Pelin Thorogood is the executive chairman of Radical scienceProof-as-a-Service pioneered the first easy path from supplements to clinical trials.
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Americans are turning to nutritional supplements in record numbers. According to the Consumer Survey 2022 of the Council for Responsible Nutrition (CRN) 75% of Americans reported using and nearly spending on dietary supplements $50 billion in dietary supplements.
From 2021, health and well-being will continue the primary reason Americans are turning to vitamins, minerals and supplements (VMS), according to the CRN, with immune system support claiming number two with significant growth in gastrointestinal (GI) health and also cognitive health.
That said, the government and academic institutions have raised concerns about the lack of evidence surrounding product and label claims in the dietary supplement industry. According to the Food and Drug Administration (FDA), dietary supplements are required by law may not be placed on the market to treat, prevent or cure a disease; only FDA-approved prescription drugs can legally make such statements. Dietary supplements are allowed to make claims about their impact on the structure or function of the body, but only if they can provide evidence to support such claims, as set forth by the Federal Trade Commission (FTC).
However, in June 2022, the US Preventive Services Task Force released a report that “current evidence is insufficient” to establish the true effects of supplements. The report evaluation was based on the thorough review of 84 studies on the effects of various vitamins, minerals and herbal ingredients on health.
Dr. John Wong, a physician in the Department of Medicine at Tufts Medical Center who contributed to the report, explained to USA today: “Our recommendation is not 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 needed to prove the health benefits and risks of each supplement.
Why is there an evidence gap with supplements?
Why are supplements struggling to provide the evidence that both consumers and healthcare providers want? And to deserve?
The short answer is that traditional clinical trials primarily serve a proprietary pharmaceutical business model an average of $1 billion to get a new drug approved by the FDA. These traditional trials have been too expensive for unpatentable natural ingredients, making trials (and therefore the resulting evidence) largely inaccessible to the supplement industry.
However, emerging trends such as virtualization, digital health innovations, AI, direct-to-consumer approaches and disintermediation have begun to transform clinical trials, making them more available to complement manufacturers.
In addition, the FTC may be about to change the status quo with them new guidelines for health product compliance. The December 2022 guidance, the first such update from the FTC in nearly 25 years, details the necessary accuracy needed to substantiate product claims and includes more than 50 examples of admissible versus inadmissible claims.
How advertisers can respond to the new guidelines
What does this mean for those advertising attachments that want to stay on the right side of the regulation? Here’s a Reader’s Digest version of the recent guidelines with three overarching themes you should be aware of:
1. Truth in Labeling: Whether it’s a claim on a product package, in a brand’s social media account, or in a radio or television advertisement, federal law clearly states that claims must be truthful and not misleading. This also applies 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 that all health-related claims must be supported by scientific evidence.
2. Proof is absolutely necessary: If you’re wondering 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 has been 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 should reflect the same characteristics as the target market population. In particular, advertisers should not rely on research results for a specific population to make claims aimed at the broad population at large. For example, most traditional clinical trials have been conducted on Caucasian men, and these results would therefore not apply to women and non-Caucasians. And for good reason. Did you know that women can have side effects from medicines? twice as many as men? Diversity in research is crucial to driving better science, as people of different ages, races, ethnicities and lifestyles may respond differently to certain products. Diversity is also essential to advancing social justice and health equity, and this recent update to the FTC guidelines may finally spur greater demographic inclusion in clinical trials.
In light of all this, clinical trials deserve serious consideration in a brand’s R&D, marketing and legal strategies more than ever. Scientists and healthcare providers remain skeptical about the benefits of supplements given the current “inconclusive” data. The new FTC publication debunks a huge number of the explicit and implicit claims being made today, raising the bar for claims in the future (i.e. gold standard RCTs) much higher.
We seem to be at a real turning point as a society. However you look at it, the future of nutritional supplements and claims will have to be based on clinical evidence.
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