FDA will try again to regulate herbal stimulant

THURSDAY, Oct. 19 The battle over a controversial stimulant in dietary supplements is moving back to the national stage after a skirmish in California ended in defeat for critics of the herb ephedra.

After a series of delays, the Food and Drug Administration is expected to release new recommendations about use of ephedra by the end of this year. In 1997, the FDA tried and failed to effectively ban use of the herb in weight-loss products. Manufacturers support less-stringent regulations.

"After three years of fighting over this, we're possibly going to make some progress," says Wes Siegner, an attorney for the Ephedra Education Council, which supports the use of the herb.

Some ephedra critics, however, have long decried the federal government's hit-and-miss approach to the herb.

"The feds seem unwilling or unable to take effective action," says Robert Herrell, chief consultant to the California State Assembly's Consumer Protection Committee. "It's a public health issue."

Earlier this month, California Gov. Gray Davis vetoed a bill that would have required warning labels on ephedra products.

Ephedra -- also known as Ma huang, Chinese ephedra and epitonin -- is an herb used for centuries in China. In the United States, it has become a common ingredient in numerous dietary supplements.

Ephedra works by stimulating the central nervous system, much like adrenaline and caffeine. Advocates say the herb can help people lose weight. Products containing ephedra also are marketed to athletes as energy boosters.

Products containing the herb have become wildly popular and now include everything from capsules to powders to energy bars. Sold in supermarkets, at health stores and over the Internet, the products have names like "Diet Pep," "Ripped Force," "Ripped Fuel" and "ThermoSlim." Some of the most popular brands are made by the Metabolife company.

The Ephedra Education Council estimates that 3 billion servings of ephedra products are consumed each year in the United States.

But medical experts say the stimulant can raise blood pressure and heart rate, cause vomiting, heart palpitations, dizziness, nervousness and more serious reactions, including heart attacks, seizures and strokes.

Questions also have been raised about how carefully manufacturers control the amount of ephedra in their products.

In March, University of Arkansas researchers found that the labels on half of the 20 ephedra products they studied misstated the amount of ephedra by more than 20 percent. In four products, the amount of ephedra varied from batch to batch, one product had no active ingredient and five contained norpseudoephedrine, a controlled substance that's similar to the sedative phenobarbital.

In 1997, the FDA tried to bring ephedra under regulatory control by seeking warning labels and strict limits on the amount of ephedrine alkaloids in supplements. The FDA also tried to ban manufacturers from mentioning the herb's weight-loss properties, a rule that effectively could have killed its use as a dietary supplement.

But after the federal General Accounting Office severely criticized the FDA's investigation of ephedra, the agency withdrew its recommendations, sending the issue back to the drawing board.

An FDA spokeswoman says public hearings were held earlier this year, and new ephedra recommendations are expected by Jan. 1. "What we have to do is review all the comments and decide what the next course will be," she says. "There's a lot of options."

As part of its investigative process, the FDA in March released a new list of 140 citizens who suffered health problems, apparently as a result of ephedra use. That brought the total number of ephedra-sickened patients to 273, the FDA says.

However, the ephedra industry blasted the FDA report, questioning whether any of the illnesses actually were connected to ephedra. And Siegner, the attorney, says the FDA is not looking at the facts.

"It's not a scientific issue [to the agency]," he says. "It's a political issue. I view it as an effort to scare the country and Congress, and get their authority back."

Some states have not waited for the federal government to act on the herb. Earlier this month, California was poised to regulate ephedra by passing an extensive law sponsored by San Diego-area Assemblywoman Susan Davis, a Democrat.

The law would have required warning labels on ephedra products and ordered manufacturers to provide toll-free numbers customers could call to report problems.

In his written veto message, Gov. Davis, a Democrat, suggested that new regulations would be "in the interest of public safety," but he added that "this is a matter of interstate commerce and clearly the responsibility of Congress to regulate, which they have thus far neglected to do."

If Davis had approved the bill, California would have joined about 20 states with ephedra laws on the books. "The reason the states are getting involved is because the feds aren't," Herrell says.

But even with state laws, ephedra's easy availability on the Internet may stymie the efforts of lawmakers.

Ohio, Michigan, Hawaii and Washington each have standards that set a per-serving limit of 25 milligrams of ephedra alkaloids and a daily limit of 100 milligrams, Siegner says, which he describes as in line with regulations the industry is seeking. However, the FDA originally wanted to limit servings to 6 milligrams each, or 24 milligrams a day.

Some ephedra critics support prescription-only use of the herb, and Nebraska has such a law, Siegner says. But the ephedra industry is working to change the Nebraska regulations, which he says were designed to prevent use of the herb in the manufacture of the drug methamphetamine.

Manufacturers of the supplement do support some ephedra laws. "The industry groups that work closely with ephedra are very much pro-regulation in terms of wanting to have regulations that set reasonable serving and duration limits and daily intake limits," Siegner says.

(From HealthScout)