Nare-ing On Nature 

Do some in Utah’s herbal industry ignore adverse effects to kick up business.

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Herbal remedies: They’re all over the place these days. You can find them in health food stores, supermarkets, on the check-out counter of the local convenience store. Neatly packaged and priced, these dietary supplements in the forms of herbal capsules, teas, tonics, gels and creams line the medicine cabinet shelves of half the American population. Cheap, legal and possibly miraculous, they claim to cure just about any ailment. Want to stave off the effects of menopause? Try blue cohosh. Feeling anxious? Pop some kava to soothe yourself (but you may want to heed the FDA’s warning that kava may cause potential liver damage). Nauseated? Sip ginger tea to stop the acrobatics in your stomach. Arthritis making you creaky? Reach for some burdock or nettle. Colds, anemia, eczema, even high blood pressure—all have herbs that claim to treat them, and lots of people are reaching for them.


“A significant percentage of Utahans are very interested in and do use dietary supplements,” says Loren Israelsen, executive director of the Utah Natural Products Alliance. “And there are a significant number of dietary supplement companies in the state—around 70 to 85.”


Chances are, the herbal remedy you use has a Utah manufacturing company on the label: Alvita Products, Nature’s Herbs, Deseret Laboratories, Young Living, Christopher Enterprises, USANA Health Sciences and Nature’s Sunshine are but a few of the industry’s well-known companies located here.


Pulling in close to $3 billion a year in Utah—part of the total $16 billion a year American consumers spend on the natural way to feel better—these herbs and other dietary supplements (a heading that covers vitamin and mineral products as well as herbals or other botanicals) are straight shots to fat bank accounts for many of the companies that sell them. The industry’s products, ceaselessly pumped out of these high-tech factories, answer the nation’s demand for everything from herbal remedies to power bars to energy drinks. A single facility in Salt Lake City can produce one million energy bars per month. This ain’t your momma’s backyard greenhouse business.


Dietary supplements have a long history of use in Utah, going back to Native Americans and pioneers who used local plants as both food and medicine for generations. One North American variety of ephedra, E. nevadensis, is also known as Mormon tea—so called because settlers used it as a tonic. The dietary supplement industry set firm roots in the Beehive State in the late 1960s and early 1970s. “This was a cottage industry for decades,” says Israelsen, “with a small but loyal core of consumers.”


But although this ancient, natural form of healing—often trumpeted as producing newly discovered wonder drugs or the latest alternative health craze—can claim tremendous sales, it also holds a place in the midst of heated controversy about the safety and effectiveness of its products. “The [current] challenges of growth are inevitable,” Israelsen states.


Yet consumers still wonder: Do the industry’s companies give full disclosure about what they are selling? How closely regulated are these “ancient remedies”? Consumers want to be confident that the natural products they take have been proven trustworthy.


Tanja Kunz, education coordinator at the American Botanical Council, notes that “Careful attention must be paid at all levels of production. This includes the planting, harvesting, and identification of the plants, as well as extraction and manufacturing.”


Amber Bailey of Lyman, a regular user of dietary supplements such as vitamins, used to take more herbal remedies before her doctor placed her on pharmaceutical medications and warned her of possible interference complications if she continued to take herbs as well. Now, she says, “I am concerned about testing and research for herbs.”


Isrealsen points out, for those who need such reassurances, the Food and Drug Administration (FDA) does regulate dietary supplements to a degree. However, they are not regulated as tightly as prescription drugs, because dietary supplements are considered a subset of foods. Prescription and over-the-counter drugs are subjected to intense scrutiny and painstaking scientific testing by that vigilant government watchdog before you can buy them. Yet Israelsen believes self-regulation is the best course for the natural products industry, especially since “the government cannot regulate everyone all the time.”


Detractors, on the other hand, argue that the FDA should be able to regulate these products before they hit the stores—not only after the fact, and only if they show some signs of having a detrimental effect on users. Bailey herself would prefer to use herbal remedies, but she is “uncomfortable with the lack of FDA labeling.”


According to the Consumer Healthcare Products Association, the FDA can take action against any dietary supplement product that is found to be unsafe or that makes unsubstantiated claims or unapproved drug claims—hence the reason you see this warning on supplement labels: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” It is a statement that can give some consumers, such as Bailey, pause in using natural products.


A major push for the industry to become more credible in the eyes of many critics—as well as less vulnerable to stricter governmental regulations, proclaim the naysayers—was the 1994 Dietary Supplement Health and Education Act (DSHEA), championed by Utah’s Sen. Orrin Hatch. According to the FDA, “The provisions of DSHEA define dietary supplements and dietary ingredients; establish a new framework for assuring safety; outline guidelines for literature displayed where supplements are sold; provide for use of claims and nutritional support statements; require ingredient and nutrition labeling; and grant the FDA the authority to establish good manufacturing practice (GMP) regulations.”


Israelsen is not a fan of the FDA, particularly with the way it treated the industry before the passing of DSHEA. “The reason [DSHEA] was introduced,” he says, “was because of confusion and the lack of a coherent regulation policy by the FDA. The law itself brought a great deal of order to the dietary supplement industry.” He is also quick to point out that “critics say DSHEA doesn’t protect consumers—but how did the FDA protect consumers before DSHEA?” Perhaps more soberingly, Israelsen says the FDA has done nothing in four years to respond to requests for implementation of good manufacturing practice regulations.


Nathan Jaynes, a master herbalist and student advisor at The School of Natural Healing, a correspondence institute located in Springville that trains and graduates herbalists, says, “a lot of the regulations are very silly—in most cases you are talking about an herb that is no more harmful than strawberries. Why would you regulate strawberries?”


He adds unequivocally, “Whole herbs are safe. Medicinal plants have safeguards put into them from nature. It’s very unlikely that you’d ever come to harm from taking [an herb].” Yet he cautions consumers against assuming that all products with the word “natural” in their title really are completely natural—or that they are necessarily safe. Many manufacturers, Jaynes says, make extracted or standardized forms, which do not come from nature.


Israelsen explains that when companies “create an extract, they boost the naturally occurring amount” of an herb’s innate properties. “But there are limits on how much can be in a capsule and ingested on a daily basis.”


Why would a company produce an extract? Because then the herb acts more like a drug, Jaynes explains. “Herbs take a little more time [to be effective] when they’re in the whole form. In the extracted form, people get a fast and immediate reaction, just like a drug.” Our fast-paced society sometimes lacks the patience to wait for the slower-acting results of using a whole herb. Jaynes believes it is “wrong for any [dietary supplement] company to manufacture and distribute drugs.” He recommends that companies who make strong extracts, with the resulting drug-like properties, put a warning about possible adverse effects on the labels.


One example of the possible dangers of using extracts can be found in the American obsession with losing weight. Using an herbal supplement for speedy results is a hugely popular choice. Ephedra has long been touted for its effective use in weight loss and energy enhancement. (It should be noted that the Mormon tea variety of ephedra has no such properties). The natural plant ma huang, which contains ephedra and is often used for conditions such as asthma or hay fever, has been used as a whole herb for centuries, says Jaynes. “It has a safe track record.”


But when humans start processing herbs to extract the essential properties, such as ephedrine alkaloids, the “inherent safety buffers” are left out. Ephedrine alkaloids can elevate heart rate and produce an effect similar to speed—in fact, ephedrine is used to make the narcotic crystal methamphetamine. “It becomes less safe—the more you process, the less safe and natural it is,” says Jaynes. “You want the wholest form [of the herb] possible.”


E’OLA International, a St. George dietary supplement manufacturing company, once marketed a popular product called AMP Pro II Drops. Hyped to stimulate weight loss and increase energy, the drops contained ephedrine alkaloids. Last year, The Washington Post reported that an Alaskan woman who had used AMP Pro II Drops to help control her weight off and on over the course of three years had a stroke that left her debilitated in 1995. Her lawyers said the drops made by the St. George company adversely affected her health. More to the point, they alleged that E’OLA knew potential health problems could arise from taking their product because the company had “spiked” their product—that is, they added a synthetic compound to the dietary supplement. E’OLA International was ordered by an Alaskan court to pay the woman a staggering $13.3 million in damages in early 2001.


Israelsen says that spiking is not allowed by the Utah Natural Products Alliance. “If all the information about it is correct, something was very wrong in E’OLA’s manufacturing process,” he asserts. “If someone does that, they are thrown out of any organizations in our industry they may belong to.”


Last October, the FDA seized some 140,000 bottles of the ephedrine-containing supplements, estimated at $2.8 million, from E’OLA and its Pleasant Grove-based contract manufacturer, Nature’s Energy, Inc. E’OLA has since replaced AMP Pro II Drops with a new weight-loss product called ThermoAmp. Advertisements for the new product on the E’OLA website are accompanied by the following warning: “ThermoAmp has ephedrine groups alkaloids in the form of herbal extracts and may cause serious adverse health effects. Read the label and follow directions.”


But even if a certain activity is prohibited, it doesn’t mean everyone will always abide by the rules—especially if they can achieve greater profits, Israelsen says. “Speed limits are out there, but people break them all the time.”


As a consumer, Amber Bailey is less circumspect. “Certain herbs I do think have been ‘tweaked’ by the system—definitely. The little packets of ‘herbs/vitamins’ that you can buy at the checkout counter of a [convenience store], especially—speed, speed, speed.” Judging by the amount of controversy and ongoing uncertainty that swirls around this industry, it is safe to venture that many agree with her.


To add insult to injury, recent recalls of contaminated natural products have received widespread media attention. In February, the FDA announced that two popular herbal products, PC SPES, sold as a treatment for prostate cancer; and SPES, advertised as a general immune system enhancer, contained prescription drugs. Coumadin, a blood-thinner; and Xanax, an anti-anxiety medication were found, according to the agency. The manufacturer, California-based BotanicLab, voluntarily recalled those products.


Despite all the bad press, Israelsen stoutly avows that the majority of companies are “working hard to do it right. About 5 percent are there for the wrong reasons. That’s a problem—no one wants them out of our industry more than we do, because they give us a bad name.”


Consumers may have to shoulder at least part of the responsibility for their own safety. Practitioners of Aryurveda, a Hindu form of medicine, follow a sensible herbal motto: “Proper herb, proper dose, at the proper time.”


The following story should be taken as a cautionary note:


In 1996, a Salt Lake County man of Polynesian descent, was pulled over for erratic driving. To the officers’ surprise, he tested clean for alcohol or drugs. The man then admitted to having drunk somewhere in the vicinity of 16 cups of herbal kava tea. For Polynesians, kava (which is reputed to soothe the central nervous system) is the drink of choice for both religious and cultural reasons. This particular fellow can now boast the very first kava DUI arrest in the nation.


Is the idea of taking someone into custody for being under the influence of a natural supplement—something that can easily, and legally, be bought at any health food store or online—ludicrous? Perhaps. But consider this: In September 1997, the American Herbal Products Association recommended the following label warning for kava: “Caution: Not for use by persons under the age of 18. If pregnant, nursing, or taking a prescription drug, consult a healthcare practitioner prior to use. Do not exceed the recommended dosage. Excessive consumption may impair ability to drive or operate heavy equipment.”


Bailey agrees that while a warning on the label is appropriate if there are possible harmful repercussions from ingesting a natural product, ultimately it’s up to the consumer to follow directions properly. “If the warnings were there and the recommended dosage was there—well, if you take too much, you’re just asking for it,” she says with a shrug.


Last November, however, German scientists reported that kava may be the culprit in 30 cases of liver toxicity in Germany and Switzerland. European nations reacted swiftly to the news: Switzerland yanked kava from the shelves. Britain requested citizens to voluntarily relinquish the herb. Germany warned manufacturers that it may soon ban kava. In January, France banned outright the sale of this herbal remedy. On March 27, the FDA announced that kava may cause liver damage. With that news, Provo-based NuSkin Enterprises immediately pulled its kava products from the market.


In February, the Dietary Supplement Industry Coalition (of which the Utah Natural Products Alliance is a member) and the National Nutritional Foods Association joined forces and put out a study that declared kava safe, adamantly stating that the herb is not a risk factor for liver-related problems.


Kava still ranks ninth in national sales among herbal supplements, Jaynes says. “Kava has been clinically proven more successful than its pharmaceutical counterparts in its anti-anxiety effectiveness. It has virtually no side effects—certainly very few compared to [prescription anti-anxiety medications].” He also notes that there should be no cause for alarm in women using it while pregnant and nursing: “I put my pregnant wife on kava and there’s no problem.”


One often-mentioned medical worry is that the general public is foolishly self-medicating with these prescription-free supplements. “I am concerned,” says Bailey, “that people can ‘diagnose’ themselves with herbs, through reading and [through] the ease of looking up an ‘ailment’ and having a list of herbs and remedies to take.”


However, Jaynes says there isn’t really a problem with consumers self-medicating, because herbs are “virtually side effect-free” as opposed to side effect-laden pharmaceutical drugs. He points a finger at the medical establishment for creating some of the public confusion and occasional distrust of herbal remedies. “Doctors think that we’re [herbalists] going through just six months of training, and they’re horrified,” he says.


The School of Natural Healing, he notes, has a three-year training program. It also has held clinics in Utah health food stores to educate store personnel about the properties of the dietary supplements they sell. Jaynes is careful to note that neither they nor he may diagnose or prescribe—those jobs fall to certified physicians. If there is a serious medical concern, you should definitely “consult a healthcare practitioner,” he adds.


Israelsen agrees that many doctors and others in the medical profession are having a difficult time adjusting to the possibility that dietary supplements may actually be effective and safe. Their viewpoint, he thinks, is, “If I don’t know it, it’s not worth knowing—and if I didn’t learn it in medical school, it’s not worth knowing. They were caught off guard by the popularity of dietary supplements.” Bailey believes that doctors “should be more educated” about herbal remedies, adding that she would take chemical-free supplements if they were recommended by her physician.


Choosing which brand of supplements is safe to take can be a daunting task—and eventually, a personal choice. Bailey often chose “some by word of mouth, [from] friends and such.” She picked other brands “just from reading and advertisements.” Israelsen himself says he still has a hard time deciding which ones are the safest and most effective. He does, however, have some tips to ease any worries or confusion. If you see a certifying label from the U.S. Pharmacopoeia, the National Formulary, or the National Standards Foundation (NSF) on a dietary supplement product, rest your fears. There are “many highly-respected [dietary supplement] companies out of Utah,” Israelsen adds. “The level of vigilance has grown enormously.”


To sum it all up, Bailey is perhaps the most succinct yet eloquent: “Everybody has to be responsible for their part of it. You should consume [dietary supplements] responsibly, and the manufacturers should sell them responsibly.” Mother Nature would, no doubt, be pleased with such a simple remedy.

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