Senator moots premarket approval for supplements

By Guy Montague-Jones

- Last updated on GMT

Related tags Orrin hatch

Senator Arlen Specter put forward the idea of premarket government approval for dietary supplements at a senate hearing yesterday on hidden steroids in body building products.

Congress called the subcommittee hearing to investigate the dangerous and illegal practice of selling body building products made with steroids as dietary supplements.

One of the highest profile victims of this trade was allegedly Philadelphia Phillies pitcher J.C. Romero. He claims to have failed a drugs test after having taken a supplement containing illegal steroids.

His case partly sparked the interest of Phillies fan and Democratic senator Arlen Specter, who chaired the hearing on the problem yesterday.

Law change

On hearing Travis Tygart - CEO of the US Anti-Doping Agency - call for more regulation, Specter raised the possibility of making it a legal requirement for supplement makers to get government approval before products hit the market. He said: “The question arises whether there needs to be a change in federal law.”

The Food and Drug Administration (FDA) is currently struggling to prevent illegal products reaching the consumer.

In his testimony, Michael Levy, director of FDA’s new drugs and labelling compliance division, said: “FDA’s ability to solve the problem is limited."

“Because FDA generally does not receive information on these products prior to marketing, FDA generally cannot identify violative products before they enter the marketplace."

“After the products enter the market, we must undertake a painstaking investigation and analytical process to show that they are violative.”

Enforcement problem

Representatives of the legitimate supplements industry have called for more resources for FDA to help them enforce the law rather than for changes to existing laws.

“Companies that are willing to ignore current laws would also ignore any new law,”​ said American Herbal Products Association (AHPA) president Michael McGuffin. “Enforcement is a better answer.”

Loren Israelsen, executive director of United Natural Products Alliance (UNPA), had a similar message saying FDA is “chronically underfunded and understaffed”​ and the priority should be on improving its ability to enforce the law.

Republican senator Orrin Hatch, who flanked Specter as the only other lawmaker at yesterday’s hearing, lent his support to the supplements industry.

Hatch emphasised the need for better enforcement of existing laws and called for more resources for what he called an “overburdened” ​FDA.

Related topics Regulation GMPs, QA & QC

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