Three Takeaways From The New Guidelines For Marketing Health Products

Pelin Thorogood is the executive president of Radicle Science , a testing-as-a-service pioneer of the first easy path from nutritional supplements to clinical trials.

Americans are seeking dietary supplements in record numbers. In fact, according to the Council for Responsible Nutrition's (CRN) 2022 Consumer Survey, 75 percent of Americans say they use supplements and spend nearly $50 billion on supplements.

As of 2021, health and wellness were the top reasons Americans are turning to vitamins, minerals and dietary supplements (VMS), according to CRN, with immune health support ranking second with significant increases in gastrointestinal (GI) and gastrointestinal health ( GI) evidence of cognitive health.

However, governments and academic institutions have raised questions about the lack of evidence surrounding product and label claims in the dietary supplement industry. According to the Food and Drug Administration (FDA), by law, dietary supplements cannot be marketed to treat, prevent, or cure any disease; Only FDA-approved prescription drugs can make such claims. Dietary supplements can make claims about their effects on body structure or function, but only if they can provide evidence to support those claims, as required 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 determine the true effects of dietary supplements. The report's assessment is based on a comprehensive review of 84 studies examining the health effects of various vitamins, minerals and herbal remedies.

Dr. John Wong, a physician in the department of medicine at Tufts Medical Center, who contributed to the report, told USA Today : "Our recommendation is not for or against taking vitamins, minerals or combinations of these nutrients. We just don't have enough evidence.' John Wong stressed that more research is needed to demonstrate the health benefits and risks associated with any dietary supplement.

Why is there a lack of evidence for dietary supplements?

Why are dietary supplements struggling to provide the evidence that consumers and healthcare professionals want and deserve?

The short answer is that traditional clinical trials primarily serve a proprietary pharmaceutical business model that costs an average of $1 billion to get a new drug to FDA approval. These traditional studies were too expensive for unpatentable natural ingredients, making the studies (and thus the resulting evidence) largely out of reach for the dietary supplement industry.

However, new trends such as virtualization, digital health innovations, artificial intelligence, direct-to-consumer approaches and disintermediation are beginning to transform clinical trials and make them more accessible to dietary supplement manufacturers.

Additionally, the FTC may be in the process of changing the status quo with new healthcare product compliance guidelines. The December 2022 guidance, the first such update from the FTC in nearly 25 years, further elaborates on the rigor needed to support product claims and provides more than 50 examples of permitted versus unauthorized claims.

How advertisers can respond to the new guidelines

What does this mean for ad integrators who want to stay safe from regulation? Here's a Reader's Digest version of the last tip, with three general themes to keep in mind:

1. Truthfulness of Labeling: Whether it's a claim on product packaging, a brand's social media account, or in a radio or television commercial, federal law is clear that claims must be true and not misleading. This also applies to implied claims or how a claim is perceived by a consumer. The definition of "deceptive" is determined by what a typical consumer perceives when reading or hearing a claim. Note that the FTC states that all health claims must be supported by scientific evidence.

2. Evidence Required: If you're wondering what kind of scientific evidence is acceptable for health claims, the "Standard for Competent and Credible Scientific Evidence" in the new FTC Health Care Product Compliance Guide has been expanded to clarify the level of expectation. The report identifies high-quality, double-blind, randomized, placebo-controlled human clinical trials (RCTs) as the gold standard.

3. Data relevance and generalizability: The new guidelines also state that study populations should reflect the same characteristics as the target market population. In particular, advertisers should not rely on search results for a specific population to make targeted claims to the general population. For example, most traditional clinical trials have been conducted in Caucasian men, so these findings would not apply to women and non-Caucasians. And for good reason. Did you know that women are twice as likely to experience adverse drug reactions as men? Diversity in research is key to improving science, as people of different ages, races, ethnicities and lifestyles may respond differently to specific products. Diversity is also key to promoting social equity and health equity, and this latest update to the FTC's guidelines may finally lay the groundwork for greater demographic inclusion in clinical trials.

With this in mind, clinical trials more than ever deserve serious consideration in a brand's research and development, marketing and legal strategies. Scientists and health care professionals remain skeptical of the benefits of dietary supplements given the current "inconclusive" data. The new FTC publication refutes a large number of explicit and implied claims made today and sets a much higher standard (ie, the reference RCT) for future claims.

As a society, we seem to be at a real inflection point. Whatever you think, the future of nutritional supplements and claims must be based on clinical evidence.

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