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Herbalife Hearings, Part II

Odom Fanning

May 15th was a sunny Spring day, ideal for a demonstration. About 8 AM., an estimated 3,000 Herbalife supporters from across the country began gathering on Capitol Hill, each wearing a large button reading: "I lost X pounds. Ask me how." They had been called to Washington for a rally whose main purpose was to grab media attention and get television reporters to ask, on camera, how they had lost their claimed poundage. The evening before, they had shared their enthusiasm in a ballroom at the Hyatt Regency Hotel, where they received buttons and instructions from a platoon of officials from Herbalife International headquarters in Los Angeles.

The 5-block walk from the hotel to the Dirksen Senate Office Building was covered by camera crews from the networks, alerted by the Washington offices of Herbalife's public relations counsel, Rogers & Cowan, Inc., of Beverly Hills, California. Of the 100 or so demonstrators who gained entrance to the building, only about 50 could fit at any one time into the spectator section of crowded Room 342, where the U.S. Senate Permanent Subcommittee on Investigations held its 2-day hearing on weight reduction products and plans.

To the credit of the audience and chairman, Senator William V. Roth, Jr. (R-DE), decorum in the hearing room was maintained at all times. Nor did the Herbalife representatives who stood for hours in the hallway hoping that space inside would become available require anything of Capitol police other than normal crowd control.

At the first day's hearing, Senator Roth had indicated that although many very-low-calorie (VLC) dietary products are being sold, his subcommittee's review had focused on Cambridge and Herbalife, "largely because they have pervaded the market." Reading from his staff's report, Roth had noted that the FDA had received 90 complaints of alleged illness due to Herbalife products, four reports of death, and 32 allegations of fraud.

"While these numbers may pale in comparison to those persons who experienced no side effects or adverse reactions," the report said, "they may nevertheless be significant enough to warrant more scrupulous attention by the FDA to better determine whether there is, in fact, a cause and effect relationship."

Testifying for the FDA, Commissioner Frank E. Young, M.D., Ph.D., conceded that under provisions of the Federal Food, Drug, and Cosmetic Act, his agency has authority over food, drug, and medical device products that are specifically promoted for weight loss. Reading his 15-page statement, Dr. Young said:

FDA has attempted, over time, to modify its strategy to make the most effective use of resources for dealing with those products which represent a health fraud. Until the 1960's, the most common tool used was criminal prosecution. A number of cases were successfully tried, and these achieved some deterrent effect. But because this is a more time-consuming and resource-intensive approach to the problem, the agency has expanded its enforcement program to include other judicial and administrative measures such as seizures, injunctions and regulatory letters.

With all seriousness, the nation's highest-ranking health regulator declared, "I believe that public education is probably the most effective and cost-efficient way of combating health fraud, especially economic fraud. This is because the surest way to reduce health fraud is to reduce consumer demands for fraudulent products. In the weight loss product area, FDA has begun a public awareness campaign that includes a slide show, exhibit, and videotape focusing on diet books, low-calorie diets, body wraps, starch blockers, and other weight loss products and urges consumers to consult their physicians prior to beginning diets and to be aware of the general principles which apply to reduction diets."

Regarding VLC diet products, Dr. Young said, "Some manufacturers and distributors are promoting herbal mixtures for a variety of weight control programs. The diet plans may replace one or more meals a day with low-calorie product mixtures including herbs, vitamins and minerals, lecithin, senna leaves, kelp, chickweed, and dandelion, but no significant data have been provided to demonstrate that such ingredients do anything to control weight gain or ensure weight loss . . ."

"In addition to not being the magic answer to weight loss. herbs can be unsafe. No one would knowingly consume poisonous herbs, of course. And no responsible herb company would even consider putting such herbs in its products. But the fact is that poisonous herbs have been found in diet aids in low levels, and F DA has taken action against products in such cases. And although we know about the toxicity of some herbs, we do not know enough about many to conclude that they are safe as currently promoted in some weight-reduction plans."

In response to a question, Dr. Young acknowledged that the FDA regards dietary products as drugs if any therapeutic claim is made for them. But he added that if the agency attempted to regulate them on the basis of more general claims, Congress might reduce its authority as it did in 1976 with the Proxmire Amendment (which ended FDA jurisdiction over the dosage and composition of ordinary food supplements).

That answer was not acceptable to Senator Warren E. Rudman (R-NH), who asked: "If a company encourages witnesses to make claims that the company can't make, and these claims are made on TV time paid for by the company. and the FDA has such evidence, how long is it going to take you to act?" (Rudman was obviously aware that the FDA has had sufficient evidence for more than two years to initiate criminal prosecution of Herbalife for making illegal therapeutic claims.) Dr. Young hedged, saying he didn't want to compromise his agency's investigation of the company. On advice of his accompanying legal counsel, he declined to go further -- and the Senators did not press him to do so. But when Rudman asked whether the FDA had a timetable? for deciding whether the evidence warranted enforcement action, FDA General Counsel Tom Scarlett replied, "It is going to be in the relatively near future. Another year."

When called by Senator Roth, Mark Reynolds Hughes, 29, Herbalife's founder and president, bounced forward with a retinue of corporate officials and consultants. Accompanying them to the witness table was Representative William E. Dannemeyer (R-CA), whose district contains a manufacturer of Herbalife products which employs 200 people.

"Consumers should be allowed a maximum of freedom of choice to make decisions for themselves," the Congressman said. "Those that make false claims or otherwise violate the law must answer at the bar of justice. We must not, however, indict a health program generally, or particularly weight control products, merely because they are 'unconventional' or 'nontraditional' by the standards of the established medical profession."

"Before coming to Congress, I was involved in matters of this nature," Dannemeyer said, referring to his former role as legal counsel for the Alta-Dena Certified Dairy, the nation's largest marketer of certified raw milk. Last October, Dannemeyer testified on behalf of Alta-Dena against federal regulation of raw milk at an FDA hearing.

After introduction by Dannemeyer, Hughes said that practically everybody in his family has had a weight problem and that he became interested in doing something about this after his mother got "hooked" on a prescription weight control product. Thus inspired, he founded Herbalife International in February 1980 when he was 23 years old and built it to gross sales of almost $500 million last year.

Hughes himself, elegant and trim, "welcomed the opportunity to be a part of this Subcommittee's effort to inform the American consumer about the worthless products which are threatening the reputations of the responsible companies." After further remarks, he presented a company consultant, David Brandeis Katzin, M.D., Ph.D., a private practitioner from Los Angeles, who said that during the past five years he had personally treated well over 1,000 individuals, many with weight-related problems. Herbalife's program is nothing more than sound basic nutrition, Dr. Katzin asserted.

Diets that contain less than 500 calories per day and consist exclusively of formula drinks "can be potentially extremely dangerous and must, under all circumstances, be supervised medically. Even then serious side effects may occur; however, medical supervision reduces the risk of prolonged or permanent complications," Katzin said. "Herbalife does not have 500 calories, it has 1,000 or more . . . In addition, the balance of protein, carbohydrates and fat is entirely different. Very low calorie diets are deficient in potassium, whereas the Herbalife nutritional program contains adequate potassium according to RDA recommendations. In addition, the Herbalife nutritional program contains a balance of vitamins and minerals which meet or minimally exceed the RDAs for these nutrients."

Katzin declared: "Literally billions of portions of the product have been served to more than a million individuals with only minimal transient side effects. I know of no other nutritional program which has been used as widely as the Herbalife program or as safely."

Katzin presented a series of charts and graphs. One, he said, was based on evaluation at the University of California, San Diego, of seven Herbalife consumers who had used the products for one to four years and showed "no deficiencies of serum potassium, magnesium, calcium, iron, zinc and copper." From this he concluded that the Herbalife nutritional program is safe." (Under questioning he listed as exceptions: "individuals on dialysis, with intestinal bypass, and others under a doctor's care.").

"How about for a pregnant woman?" Roth asked.

"If told to reduce by a physician, then it would be safe for her," replied Dr. Katzin. However, he added, he wouldn't recommend that a pregnant woman lose weight. Hughes later agreed with a suggestion by Senator Roth that such products be labeled to warn pregnant women that they should consult a physician before taking them.

Other charts Katzin presented were based on a retrospective study of 428 users, including one chart of "transient side effects" which indicated that of 428 Herbalife users, 18.6% had experienced headache, 12.5% had constipation, 11.3% had diarrhea, 9.7% had nausea, 9.6% reported lightheadedness, 2.6% had heart palpitations and 10.1% had other symptoms. Altogether, about 40% of those surveyed had some symptoms that might be attributed to taking Herbalife products, Katzin said. (The above numbers add to more than 40% because individuals can have more than one symptom.) Hughes, basing his estimate on feedback from distributors had said earlier that roughly 10-15% of users have such side effects, which usually last only a week.

Senator Rudman was relentless in questioning both Herbalife witnesses. To Dr. Katzin:

"You were hired about three months ago?"

"Yes."

"That was about the time Mr. Hughes learned that Herbalife would be invited to testify," said the Senator. After more exchanges in which Katzin was evasive, he insisted on a yes-or-no answer to the question: "Weren't you hired to come to this hearing?"

"Yes," replied Dr. Katzin.

Senator Rudman asked Hughes why Richard Marconi, the manufacturer of Herbalife products, was not present for the hearings.

"Doctor Marconi is in China," said Hughes. (Marconi claims to have a Ph.D. in nutrition from Donsbach University, which is a correspondence school located in Huntington Beach, California.)

"This doctorate this man allegedly has is from a totally unaccredited university . . . he, in fact is really not a Ph.D. in nutrition. Do you know that?" Rudman asked.

"I don't know about that . . ." Hughes came back. "Dr. Marconi is one of the most brilliant guys I know."

"Isn't it true that you have no college degree." Rudman then asked Hughes. "You completed the ninth grade in school, but consider yourself an authority on nutrition?"

"I know that this plan works," responded Hughes. Later he called himself "an authority on helping people lose weight."

Rudman focused much of his questioning on an early edition of Herbalife's Official Career Book, a training manual for distributors, and read statements of claims for cures of cancer, arthritis, and other diseases. Hughes replied that the copyright laws required picking up significant amounts of material where Herbalife products are endorsed -- "in order not to take statements out of context." Therefore, said Hughes, the Career Book had reproduced many pages from magazines, in which the authors may make unrelated claims.

"Because some quack somewhere said something might cure cancer, you thought it all right to publish?" Rudman exploded.

"No, I am not saying that," insisted Hughes.

"That's one of the most incredible bits of snake oil I've ever heard!" the Senator declared.

Rudman's final line of questioning had to do with Herbalife's cable television broadcasts. "People come up on your cable program and give testimonials about being cured of cancer, don't they?" he asked.

Hughes admitted that that had happened, but insisted, "After two live shows, when we found out that happened, we went to the tapes and edited out any health claims."

"The representatives, might they not make health representations?" Rudman pressed him.

"No, we have three categories for representatives being suspended, and 358 representatives have been terminated for misadvertising, failure to make refunds, etc. I terminated one representative who was making $30,000 a month."

"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."

Senator William S. Cohen (R-ME) asked Hughes about the use in Herbal-aloe of comfrey and chaparral, which witnesses on the previous day had testified have cancer-causing properties. Hughes said that neither he nor the FDA was concerned because quantities in the formula were well below the unsafe level. Although Commissioner Young had indicated a few hours earlier that the agency was still considering action against the company for unfounded medical claims made on behalf of its products, Hughes also said Herbalife was cooperating with the FDA.

Regarding side effects, Senator Roth asked, "Shouldn't there be warnings . . . on the labels?"

Warnings are made "basically by word of mouth" through the distributors, Hughes replied.

"But isn't the public entitled to know about these?" Senator Roth pressed him.

"Yes," conceded Hughes. "This company is open and willing to consider labeling."

Senator Rudman closed the questioning of Hughes: "Last night there was a rally of 3,000 to 4,000 Herbalife representatives at the Hyatt Regency/Capitol Hill Hotel. Towards the end, Larry Thompson, executive director of sales for Herbalife International, solicited testimonials and obtained them from three people. One said she was told by a doctor that her child was dying, put the child on the product, and the child didn't die. Another was supposedly cured of diabetes. And the third supposedly was on crutches for some time, took Herbalife, and no longer had to use them. If you were running a first-rate company, do you think you should allow such testimonials?"

Before Hughes could respond, Rudman added a final question: "Don't you think you ought to clean up your act?"

"I think we should," Hughes agreed, "and we're trying to do that right now."

The hearing was adjourned at 3:00 p.m., too late for a 1:30 press conference Herbalife's public relations firm had planned for Hughes at the Hyatt Regency.

__________________

This article was published in the October 1985 issue of Nutrition Forum, when Mr. Fanning edited and published a newsletter called Con$umer New$weekly. Before that, he was a science writer for The Atlanta Journal and director of information for the U.S. Centers for Disease Control and Prevention.

Addendum

Stephen Barrett, M.D.

Richard Marconi's dubious credentials of had exposed prior to the hearings in a 4-part investigative report on Herbalife that was aired nationally by Cable News Network. CNN revealed that although Hughes claimed that Herbalife products had been formulated with the help of Marconi and his "research staff," no research on effectiveness had actually been done before the products were marketed. And Herbalife's supposed "research laboratory' turned out to be 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 CNN report also demonstrated that Herbalife's Official Career Book once claimed that ingredients in Herbalife products were effective against arthritis, bronchitis, emphysema, gangrene, snake bites, ulcers, venereal disease and a wide range of other serious health problems. Vigorous FDA enforcement action at that time might well have stunted Herbalife's growth.

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