By Brenda Porter 

It seems that there is a skewed perspective toward the herbal products industry as a whole by regulatory agencies, the pharmaceutical industry, and the medical community,” explained Gaia Herbs’ Mark Nathan. He pointed to ephedra as “a prime example of a natural herb with numerous health benefits that has been removed from the market. “Sadly the mentality of ‘if a little is good, a lot must be better’ has created very negative effects for both consumers and the herbal community.”

Dozens of news reports have steadily cast a dark shadow over the industry, although industry groups would argue that such reports are ill-informed. In the May issue of Consumer Reports magazine, an article outlined what it claimed were the 12 most dangerous supplement ingredients, nine of which were herbs: comfrey, chapparal, germander, kava, bitter orange, lobelia, pennyroyal oil, scullcap, and yohimbe. Aristolochic acid, a chemical found in the plant Aristolochia fangchi and at one time used in a number of herbal products, is also on the list, but identified incorrectly as an herb, experts say.

Add to that article more unfriendly editorial from well-known news outlets like The New York Times or the Los Angeles Times, and Mark McClellan, until recently the Food and Drug Administration (FDA) commissioner, in a speech earlier this year, identifying several herb-based weight loss ingredients as ones FDA was keeping an eye on.

These reports may lead users to wonder about the safety of taking herbs and the government’s role in protecting consumers.

“In 1960, FDA banned the sale of sassafras, because it was deemed unsafe for use as a food additive. So safety is not a new idea. The industry and the regulators are always concerned about safety,” said Michael McGuffin, president of the American Herbal Products Association (AHPA), Silver Spring, MD.

Mark Blumenthal, founder and executive director of the Austin, TX-based American Botanical Council (ABC), added, “There is significant misinformation out there. It looks like there’s a problem out there [industry-wide] by looking at a few companies that sell something that is either unsafe, and/or they make inappropriate and unsubstantiated claims. Even if the combined sales of these companies are relatively small compared to the entire market, this exaggerated view can distort the perspective on the entire industry.”

Noting that one bad apple doesn’t spoil the whole bunch, Blumenthal and McGuffin discounted the Consumer Reports list, suggesting that some of the herbs listed have not been in use by legitimate formulators for some time. However, they acknowledged that a few have slipped through the cracks.

For example, in the last 10-20 years germander has been substituted in some formulas for scullcap, although scullcap still appears on the ingredient list. “In traditional Chinese medicine, if herb A is called for but unavailable, you can substitute it for herb B, which has the same properties of herb A,” said Blumenthal. “Scullcap should not have been on the list. Germander has been shown to promote liver toxicity. So the question about the safety of scullcap is a situation of guilt by association or substitution. This is strictly poor quality control here.” He added that he was not certain if the scullcap adulteration was still occurring.

In an open letter to the editor of Consumer Reports, AHPA wrote, “The safety concerns associated with aristolochic acid, for example, are sufficiently well established to support removal from the market of any product containing herbs in which this compound occurs,” contrary to what Consumer Reports has printed.

About the remaining herbs, the group wrote, “With regard to the other… herbs listed in this article, the evidence on each of these suggests that consumers who choose to use these products should be provided with information to assist them in making such choices.”

Fighting Back
To counter this negative view of the herbal industry, companies and organizations alike are exposing media reports’ inaccuracies, experts say.

“We respond, but it’s discouraging because it’s like a squeak against a roar,” said McGuffin. “A lot of the reason we participate actively with DSEA [Dietary Supplement Education Alliance] is that their interest is in telling the good news. We are all working to make sure we have a forum to get our message out.”

Nature’s Answer (Hauppauge, NY), named in the Consumer Reports article, has also turned to the power of the pen (or keystroke these days).
“Nature’s Answer has responded to the Consumer Reports piece by writing a letter that compares the relative high safety of herbal remedies to the extremely high level of adverse events linked to pharmaceutical drugs,” said Ellen Kamhi, Ph.D., R.N., author of The Natural Medicine Chest, and professional herbalist for Nature’s Answer. “Overall, the Consumer Reports piece was not actually focused on health issues, but rather regulatory issues. Since it is obvious, as we see in the case of pharmaceutical drugs, that increased regulation does not equal increased safety, Nature’s Answer supports increasing the availability of funds to FDA for them to fulfill their regulatory responsibilities, as outlined by the [DSHEA, or the Dietary Supplement Health and Education Act], rather than blatantly increasing their already adequate regulatory powers.” Consumer Reports and its parent organization, Consumers Union, have stated their support for legislation that would give FDA more authority over supplements.

Government. For some in the industry there needs to be a reevaluation of existing legislation. “The herbal industry in general is trying to address the issue of herb safety,” said Dr. Albert Y. Leung, PhD, president of Earth Power (Woodbine, IA), makers of PhytoChi, a balance and well-being formula consisting of 16 herbs traditionally known in Chinese medicine to have antioxidant and anti-inflammatory properties.

According to Leung, DSHEA is too broad. “DSHEA does not distinguish therapeutic herbs (medicines) from true supplements. I think DSHEA went overboard by including herbs that have never been used to supplement one’s diet but rather used strictly as medicines (such as ma huang) and there should be a separate category for herbal medicines to allow qualified practitioners to practice their healing art without being adversely affected by a few bad apples in the dietary supplements industry who indiscriminately promote herbal drugs as safe dietary supplements,” said Leung, an internationally renowned pharmacognosist (i.e. a scientist who specializes in botanical medicine) and author.

Leung said he would also advise training future doctors and pharmacists across multiple medical disciplines, including traditional herbal practice.

“We need to train more people to understand and know herbs, not just their chemistry and pharmacology, but also their traditional properties and how they have traditionally been used,” Leung remarked. “Unfortunately, the way it is now, we are recruiting scientists who still conduct herb research with the drug approach and treating herbs as if they were pure chemical drugs.”

Leung recommended two basic approaches to herbal research:

• Be sure the test herbal material is correctly identified and well defined, which the National Center for Complementary and Alternative Medicine has already mandated; and

• Be sure to clearly identify the right properties associated with the herbs which one wishes to study.

The Eclectic Institute, Inc. is currently involved in creating a nonprofit entity, “which will begin to establish a much needed language for herbal products,” said Dr. Ed Alstat, co-founder of the Eclectic Institute, located in Sandy, OR. “The group hopes to be a clearinghouse for the media so clarity can be increased.”

For instance, Alstat said, there are many standardized products which are standardized to the same marker—such as echinacea with phenols—yet most of the products have very little in common with the echinacea in its whole form, due to the processing necessary to achieve this standard.

“Many extracts claim to be made with whole herbs and are standardized, when in fact much of the activity of these herbs can end up on the compost pile due to the various chemical solvents used. So why is it even called echinacea?” asked Alstat.

“The critical reason that this [difference between standardized and whole herbs] needs to be clarified is the potential for side effects, contraindications, toxicity, etc.,” Alstat said. “Kava kava is a good example of how a water extract of a plant used for centuries is given the same ‘toxic ‘label as a standardized extract—each made differently and bearing little resemblance to one another.”

Customer Advantage. “Consumers and retailers don’t need to feel frightened and the vast majority of herbs certainly don’t justify the paranoid sensationalism that is rampant in the mass media. The primary aspect to remember is that herbals can have very beneficial effects on the body when used correctly and should be purchased from reputable herbal products companies… and used as directed on the label or by a qualified alternative medicine practitioner,” said Gaia Herbs’ (Brevard, NC) national key accounts manager, Mark Nathan.

Added Geni Herbs’ Sonya Cropper, “We always make safety a priority; however as a raw material supplier we can not control how consumers mishandle their intake of supplements. We promote our materials strictly on their scientific merit, and we do educate manufacturers on our ingredients, including clinical data, toxicity data, and label claims ‘wrongs and rights.’ ” Cropper is director of operations and communications for Noblesville, IN-based Geni Herbs.

An Herb for All Seasons
Aside from the question of defending the safety of herbs, a number of conditions like PMS and menopause for women or sexual enhancement herbs for men have garnered consumer attention.

“For virtually every malady, there are natural remedies for those willing to try them,” noted Scott H. Smith, vice president of corporate development for Castle Rock, CO-based Natural Balance. The company recently introduced its Super Value line of supplements, with one of the first launches being a menopause symptom relief formula, simply called black cohosh.

Retailer Daniel Gagnon of Herbs, Etc., Santa Fe, NM, said he sees consumers turning toward herbal medicine for self-limiting ailments.

“This includes such conditions as colds and flu, sleep disturbances, seasonal allergies, stress, mild anxiety, menstrual problems (PMS), menopause, benign prostratic hypertrophy, middle ear infection, fatigue, digestive problems, and sore throats.”

According to Gagnon, medicinal mushrooms such as reishi, shiitake, maitake, and cordyceps are poised to gain from the baby boomers’ focus. This also applies to herbs such as ashwagandha and rhodiola.

“I believe that the adaptogen and tonic herb category is going to gain significantly in the next 5-10 years,” he said.

Kamhi added that there is a lot of interest in increasing the protection afforded by antioxidants. For example, Nature’s Answer offers the combination formula Anti-Oxidant Supreme, which combines curcumin, green tea, lycopene, pine bark, and other herbals along with vitamins including C and E, and selenium.

Other issues for baby boomers, Kamhi said, include insomnia and sexual health.

Nature's Answer has Brainstorm, Slumber, and Male Complex formulas to address these problems, as well as individual herbs including Ginkgo biloba, valerian root and damiana, to name only a few.

Rhodiola, a U.K. crossover, is a recent newcomer in terms of popularity, Kamhi added. Another herb showing growth potential is cinnamon, “due to media attention on a scientific study showing that cinnamon helps to balance blood sugar,” she noted.

Geni Herbs has seen growth in its branded ingredients with science behind them, such as WokVel, CalZBone, TinoFend, and BaCognize.

“All of these ingredients have been used in numerous studies with excellent results, and with the looming FDA it is more critical than ever to have science to back your product,” said Cropper.

Formulas Vs. Individual Herbs
Just as in homeopathy, for example, where natural medicine manufacturers have found a niche in attracting new consumers through combination formulas, so it seems that herbals are evolving along similar lines.

“I have been a retailer for 28 years,” said Gagnon. “Since those early days, the whole herb business has changed considerably, to say the least. For one, so many more herbs are available now than in the past. The other observation is that in the past, single herbs outsold single herbs. These days, herbal formulas are outselling single herbs.”

According to SPINS data, herbal formulas accounted for nearly 20 percent of sales in the natural channel, while sales of herbal singles amounted to more than 17 percent in the 52 weeks ending in late March 2004. San Francisco-based SPINS is a natural products industry market research firm.

One reason for combination formulas is simply to make supplementation easier on the consumer.

Explained Gagnon, “The consumer does not have to become an herbalist to address his/her health issue because the formula is designed to address the problem.”

For example, Gagnon said, if a consumer has a problem sleeping, he/she does not need to decide if he/she should take valerian, California poppy, passionflower, or chamomile, to name but a few herbs.

“So, the consumer peruses the shelf and finds formulas called Deep Sleep, Sleepy Time, and Nighty Night that addresses their needs,” Gagnon related.

According to Natural Balance’s Smith, additionally, “In many cases, the synergy of herbs in combination provides better results.”

On the other hand, Alstat theorized that this shift in focus has taken place probably in response to marketing rather than research.

“The irony in this approach is that standardized extracts are just fractions of the original whole herbs, so their attempt to combine several fractions from various plants indicates that something could be missing in the original approach,” he said. “It’s like enriching white bread.”

The Eclectic Institute has developed a line of encapsulated botanicals which are fresh freeze-dried instead of air-dried. The fresh freeze-drying of the herbs is said to maintain the active constituents of natural potency of most herbs, according to the Institute.

However, many single ingredients are becoming well known and consumers are looking for them, with green tea being one example. SPINS places sales of herbal singles at more than $86 million in the natural channel and $146 million in the mainstream in the 52 weeks ending in March. (Mainstream sales figures are provided to SPINS by ACNielsen ScanTrack.)

Recovering From A Slump
Recent reports have documented rising numbers in consumer confidence and spending, a turnaround from the reports of a slumping economy. Vitamin Retailer’s April Retailer Snapshot survey reported, “The percentage of retailers whose total sales increased in the past year was up, and the percentage of retailers whose sales declined was down. More to the point, the figures suggest that the recovery is accelerating.”

For example, SPINS reports that units of herbal formulas sold in the natural channel increased sales over last year by 17 percent. Those same sales declined slightly more than 1 percent in the mainstream channel this year.

In the late ‘90s to early ‘00’s, “Part of the decline in sales of herbs can be attributed to consumers who bought a product once and expected a drug-like quick fix, but were disappointed,” said Smith. “We need to avoid the exaggerated promises and substandard quality that may have attracted a customer once, but could not keep them.” He added that both manufacturers and retailers need to establish appropriate expectations for herbs, while delivering the quality, dosage, and potency needed in the product. VR