Ephedra Surfaces --- Again

The controversial stimulant ephedra seems to have nine lives. It continues to surface despite a federal ban and concerted efforts at both the federal and local level to expunge it from store shelves.

Recently, for example, U.S. marshals at the request of the Food and Drug Administration seized $150,000 of ephedra-related dietary supplements from distributors in Texas and Ore.

The targeted product is labeled as Nature’s Treat Energy Plus #1, an herbal source of ephedrine alkaloids that is distributed by Nature’s Treat, Inc., Gainesville, Texas and ACD Distributing, LLC, of Eugene, Oregon.

An FDA ban on the sale of supplements containing ephedra went into effect April 12, 2004, though at least one supplement manufacturer, Nutraceutical Corp. and Solray Inc. of Park City, Utah, has managed to avoid complying fully with this ban, following a recent District Court ruling earlier this year. In April, a U.S. District Judge in Salt Lake City ruled in favor of the supplement manufacturer, which contended that the FDA had not met the burden of proof that any specific dosage of the controversial substance was dangerous.

The FDA’s rationale for the recent seizure of supplement products in Texas and Oregan is that the ruling only allows the Utah-based company to continue to sell ephedra products at lower doses than Nature’s Treat products.

A number of serious side effects are associated with ephedra, including rapid heart beat, insomnia, nausea, headaches, vomiting and urination problems. Poison control centers throughout the country have reported more than 1,200 calls associated with ephedra use.

More than 155 deaths have been linked to the substance.

At Auburn University, Dr. Robert Keith, an Alabama Cooperative Extension System nutritionist and Auburn University professor of nutrition and food science contends that the problems associated with supplements, such as ephedra and similarly potentially harmful supplements, are the reason why an overhaul of the 1994 Dietary Supplement Health and Education Act is long overdue.

“Supplement makers should be held to the same exacting truth-in-labeling standards as drug manufacturers, though they aren’t under the current law,” Keith said. “Congress also should consider requiring warning labels on supplement products to remind consumers that the health claims associated with many of these products simply aren’t true or haven’t been scientifically tested.”

Under federal law, drugs must be tested and shown to be safe and effective before they are allowed on market shelves. With supplements, on the other hand, the government must show they are harmful before they can be removed from shelves.

Ironically, even if the FDA manages to overturn the District Court ruling and enforce the ephedra ban to the maximum degree possible, the substance still will be widely available.

The FDA’s ban on ephedra specifically excludes uses of the herb in traditional Eastern medicine. Teas, pills and powders containing ma huang, a type of ephedra, are commonly used with acupuncture and other Eastern medicinal practices to treat common ailments such as colds, headaches asthma and chronic coughs --- and still are, despite the ban.

Posted by Jim Langcuster at December 7, 2005 03:25 PM | TrackBack