WASHINGTON
— Promoters of weight-reduction products, including those of Los
Angeles-based Herbalife International, often make exaggerated claims for
pills and powders that can pose serious health hazards, Senate
investigators have concluded.
In a study to be released this
morning, the staff of the Senate Governmental Affairs permanent
investigations subcommittee says that four deaths since last November
have been associated with Herbalife products.
Allegations of Fraud
In addition, the Food and Drug Administration has received 90 complaints of illnesses allegedly caused by Herbalife products as well as 32 allegations of fraud against the company, according to the staff report. Such a volume of complaints warrants more attention by the FDA to the side effects of "very low calorie" diet plans, investigators said.
Herbalife, the nation's largest distributor of weight-loss and nutrition products, says it has 800,000 independent distributors in the United States, Canada, Australia and Great Britain. Attempts to obtain comment Monday from Herbalife officers on the report's charges were unsuccessful.
Prepared as Introduction
The staff report, a copy of which was obtained by The Times, was prepared as an introduction to two days of Senate hearings on how major diet products are marketed. Mark Reynolds Hughes, Herbalife's founder and president, is among witnesses who have been subpoenaed.
Sen. William V. Roth Jr. (R-Del.), the subcommittee chairman, said that Herbalife and other weight-reduction plans amount to a multibillion-dollar industry. Some smaller marketing schemes, Roth said, involve "a variety of worthless products such as pills that promise to help you reduce while you sleep and creams that you rub in which are supposed to take fat off."
"These items reduce nothing but the pocketbooks of the consumers who use them," Roth said in a statement.
The subcommittee staff said that it had interviewed a number of persons who had had adverse reactions to Herbalife products, including nausea, dizziness, headaches, diarrhea and constipation, and that some Herbalife distributors had claimed the products could cure cancer. Herbalife officers insisted that the company does not support such medical claims but noted that the firm has little or no control over its independent distributors, according to the subcommittee staff.
Disclaimers in Small Print
The Senate staff report said that some promoters of low-calorie products fail to emphasize that their pills and milkshake-type powders are intended to be used only as part of an overall diet plan under medical supervision. To avoid enforcement actions by the Federal Trade Commission, such disclaimers often are carried in small print on the packages, it said--but the impression is left that the products themselves are responsible for the weight reduction.
Other promoters--but not Herbalife--market exotic products like plastic devices to be worn on the ear that touch acupuncture points and allegedly help suppress a person's appetite, the subcommittee report said.
The Senate hearings will be the latest in a series of government actions involving Herbalife. The FDA, based on a lengthy investigation, cited the company for six violations of the Food, Drug and Cosmetic Act in 1982 but never issued any sanctions. Herbalife subsequently sued the FDA, alleging that the agency had engaged in a "widespread, even corrupt, trial-by-publicity campaign" against the firm. But Herbalife recently withdrew the suit.
In addition, the Food and Drug Administration has received 90 complaints of illnesses allegedly caused by Herbalife products as well as 32 allegations of fraud against the company, according to the staff report. Such a volume of complaints warrants more attention by the FDA to the side effects of "very low calorie" diet plans, investigators said.
Herbalife, the nation's largest distributor of weight-loss and nutrition products, says it has 800,000 independent distributors in the United States, Canada, Australia and Great Britain. Attempts to obtain comment Monday from Herbalife officers on the report's charges were unsuccessful.
Prepared as Introduction
The staff report, a copy of which was obtained by The Times, was prepared as an introduction to two days of Senate hearings on how major diet products are marketed. Mark Reynolds Hughes, Herbalife's founder and president, is among witnesses who have been subpoenaed.
Sen. William V. Roth Jr. (R-Del.), the subcommittee chairman, said that Herbalife and other weight-reduction plans amount to a multibillion-dollar industry. Some smaller marketing schemes, Roth said, involve "a variety of worthless products such as pills that promise to help you reduce while you sleep and creams that you rub in which are supposed to take fat off."
"These items reduce nothing but the pocketbooks of the consumers who use them," Roth said in a statement.
The subcommittee staff said that it had interviewed a number of persons who had had adverse reactions to Herbalife products, including nausea, dizziness, headaches, diarrhea and constipation, and that some Herbalife distributors had claimed the products could cure cancer. Herbalife officers insisted that the company does not support such medical claims but noted that the firm has little or no control over its independent distributors, according to the subcommittee staff.
Disclaimers in Small Print
The Senate staff report said that some promoters of low-calorie products fail to emphasize that their pills and milkshake-type powders are intended to be used only as part of an overall diet plan under medical supervision. To avoid enforcement actions by the Federal Trade Commission, such disclaimers often are carried in small print on the packages, it said--but the impression is left that the products themselves are responsible for the weight reduction.
Other promoters--but not Herbalife--market exotic products like plastic devices to be worn on the ear that touch acupuncture points and allegedly help suppress a person's appetite, the subcommittee report said.
The Senate hearings will be the latest in a series of government actions involving Herbalife. The FDA, based on a lengthy investigation, cited the company for six violations of the Food, Drug and Cosmetic Act in 1982 but never issued any sanctions. Herbalife subsequently sued the FDA, alleging that the agency had engaged in a "widespread, even corrupt, trial-by-publicity campaign" against the firm. But Herbalife recently withdrew the suit.
The state attorney general, the state Department of Health and the Santa Cruz County district attorney filed a civil lawsuit against Herbalife alleging that the company makes false medical claims about some of its products and employs an illegal pyramid-type scheme to market them.
WASHINGTON
— The founder and president of Herbalife International told a stormy
Senate hearing Wednesday that his controversial diet powders and pills
are absolutely safe and he derided some of his medical critics for being
overweight.
Referring to a panel of three nutrition and weight-control authorities who had questioned the safety of Herbalife products Tuesday, founder Mark Reynolds Hughes, 29, asked senators: "If they're such experts, then why are they fat? I've lost 16 pounds in the last few years."
Referring to a panel of three nutrition and weight-control authorities who had questioned the safety of Herbalife products Tuesday, founder Mark Reynolds Hughes, 29, asked senators: "If they're such experts, then why are they fat? I've lost 16 pounds in the last few years."
For
nearly two hours, Hughes responded with breezy, clipped answers to
hostile questioning by members of the Senate Governmental Affairs
permanent investigations subcommittee, which has been prodding the Food
and Drug Administration to investigate the diet formulas and sales
techniques of Los Angeles-based Herbalife.
Rapid-Fire Questioning
At one point, Dr. David B. Katzin, a consultant to the firm, interrupted rapid-fire questioning by Sen. Warren B. Rudman (R-N.H.) to exclaim: "I don't feel the gentlemen here (from Herbalife) are getting a fair shake!"
Rudman charged that Katzin, a physician, had been put on
the firm's payroll only three months ago to deal with the subcommittee
in place of Richard Marconi, the manufacturer of Herbalife's food
supplements who, Rudman said, had avoided testifying by going on a trip
to China.
Rudman asked Hughes if he knew that Marconi, who says he is a doctor of nutrition, had received a mail-order doctorate degree from Donsbach University School of Nutrition, a non-accredited correspondence school in Huntington Beach, as disclosed last month by The Times. Hughes turned away the question by terming Marconi "one of the most brilliant men I know."
Sales of $1 Billion
Pressed by Rudman, Hughes acknowledged that his own formal education had stopped at the ninth grade. Asked how he was qualified to take issue with criticism of Herbalife from some leading medical authorities, Hughes snapped: "I defy anybody to be able to produce results as this company has."
Hughes said his 5-year-old firm, which projects sales of $1 billion this year, has sold 9.6 billion portions of its nutrition and diet formulas.
Sen. William V. Roth Jr. (R-Del.), the subcommittee chairman, reminded Hughes of criticism by some physicians that Herbalife--unlike similar products sold under the Cambridge diet plan--does not recommend that consumers seek guidance on their diets from doctors.
"Do you believe it's safe to use your products without consulting a doctor?" Roth asked.
"Sure," replied Hughes. "Everybody needs good, sound basic nutrition. We all know that."
Two Controversial Herbs
Sen. William S. Cohen (R-Me.) asked Hughes about the use of two controversial herbs, comfrey and chaparral, in a formula called Herbal-Aloe. A panel of nutritionists on Tuesday said the substances had cancer-causing properties.
But Hughes said neither he nor the FDA was concerned because quantities were well below the unsafe level. Hughes said Herbalife was cooperating with the FDA, although FDA Commissioner Frank E. Young told the subcommittee that the agency is considering action against Herbalife for unfounded medical claims for its products.
Asked about previous testimony by doctors that Herbalife products sometimes induce nausea, diarrhea or constipation in consumers, Hughes said that these "transient side effects" occur in 10% to 15% of all users and usually last only a week. There are no warnings on Herbalife's labels about such occurrences, he said, because warnings are made "basically by word of mouth" through independent distributors.
Rapid-Fire Questioning
At one point, Dr. David B. Katzin, a consultant to the firm, interrupted rapid-fire questioning by Sen. Warren B. Rudman (R-N.H.) to exclaim: "I don't feel the gentlemen here (from Herbalife) are getting a fair shake!"
Rudman asked Hughes if he knew that Marconi, who says he is a doctor of nutrition, had received a mail-order doctorate degree from Donsbach University School of Nutrition, a non-accredited correspondence school in Huntington Beach, as disclosed last month by The Times. Hughes turned away the question by terming Marconi "one of the most brilliant men I know."
Pressed by Rudman, Hughes acknowledged that his own formal education had stopped at the ninth grade. Asked how he was qualified to take issue with criticism of Herbalife from some leading medical authorities, Hughes snapped: "I defy anybody to be able to produce results as this company has."
Hughes said his 5-year-old firm, which projects sales of $1 billion this year, has sold 9.6 billion portions of its nutrition and diet formulas.
Sen. William V. Roth Jr. (R-Del.), the subcommittee chairman, reminded Hughes of criticism by some physicians that Herbalife--unlike similar products sold under the Cambridge diet plan--does not recommend that consumers seek guidance on their diets from doctors.
"Do you believe it's safe to use your products without consulting a doctor?" Roth asked.
"Sure," replied Hughes. "Everybody needs good, sound basic nutrition. We all know that."
Two Controversial Herbs
Sen. William S. Cohen (R-Me.) asked Hughes about the use of two controversial herbs, comfrey and chaparral, in a formula called Herbal-Aloe. A panel of nutritionists on Tuesday said the substances had cancer-causing properties.
But Hughes said neither he nor the FDA was concerned because quantities were well below the unsafe level. Hughes said Herbalife was cooperating with the FDA, although FDA Commissioner Frank E. Young told the subcommittee that the agency is considering action against Herbalife for unfounded medical claims for its products.
Asked about previous testimony by doctors that Herbalife products sometimes induce nausea, diarrhea or constipation in consumers, Hughes said that these "transient side effects" occur in 10% to 15% of all users and usually last only a week. There are no warnings on Herbalife's labels about such occurrences, he said, because warnings are made "basically by word of mouth" through independent distributors.
"A
change in anyone's diet would have the same effects," Hughes said. His
testimony concluded two days of hearings by the subcommittee into
weight-reduction products and devices being sold by mail or through
multilevel marketing plans.
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