"FDA generally cannot identify violative products before they enter the marketplace," said Michael Levy, director of the FDA's division of new drugs and labeling compliance, at a hearing of the Senate Judiciary crime and drugs subcommittee. "After products enter the market, we must undertake a painstaking investigative and analytical process" to show the products violate the law.
Levy said that makers of dietary supplements need not prove a product is safe unless it contains a new ingredient not previously part of the food supply. That allows unscrupulous companies to market products that can pose health risks, he said.
"Marketing a steroid product as a 'dietary supplement' conveys to the consumer a false sense of safety and legitimacy for these potentially harmful products," Levy said.
Daniel Fabricant, interim executive director and CEO of the Natural Products Association, which represents retailers, manufacturers, suppliers, and distributors of health foods and dietary supplements, said his industry was being "victimized by a guerrilla-style criminal drug-peddling operation." He said the solution was enforcement of current laws.
The subcommittee chairman, Arlen Specter (D., Pa.), a Phillies fan, said before the hearing that his interest was piqued in part by the case of Phils pitcher J.C. Romero, who was suspended for 50 games this season after testing positive for androstenedione, a substance that slugger Mark McGwire used in the 1990s and that baseball later banned.
Romero sued the manufacturer of an over-the-counter supplement earlier this year, arguing that it should bear the blame for his suspension because it misrepresented its products and ingredients.
"We're looking at whether there's adequate protection for consumers from getting these supplements which have steroids or steroidlike substances," Specter told the AP. "These tainted products can cause life-threatening injuries, such as kidney failure and liver injury."
Congress rewrote the supplement regulations in 1994. Some critics say the regulations are not strong enough.
Now, the Major League Baseball Players Association is pressing Congress to establish stricter reporting requirements for supplement-makers and tougher penalties for repeat offenders. The union is also lobbying Congress to require that supplements be analyzed by a federally certified lab that would verify ingredients listed on the label.
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