Texas Delays Diet Supplement Rules

WASHINGTON —  Public health officials in Texas, citing “advice” from the Bush administration, have suspended enforcement of a new state regulation designed to protect athletes and other users of dietary supplements.

The Texas regulation centers on supplements that contain ephedrine, a powerful stimulant that is suspected of causing at least 80 deaths nationally. The new rule requires the labels on those products to provide a toll-free number for reporting suspected side effects to the U.S. Food and Drug Administration.

The state would be the first in the nation to impose such a labeling requirement on the $16.8-billion-a-year dietary supplement industry, which is exempt from federal prescription drug regulations. Attempts to enact similar regulations in other states, including California, have failed in the face of strong industry opposition.

Calls for the stricter controls of the supplements in Texas followed several deaths there. The new rule was supposed to take effect Sept. 1. But in the last week, noting Bush administration concerns, Texas health officials have instructed staff to allow the sale of supplements without the required labeling information for at least 60 days.

The instruction to postpone enforcement of the labeling provision followed telephone calls to Austin, Texas, over the last month from a senior aide to U.S. Health and Human Services Secretary Tommy G. Thompson in Washington, according to records and interviews.

The calls came after Thompson was approached Aug. 1 by a lawyer representing Metabolife International Inc. of San Diego, a major dietary supplement manufacturer. The lawyer, Jeff Wentworth, who is also a Republican Texas state senator, said in an interview that he voiced the company’s concerns to Thompson following a speech the Cabinet secretary gave to a group at the Marriott Marquis hotel in New York City.

Wentworth said he raised the suitability of the FDA’s toll-free number with Thompson during a conversation that lasted about “three or four minutes.”

“I just told him that I wanted to visit with him about the [toll-free] line and my belief that it could be improved,” Wentworth said.

He said he did not think the FDA’s system could handle the influx of calls or adequately address the needs of callers.

FDA officials disagree and say they are well prepared to accommodate calls from supplement users.

Company Concerned About ‘Bad Data’

In a separate interview, Metabolife spokeswoman Jan Strode said the company is concerned about how the FDA or public might use information reported to the toll-free number.

“The issue that Metabolife and others are concerned about is the gathering of bad data,” she said.

According to records and interviews, one of Thompson’s aides subsequently called Don A. Gilbert, Texas’ commissioner of health and human services. Gilbert was first appointed in 1998 by then-Gov. George W. Bush and was reappointed this year by Bush’s successor.

A spokesman for Thompson said Wednesday that the department did not try to influence Texas regulators. But the calls from Thompson’s policy aide, Mary Kay Mantho, were cited by Texas health officials during staff meetings and in e-mail as the basis for tempering enforcement of the state’s regulation.

One of the e-mails, distributed to the health department staff on Aug. 28 by Dr. Charles E. Bell, executive deputy commissioner of the Texas health department, said: “[I]t seems to be in the best interest of TDH [the Texas Department of Health] to take the advice of Secretary Thompson’s office and delay either our implementation date or our enforcement of the rules that would take effect September 1st, 2001 for 60 days.”

In a separate e-mail, also distributed last week, officials in the Texas health department received this specific instruction:

“During this period please DO NOT detain dietary supplements containing ephedrine that lack the [FDA’s] 800 number when performing inspections/investigations.” The instruction was signed by John L. Gower, a director in the Texas department.

The high-level focus on implementation of the new policy in Texas comes at a time when the dietary supplement industry remains relatively clear of federal regulation. The supplements are sold in supermarkets without a doctor’s prescription. And if a supplement manufacturer learns of a death or other suspected side effect, the company is under no legal obligation to report such an event to the FDA.

Yet with the products now in widespread use--including among athletes--deaths are drawing increased attention. The Canadian government in June advised consumers not to use products containing ephedrine. On Wednesday, two nationally prominent physicians, Raymond L. Woosley of the University of Arizona Medical Center and Sidney Wolfe of the consumer group Public Citizen, called on Thompson and the FDA to ban the production and sale of ephedrine.

Ephedrine is derived from the ma huang plant and increases the body’s metabolism. Dieters use it to lose weight more quickly, and athletes use it for energy boosts.

Wolfe and Woosley cited 81 voluntarily reported deaths associated with use of supplements containing ephedrine, plus other, nonfatal heart attacks, strokes and seizures. In a letter to Thompson, the two doctors said the available information “demonstrates a significant and unreasonable risk of illness and injury. Especially because these risks are not balanced by any long-term benefits, it is imperative that you act quickly and decisively to prevent future death and injury.”

Metabolife’s spokeswoman, Strode, said the company believes that, when taken as directed, its product is safe. Providing the FDA’s toll-free number on package labeling, she said, would cause “confusion” and lead to reports of side effects that may be unrelated to use of dietary supplements.

“We are pushing for a science-based regulation,” she said.

Strode noted that Metabolife’s product that contains ephedrine, a weight-loss tablet called Metabolife 356, carries a toll-free number that is staffed 24 hours a day by company representatives.

Strode said Metabolife favors “balanced regulation,” including recommended restrictions on dosages and prohibitions of the sale to minors. Another regulation, recently enacted in Texas, requires manufacturers to alert consumers to any product sold over the counter that contains ephedrine.

Texas Directive ‘Extremely’ Unusual

One senior official in the Texas health department said the directive to not detain products with labeling in violation of the new regulation was “extremely” unusual. Speaking on a condition of anonymity, the official pointed out that the effective date of the regulation was agreed to 18 months earlier by industry representatives and the health department. “There was never a discussion with industry that there would be a grace period.”

Gilbert, Texas’s top health official, characterized the directive to not detain the products as consistent with the department’s informal practice of allowing “a period of voluntary compliance” for newly implemented regulations.

Metabolife’s spokeswoman said the company has no plans to include the FDA’s toll-free number for at least the next two months.

Gilbert confirmed that the phone calls to him from Washington were placed over the last several weeks by Mantho, a senior advisor to Secretary Thompson. Mantho, who earlier served as a policy analyst for the Wisconsin health department when Thompson was governor of that state, declined to be interviewed.

A spokesman for Thompson, Bill Pierce, said Wednesday night that as far as he was aware, the secretary’s office has not advised officials in Texas to delay implementing the new state regulation.

“We talked with everybody since it was brought to our attention that there might be some concern with this,” Pierce said. “And we simply just touched base with all the necessary folks to make sure everybody was on board and everybody understood what was going to happen, and reiterated with the FDA what their role was and whether they were ready to go. . . . All we did was simply make sure that we were able to handle the volume of [toll-free] calls. . . . And far as we know, Texas then said, ‘Well, then we’re going to go ahead and implement this thing on the 1st of September.’ ”

Pierce said he was unaware of a delay in the enforcement of Texas’ regulation. “I can’t verify that or not. If that’s what Texas has decided to do, that’s Texas’ decision, I suspect.”

Gilbert, in a telephone interview from Austin, said that over the last month he has fielded concerns voiced about the new regulation from Thompson’s office and from representatives of the dietary supplement manufacturers. The comments, Gilbert said, centered on the FDA’s ability to properly screen the reports of side effects expected to be received by the agency’s toll-free MedWatch line.

Officials at the FDA have informed both Thompson’s office and government health specialists in Texas that the federal agency is equipped to respond to an influx of calls. Asked about the matter Tuesday, an FDA spokeswoman said: “We’re aware of the issue and we’re confident that the [MedWatch] system can handle it. . . . It’s not a problem.”

Despite similar assurances from FDA officials, defenders of the dietary supplements, including the chairman of the House Government Reform Committee, Rep. Dan Burton (R-Ind.), have protested. Burton voiced concerns about the Texas regulations in letters to the chairman of the Texas Board of Health on April 10 and July 23.

In his second letter, Burton ridiculed as “inadequate” the FDA’s MedWatch system for receiving and filtering voluntarily reported side effects experienced by users of dietary supplements.

“I am concerned that state-specific labeling requirements will pose an undue burden on manufacturers, especially the smaller manufacturers,” he said

Wentworth, the Texas lawyer and state legislator who represents Metabolife and who approached Thompson last month in New York, said the FDA’s toll-free number is inferior to the line maintained by the company.

“Congressman Burton has expressed his concern to Secretary Thompson, and Secretary Thompson has asked that the enforcement of that rule be delayed for 60 days,” Wentworth said.

Wentworth said that he has recently written to Thompson and is seeking a meeting with him in Washington.

The California Legislature last year approved a labeling requirement for dietary supplements similar to what is now being disputed in Texas. California Gov. Gray Davis vetoed that bill, prompting criticism that his action was influenced by $100,000 in campaign contributions from Metabolife.

“This industry has spent a truckload of money trying to persuade legislators and governors to resist these kinds of bills,” said state Sen. Jackie Speier (D-Hillsborough), who coauthored the measure that Davis vetoed. Speier’s latest bill to require the listing of the FDA’s toll-free MedWatch number has cleared the state Senate and is now pending in the Assembly.

Metabolife or its employees donated just more than $1 million to the two major national parties and to candidates for federal offices in the 2000 election campaign, according to the Center for Responsive Politics. Of those donations, 55% went to the Democratic Party or its candidates; 45% went to Republicans.

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Times researcher Janet Lundblad in Los Angeles contributed to this story.