Blog | Wednesday, June 8, 2016

Nutrient supplements in the land of the law of unintended consequences

In principle, the law that constrains the marketing of nutrient supplements in the U.S. is the Dietary Supplement Health And Education Act of 1994 (DSHEA). In practice, the law of unintended consequences may exert an even greater influence.

I write this in the immediate aftermath of a meeting with an innovative nutrient supplement company for which I serve as a scientific advisor. My role involves reviewing research evidence, participating directly in new product formulations, and advising on needed research. The role, and the results of the collaboration, are quite rewarding, and have produced at least 1 product I myself take daily, to very good effect. But none of that is the crux of today's story.

I presented to the business team, including gurus of marketing, and the in-house legal counsel, some of my priorities for the information they make available. Those priorities, and my perspective, derive directly from 25 years of patient care. In the typical scenario, a patient reads about some new supplement, is intrigued, and brings something they printed off the Internet to their subsequent appointment with me to get my opinion. What information do I need to make an informed judgment?

For starters, I am somewhat prone to judge this kind of book by its cover. In other words, the tone of any marketing material matters to me. I do not want to see any mention of miracle, or wonder. I don't want to see effects promised, or results guaranteed.

But here, the law is something of a problem for those on the marketing side. Among the salient stipulations of DSHEA is that supplements cannot be marketed to “treat” anything. So, for instance, niacin can still be a nutrient if it “supports healthy metabolism,” or some such very vague thing. But if it treats hypertriglyceridemia (which it does), then it is a drug.

That sounds reasonable in principle: nutrients support general health, drugs treat diseases. But the reality is that nutrients and botanicals overlap substantially with drugs. Niacin is both a drug, and a B vitamin. Coenzyme Q10, a product that in many ways epitomizes the divide between pharmaceuticals and alternatives to them, is a nutrient widely distributed in plants, and also, potentially 1 of the more significant treatment advances for heart failure of the past decade. Say that CoQ10 “treats” heart failure, however, and you run afoul of DSHEA, and face penalties.

What ensues? Marketing hype. If you happen to be marketing a nutrient that seems to be quite effective for treating something in particular, you are not allowed to say so. But when you can't say the very thing that you want to say, and that customers need to know, you are left to gild the lily. Marketing of supplements thus often involves a great deal of language in the service of sales that tends to make me, and I presume most of my colleagues, wince.

The problem? You can't very well whisper and be heard where everyone else is shouting, so the result is something of a marketing hype arms race. This, of course, has the potential to confuse the public about likely effects, and dissuade health care professionals from giving nutrient supplements any consideration at all, a reaction that has been on rather prominent display in recent years. Anyone marketing a supplement, however sound, sensible, and science-based, must compete in this noisy space.

Once I get past that initial impression, my interest turns to the underlying science. I, and my colleagues, want to see the relevant evidence. I want to know if the components of the formulation have been studied, and if so, I would like easy access to those references. I would like to know if the formulation itself has been studied. If those data are not yet available, I want to know if such studies are under way, or planned. If so, I would like information about those plans.

And, of course, if the company cannot provide such substantiation, I am apt to think it doesn't exist. In the absence of such evidence, I will tell my patient, better safe than sorry. Let's stick with what we know.

Once again, however, the law of unintended consequences is at work. Consider, for instance, if a supplement maker uses the results of a randomized, double blind, placebo-controlled trial of osteoarthritis to incorporate a compound found to be effective into its “joint formula.” Including reference to that trial, anywhere in their marketing material or on their website, is taken by regulators as a claim that their product “treats” osteoarthritis, which violates DSHEA. Rather than risk such sanctions, supplement makers generally don't reference the studies.

This is a serious impasse. Doctors need studies to inform their decisions, and in the case of nutrient supplement makers, those tend to be the very studies they can't share. No one does, and no one should, run studies of vague “support for metabolism.” While DSHEA encourages such vague language, the considerable investment of a clinical trial requires perfectly clear outcomes, and decisive measures. Those, in turn, translate to treatment- which cannot be implied. So supplement makers can, and at times do, have a bounty of good evidence to support a particular product, yet be precluded from letting anybody know.

I am by no means suggesting that is always the case. Many supplements that don't work at all are marketed routinely, and some, very successfully. I have always maintained that this was a domain of both baby, and bathwater, and that differentiating is essential. That is true of pharmaceuticals too, by the way.

It is the job of health care professionals to help patients make that distinction. To do so, we need the very information nutrient supplement makers are precluded, for the most part, from sharing. And so it is we are left to make, take, market, and choose nutrient supplements with less information than we should have, because the law of the land is the law of unintended consequences.

David L. Katz, MD, FACP, MPH, FACPM, is an internationally renowned authority on nutrition, weight management, and the prevention of chronic disease, and an internationally recognized leader in integrative medicine and patient-centered care. He is a board certified specialist in both Internal Medicine, and Preventive Medicine/Public Health, and Associate Professor (adjunct) in Public Health Practice at the Yale University School of Medicine. He is the Director and founder (1998) of Yale University's Prevention Research Center; Director and founder of the Integrative Medicine Center at Griffin Hospital (2000) in Derby, Conn.; founder and president of the non-profit Turn the Tide Foundation; and formerly the Director of Medical Studies in Public Health at the Yale School of Medicine for eight years. This post originally appeared on his blog at The Huffington Post.