Is a regulatory reckoning just around the corner for vitamins, minerals, herbals and supplements?

Steven Robbins

The more my partners and I at the New England Consulting group look at some of NIH’s (National Institutes of Health’s) recent programming and FTC’s (Federal Trade Commission’s) enforcement actions since the beginning of COVID and their recent publication, “FTC (2023) Health Products Compliance Guidance,” the more I am beginning to believe that there is a significantly higher level of regulatory scrutiny and action on the horizon and that the industry needs to create a proactive framework for claims performance testing beyond DSHEA before being dragged into a clinical standard that will be impossible to meet,

There is a thin line between building strategic scenarios and going down the dark path of conspiracy theories. Both endeavors require one to collect available data in the present, synthesize it and then create a story about what that will mean for the future. In scenario planning, you create several potential environments and then establish beacons, things to look for that hint at which possible future is more likely to emerge. Some of those scenarios are dark places where political interests overwhelm market forces. Others point toward an unfettered marketplace with an expanding array of players driving demand through innovations designed to deliver expanded consumer benefits.

For the past several years, the VMHS category has thrived and generally represents the second scenario. DSHEA has been a boon to the industry. The category has expanded dramatically from a formulation standpoint and from the real or implied benefits captured in more evocative naming conventions. COVID did not help every segment of VMHS, but it helped some. Immunity boosters ranging from zinc, vitamin C, elderberry products and more flew off the shelves as consumers hoped to avoid getting COVID. Multi-ingredient formulations like Airborne had a resurgence despite having dropped the immunity claims that made it a sensation 15 years ago.

Beyond COVID, beauty-related supplements continue to contribute to healthy growth. Beauty offerings have increased distribution in traditional channels and also expanded to specialty outlets like Ulta, Sephora and Blue Mercury, promising not only stronger nails and more radiant hair but also broader benefits like an overall glow and even beauty at the cellular level (finally, something to bring out the inner beauty we are told to look for in people). Improvement at the cellular (or microbial) level is consistent with another tailwind, products claiming to help your gut microbiome, that magical stew of bacterial diversity that has become a significant focus across the health care spectrum. You can now find dozens of new products designed to deliver multiple benefits by helping optimize your gut flora and improve regularity, weight loss, energy, clearer thinking and your overall pickleball game (OK, I made that up to see if you are paying attention). Add in cognitive health and memory, and you have a category that is the envy of many.

However, the aggressive marketing of some of these products has not gone unnoticed. FTC has, from time to time, stepped in and warned companies that they are guilty of false and misleading advertising. More recently, they have fined a major VMHS player for misleading advertising tied to bundling online ratings and including products that were not, in fact, best-sellers or rated highly for satisfaction. They also had to sign a consent decree limiting their ability to bundle products online.

However, the recent FTC publication of a compliance guideline is more concerning. This document is surprisingly easy to understand and features 52 (hey, that’s a lot!) very straightforward examples of what they believe is “potentially” illegal advertising. By the time I got to the midpoint, I could think of 10 examples I had seen that would be problematic. FTC also reiterates its standard, “FTC law focuses not on the marketer’s intent but on the consumer’s understanding … Furthermore, the FTC views advertising claims from the standpoint of the audience.” I encourage you to read FTC’s (2023) Health Products Compliance Guidance. In my opinion, the straightforward and clear examples are a shot across manufacturers’ bow. It serves as a scorecard that can be produced during any discussion of potential FTC violations.

The best way to meet any increase in FTC activism is to be proactive and prepared. Responsible VMHS manufacturers have done an excellent job of validating the ingredients’ quality and the manufacturing processes that produce today’s products. The following steps provide sound evidence of the benefits that are claimed (or implied). The risk of ultimately being held to a clinical standard that would bankrupt the industry and virtually eliminate many multi-ingredient combinations is unacceptable, but what is the industry’s recommended alternative approach and standard? With an aging population taking more prescription products, it seems more and more likely that there will be pressure on the VMHS manufacturers to show interaction data and contraindications down the road. Suppose FTC becomes as active here as it has been concerning corporate mergers and acquisitions. In that case, there will need to be an alternative evidence framework or the risk of accepting standards developed by others. The time to act is now.

Steven Robins is managing partner/principal at the New England Consulting Group.