An outright ban on ephedra is looking likely after last week's hearing on the weight-loss herb but the momentum created by the case could also sweep along with it changes to regulation affecting the whole industry.
The two-day hearing,called by the House Energy and Commerce subcommittee on government oversight, heard from industry, government and scientists, as well as professional sports leagues, and the parents of two people whose deaths were linked to ephedra.
FDA commissioner Mark McClellan said that the agency's final decision on ephedra was near, after calls for public comment on the need for increased labeling provoked more than 16000 responses. But he also implied that the case of ephedra would reveal the potential of DSHEA to regulate the industry.
"Our intent is to give DSHEA the meaning in practice that many of its supporters say it should have, by clarifying that public health authorities can use the standard in the law to determine whether a product poses unreasonable, albeit uncertain, safety risks and then take appropriate regulatory or enforcement action," said McClellan in his testimony.
But comments from the House committee clearly reflected a desire for new legislation to expand the power of FDA to regulate dietary supplements. On Wednesday, Health and Human Services Secretary Tommy Thompson said supplement manufacturers should have to tell the FDA about potential side effects, as for pharmaceuticals.
"FDA is somewhat hampered. We are unable to really do as effective a job as possible," Thompson told Associated Press.
David Seckman, executive director and CEO of the National Nutritional Foods Association (NNFA), said: "Whatever the verdict is on ephedra, it has acted as a lever for Congress to begin prying apart DSHEA. Even if the FDA were to ban ephedra tomorrow, which we believe they have the ability to do under the law, I believe there's already too much momentum in Congress to avoid a full-scale legislative assault on DSHEA."
Although McClellan did not claim that DSHEA prevented the FDA from taking action against potentially dangerous products, he did say that DSHEA made enforcement more difficult and drawn-out, said NNFA. It argued that the agency has all it needs to clamp down on this particular supplement.
"A wealth of scientific information, expert testimony and consumer input already exists, including reports commissioned by the FDA itself, that the agency can use to determine once and for all whether ephedra presents a hazard to public health," Seckman told reporters. "We urge the agency to utilize its powers [as granted by DSHEA] for a swift regulatory resolution that will put this debate to rest and make hearings such as these unnecessary."
Also at the hearing, three Metabolife officials took the Fifth Amendment and declined to testify at the hearing. The Justice Department is investigating whether the company hid complaints of serious side effects from consumers of ephedra from the FDA.
NNFA is currently campaigning to support DSHEA through its online Advocacy Action Center.