Medicine, supplements and science: opportunities and realitiesMedicine, supplements and science: opportunities and realities

In principle, the law that constrains the marketing of nutrient supplements in the U.S. is “DSHEA,” or the Dietary Supplement Health And Education Act (of 1994). 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 adviser. I presented to the team some of my priorities for the information they make available. They gave me a reality check.

For starters, 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, I learned, the law is something of a problem. Among the salient stipulations of DSHEA is that supplements cannot be marketed to “treat” anything. Niacin can still be a nutrient if it “supports healthy metabolism.” 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 one 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.

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.

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 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.

Of course, some supplements that don’t work at all are marketed very successfully. This is a domain of both baby and bathwater —and differentiating is essential. That is true of pharmaceuticals too, by the way.

It is the job of health care professionals to help patients differentiate. To do so, we need the very information nutrient supplement makers are precluded, for the most part, from sharing—in the land of the law of unintended consequences.