Call for new category of herbal products likely to fall on deaf ears

By Hank Schultz

- Last updated on GMT

Call for new category of herbal products likely to fall on deaf ears

Related tags Herbal supplements

Suppliers of herbal ingredients that are well characterized with reams of research continue to chafe about the strictures involved in communicating the benefits of these ingredients in the US market. Word on the street is, that situation is unlikely to change.

During a recent conversation at the Expo West trade show in Anaheim, CA, Pierce Sioussat, CEO of Bioforce USA, rued the inability of herbal product manufacturers to fully communicate the science behind their ingredients.  Sioussat's firm has a long history with European herbal product manufacturers.  One of the companies his firm represents, A. Vogel, represents ground zero for the paradoxes inherent in the sale of dietary supplements in the US market.

Echinacea pioneer

A. Vogel/Bioforce AG is a company founded by Alfred Vogel, a Swiss naturopath who passed away in 1996. Vogel’s concept was that extracts made from fresh herbs would have higher activity than those made from dried stock, which was common in the late 1930s when he started making his own extracts.  Having fresh herbs available pretty much meant growing them yourself or contracting with farmers in the neighborhood.  Vogel began his farming operations in Switzerland in the 1950s, an effort that continues today where the company grows its organic echinacea and other crops.

Within Europe, various jurisdictions have herbal medicine regimes which were incorporated into the overall structure governed by the European Food Safety Authority.  Having a separate category that enabled drug like claims to be made encouraged manufacturers who had truly efficacious ingredients to conduct research on them which could then be used to support the products in the marketplace.

Only a few companies clear the evidence bar

This led to a situation in which the cream rose to the top, Sioussat said. In the herbal medicine field (as opposed to dietary supplements, which of course are sold in Europe, too) there was only room for companies that could prove their stuff worked.  There was no large cadre of me-too products that are common in the US market.

“If you go to Switzerland and you got into a pharmacy, it’s filled with herbal medicine. But it’s only Echinaforce and about three or four brands, because those are the ones that have done the clinical research to be sold in that setting,​ Sioussat said.

But without that separate category, all herbal products compete on the same shelf in the US, he said.  That places the well characterized, highly researched products with ingredients of proven provenance alongside products that feature commodity ingredients that have no research whatever on their finished formulations.

Among A. Vogel’s key products is Echinaforce.  Its based on an echinacea extract made from plants grown on their own farm.  Company lore has it that Vogel learned of the cold and flu preventing properties of echinacea from a Native American healer on a trip to the US in the 1950s.

“A. Vogel has done dozens of clinical trials on their Echinaforce product,​ Sioussat said. “They have a registration in Switzerland for the prevention of cold and flu. It’s the only one of its kind in the world, because they have the data to back it up.

One size fits all through DSHEA

“In this country, Echinaforce is on the same shelf with products that are called echinacea but sell for only a fraction of the price. Many of these are not the same kind of extractions or might not even be from the same plant parts. There are some brands that might actually be good products but they don’t have any research,​ he said.

Sioussat laid the blame for this situation at the foot of the Dietary Supplements Health and Education Act, which he views very much as a double edge sword. DSHEA created a thriving marketplace and kept strong opponents of the industry at arm’s length.  But the ‘education’ part of this law really never came into full fruition, Sioussat said.  It has served, rather, as a way to keep some valuable information out of the marketplace.

“I think DSHEA really saved the dietary supplement industry from oblivion,​ he said. “But it’s not sufficient now because it doesn’t take into account all of the research that has taken place in the past 20 years. We struggle now with an inability to communicate with our consumers in a meaningful way.

“I think we are at a point where we have to take another look at that. I think we what we really need is to have a category like they have in the UK for traditional medicines,​ he said.

ABC founder: Don’t hold your breath for new category

Mark Blumenthal, founder and executive director of the American Botanical Council, agreed that some herbal products that come out of Europe put American products to shame in terms of their research backing.

“Echinaforce is at this point the world’s most clinically tested echinacea.  One of their trails had more than 700 subjects enrolled.  It was the largest echinacea trial ever published and probably one of the largest trials ever done on any herbal product.  But in the US market they probably can’t say much about that,​ Blumenthal said.

The frustration that Sioussat voiced is not new, Blumenthal said. Companies have complained for years that they can’t communicate research results to consumers.  What to do about it is another matter, he said.

“I’ve heard this from other companies as well that they can’t really talk about their research.  The problem as I see it, to create a new class of drugs . . . well, from a political and cost perspective, that’s just not going to happen,​ he said.

Blumenthal said that in this era of relaxed regulation under the Trump regime, it’s possible that with the help of sympathetic lawmakers some wiggle room might be wrested from FDA on the education question.  But even then, he said he’s at best guardedly optimistic.

 And in any case, he would want to see limits put around who could say what. He would want to restrict any new found freedom to those companies that can prove they have well characterized ingredients that are directly linked to what was used in the clinical trials. And companies would still have to tread very carefully around the edge of making a disease claim.

In the meantime, Blumenthal said companies can always—carefully—refer consumers to the research that has been popularized through ABC.

“I’ve been at this since eight years before DSHEA,​ he said. “A consumer could always come to our site to learn more about echinacea.  We disseminate our information to consumers in ways that are responsible and are peer reviewed.

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