Tuesday 4 December 2012

HERBALIFE SIDE EFFECTS-1995

Stephen Barrett, M.D.
Herbalife International, of Inglewood, California, markets weight-control products, dietary supplements, and personal-care products. The company was founded in 1980 by twenty-four-year-old Mark Hughes, who states he was inspired by his mother's unsuccessful struggle to control her weight with amphetamines. Herbalife's 1993 retail sales totaled $247 million in the United States and $693 million worldwide. Its principal products are Formula #1 (a meal-replacement protein drink mix), Formula #2 (an herbal tablet), Formula #3 (a multivitamin/mineral tablet), and Thermojetics, a weight-control system that includes herbal tablets. The numbered formula products were originally marketed as components of Herbalife's Slim and Trim Program. Today the program is called Herbalife Cellular Nutrition Health and Weight Management System, and some of the ingredients are different.
Hughes dropped out of high school after ninth grade and wound up in legal difficulty that resulted in his staying for three years at a residential school for troubled youngsters. When he was nineteen, his mother died of a drug overdose. According to a 1985 issue of the Herbalife Journal:
Mark became aware of the need for a safe, effective way to lose weight . . . when his mother died as a direct result of following years of unwise dieting practices. This event left him with a vital interest in nutrition and a fervent desire to find a product that would enhance and build health while allowing an individual to take weight off sensibly and safely. . . .
During his search, he had met Richard Marconi, Ph.D., with whom he shared his dream. . . . After a lot of research and testing, Herbalife Slim and Trim was born.
After working for two multilevel companies that sold weight-control products but went out of business, Hughes founded Herbalife with help from Marconi, who had manufactured products for one of these companies. Herbalife publications describe Marconi as a "well-respected nutritional expert" and "the leading authority on nutritional products." His "Ph.D." was obtained from nonaccredited Donsbach University after Marconi hooked up with Hughes. After this fact was brought out at a Congressional hearing (described below), Herbalife's Journal stopped referring to Marconi as "Dr."
Herbalife's initial marketing included lengthy cable television programs that were filled with financial and health-related testimonials. Sales were also promoted with buttons and bumper stickers that said "Lose Weight Now, Ask Me How."
In 1982, the FDA sent Herbalife a Notice of Adverse Findings, which stated that certain products were misbranded because of labeling claims that they were effective for treating many diseases, dissolving and removing tumors, rejuvenating, increasing circulation, and producing mental alertness. A 1984 FDA Talk Paper notes that the agency had received many complaints about side effects that had occurred during the use of Herbalife products and had stopped when use of the products was stopped. In fact, said the Talk Paper, "Literature given Herbalife distributors states that up to 25% of product users will have adverse effects but claims that this is evidence of the body's improving itself." Several suits were filed by people who alleged that the products had harmed them. Some of these suits were settled out of court with substantial payment, but the amounts have not been disclosed and the case records are sealed.
By 1985, Hughes claimed that Herbalife had over 700,000 distributors and an annual income approaching half a billion dollars a year. But trouble was brewing. In May 1985, Senator William V. Roth, Jr. (R-DE) held two days of hearings on weight-reduction programs, during which he grilled Hughes about the "research and testing" done prior to marketing Herbalife's products. Hughes said, "We have a lot of scientific data on the herbs," but Roth ascertained that no actual testing of Herbalife products had taken place. The hearing also brought to light a study done by Herbalife of 428 users of its products. About 40% had experienced headache, constipation, diarrhea, nausea, lightheadedness, palpitations, and/or other transient symptoms that might be attributable to Herbalife products. The occurrence of side effects came as no surprise because several ingredients in Herbalife products were potent laxatives and one product (N.R.G.) contained guarana, which is high in caffeine.
In March 1985, the California Attorney General had charged Herbalife with violating California's consumer protection laws. The suit charged that early editions of the Herbalife Official Career Handbook made illegal claims that various herbal ingredients were effective against more than seventy diseases and conditions. Although most of these claims were deleted in subsequent editions of the handbook, the company had not replaced the original pages sent to distributors with the revised pages or asked these distributors to destroy them. Similar testimonial claims had been made in the company's cable television broadcasts. The suit also charged that Herbalife had been operating an illegal pyramid scheme. The case was settled in 1986 when Hughes and the company agreed to pay $850,000 and to abide by a long list of court-ordered restrictions on claims and marketing practices.
Just before the Senate hearings, Cable News Network aired a four-part report which revealed that Herbalife's supposed "research laboratory" was a conference room that housed a large table and books on herbs, located at one of Marconi's factories. Marconi told a CNN interviewer, "We employed hundreds . . . even thousands of Ph.D.s in the research program for our products." But when asked who they were, he replied, "Why, the research papers that are published and printed that we have access to on our computer."
The adverse publicity caused Herbalife's income to drop sharply, but the company survived, expanded into many foreign countries, and is now a publicly held corporation. The claims have toned down and several potentially toxic ingredients have been removed.
1995
Most Outrageous: Mushroom tea
Variously called Mushroom tea, Kombucha, Fungus, Kargasok, Manchurian, or Kvass tea, this outrageous brew is made by adding tea, water and sugar to a fermented starter batter of yeast and bacteria. Burning body fat and causing weight loss are only two of some 50 benefits claimed for the tea. Others are curing AIDS and cancer, and detoxifying the body. Many claims relate to looking and feeling younger. "Drink black tea in the morning for energy, green tea in the evening to improve the immune system," advise promoters.
            W'hen an Iowa woman died and another became ill after drinking the tea, the Iowa health department issued a warning. The FDA also warns the mushroom tea may be harmful. AIDS patients, many of whom are drinking the popular tea to bolster their immune systems, may risk most harm, said the National Council Against Health Fraud.

Worst Gadget: Ninzu ear clips
A device that fits on the ear and is claimed to suppress appetite through acupressure, Ninzu is one of three such gadgets in three questionable companies run by a Baltimore man. Other ear clips promoted by Michael Metzger with similar claims are Auricle Clip and B-Trim. "The proven principles of acupuncture without needles! In just seconds your hunger pains disappear. You eat less, you lose weight quickly. . . It's safe and it works. We guarantee it. Wearing Ninzo for less than 3 hours a day will produce dramatic results." The FTC charges that claims for the three ear clips are false and misleading.

Worst Product: Ephedrine-laced diet pills
Ephedrine is sold legally as a nasal decongestant, even when "asthma" pills are suggestively named Mini Thin. It avoids drug regulation entirely in the form of the Chinese herb ma huang. Two suspected deaths and 37 hospitalizations in Texas resulted in a temporary state ban on the popular ephedrine-containing diet pill Formula One. Herbalife's big weight loss seller Thermojetics, boasting the popular ingredient "Chinese Ma Huang," reportedly brings in 40 percent of the company's U.S. sales, about $70 million. Side effects of the drug are heart damage, stroke, increased blood pres-sure and seizures, especially when abused—and it's clear that diet pills often are abused. In the past two years, FDA reports some 330 adverse reactions to ephedrine-containing products, primarily ma huang, including about a dozen deaths.

 
Worst Claim: Gorayeb Hypnosis seminars
The worst claim of the year promises large, rapid weight loss upon at-tending a single two-hour Gorayeb hypnosis seminar. "You can expect results ranging from 30-60 Ibs. in 3 months to 120 Ibs. in one year." There's more, of course, "No willpower, no hunger, no dieting, just success. Using the power of hypnosis, you will lose unwanted cravings, eliminate the addiction to sweets and break the compulsive eating habit—once and for all. Stop having weight as an issue in your life." In related smoking-cessesation hypnosis seminars, Ronald Gorayeb claims participants will stop smoking without gaining any weight. The Federal Trade Commission called the Gorayeb claims false, misleading and in violation of the FTC Act.


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