November 8, 2001 - Legal Issue Murky without Tough Laws on Dietary Supplements
The ephedrine debate goes beyond sports. In the big arena, the rules are according to ''Da-Shay.''
That's the federal Dietary Supplement Health and Education Act (DSHEA) of 1994. In lobbying for the law, the industry argued it would make beneficial products available and limit excess regulation.
The law defines ''dietary supplements'' to include, in part, products containing vitamins, minerals, herbs and other plants. Some have been dubbed ''sports supplements'' because of their use in athletics, and some of those have drawn scrutiny:
* Creatine, a synthetic form of a substance found in some foods and made by the body, is sold as a muscle builder. There are anecdotal reports it causes cramping and other problems. Its long-term effects are unknown.
* When baseball's Mark McGwire set a home run record in 1998, he used androstenedione. It's not banned by baseball. It is banned as a steroid by the NFL, NCAA, NBA, pro tennis and the Olympics. McGwire said he stopped his use in '99.
* Now it's ephedrine, a natural stimulant from an herb. Manufacturers says it's a safe weight-loss aid and energy booster. Critics say it can be deadly.
FDA
Firms don't need Food and Drug Administration approval to market a supplement. For the FDA to ban one, it would have to show ''unreasonable risk of illness or injury'' under use recommended on the label or ''ordinary . . . use.''
The Public Citizens Health Research Group, a consumer group, has petitioned the FDA to ban ephedrine. Larry Sasich, a pharmacist with the group, describes the industry stance as the ''tobacco defense.''
''For 60 years, the tobacco industry was successful in court because they could argue we don't have any scientific studies that show a cause and effect relationship between smoking and cancer,'' Sasich says. ''When the weight of evidence gets heavy enough, you say, 'This is a problem. Do something.' ''
Sasich's group points to FDA data linking ephedrine to 80 deaths since 1993, but he admits proving a connection in court is different: ''It would wind up in court, and we don't know what standard the court might require.''
In 1997, the FDA proposed a regulation to limit daily dosages of ephedrine and ban mixing it with caffeine.
In 1999, the Government Accounting Office criticized the scientific foundation of the proposal. It said FDA data on ''adverse events,'' including the deaths, weren't substantiated. The proposal went nowhere.
Says Wes Siegner, counsel for the industry's Ephedra Education Council: ''If there was real evidence ephedra was out there killing people, this (a ban) would have happened years ago. The problem is the FDA basically knows adverse events aren't real scientific data.''
Most ephedrine labels say not for use by persons younger than 18 or pregnant. They recommend consulting a doctor before use if you have a history of certain illnesses or are on medications.
Industry groups have made their own proposals to the FDA for limits of daily servings, but they're about four times higher than the FDA's proposal.
U.S. Rep. Henry Waxman, D-Calif., says the FDA might need ''stronger legislation . . . to protect the public.'' He adds, ''Since 1994, it's pretty clear that the FDA has been hampered by that law.''
But he's not optimistic Congress will act. ''The industry has been very powerful in making sure that it can bottle up any legislation,'' he says. ''As there are more tragic stories of . . . young athletes reported, maybe the prospect for legislation will brighten. But at the present time, it's quite remote.''
But the FDA isn't powerless. Last week, at the FDA's request, U.S. marshals seized 140,000 bottles of a weight-loss product sold on the Internet.
The FDA alleges the product, AMP II Pro Drops, contains an ingredient prohibited from use in dietary supplements -- ephedrine hydrochloride, a synthetic categorized as a prescription drug. The product is marketed by E'Ola International of Utah.
Legal assaults
On the Internet, law firms offer consultation to those who think they've been harmed by ephedrine.
In May, a jury in Kansas found that Shane Garrett, who had a heart attack in 1997 at age 22 after using an ephedrine drink before lifting weights, was equally at fault as the manufacturer. No damages were awarded.
The company, Weider Nutrition International, maker of Ripped Force, argued Garrett had asthma and failed to heed a label warning. Garrett's suit said he suffered brain damage after going into a coma and claimed the product was dangerous and the label inadequate.
E'Ola International, raided last week by U.S. marshals, also lost a court case last February in Alaska. A jury awarded $13 million to a woman who suffered a stroke after taking AMP II Pro Drops, the same product confiscated last week.
The jury ruled that the company misled customers by marketing the product as ''all natural'' even though it contained the synthetic ephedrine hydrochloride.
Some ephedrine suits have been settled out of court.
Attorney Patrick Keegan of San Diego currently has a class-action suit in California against Starlight International Inc. over a product called NaturalTRIM.
''When these cases started . . . the labels were really lackadaisical,'' Keegan says. ''As the industry has increased their warnings, certain cases are tougher. But there are still a lot of other warnings they should give.''
Attorney James Frantz of San Diego, also involved in ephedrine suits, says there could be more fallout from legal cases. ''I think if there are enough verdicts against the companies,'' he says, ''it puts them on pretty substantial notice that there is something wrong with their products.''
Siegner on the suits: ''My best guess is that it's not that big a deal. The insurance companies are still covering companies making ephedrine products.''
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