WASHINGTON – Senators criticized the Food and Drug Administration Tuesday for failing to regulate potentially harmful dietary supplements.
Sen. John McCain,R-Ariz.,chaired the Committee on Commerce's hearing and drilled John Taylor,the FDA's associate commissioner for regulatory affairs,with questions.
Speaking of harmful products,McCain asked,”How many lives are destroyed before you decide it should be banned?”
He criticized the agency for taking nine years to write a single rule to enforce the Dietary Supplements Health and Education Act of 1994.
The act allows the FDA to ban the sale of specific dietary supplements or an entire class of supplements if it poses an imminent health risk. The act also allows the FDA to stop a new dietary ingredient from being marketed if the safety data is insufficient.
McCain asked Taylor what the FDA was doing to notify consumers about health risks and why it doesn’t require supplement manufacturers to report adverse effects. And he asked when the FDA will complete research on steroid precursors,supplements that turn into steroids only after they are ingested.
The senators also heard from a former high school football player who suffered ephedra-induced seizures.
Greg Davis,21,now a student at the University of San Diego's law school,began taking supplements containing ephedra,a stimulant,more than four years ago to maintain his competitive advantage after other players began taking it.
He said he researched the product and was “really reassured about its safety.”
Two months after he began taking the product,he suffered his first grand mal seizure. He was rushed to the hospital,but tests came back negative. Doctors sent Davis home,telling him “sometimes these things happen,” Davis said.
The next year,Davis was driving to a friend’s house when he suffered a second seizure. This time,his car veered off of the road and came to rest against a tree. Davis said he considers himself lucky because “the tree was right next to a 20-foot drop off.”
Once again,doctors could find nothing abnormal. But,this time,when they ran a blood test,it came back positive for amphetamines.
“Most young people who purchase something expect it's going to be safe if used as directed,” said Davis,who stopped taking the supplement. “Ephedra caused me to have these seizures.”
Senators asked if other legislation is needed to support the 1994 law. Taylor said the agency hasn’t had the time or money to properly enforce the law.
Taylor said the FDA has sent warning letters to a number of companies and seized and destroyed unsafe supplements. He listed 34 enforcement actions in his prepared remarks.
Taylor said the FDA is reviewing the science of steroid precursors and is “working to determine how to classify them.”
But Taylor said that,under current rules,pre-market approval is not required for dietary supplements. Adverse event reports are strictly voluntary.
McCain said the use of dietary supplements by adolescents is “a growing problem that is going to deserve our attention.”
He said he is concerned that young people will be tempted to use the same supplements that some professional athletes have used.
Terry Madden,CEO of the U.S. Anti-Doping Agency,said steroid precursors should not be on the market. Steroids help build body mass.
“It’s illegal to sell a steroid without a prescription,” he said. “But currently it is perfectly legal to sell a pill that creates the steroid in the body.”
He argued,”Congress would take immediate action to prevent a pill that,once swallowed,would metabolize into cocaine from being sold over the counter.”
Recently a number of stores,including Wal-Mart and Walgreens,stopped selling products containing ephedra. But the FDA has only issued warnings about its use and has not ordered it off the market.
David Seckman,executive director and CEO of the National Nutritional Foods Association,which represents supplement makers and sellers,said just because ephedra is still on the market does not mean the supplements law is ineffective.
“No matter your opinion on the safety or effectiveness of ephedra,what should be indisputable is that [the law] clearly provides the FDA with the power to take unsafe products off the market,” Seckman said.