Senate Bill 722

[Guest guest]

All,

In the latest issue of "Men's Fitness" magazine, there is an informative article on S-722. I'm not totally clear how my office ended up with a subscription to this big-muscles-and-better-sex rag, but this is a good article. The author, Jeff O'Connell, states that one of the primary reasons for the introduction of the bill is that the DSHEA law of 1995 has never been properly enforced by the FDA. He says many think that DSHEA weakened the FDA's power over supplements and herbs, but the reverse is true. DSHEA gave the FDA more power to regulate these things, but due to FDA staffers' philosophical opposition to the benefits of nutritional supple-mentation, they have dragged their feet on enforcement, thus allowing problematic situations to worsen for consumers. S-722 would make the FDA act more forcefully.

 

Under DSHEA, supplement manufacturers don't need to prove safety any more than food manufacturers do, but the FDA can remove any unsafe food or supplement from the market. Under S-722, an adverse-event system must be implemented, and one report categorized as "serious" shifts the burden of proof of safety onto the manufacturer, which costs could be in the many millions: see what it costs drug companies. Also, the expensive process of post-market surveillance kicks in when a serious adverse event has been reported, which is an expensive red-tape labyrinth with a short deadline: the surveillance plan must be provided by the manufacturer within 30 days of post-market surveillance initiation. Imagine some small company or herbalist having to hire lawyers and consultants and create such a legal FDA-worthy plan within 30 days.

 

Then there is the aspect of the bill excluding anything "chemically or pharmaco-logically related to testosterone," which reclassifies products such as DHEA (and who knows what kd yang herbs?) as prescription drugs, regulated by the DEA, no less. We must all contact our senators and tell them that the DSHEA is perfectly adequate to the task of policing this field, as long as the FDA does its job of enforcement, as the nation's law has been telling it to for the past eight years. Sorry for all the govt. abbreviations.

Joseph Garner