FDA’s Supplement Your Knowledge does not cure misinformationFDA’s Supplement Your Knowledge does not cure misinformation
FDA's "Supplement Your Knowledge" education initiative on dietary supplements is admirable, but fails to fulfill its potential, writes regulatory expert Blake Ebersole.
October 21, 2022
This op-ed commentary represents the view of the author.
In June 2022, FDA launched a new education initiative to “broaden public knowledge” of dietary supplements—the first of its kind since the Dietary Supplement Health and Education Act (DSHEA) was passed in 1994. I was ecstatic when I saw the headline. Finally, FDA would put to bed rampant misinformation surrounding supplement regulations, I hoped. But after review, I saw a lackluster effort. FDA’s initiative, Supplement Your Knowledge, is an apple-cider-vinegar-gummy that satisfies industry critics’ sweet tooth, but doesn’t fulfill its potential.
But first, the positives. The stated mission of Supplement Your Knowledge (SYK) is admirable: to help consumers, educators, physicians and healthcare professionals learn how supplements are regulated. The mission includes how to evaluate the credibility of information about supplements, and how to expand knowledge through continuing medical education.
And the narrative starts reasonably. Supplements can benefit overall health, but they can carry some risks. These risks include taking too much of some supplements or combining or replacing medications with supplements without consulting a health professional. This is all generally factual, good information. It’s also useful information that consumers should report adverse events to FDA. And I appreciate the now-refined statement that “products marketed as dietary supplements” (rather than supplements themselves) can contain unapproved drugs.
But from there, much of the information is paltry and vague, unexplained and unreferenced. I felt a familiar sour taste in my mouth, with tiny bits of sugary red goop stuck in my teeth.
The dedicated webpage for SYK includes factsheets and videos for consumers, educators and health professionals, repeating many of the same themes focused on negative blanket statements about supplements.
The first bulleted consumer factsheet on the SYK page, “Understanding Dietary Supplements,” contains both useful, truthful information, as well as misleading information. For example, the leading statement on the factsheet warns supplements can carry risks. But which supplements? And which risks? I inspected the consumer SYK pages for answers or references, but I was left in the dark. In the sections intended for physicians, the only specifics are drug interactions from St. John’s wort and potential interference of biotin with clinical lab tests.
I just wanted SYK to identify the bogeyman products behind stated health risks so often assumed to offset or negate their benefits.
The second section of “Understanding Dietary Supplements” was a single paragraph titled, “How are Dietary Supplements Regulated?” As we know, supplements are subject to many regulations. We have cGMPs (current good manufacturing practices) under 21 CFR Part 111. We have new dietary ingredient notifications, required under DSHEA. And we have the requirement to submit structure-function claims to FDA, which is not enforced, to my knowledge. Also, product claims must not be false or misleading. These requirements, which many of us in industry live and breathe, don’t receive a mention in SYK.
But what is simply stated in boldface under “How are Dietary Supplements Regulated?” (and repeated in several other places in SYK) is quite telling: “Unlike drugs, FDA does not have the authority to approve dietary supplements or their labeling before they are sold to the public.”
FDA’s job, in part, is to inspect and review dietary supplement manufacturers, ingredients and label claims—the primary elements of dietary supplements products. In my view, claiming “no authority” on supplement products is not just shirking responsibility, it misleads the American public (including physicians and health professionals) into thinking supplements are unregulated. If we thought the “unregulated supplements” false meme was bad, we now have the regulator joining the sad chorus in singsong.
And what about the benefits of supplements? Does SYK discuss the many supplement benefits and strong record of safety gleaned from the tens of thousands of well-designed human clinical studies searchable on the NIH (National Institutes of Health) Medline database, or from the well-researched webpages published by the NIH Office of Dietary Supplements?
No, SYK does not.
As far as “broadening knowledge” goes, the first iteration of SYK marketing appears to still be in beta testing, meaning hope remains that it’s just a first stab. Despite 127,000 YouTube subscribers, FDA’s videos for consumers didn’t reach more than a combined 10,000 views in the few months before the time of this publication. Views of all SYK videos made for health professionals are in the low thousands. A real effort to broaden consumer knowledge these days includes funding for advertising. But apparently, sponsoring a few hours of YouTube ads with @MrBeast was not in the budget for our $60 billion-plus industry.
None of this denigrates the efforts and work of hardworking FDA staff. Despite the limitations of FDA systems and funding, FDA staff behind the scenes keep our consumers safe and healthy, addressing the most critical safety issues, and help our industry continue to grow. Supplements continue to be the safest class of ingestible goods regulated by FDA, and they should get some credit for that. But we also need a fact-based and rational FDA to truthfully and effectively broaden knowledge on dietary supplements.
SYK should be revised in a new version, to become balanced, truthful and not misleading. Or it will risk becoming known as the meme I remember from way back: “Sike!”
Blake Ebersole is president and founder of NaturPro Scientific LLC, a scientific and regulatory consulting firm offering decades of experience in the R&D, product development and quality assurance of natural products for the dietary supplement and food industries. Follow him on LinkedIn.
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