From the Editor's Desk

If botanicals don’t fit easily under supplement heading, why not try to fix that?

By Hank Schultz

- Last updated on GMT

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Getty Images
Should the creation of a new herbal medicine category be one of the goals of the upcoming discussions about a new regulatory framework? If it were possible, such a change could clear up many of the ambiguities surrounding the marketing of these products as dietary supplements.

When Dietary Supplement Health and Education Act (DHSEA) was signed into law almost 25 years ago, many in the then nascent dietary supplement industry felt as if they had gotten most of what they wanted. DSHEA allowed products to come to market without pre approval from the US Food and Drug Administration. It created a freewheeling, innovative market that has exceeded expectations and has grown strongly from 1994 to now, proving more or less impervious to business cycles.

But like every piece of legislation it included compromises. Lumping botanical products in with products that are clearly nutritional in nature, like multivitamins, was one of these.

Long history of herbal medicine

Herbal medicine has a long history in the United States, attendees at the recent International Conference on the Science of Botanicals were reminded. The conference wrapped up Thursday, April 11 at the University of Mississippi in Oxford.  The conference is put on by the National Center for Natural Products Research.

The event had a theme of looking back over the 25 years of DSHEA, and even further back into the history of botanicals. And it had a forward looking aspect, too, with many in the audience offering comments about how any future changes to DSHEA might serve botanicals better.

Prior to the rapid and wide scale development of synthetic drugs starting in the 1940s, physicians and pharmacists in the US were well versed in herbal medicine.  One of the presenters at the event, pharmacy researcher Bill Gurley PhD, of University of Arkansas School of Medicine, told of an antique two volume physicians’ desk reference in his possession that is essentially an herbal pharmacopeia.

Rise of drugs put botanicals into shade

But with the advent of life saving allopathic medicine, and the rise of wealthy drug companies that could fund large scale ongoing research, this type of knowledge fell by the wayside. By the time the herbal products business was ramping up in this country, starting with the counterculture movement of the late 1960s and moving into the blossoming of the first health food stores in the 1970s, herbal medicine had become the exclusive purview of a small cadre of alternative health care practitioners.

This led many healthcare authorities, most of whom were educated with almost nothing in the way of nutritional curriculum, to denigrate these types of products.  But it wasn’t so in other parts of the world that had also adopted the Western drug model, like Europe.  There herbal knowledge became codified as traditional medicines, and some of the pioneering companies felt empowered to do extensive high quality research on their products’ effects.

Uneasy fit

When DSHEA was being crafted, botanicals were placed in the dietary supplement category, which has never been an easy fit. Not everyone was happy with this marriage of convenience. The European herbal manufacturers, companies like Schwabe, and others that emulated their evidence-based approach, like Traditional Medicinals, found their research was of little use in marketing their products under the new paradigm.

“We weren’t a supplement. We were traditional medicine,”​ said Josef Brinckmann, a research fellow in medicinal plants and supply chain with Sebastopol, CA-based Traditional Medicinals. Brinckmann said there was a sometimes painful learning curve to living within the new guidelines. 

In the years since, botanical products companies learned to accommodate themselves to and even prosper under the new strictures in which any mention of disease states was strictly forbidden. The deal DSHEA struck was deemed to be so advantageous for the industry as a whole that there was an unspoken agreement to hush up complaints about some of its rougher edges, like the position of botanicals.

Lack of clarity on science communication 

Now that there is broad consensus that a modification of DSHEA might not only be inevitable but could even be a good thing, experts in the industry are also starting to revisit what a new paradigm for botanicals might look like.

Comments at the meeting in Oxford centered on the long standing frustration with the inability to talk about some of the evidence for the effects of botanicals.  Why do research into the pharmacokinetics and pharmacology of your ingredient, for example, if most of that information has to be staked out behind the woodshed and referred to in only the vaguest of terms? The kind of companies who send representatives to these sorts of meetings tend to do a lot of this kind of work anyway, if only to satisfy their own ethical imperatives and for product liability concerns. But this ‘mum’s the word’ situation created by the regulations also allows the existence of products in the market for which there is really almost no evidence whatsoever.

New category for botanicals? 

One of the commenters at the conference said that it would probably require an act of Congress to create something in the US analogous to what is in Europe. 

Well, if that’s true, is that something that the industry should shoot for?  If there is value in herbal medicine—and I’m sure every attendee in Oxford would agree that there is—then why not think about a better way to communicate that to consumers?  Structure function claims might meet the letter of the law, but I doubt they were put into place with much in the way of consumer research.  Even today, I would be willing to bet that if you read a structure function claim verbatim to a consumer (and even to many physicians) without additional context, most would say, “Huh?”

I’m sure many in the industry will opine that this pie in the sky kind of talk. But I’ll bet, too, that if you had polled industry watchers in the late 1980s and early 1990s whether something like DSHEA were possible, many would have been equally incredulous. If botanicals don’t fit, why not try to fix that?  

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