Pelin Thorogood is the Executive Chair of Radicle Science, Proof-as-a-Service pioneer of supplements’ first easy path to clinical trials.
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Americans are reaching for dietary supplements in record numbers. In fact, according to the 2022 Consumer Survey from the Council for Responsible Nutrition (CRN), 75% of Americans reported taking dietary supplements, spending nearly $50 billion on dietary supplements.
As of 2021, health and wellness remained the primary reason Americans turn to vitamins, minerals and supplements (VMS), according to the CRN, with immune health support claiming the number two spot with significant growth in gastrointestinal (GI) health and cognitive health as well.
That said, government and academic institutions have raised issues about the lack of proof around product and label claims in the dietary supplement industry. According to the Food and Drug Administration (FDA), by law, dietary supplements are not allowed to be marketed to treat, prevent or cure any disease; only FDA-approved prescription drugs can legally make such statements. Dietary supplements are allowed to make claims regarding their impact on the structure or function of the body, but only if they can show the proof to back up such claims as outlined by the Federal Trade Commission (FTC).
However, in June 2022, the U.S. Preventive Services Task Force released a report that “current evidence is insufficient” to determine the true effects of supplements. The report evaluation was based on the thorough review of 84 studies examining the effects of various vitamins, minerals and botanicals on health.
Dr. John Wong, a physician from the Department of Medicine at Tufts Medical Center who contributed to the report, explained to USA Today: “Our recommendation is neither for or against taking vitamins, minerals or combinations of those nutrients. We just don’t have enough evidence.” Dr. John Wong indicated that additional research was necessary in order to prove the health benefits and risks associated with each supplement.
Why Is There A Proof Gap With Supplements?
Why do supplements struggle to generate the proof both consumers and healthcare providers want and deserve?
The short answer is that traditional clinical trials primarily serve a patented pharmaceutical business model, which averages $1 billion to bring a new drug through FDA approval. These traditional trials have been too expensive for non-patentable natural ingredients, thus making trials (and thus, the resulting proof) largely inaccessible to the supplement industry.
Emerging trends such as virtualization, digital health innovations, AI, direct-to-consumer approaches and disintermediation, however, have started to transform clinical trials, making them more available to supplement manufacturers.
What’s more, the FTC may be poised to change the status quo with their new Health Products Compliance Guidelines. The December 2022 guidelines, the FTC’s first such update in almost 25 years, further detail the necessary rigor needed to substantiate product claims and include over 50 examples of permissible versus impermissible claims.
How Advertisers Can Respond To The New Guidelines
What does this mean for those advertising supplements seeking to stay on the right side of regulations? Here’s a Reader’s Digest version of the recent guidance with three overarching themes you should be aware of:
1. Truth In Labeling: Whether it is a claim made on a product package, within a brand’s social media account or on a radio or television ad, federal law is clear that claims must be truthful and not misleading. This is also applicable to implied claims or how a claim is perceived by a consumer. The definition of “misleading” is determined by what a typical consumer perceives when reading or hearing a claim. Note that the FTC states all health-related claims need to be supported by scientific evidence.
2. The Evidence Imperative: If you are wondering about what kind of scientific evidence is acceptable to make health related claims, the “competent and reliable scientific evidence standard” within the new FTC Health Products Compliance Guide was expanded to clarify the level of expectation. The report identified high-quality, double-blind, randomized, placebo-controlled human clinical trials (RCTs) as the gold standard.
3. Data Relevance And Generalizability: The new guidelines also outline that study populations must reflect the same characteristics of the target market population. Specifically, advertisers should not rely on research results for a specific population to make claims targeting the broad population at large. For example, most traditional clinical trials have been conducted on Caucasian males, and these results would therefore not be applicable to women and non-Caucasians. And for good reason. Did you know women have adverse drug effects at twice the rates of males? Diversity in research is critical in driving better science, as people of different ages, races, ethnicities and lifestyles may react differently to certain products. Diversity is also essential to promoting social justice and health equity, and this recent update to FTC guidelines may finally be the groundswell for greater demographic inclusion in clinical trials.
In light of all of this, clinical trials now merit serious consideration in a brand’s R&D, marketing and legal strategies more than ever before. Scientists and healthcare providers continue to be skeptical as to the benefits of supplements given the current “inconclusive” data. The new FTC publication invalidates a tremendous amount of the explicit and implied claims being made today, creating a much higher bar (i.e., gold standard RCTs) for claims going forward.
As a society, we appear to be at a real inflection point. Any way you look at it, the future of dietary supplements and claims will need to be grounded in clinical proof.
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