducted consumer focus groups to inform its content development, Dr. Welch and her team explained, addressing why certain decisions were made to how supplement regulation is positioned. “Some of this is from the consumers,” Dr. Welch said. “The questions that we're hearing…and messages tailored to their questions…and we needed to be very clear FDA does not approve dietary supplements. So, it might reflect differently to you because you are highly educated about supplements.”
Dr. Welch acknowledged that receiving the feedback in written form, along with meeting is helpful, but advised she was not committed to making changes addressing all of CRN’s points. She said CRN’s comments would be a helpful resource when the agency updates its materials, noting there is no planned date to do so at this time, but that they will need to keep the content current.
CRN emphasized its desire to serve as a resource to FDA, reminding the group of its educational content about dietary supplement labels and calling for a larger ongoing conversation between the association and the agency on future opportunities to collaborate.
First-time staff conference attendee reflects on industry’s unique collaborative spirit
This year’s Now, New, Next symposium, taking place last month, was CRN Director of Government Relations Mike Meirovitz’s first in-person conference since before the pandemic.
“Being one of the newest additions to CRN’s staff, joining earlier this year, I came to Phoenix uncertain of what to expect,” Meirovitz shared in a new post for the association’s “Supplemental” blog.
The one message Meirovitz said he heard consistently from his CRN colleagues is “the best part of working here is our membership.” And he was not disappointed as “members were welcoming, kind, and engaged around CRN’s initiatives.”
“As my role focuses on public policy, I truly enjoyed conversing with members about their legislative concerns and getting a sense of how what happens in Washington and/or state capitals around the country impacts them on a personal level,” Meirovitz observed. “I left Phoenix energized and inspired, and grateful to be advocating on behalf of such a special industry.”
Go deeper: Read the “Supplemental” post in its entirety here, and join the conversation on LinkedIn and Twitter. Share your unique take on the industry through CRN’s Supplemental blog—see our editorial guidelines and contact Craig Muckle to contribute.
Dr. Wong appointed to Institute for Organization Management Board of Regents
Institute for Organization Management, the professional development program of the U.S. Chamber of Commerce, has appointed CRN’s SVP Scientific & Regulatory Affairs, Andrea Wong, Ph.D., to the Northeast Institute Board of Regents. As a member of this board, Dr. Wong will implement the policies created by Institute’s National Board of Trustees.
Dr. Wong is a recent Institute graduate, having completed the program of study in areas including leadership, advocacy, marketing, finance, and membership.
Institute’s four Boards of Regents serve on behalf of the National Board of Trustees. Each Board of Regents is responsible for recruitment, retention, and marketing of the program nationwide. Each regent is an Institute graduate nominated by their peers.