While unlikely, new framework for disseminating study results would improve DSHEA

The formal name of the law includes the word education within it. But this part of the scheme for regulating dietary supplements has never came to fruition in the way it was originally envisaged.

At the time DSHEA was signed into law in 1994 FDA was being very aggressive in communications about the scientific studies backing dietary supplements, viewing them as essentially unlawful drug claims about the products.  Part of the goal of DSHEA was to come to some sort of compromise on the subject.

Original question no longer obtains

The original question that was addressed in DSHEA is one that in most ways no longer obtains. At the time, printed matter, or what a consumer might hear on the radio or see on TV, was the only way for scientific information backing the products in the marketplace to get to the consumer.  DSHEA set up boundaries as to how pamphlets could be displayed in stores, and their proximity to (or distance from) the supplements being sold in the same store.

Now of course all of that is moot. Consumers can with a few keystrokes access more information than they could have with weeks of diligent hunting back in 1994.

A disease claim is still a disease claim

What hasn’t changed, though, is how FDA views that information. Any study that mentions a connection to any sort of disease state is automatically out of bounds, however scrupulously it might have been done.

The result has been that unless a study is designed very carefully to conform to structure/function claim strictures, it’s not of much use in marketing the product, even if it might have important and truthful things to say about that product’s effects.

And there has been a plethora of studies on nutrients and other dietary ingredients on their effects on the body done primarily by third party researchers that don’t conform to these boundaries.  The biochemists, medical doctors and others doing these studies have important questions of their own to answer and have no interest in splitting regulatory hairs.

Research as a benchmark of quality

One of the questions consumers continually ask authorities within the industry is which of the 80,000 or more products on the market are the best.  One solid way to answer that question would be to reply: those that have the most research behind them.  Not only would that that mean a consumer would be getting a product that has some proof that it works, but would also be buying from a company that has invested in its own offerings.

A number of companies, especially but not exclusively the older herbal ingredient suppliers, have done reams of research on their products. Some of this fits within the structure/function box, but not all.

In the present scheme of things, there is less incentive to do research than there might be. Imagine if companies could present the full suite of data to consumers in the guise of, here’s why we believe our product works and here’s how we suggest it be used.  Wouldn’t that go a long way toward helping consumers figure out which are the best products?

What about the me-toos?  Etc. 

There are a number of questions that would have to be worked through. Such as, what about all of the me-too products?  Some of these merely allude to research done by other suppliers, while others are so brazen as to link directly to these studies, even if they hadn’t done them.  Should that activity be constrained in some way, even made illegal? Or would that violate free speech?

And how about those studies themselves?  I don’t have a numbers to put to this idea, but I think it’s quite likely there are as many as 10 times more scientific journals out there today than there were in 1994.  And those journals are of varying quality with, one assumes, a range of rigor when it comes to peer review.  So some ‘peer-reviewed’ studies might be valuable advancements of human knowledge while others might be little better than pretentious gibberish. How to delineate between the two?

Another issue to consider is the significant number of herbal products on the market that are formulated with traditional modes of use in mind.  I have been reminded more than once that just because this kind of knowledge doesn’t fit the Western clinical trials mode does not mean it isn’t of value.  Any new scheme of the sort I’m suggesting would have to take this caveat into account.

Issues being outshone by CBD glow

I’ve barely scratched the surface here. I'll have to leave it to minds greater than my own to come up with a new framework for disseminating this information, a framework that would fit within the wider ‘DSHEA 2.0’ discussions.

But I’m not hopeful it will happen. I was at a session connected to the recent SupplySide West trade show in Las Vegas on the future of DSHEA. Keep in mind this was not a theoretical discussion, as it might have been eight years ago. The feeling is some kind of alteration of DSHEA definitely will be proposed. This is something that industry stakeholders would not have even considered in the past.

Yet the room was barely a third full, if that, and the crowd definitely skewed older. While these important issues are mulled over, much of the industry, especially the younger set, is chasing the pot of gold at the end of the CBD rainbow.