Features

Hot Herbs

It all comes down to science and standardization.

The Herbal Movement

As the industry moves forward-and from most accounts it has come a long way in a short time-key concerns are knowing which herbs will become, and remain, popular and where to get high quality raw materials.

The media plays a role in the former. An article in The New York Times or a spot on Dateline can work wonders in terms of consumer awareness and acceptance. "New herbs' popularity is predicated on the media, which can make it happen easily," commented Jeff Morrison, President of the American Herbal Products Association (AHPA), Silver Spring, MD.

Then it's up to the industry. "Once herbs have gained public awareness, what matters is the ability of the product to stand on its own and become a staple in the market," said Roger Rohde, Jr., President, Triarco Industries, Wayne, NJ.

Moving forward from that point, companies must also stay ahead of the next hot trend. Suppliers invest a great deal of time and money to stay on top of the market, wherever that may lead. "A lot of what we're seeing is the globalization of herbal markets," said David Wilson, President and CEO of Folexco, Montgomeryville, PA. "Initiatives are going into China, India and South America and now there is a pretty good information flow."

But how do you go about developing the herbs of tomorrow? Wolfgang Aulenbacher, Vice President-Sales and Marketing at East Earth Herb, Eugene, OR, offered two scenarios. "There are two ways to go. The first is to look to the pharmaceutical industry for guidance. What drugs have been successful and what herbs can replace them? The most successful drug at this time is of course Viagra and a number of herbal based Viagra-type drugs have been introduced.

"The second method," he said, "is to expand the research of traditional herbalists, to look toward India, China and to some degree, South America. These are the areas where traditional herbs have been used for years. To be truly successful with mainstream customers, however, we have to confirm the herbal knowledge with Western science."

Along with doing the science, companies are also concerned about having a quality supply source available. A recent trend among suppliers has been in backwards integration as more companies are investing in the actual farming or cultivation of the product. For example, Quality Botanical Ingredients (QBI), Plainfield, NJ, has a crop cultivation division and is doing research to develop heartier and higher quality herbs. "Currently we are cultivating 13 different herbs in the U.S., working with 30 farmers in five states. Right now it's only a small percentage of what we do but it is an important focus," said Scott Rosenbush, Executive Vice President. "We are investing heavily in backwards integration to guarantee the future supply of our product."

Likewise Folexco has started its own farming operations. "Echinacea used to be available only when it was harvested in the fall," said Mr. Wilson. "We said, 'why don't we go to Latin America, where we can get it all year around?' We're also growing in Oregon and Washington as well as the southeast U.S. When someone wants an ingredient, we can generally get it. He continued, "This also brings us control over our supplier source. We dictate where we grow, how much they plant, what kind of seed, when they harvest, etc. Every manufacturer should make it a point to know their suppliers and find out where their supply is coming from," he advised.

Triarco's Mr. Rohde agreed on the importance of controlling the supply. "We have taken the next step and started a 500 acre organic farm. We want to know what we're starting with. This was not a cheap undertaking, but we have put our money where our mouth is. This has been a major commitment for us and we've learned a lot about quality. We're actually seeing a paradigm shift where customers are calling us," he said. "They want to know that they can have a quality, consistent supply of ingredients."

Backing Up What's In The Bottle

Once the supply source has been established, the next challenge is proving that what it says on the bottle is what's in the bottle. Standardization is a tricky word because it can actually mean several things. Standardization of extracts is an important part of the business and suppliers continue to standardize to specific markers to guarantee they're providing the herb they say they are.

Tied into that, however, is standardizing in terms of consistency from batch to batch. This is more difficult because the testing methodology framework is not in place. Negative press from consumer media claiming the industry has no standards at all certainly doesn't help matters. This is being addressed, however, with several industry-wide programs. (One such program, MVP-Methods Validation Program-is profiled in the sidebar on page 52 of the print version of Nutraceuticals World).

Suppliers across the board agree that standardization is an absolute necessity. According to Jeffrey Wuagneux, Partner, RFI Ingredients, Blauvelt, NY-which is the North American sales and marketing representative for ingredient supplier Hauser, Boulder, CO, "There simply must be guidelines set up for nutraceuticals, especially in the food industry. The majority of food companies will not use something that does not have established standards."

"You must be able to guarantee batch-to-batch consistency," agreed Gregory Ris, Vice President of Sales, Indena, Seattle, WA. "We introduced standardization 12 years ago in the marketplace," said Mr. Ris. "Scientific validation of standardized extracts is absolutely necessary."

"I've been in the herbal business for 25 years and I can clearly see a move towards science and process validation," said East Earth Herb's Mr. Aulenbacher. "The Western world is run by a scientific paradigm and herbs have been shunned in the past because they were outside the paradigm. Herbs were always efficacious of course, but scientific validation is a necessary step to move them into the mainstream. Science is the only way for herbs to penetrate the mainstream consciousness."

Although everyone agrees that standardization is the way to go, there is less agreement about how best to standardize. Obviously, test methods need to be reproducible in other labs. According to Folexco's Mr. Wilson, studies have shown that the quality of products can vary dramatically from one company to another, even from batch to batch within the same company. Programs like MVP will go a long way towards correcting that but the industry still has work to do.

Picking the correct standardization marker remains a challenge. "Standardization is good from an economic standpoint because you can compare apples to apples," said Triarco's Mr. Rohde. "However there is the possibility that we will standardize to the wrong thing; the question then arises, is it still a botanical extract?"

St. John's Wort is a perfect example. Companies have been standardizing to 0.3% hypericin; now European suppliers are saying that hyperforin is the active ingredient. According to one U.S. supplier, "In this country, suppliers are not so sure they agree with the Europeans, but they're going to check for hyperforin just in case."

Beyond standardizing to a certain marker is the concern that what is eliminated may actually be a necessary and synergistic element of the herb. Kim Danziger, Owner of Good Hope Botanicals, Novato, CA, commented. "What is the best direction to go? Do you standardize to a certain ratio? Who's to say that's the active? You could be wiping out other actives that could provide a synergistic effect."

"I don't necessarily believe in only one marker standardization," agreed Paul Altaffer, President, Nat-Trop, Oakland, CA. "We are not in pharmaceuticals and we need to take a more holistic approach."

Todd McBride, Brand Manager at Hauser, Boulder, CO, added, "We think it's important not to change what nature offers us. We at Hauser have a trademark term called 'Natural Ratio,' which means if an herb contains Compound A and Compound B, we want both to be present, but we also want both to remain in the same ratio that they were before processing. These herbs have been effective in nature for hundreds of years; it's our philosophy to keep as close to nature as we can in our extracts."

So who should be responsible for the standardization? Almost unanimously, suppliers favor self-regulation over the government stepping in. "The best opportunity is to take the high road and encourage companies to regulate themselves," said Paul Heising, Vice President-Marketing, Pharmanex, Simi Valley, CA. "Key manufacturers understand the importance of labeling properly, keeping ingredients consistent with studies, etc. Those are the manufacturers that will rise to the top."

Mr. Aulenbacher agreed. "There are some black sheep out there putting cheaper product on the shelves who are just in it for the money. We need to improve our industry's self-regulation. Associations like CRN (Council for Responsible Nutrition), AHPA and NNFA (National Nutritional Food Association) need to influence their members to get voluntary compliance. If we don't do self-policing and self regulation, if we miss the boat on this, the government will step in," he said.

AHPA's Mr. Morrison said the trend is toward self-regulation. "The industry is taking prudent, responsible steps in this direction. The MVP program (mentioned above) is one example. The industry also strongly supports GMP's and voluntarily submits to these."

"In general a lot can be said for the direction in which the industry continues to go," commented Mr. Rohde. "Maybe 10 years ago I would have said, 'yes, FDA will have to step in,' but now we have seen incredible improvement. Today the consumer demands it so the government doesn't have to. Educated consumers want a quality product; they are the drivers for everything."

Dosage is also a concern, as here again, confusion reigns on store shelves. Determining dosage is not an easy task, however. According to Nat-Trop's Mr. Heising, "How do you maintain a point of differentiation? There is now a lack of understanding and while efforts are underway to begin the standardization of dosage, the process will be lengthy and won't happen in the next five years."

Price is another consideration in terms of dosage requirements, pointed out Mr. Rosenbush of QBI. "Dosage recommendations will remain controversial and will generally divide along distribution channel lines," he said. "Mass market manufacturers have to hit a certain price point, while health food stores can price differently, as can multi-level marketers. Some companies focus on more than one distribution channel and it will be very hard to standardize dosage due to price concerns."

Most suggest that a dosage will end up being a range rather than a set number. According to Ms. Danziger, "The dosage should be in a ratio that is generally recognized as safe; one dosage is not necessarily better than another. What is effective should be within a range, not a set number."

Mr. Altaffer agreed. "Sometimes there's a 'more is better' syndrome and there is a point of diminishing returns in terms of increasing dosage. I think the natural inclination will be toward a narrower range."

Food Versus Pill: Does Form Follow Function?

It depends on how you look at it. All the suppliers interviewed reported interest and ongoing conversations with food companies about the potential of incorporating botanicals into traditional food products. Obstacles line the path, however.

"We are starting to work with some of the big food companies now, but the question remains, is it feasible and cost effective to include a therapeutic dose?" said Indena's Mr. Ris. "There are also issues about heat sensitivity and taste, although flavors today can do a pretty good job masking that," he said.

QBI's Mr. Rosenbush commented, "Efficacy versus cost effectiveness is the battle in the food and beverage industry. Herbs as functional foods have to have GRAS status and the food industry is not used to using raw materials that are expensive in general," he said. "The availability of raw material is also a question for large food companies; these companies do not think small. As a result this will probably remain a niche type product."

"The food industry is interested but they are resistant to getting involved for two reasons," said Mr. Altaffer. "One is that herbs are not enough in the mainstream. The second is the fear of stepping over that imaginary line into therapeutic or perceived therapeutic products, which brings with it liability."

Overall, suppliers-at least for now-believe dietary supplements will remain the way to go. "Food is an untraditional delivery system," said Mr. Aulenbacher. "No herbalist would recommend food over a dietary supplement. Dietary supplements are a better way to control the dosage." Daniella Ernst, Marketing Manager at Starwest Botanicals, Rancho Cordova, CA, agreed. "Food will be used for nutritional value, but capsules have the highest dosage and will be the most used, most convenient form."

RFI's Mr. Wuagneux added, "The major food companies are not going to risk their brand identities in today's current nutraceutical climate. The only thing that may change that is a move towards standardization throughout the industry."

One dissenting opinion was offered by Jagat Joti Singh Khalsa, International Sales Manager-Botanicals at Yogi Botanicals, Eugene, OR. "Food is absolutely the direction that botanicals are going to go," he said."It takes time to take supplements; it's easier for people to drink more tea and eat more functional food. Over the course of the day it's a cumulative effect," he said.

And How Would You Like Your Herb?

Another topic of discussion in the herbal extract business is whether the future is single herbs or combinations. Here suppliers were divided. On the single herb side was Pharmanex's Mr. Heising. "Single herbs continue to show the most promise, they are more easily understood," he said. "The science is more accepted than for combination products. My guess is that single individual herbs will remain the focus of the largest bulk of substantial science."

On the other side of the coin, Starwest's Ms. Ernst said, "While single herbs will always have a place, I believe we are moving towards combinations." Good Hope Botanicals' Ms. Danziger agreed. "I think formulations will continue to be the way to go, as you can take advantage of the synergistic effects."

According to Mr. Altaffer, "What really sells a product is the health food store employee or pharmacist. Here's where you're building brand loyalty. Another part of this brand awareness is formulations. Companies can put together unique formulas as a point of differentiation; as a result I think you'll see a stronger push for formulas."

The issue divides also along geographic lines. "Europe is much more fond of the single herb, while other herbal traditions use more combinations of herbs," commented Mr. Aulenbacher. "Since we have almost exhausted the European list, I think that multi-herb formulas will be the wave of the future," he said.

Several suppliers believe there's room for both. "The market has not been determined yet; Bayer introduced One-A-Day herbal blends, while Warner Lambert has rolled out single herb supplements," said Mr. Rohde. "For now the market remains divided and there's room for both. Good strong products generally stand alone in single herbs; combination herbs have an advantage because you can also blend in more than just herbs, taking advantage of minerals, for example, that have a synergistic effect."

"The split between single herbs and combinations will continue," said Jagat Joti Khalsa. "It's a market-driven environment and right now there's a lot of confusion out there at the consumer level, especially about formulations. So companies will put out a line of 10 single herbs, then as the market evolves they'll go back to introducing formulas."

Finally, consumers' age and familiarity with herbal products play a role. According to Hauser's Mr. McBride, "People on the sidelines, those who are just getting into it, will try a single herb to start out. As their confidence grows and they want to take more supplements, they'll start to look at combinations." Another point in favor of formulations, said Mr. McBride, is that as people get older, they have a harder time swallowing a large number of pills.

Where To From Here?

For the future, suppliers are optimistic. "The biggest trend has been growth in the herb and botanical area," said Mr. Heising. "Vitamins and minerals have penetrated about two thirds of households in the U.S., while herbs and botanicals are only used by maybe a third of the adult population. There has been more interest in the herbal and botanical market recently and this is where we will continue to see action in the next several years."

Mr. McBride summed up. "We are at the same point that vitamins were ten years ago. We're at a young and growing stage, but we are gathering the knowledge that will give us the acceptance that vitamins have today."