Shell Game

Some 'miracle' supplements made mostly from the outer shells of shrimp and crabs promise to make you trim, but the claims are largely unfounded

They're called Fat Busters, Fat Trappers, Fat Absorbers and Fat Magnets. They claim effortless weight loss and the chance to shed pounds without sacrificing favorite foods or engaging in activities that might cause you to break a sweat, like exercise.

Not quite good enough? Well some even claim to reduce your risk of cancer, lower your cholesterol, heal your infections and control your blood pressure. And they are "all natural" to boot.

Meet chitin and chitosan, two of the newest darlings of the supplements set and the main ingredients in these fat-busting weight-loss products. They are heavily promoted in television infomercials, magazine and newspaper ads and on dozens of Web sites.

With more than half of the U.S. population overweight or obese, the market for quick weight-loss formulas has never been bigger. These products -- made from the shells of shrimp, crabs and other seafood -- claim to capture part of the fat a person consumes and pass it out of the body before absorption occurs.

They are being gobbled up by consumers. Sales of three leading brands have topped $ 6 million since February 1999, according to Information Resources Inc. of Chicago, which tracks sales and marketing information. In Japan, sales of chitosan dietary supplements total almost $ 1 billion a year, according to Everett Nichols, director of research and development at Vanson Inc. of Redmond, Wash., the leading U.S. chitin and chitosan supplier.

"Americans, not to mention [people in] many other countries, have also been consuming large quantities of chitosan without any known problems arising from such use," notes Nichols in court documents filed in California.

And they've been doing so without much scientific evidence that the products work. The Federal Trade Commission (FTC), which enforces federal consumer protection laws prohibiting unfair and deceptive practices, last year won an $ 8.3 million judgment against a company named SlimAmerica and its principals, Frank J. Sarcone and Robert Wyman, for violating federal consumer protection laws with SlimAmerica's chitin claims.

And two district attorneys in California also filed lawsuits for false advertising claims against five makers of chitin or chitosan weight loss products, including one of the most visible: Enforma, which features former Los Angeles Dodgers baseball star Steve Garvey as a pitchman on its television infomercials for a product called Fat Trapper. Industry experts say more legal action by both federal and state officials is expected.

But manufacturers insist the products are safe and effective. "The proof is in the pudding," says Bruce Miroglio, an attorney for Enforma." 'The success of the product is demonstrated by the thousands of people who continue to reorder the product for its use and their incredible tales of success with weight loss."

Chitin (pronounced KITE-in) is one of the most common substances in nature, more common even than its chemical cousin cellulose, itself a building block of nearly all plants. "Billions of tons of chitin are produced every year," says Ray Pariser, a retired senior scientist at the Massachusetts Institute of Technology. All arthroprods, from ants to shellfish, have chitin in their armored exoskeletons, Pariser says. So do a large number of fungi, molds and yeast that use chitin to reinforce their walls. Chitosan is a processed version of chitin.

A long chain of sugars, the chitin molecule varies widely from species to species. "Some have 1,000 sugar rings," Pariser says. Some have 10,000. Each permutation "changes the properties enormously."

But what all chitin molecules have in common is the ability to latch on to heavy metals, amino acids and fat, like a crab catches dinner in its claw. Thanks to this process, called chelation, the chitin molecule "will simply not let go," Pariser says.

It is this chemical stubbornness that makes chitin so intriguing. To proponents of chitin and chitosan, chelation means that chitin can potentially capture fats in the intestine and sweep them through the body before they are metabolized.

"Studies have shown that, within weeks [of starting to use chitin], individuals begin to experience an improvement in their lipid profile and lose weight," notes Alexander G. Schauss, director of natural and medicine products research at the Life Science Division of the American Institute of Biosocial and Medical Research Inc. in court documents filed on behalf of Enforma.

But chelation is also one of the leading reasons why critics warn about the potential dangers of chitin. The composition of the chitin can vary depending on the seawater, the time of year and the animal it is extracted from. For example, shrimp from different regions can absorb through the natural chelation process different impurities from the surrounding water, experts say.

Although many brands advertise that they have pure chitin or chitosan, "there is no . . . pure form," says Pariser. "It's always combined with lots and lots of other things, and those other things are very hard to remove. . . . It's exactly why I am afraid of its use as a biomedical product."

Nor can consumers count on the Food and Drug Administration for much regulation of these products. Most are labeled dietary supplements by their makers. With the passage of the Dietary Supplement Health and Nutrition Act in 1994, Congress eased the way for supplement makers to bring their products to consumers and limited the FDA's ability to regulate vitamins, minerals and other dietary supplements, including chitin and chitosan.

Manufacturers don't have to divulge the source of their products' chitin or chitosan, which can vary widely from product to product and could come from multiple sources. Some makers warn that consumers with seafood allergies should avoid their products derived from crustacean shells, but many manufacturers do not.

"If there is residual protein left, you can have an allergic reaction to insects as well as to shellfish," says Elizabeth Yetley, lead scientist for nutrition at the FDA. "Consumers, if they are interested in weight loss, should consult with a physician or their pharmacist before they take these products."

The proliferation of these weight loss products also worries many diet experts, who believe the promotional claims offer false hope to very desperate, overweight people. "They hope that these products might have even some small effect," says Steven B. Heymsfield, co-director of the obesity center at St. Luke's-Roosevelt Hospital Center in New York. "I discourage my patients from taking them."

The scientific evidence just doesn't support their use, according to Heymsfield, who served as an expert witness in 1997 for the FTC trial against SlimAmerica, which claimed that it could "blast" up to 49 pounds off in only 29 days and "obliterate" five inches from waistlines and "zap" three inches from thighs--all without dieting or exercise.

To prepare for the FTC trial, Heymsfield reviewed all the published literature on using chitin and chitosan for weight loss. Most of the studies that Heymsfield found "were uncontrolled and involved just anecdotal evidence," he says. "Right off, that disqualifies it. I testified then that there were no high-quality, randomized, double-blind, placebo-controlled trials to support the efficacy of the product. They failed to comply with the minimum accepted scientific standards."

Since then, Edvard Ernst, director of the department of complementary medicine at the University of Exeter in England, has conducted a meta-analysis of five, more recent Italian studies that put patients in random groups and were double-blind, which means that neither the patients nor the physicians knew who was getting the supplement and who was getting a sham pill, called a placebo. These were the only such studies that he could find to evaluate.

The meta-analysis showed that chitosan could help with weight loss when subjects also ate a low-calorie diet. "But when we looked at individual studies, we could not feel but considerable reservations about the quality of data," he says in an interview. Most of the studies came from the same lab in Italy and had been sponsored by a maker of chitosan. It appeared, Ernst says, "that they were reporting more or less based on the same data that had been reported or changed in a slight way. This meta-analysis was an example of how meta-analysis can mislead researchers and it led us to do our own trial."

Ernst's trial, which was also sponsored by a chitosan maker, tested the product on 34 overweight men and women, aged 19 and older, who were randomly assigned to receive either a placebo or the chitosan product. During the 28-day study, they ate their normal diet, a practice that many makers of these products advise. The study, which was published in the British journal Perfusion, found no significant weight loss in either group.

But that finding has not deterred the manufacturers of chitin and chitosan supplements from continuing to claim that their products can help consumers lose weight and do a lot more.

Ads proclaim "all natural" products that are "safe" as "natural weight loss agents." Some promise quick--and staggering--blood cholesterol reductions of up to 32 percent. Others tout that consumers can eat up to 125 grams of fat a day--nearly 1,125 calories--without gaining weight. They claim the products can bind to fats, heal wounds, improve liver function and lower blood pressure. They proclaim that the supplements have antibacterial qualities that "may promote overall digestive tract health, aid digestion and regularity, strengthen bones and lower stress on the liver and other organs."

"Critical studies have not been done to demonstrate this," says John Vournakis, professor of medicine at the Medical University of South Carolina in Charleston. "Nor do we know what doses, what delivery systems should be used or how these products function in the upper and lower intestine in detail. The people who are selling these products are not people who have gone to the expense of doing careful clinical studies. If you read their claims, they are very, very superficial and they hint about the effects using misleading language."

It is that concern about misleading consumers that prompted the lawsuits by officials in Napa and Sonoma counties in California. One suit--against Higher Ideals of Nevada--was settled when the company agreed to pay more than $ 15,000 in fines and stopped marketing the product. Another suit, against Larry Clarence Ormson, head of the Wisconsin-based Try-Lean Diet program, resulted in a default judgment, civil penalties of $ 100,000 and another $ 100,000 in restitution for consumers.

The other three lawsuits--against Enforma (makers of Fat Trapper and Exercise In A Bottle), Danmark Inc. (Chitosol and Chitosan Plus) and Television Marketing Group Inc. (FTF--Fight the Fat)--go to trial in June.

These companies have made "unsubstantiated ad claims" about their products "that are false and misleading," says Napa County Deputy District Attorney Daryl Roberts. "Basically our contention is that the products don't do what is claimed for them in their advertising."

The makers disagree. "We deny that," says Bruce Miroglio, attorney for Enforma. "That is not the case."

"The district attorney in Napa believes that our product does not cause weight loss," says Charles Chernofsky, attorney for Television Marketing Group, makers of Fight the Fat. "I don't know what he bases that on. He hasn't shown me anything yet. There are human studies showing that chitosan does cause a weight loss. Think about it: Our government keeps telling us that we should reduce the fat in diet. If this product reduces the amount of fat that we ingest, logically it will cause a weight loss."

Proponents also point to the FDA's Special Nutritionals Adverse Event Monitoring System, which tracks reactions from consumers and health professionals. No adverse reactions are listed for chitin or any of the other leading chitin-containing products. Only two adverse events--one for premature ventricular heart contractions, the other for constipation--are listed for chitosan products. And the FDA underscores that even these adverse events do not prove cause and effect. Critics note, however, that the system has a pattern of under-reporting in all areas.

Advocates also note that chitosan is an approved food additive in Finland and in Japan. "The safety of chitosan is further attested to by its use in the dental and cosmetic industry and in ophthalmic applications including contact lens coating or in the contact lens material itself," notes Schauss in court documents filed in support of Enforma.

But to many of the scientists and the physicians who have studied chitin and chitosan for decades, the dietary supplements simply don't measure up for weight loss purposes.

Were the various chitin and chitosan weight loss products as good a fat binder as their claims assert, they would also likely cause massive diarrhea and strip the body of essential fat soluble vitamins, according to experts such as Heymsfield. Yet, the University of Exeter's Ernst found no evidence that either happens.

"I would not recommend these products," says the Medical University of South Carolina's Vournakis, "and I would definitely oppose anybody in my family or anyone who asked my advice about it from taking this stuff."

Cathy Miller contributed to this story in Napa, Calif.