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Articles from 2003 In January


Delicious Living

February 1, 2003

New Monograph To Raise Quality Standards For Omega-3s

United Kingdom

The Council for Responsible Nutrition (CRN) has just raised the bar for manufacturing quality long-chain omega-3 EPA and DHA fatty acids.

After a year's work, CRN's Working Group has developed a voluntary monograph for long-chain omega-3 EPA and DHA fatty acids that identifies desirable limits for measures of oxidation in the polyunsaturated oils that are susceptible to degradation because of the unsaturated bonds characteristic of EPA and DHA.

"This monograph includes standards for safety, efficacy and quality, as well as analytical methods for testing products," says Robert Orr, president of Nova Scotia-based Ocean Nutrition, who spearheaded the Working Group along with Roche and Pronova and won support of 26 member companies producing and marketing EPA and DHA. "This effort is intended to raise confidence within the industry and among consumers in long-chain omega-3s because this is a category that is about to explode."

The timing of the monograph is excellent because the American Heart Association has just begun urging people to consume omega-3s for heart protection.

Last year, FDA authorised a qualified health claim for EPA and DHA for reducing the risk of coronary heart disease. Salmon and other fatty fish containing omega-3 fatty acids may be first in line to benefit from FDA's recent announcement that it is relaxing the requirements for health claims on foods.

While long-chain EPA and DHA is the subject of some 5000 clinical studies linking these nutrients to heart health, Unilever announced in December it will begin adding short-chain omega-3 flaxseed-derived alpha-linolenic acid to its entire range of Flora polyunsaturated spreads. To date, only epidemiological studies on the Mediterranean diet support the health benefits of these short-chain vegetable-based oils.

Embattled ephedra status uncertain

The FDA is under increasing pressure from consumers, politicians and doctors to ban ephedra from the market while some manufacturers are already voluntarily withdrawing the ingredient. American Medical Association Trustee Ron Davis, MD, told Congress last October: "The risk/benefit ratio for these products is unacceptable."

New York-based Twinlab Corp is voluntarily pulling out of the market, citing escalating insurance costs and regulatory uncertainty as principal reasons. It was recently granted a US patent for an ephedra-free weight-loss formulation.

In Suffolk County, New York, in late December, legislators considering an outright ban on sales of ephedra instead passed a resolution preventing retailers from selling the weight-loss supplement to anyone under the age of 18.

General Nutrition Centers has stopped selling ephedra products to minors. GNC, a division of Dutch company Royal Numico NV, will comply with the decision even though it is not legally required to do this in most US states. One exception is California, where ephedra and other 'steroid hormone precursors' can be purchased only by those over the age of 18.

The Washington, DC-based Council for Responsible Nutrition has also come out against ephedra, giving it a 'red light' in its 'Guidelines for Young Athletes.'

Last year San Diego-based Metabolife International was ordered to pay $4.1 million to four people who sued the company over claims they suffered heart attacks or strokes after taking Metabolife 356, a weight-loss product that contains ephedra. Metabolife, facing additional personal injury lawsuits in other jurisdictions, is appealing the decision on the grounds the plaintiffs did not use the product as directed.

FDA makes a U-turn on food health claims

In an unexpected move, the US Food and Drug Administration (FDA) has announced a major initiative that puts foods on the same footing as dietary supplements as they relate to health claims. The decision is an abrupt departure from the agency's long-held position that no nutrient-disease claims should be allowed for foods or dietary supplements unless proven to a near-conclusive degree.

Jonathan W Emord, principal of Emord & Associates, the Washington, DC, law firm that has repeatedly and successfully sued the agency for just such a move, welcomed the initiative: "As never before, companies will be able to inform consumers of the disease risk-reducing and preventive-disease effects of certain foods and dietary supplements."

FDA Commissioner Mark McClellan, MD, said the move, known as the Consumer Health Information Initiative, would provide American consumers with more and better label information about their foods. It is an acknowledgement that, as a result of better science and innovation, foods can be used to achieve health benefits beyond basic nutrition. The agency will now change its previous position which stated that nutrients must demonstrate 'significant scientific agreement' to a looser 'weight of the scientific evidence' standard.

The move stems from the 1999 Pearson vs Shalala lawsuit, which enabled supplements manufacturers to make 'qualified health claims' (meaning no consensus was achieved but a lot of scientific research supported a particular nutrient's effect on health) that are not as airtight as 'significant scientific agreement.' Since conventional and functional foods were not a part of the case, FDA has until now refused to allow those manufacturers the same rights as supplements producers.

"Our foods have long since moved beyond meeting only the basic dietary needs of Amer-ican consumers. The FDA's action has opened the door for food companies to improve labelling statements and health claims that are important to consumer choice," said Alison Kretser, Director of Scientific and Regulatory Policy for Grocery Manufacturers of America. "This decision will now allow food manufacturers to inform consumers about the health benefits of their foods and to develop new products to meet consumer demand."

Incoming president of the Washington, DC-based Council for Responsible Nutrition, Annette Dickinson, PhD, also applauded the move, saying it's a "logical position that qualified health claims should be available for all categories of food because they all provide beneficial nutrients that promote good health and help protect against disease."

As part of the announcement, McClellan also said the agency will "aggressively" crack down on supplements companies that make fraudulent health claims.

McClellan also announced the formation of the Task Force on Consumer Health Information for Better Nutrition, with a June deadline to create a framework to facilitate consumer access to scientifically based information on foods and supplements.

More information is available at www.fda.gov/oc/nutritioninitiative/whitepaper.html

EFSA expected to streamline approvals

The European Union's newly established food safety evaluation body, the European Food Safety Authority (EFSA), has replaced the Scientific Committee on Foods (SCF) and is now responsible for providing "independent scientific advice on all matters with a direct or indirect impact on food safety" within the EU.

The new body differs from the SCF in that it has a full-time staff of food scientists to deal with all food-related matters including the assessment of dossiers pertaining to the EU's Food Supplements Directive.

Industry analysts expect this change to dramatically streamline the assessment process while adding authority to the final opinions.

The SCF had recourse only to scientific volunteers and its turnaround time for assessing such matters was notoriously slow. "There will be a greater chance for industry to be consulted by those evaluating their dossiers," one industry observer noted.

Unlike the SCF, EFSA is independent of the European Commission and consists of eight independent Scientific Panels overseen by a Scientific Committee to ensure consistency among the Panel's differing fields of operation.

One of these Panels—the Panel on food additives, flavourings, processing aids and materials in contact with food—will handle food supplements issues.

EFSA is temporarily based in Brussels while it awaits its permanent location to be determined—most likely Parma in Italy or Helsinki in Finland. The former chief executive of the UK's Food Standards Agency, Geoffrey Podger, has been appointed executive director.

Nutrition industry under fire from tough taskmaster

Marion Nestle, PhD, a professor of nutrition and food studies at New York University, has a big problem with the food industry. And she doesn't think much of functional foods or dietary supplements, either. Nestle is the author of Food Politics: How the Food Industry Influences Nutrition and Health (University of California Press, 2002). Her premise is that industry's fundamental goal is to make money by influencing consumers to eat more, and this has greatly contributed to a growing obesity crisis in the Western world, with staggering implications to public health.

Nestle's book has been called a timely analysis of the origins of this epidemic and the many influences on the American diet. Her background has positioned her well for this analysis. She is a former staff member of the US Surgeon General's Office, she served on the dietary guidelines committees and the advisory committees to the US FDA and is a food consultant. While Nestle's viewpoint is certainly unpopular and even infuriating to many in the industry, there is no disputing the public health impact of the obesity crisis and the value of her insider perspective on ways in which industry influences Congress, federal agencies and public health policy.

Her keynote address at Nutracon 2003 represents a first step toward dialogue between industry and public policy-makers to find a new system in which products are developed based on sound health data rather than well-intentioned theories or raw profit motives.

Here she talks to New Hope Natural Media's Karen Raterman about her contentious views on health claims, DSHEA, functional foods and the role of the FDA.

FF&N: In reading the section in your book about dietary supplements, it is pretty safe to say that you don't think much of DSHEA. If this is not the right regulatory framework, then how do we develop one that balances the risks vs. benefits to make products widely available yet safe and efficacious?

MARION NESTLE: You're talking about products in diets that are very complex. I just think of them as products, not as medicines. I think you can eat a perfectly healthy diet with real food. Do I think that people ought to be putting wood pulp into margarine—No. Should people be putting vitamins into Sugar Frosted Flakes—No. Vegetable extract into gummy bears—No.

As for herbal remedies—as far as I can tell, the more rigorously they are studied, the less they show. That is one of the difficulties. Take the anecdotal stuff—do people feel better if they take herbs? Absolutely. Does the science show it? It depends on how well it is done, and the better it's done the less I think it shows—and that's a problem.

FF&N: As you say, we are talking about very complex botanicals. And perhaps trying to fit traditional medicines into a Western allopathic paradigm of the double-blind, placebo-controlled study is like trying to fit a square peg into a round hole. But if we are talking about herbs not as food, but as medicines, if it is not DSHEA, is there a standard that would be appropriate?

MN: I don't know. I go into health food stores and look at what's there, and I am pretty astounded at what people put in their bodies. But I guess I am in favour of honesty in labelling and appropriate health claims. If it were up to me I would not permit health claims in foods and probably not on supplements either. But Congress in its wisdom has decided otherwise. Obviously in the next two years, the administration won't be looking at DSHEA. I think the only thing that would make Congress take another look at DSHEA is a disaster. And I think there is a disaster waiting out there.

FF&N: But we certainly have seen our share of food recalls recently, so one could argue that the food safety standards are not all that rigorous. With drugs, the standards are much more rigorous but there are thousands of deaths every year from both food and drugs. So why is it that there is so much concern about dietary supplements?

MN: I suspect that if the death certificates were filled out correctly, food and drugs would be right up there on the top-ten list of causes of death. This is one of the arguments that is routinely used in defence of supplements. The problem is the claims that are made for them. If they are just available and people want to take them—fine. Sixty per cent of the adult population in the US takes supplements, and those who do feel that they help them. And you could argue that it doesn't matter if it is a placebo. If it helps people, it's a good thing. And if they don't substitute them for something that they really need. And most supplements manufacturers aren't putting poisons in them, so for the most part it is a system that works. I get concerned when inappropriate and misleading claims are made for them.

FF&N: You say that the FDA needs to be strong. But since the passage of DSHEA, how many years did it take for FDA to establish good manufacturing practices for dietary supplements. Aren't they interested in supplements?

MN: The FDA is just a totally crippled agency. Congress is furious with it and doesn't give it any money. It's partly a resource issue and partly a personnel issue. They don't have the resources or the political will—because it is an agency under siege all the time. They have an enormous and ridiculous mandate that no agency could be expected to fill. The gap between what they are supposed to do and what they have the resources to do is so enormous that it's laughable. It is tough to try to regulate and do things right when you're being taken to court and losing all the time. And the companies that are taking FDA to court are being encouraged to do so.

The fact that FDA is so weak is not good for industry. Certainly the FDA's role in adhering to science-based standards in the way they did, was totally inflammatory to the industry and its supporters. And there might have been more creative ways to deal with it, but they didn't do that, so they bear some responsibility as well. But then that result is not good for the American public in the long run.

FF&N: What are your thoughts on functional foods?

MN: I don't think they are necessary or desirable. Food is food, and we have plenty of food. It is perfectly possible to eat a great diet with food that already exists. I see them as a marketing tool developed specifically to market foods that will fit into health claims. I don't believe in health claims—if it were up to me we wouldn't have health claims on food. I take a very extreme position on this.

FF&N: What would be your ideal regulatory system for foods?

MN: Decent labelling that discloses what's in them and no health claims.

FF&N: What do you see as the problem with health claims?

MN: They are totally misleading. There is no way to have a health claim that isn't misleading because the claim suggests that if you eat this product, you're going to solve that disease problem. Wouldn't it be wonderful if it were true? But it can't possibly be true. Eating Cheerios isn't going to prevent a heart attack. Now I'm not picking on Cheerios—I like Cheerios—but it's not going to prevent heart attacks. Then there's the label that shows up on the Heinz ketchup brand with the illegal claim for lycopene and prostate and cervical cancer. You put ketchup on your potatoes and you're protected against cervical cancer—I don't think so.

FF&N: But there is some good science behind lycopene. Don't you think the ingredient itself may serve a purpose in preventing, say, prostate cancer?

MN: No, I think vegetables and vegetable-based diets do. If you take it disease by disease and component by component, plants have hundreds of components that may induce or prevent carcinogenesis, but these systems are really complex and I don't think you can single one out. But if you look at the enzyme systems that metabolise carcinogens, you have no way of knowing whether a single factor is going to stimulate something that is going to make something more or less toxic because the systems are so complicated. So is lycopene a good thing? Probably, but so what? So is soforophane, so are all these others. That doesn't mean that you take them one by one or look at them disease by disease.

It seems to me that the really profound concept about nutrition is that the same kind of diet is protective against many diseases and diets too high in calories derange metabolism in a way that leads to a whole variety of diseases. So there is a unifying way of looking at this that just doesn't work if you take it nutrient by nutrient or factor by factor.

Marion Nestle, PhD, is the keynote speaker at Nutracon 2003 on Thursday, March 6, at 8:30 am at the Anaheim Convention Center, Anaheim, California. More information: www.nutraconference.com

UK Bans Kava Kava

United Kingdom

After a year of deliberations, the UK-based Medicines Control Agency (MCA) has joined a growing list of authorities to ban the herbal relaxant, kava kava.

The ban, which came into effect in January, followed a public consultation period after which the Committee on Safety of Medicines (CSM) and the Medicines Commission found strong evidence linking kava kava with rare cases of liver toxicity. The MCA noted 70 reports of adverse liver reactions in various parts of the world, including four within the UK.

Other countries to have banned kava kava include Germany (where it is available by prescription only), Canada, Singapore (where it is classified as a poison), Australia and France. The FDA is investigating the herb in the US, where a voluntary ban is in place.

The MCA stated: "Investigations have been unable to identify factors that would predict which individuals are at risk of adverse reactions to kava kava and the mechanism of liver toxicity related to kava kava remains unknown." It added that it was not "reassured that the risk of liver toxicity could be reduced by measures such as label warnings."

Professor Alasdair Breckenridge, Chairman of the CSM, hinted the ban would not necessarily be final. "A prohibition on safety grounds can be reviewed at any time if new evidence emerges," he said, adding, "The MCA will undertake a specific review in two years time to assess whether this ban remains justified." Maurice Hanssen, director of the UK-based Council for Responsible Nutrition, said it was a disappointing decision. "We'll try and get kava back on the list when the Traditional Herbal Products Medicines Directive comes into play in the next year or two," he said.

Straight Talk

Straight Talk
The safety and efficacy of kava, ephedra, and St. John's wort have recently come under dispute. Do these popular herbs deserve the bad rap they get?

By Gargi Talukder, PhD

Seems like every time you pick up a newspaper or a magazine, you see another report on the dangers of using certain herbs. "Popular Herb May Severely Harm Liver" was a 2002 headline in the San Francisco Chronicle, referring to kava. "St. John's Wort Ineffective," wrote editors at the Washington Post in 2001. "Side Effects Raise Flag on Dangers of Ephedra" was the banner in the New York Times. Recent media attention has focused on research projects that highlight the dangerous side effects or ineffectiveness of these herbal supplements. But many researchers and medical professionals still believe these herbs, when used correctly, produce benefits with little risk of harm. We've taken a closer look at kava, ephedra, and St. John's wort to help you sort through the confusion and make the best choices about whether to use them.

Kava (Piper methysticum)
The claim: Kava causes extensive liver damage.
The truth: Kava has been shown to cause extensive liver damage only when taken in quantities much larger than the recommended amount.

In March 2002, the Food and Drug Administration (FDA) issued a consumer advisory warning that kava, an herb used by many to relieve stress, anxiety, sleeplessness, and menopausal symptoms, can cause severe liver injury, including hepatitis, cirrhosis, and liver failure. The advisory stated: "Although liver damage appears to be rare, the FDA believes consumers should be informed of this potential risk." Such a pronouncement from an agency that safeguards the public's welfare was understandably received with concern. Most of the newspaper and magazine articles that soon appeared simply reiterated the warning, leaving out background information on what spurred the FDA's advisory in the first place.

For example, buried in the news coverage of the kava advisory—if mentioned at all—was the fact that the number of reported cases of liver damage possibly due to kava was low. And of the 25 cases reported by people taking kava in Europe, many involved people who had liver damage prior to using kava or who used alcohol, a substance known to harm the liver. "These were a very small group of reports, and there was very little evidence that there was a direct link between liver toxicity and kava," says Phil Harvey, PhD, chief science officer with the National Nutritional Foods Association (NNFA). "Many of the individuals were taking other medications at the same time, and these other medications may have actually been the cause of the liver toxicity."

The first reaction should not be to ban kava but to study it and really understand what's going on with the way the body processes it. Subsequently, the sale of kava has been restricted or banned in several European countries, and the FDA is now in the process of examining some 38 cases of possible kava-related liver damage in the United States, though the number changes weekly. Among the U.S. reports filed are one about a woman who took up to 15 kava pills daily (well above the product's recommended dosage) in addition to prescription medications and one about a 13-year-old who deliberately took an overdose of kava.

After the FDA issued its advisory, a number of herbal products trade groups, including the American Herbal Products Association, the National Nutritional Foods Association, and the American Botanical Council, commissioned a University of Illinois researcher to investigate these reports of adverse effects from kava filed in the years 1998 to 2001. The researcher, Donald Waller, PhD, professor of pharmacology and toxicology in the department of pharmaceutics and pharmacodynamics at the University of Illinois at Chicago's College of Pharmacy, found "no clear evidence that the liver damage reported in the U.S. and Europe was caused by the consumption of kava." Many of the reports involved people who were taking large amounts of the herb (the American Herbal Products Association recommends doses not exceeding 300 mg of total kavalactones or kavapyrones, the active compound in kava, per day) or who were taking other medications or supplements, or were consuming alcohol.

One month after Waller submitted his report to the FDA, the agency responded with another consumer advisory that essentially repeated Waller's findings, concluding with a message that the FDA would further investigate kava's risks. "The agency will alert consumers, and if warranted, take additional action as more information becomes available" was the FDA's official announcement. Thus far, the FDA has issued no further warnings on the potential harms posed by this herb.

More information:
Here are some Web sites to visit for more details on the safety of herbal remedies.

The Food and Drug Administration (FDA) site for dietary supplements
www.cfsan.fda.gov/~dms/ds-faq.html

American Herbal Products Association
www.ahpa.org

National Nutritional Foods Association
www.nnfa.org

American Botanical Council
www.herbalgram.org

Council for Responsible Nutrition
www.crnusa.org

Ephedra Education Council
www.ephedrafacts.com

The main concern regarding kava appears to be the danger of taking too much, which, as with any other drug, can be harmful. Research trials that have found no adverse effects of kava generally prescribe 120 mg of kavapyrones per day. Batavia, Illinois-based chiropractor Mathew Hajzl, DC, publisher of a newsletter on natural remedies and who uses both traditional and pharmaceutical remedies to relieve muscular and skeletal pain in his patients, has found the 120-mg dose to be beneficial and has not seen any liver toxicity in his patients. Hajzl also says up to 500 mg per day should be fine when carefully monitored by a physician. "It's still hard to make a statement about kava and its potential harms," Hajzl says, "because its actions are complicated, and each person is going to respond to it a little differently. But this is true of all drugs." That's why Hajzl says it's crucial to talk with your doctor before starting any herbal regimen and tell him or her about any other supplements or prescriptions you are taking. You also need to stick to recommended doses. "I know not everyone wants to do this," he says, "but it really is the best way to know that you are being as safe as possible."

Many experts applaud the FDA's actions so far. "I think the FDA is doing the right thing by warning consumers about the drug," says Chun-Su Yuan, MD, of the University of Chicago, an anesthesiologist who has studied the sleep-inducing effects of valerian on humans and of kava on animals. "They haven't jerked the products off the shelf yet; they are waiting for detailed reports. The FDA wants to be careful, and they are waiting for some real evidence before they make a strong move for or against it."

Harvey echoes this sentiment, adding, "It is possible that individuals taking certain medications should not take kava, but that doesn't mean kava is a bad supplement. The first reaction should not be to ban it, but to study it and really understand what's going on with the way the body processes it."

The bottom line? If you have liver problems or take medications that affect your liver, or if you drink alcohol regularly, speak with a doctor before taking kava. The American Botanical Council, a nonprofit education and research organization, also recommends that people avoid taking kava on a daily basis for more than four weeks in a row. And as with any herb, follow the recommended dosages.

Ephedra (Ephedra sinica)
The claim: Ephedra is a dangerous weight-loss herb that causes high blood pressure, stroke, and heart attack.
The truth When taken in recommended doses, ephedra is considered to be safe.

The market is flooded with ephedra products, stemming in large part from the herb's much-touted reputation as a weight loss wonder drug. But on Oct. 8, 2002, the American Medical Association (AMA) offered testimony on ephedra's dangerous effects to Congress, urging legislators to remove dietary supplements containing ephedra from supermarket shelves. The AMA's request came after several high-publicity ephedra-related deaths, among them the deaths of three college and pro football players in 2001, including Minnesota Vikings tackle Korey Stringer. Although investigators found no evidence of stimulants in Stringer's body, an empty bottle of an ephedra-based product was found in his locker, leading many to point to ephedra as the cause of his death. Following these incidents, ephedra was banned from the Olympics, the NFL, and college sports. After so many sports organizations have taken action—and so many health incidents have been tied to this energy-boosting herb—the AMA's urge to ban ephedra seems more than warranted by some, but to others it seems a reactionary move based on few facts.

Politicians and the media are relentless in trying to find the negative in ephedra. To understand the argument, it helps to know how ephedra works as a weight loss drug. One effect of ephedra is its thermogenicity, or ability to produce heat. This changes the body's metabolism, speeding the way fuel is used, which can result in weight loss. In an attempt to take advantage of ephedra's promotion of weight loss, some people have taken large quantities based on a more-is-better philosophy (the industry-recommended dose is no more than 25 mg ephedrine alkaloids per serving and no more than 100 mg total per day). Large amounts of ephedra may lead to serious consequences, such as high blood pressure, stroke, or heart attack, because ephedra influences the nervous system and the way the heartbeat is regulated (Mayo Clinic Proceedings, 2002, vol. 77, no. 1; New England Journal of Medicine, 2000, vol. 343, no. 25).

However, research shows that ephedra is safe when used in recommended doses. Douglas S. Kalman, MS, RD, FACN, a researcher at the clinical research organization Miami Research Associates who has published numerous studies on ephedra-based products' effects on weight loss, has found that small doses of ephedra taken once daily (20 mg ephedra combined with 200 mg caffeine) are effective for weight loss and have no apparent negative effects. "However," Kalman cautions, "we were very careful about the patients we allowed in our clinical trial. For example, before the study even began, we excluded anyone with heart disease or unstable hypertension. People who are not in optimal cardiovascular health should be very careful about using ephedra." Also, the doses of ephedra used in Kalman's trial involved one-third the amount of the herb used in most ephedra-based diet aids.

Harvey, chief science officer of the NNFA, finds Congress' consideration of an outright ban on ephedra too drastic. "Politicians and the media are relentless in trying to find the negative [in ephedra], but we should keep in mind that ephedra has been used in Traditional Chinese Medicine for 5,000 years."

More problematic some experts believe, is the herb's misuse by drug users, who aren't necessarily looking at the weight loss benefits. "What we and most other associations are really pushing for with Congress and the FDA is to actively work against the use of ephedrine [a substance derived from the plant ephedra] as a so-called street-drug alternative," says Kim Smith, the NNFA's director of legislative affairs. "This is when the potential for abuse comes in because people are taking large quantities in order to get a high that is similar to that of street drugs."

The secret to using ephedra safely as a weight loss drug is to stick to the proper doses. "Ephedra is effective in weight loss," says Harvey, "and our organization, along with others, such as the America Herbal Products Association, have put out pamphlets and educational statements urging people to stick to the recommended doses. Most ephedra products have significantly detailed warning labels, and anyone who is considering taking this supplement should take those labels seriously and see their doctor or health care professional if they have any questions."

No matter what, if you're thinking of taking ephedra as a weight loss drug, first speak with your doctor. Note that the U.S. Department of Health and Human Services (HHS) issued a report in June 2002 that cautioned pregnant or nursing women to avoid all ephedra products. HHS also suggests that only adults over the age of 18 use these products and that anyone with a history of high blood pressure, heart or thyroid disease, depression, diabetes, or prostate enlargement or using any prescription medication should consult a health professional before using ephedra. HHS also recommends that ephedra use be discontinued if any of the following symptoms develop: rapid or irregular heartbeat, chest pain, severe headache, shortness of breath, dizziness, loss of consciousness, sleeplessness, or nausea.

Finally, some companies market "natural" weight loss products that actually contain synthetic ephedrine—that is, ephedrine not derived from a plant—and these should be avoided, according to HHS. Although this mislabeling is illegal and HHS is actively pursuing manufacturers that use such marketing practices, it is still a good idea to read the label of an ephedra product and make sure that the ingredients come from either "whole plant" or "botanical" extracts.

St. John's wort (Hypericum perforatum)
The claim: St. John's wort has no effect on depression.
The truth: St. John's wort is beneficial in treating mild to moderate depression, but has been shown to be ineffective in treating severe depression.

The controversy surrounding St. John's wort, commonly used nowadays as a natural treatment for mild to moderate depression, involves several research studies that many in the media have presented as proof that the herb doesn't improve symptoms of depression. In 2001, an article in the Journal of the American Medical Association (JAMA) reported the results from studies done at 11 academic medical centers in the United States showing St. John's wort was ineffective against major depression (2001, vol. 285, no. 15). But many in the media misinterpreted the details of this study. For one, herbalists and alternative health care practitioners recommend St. John's wort as a treatment for mild or moderate depression, not major depression; however, many articles didn't explain this distinction. Some 30 studies have in fact shown St. John's wort to be effective in treating less severe depression. Research suggests that the herb is at least as effective in treating mild to moderate depression as prescription medications are (Clinical Therapeutics, 2000, vol. 22, no. 4).

The study reported in JAMA also found the pharmaceutical sertraline (Zoloft) to be only slightly more effective than a placebo in easing the depression of patients in the study. Yet this wasn't nearly as widely reported as St. John's wort's supposed ineffectiveness. (It should be noted that the multicenter study was supported in part by a grant from Pfizer, manufacturer of both Zoloft and St. John's wort extract.)

In another study, St. John's wort stood up well in a head-to-head comparison with sertraline. Researchers in Montreal compared the effects of this prescription medication to St. John's wort in patients suffering from major depression and found that sertraline was not significantly better at treating major depression than the herb. In fact, the researchers concluded that St. John's wort is a better first-step treatment choice because it produced fewer side effects than did the sertraline (Canadian Family Physician, 2002, vol. 48).

Although St. John's wort appears to be an effective treatment for mild to moderate depression, it's still important to observe some precautions. "As far as I know, there's not much toxicity associated with this drug, but people need to be aware that St. John's wort is just that—a drug," says Joel E. Gallant, MD, MPH, of Johns Hopkins University School of Medicine, who has written on the interactions of St. John's wort with other drugs. "It can interact with other kinds of medications, so if someone is thinking about incorporating it into their diet, they really need to make sure that it won't react badly with something else that they are taking." For example, some studies have shown that St. John's wort can hinder HIV medications and chemotherapy, so people undergoing those treatments should seek a doctor's advice before using this supplement (Phytomedicine, 2001, vol. 8, no. 2; Biochemical Pharmacology, 2001, vol. 62, no. 8).

Overall, if you're looking to ease symptoms of mild to moderate depression—meaning you have low moods from time to time—St. John's wort appears to be effective and safe. More severe depression warrants medical treatment from a health care practitioner. It's also important to note that St. John's wort can decrease blood levels of certain prescription drugs, including blood thinners, oral contraceptives, and antivirals. So, as always, be sure to consult with your health care practitioner and follow the recommended doses when you use this herbal supplement.

Gargi Talukder, PhD, a science writer and first-year law student at the University of Chicago, has become a fan of tofu since starting her research for this article. She has now gained a reputation among her friends as a "tofu junky."




Industry Event Value: Focus on Nutracon

With numerous event and business opportunities to consider over the course of the year, companies are more discerning than ever in determining level of event participation. And they need to be, as the number of events multiplies and sector and interest overlap increases (food, beverage, supplements, organics, business, brand and marketing strategy, regulatory, health and nutrition and more).

Over recent weeks the level of interest in New Hope's Nutracon event has risen. The more sceptical of our viewers have watched it change dramatically in recent years in timing, location and attendance, in some cases having difficulty finding a compelling reason to add it to their list of 'must do' events. (Nutracon, running this year from March 6th to 8th, attempts to build a unique bridge between industry business and science issues.)

We asked Rob Lutz, Director of Business Development and Nutracon Show Director about this year's program and the changes and value the show promises. Lutz noted two significant changes, "the addition of SupplyExpo, a four day health ingredient sourcing tradeshow which allows our attendees, without having to travel to another event, to source the ingredients they need to develop their next new product", and added, "the co-location with ExpoWest creates new synergies and networking opportunities for all sides of the industry value chain."

Planning event attendance means understanding the value proposition of the event itself. While it is worthwhile to meet existing and potential clients in a tradeshow environment and the associated networking opportunities, it's usually apparent that show participants have a range of objectives and getting on the same page can be difficult. Lutz notes,

"Nutracon has always delivered: Strategic planning advice for brand managers. Industry intelligence for CEOs, Presidents and VPs. Market trends for research analysts. Cutting-edge science for research teams. Revolutionary ingredients for product developers. This is the information our attendees have relied on to guide product development teams. The combination of accurate market analysis and evidence based science - this is Nutracon - making innovation possible."

The GSN News Turns Two

Garden State Nutritionals is proud to be kicking off of the second year of its informative free newsletter, the GSN News. This bi-monthly publication provides commentary on the latest supplement ingredients, important industry topics and innovations and developments at GSN, the industry’s premier custom contract manufacturer.

According to Terry Coyle, GSN’s Director of Corporate Communications, the newsletter has been an unequivocal success. “In the first year of the GSN News we have doubled the subscriber base and created a lot of buzz in the industry. In fact, we regularly receive inquiries from non-subscribers who have obtained pass-around copies of the newsletter through the grapevine.”

You are invited to experience some of the creative ideas, cutting edge science and proprietary technologies that have made GSN the trusted leader in the formulation, development and manufacture of custom dietary supplements. Visit http://www.gardenstatenutritionals.com and click on the Newsletter tab for back issues and to activate your free subscription to the GSN News.

Over the past three decades, Garden State Nutritionals has built a reputation as the leading custom contract manufacturer of specialty nutritional formulas. From tablets and capsules to liquids and effervescents, our customers rely upon us to give their products the flair, effectiveness and differentiation they need to find success in the marketplace.