S.3546 Dietary Supplement and Nonprescription Drug Consumer Protection Act

On December 9, 2006 at 3:06 am, Congress passed the On Motion to Suspend the Rules and Pass Bill S 3546. This bill was to amend the Federal Food, Drug, and Cosmetic Act with respect to serious adverse event reporting for dietary supplements and nonprescription drugs, and for other purposes. Click here for the specific voting results by party, state and region.

We agree with the stance of the American Association of Health Freedom -

"As the politically active voice of the healthcare practitioner and their patients, AAHF sees S. 3546 as part of a bigger picture that would like to treat dietary supplements more like pharmaceuticals and not as food as it currently stands. We believe that as soon as you accept differential treatment between dietary supplements (as concentrated nutrient forms) and conventional foods, you have given up very valuable ground.

S. 3546 would also discourage consumers from properly submitting their adverse events. Consumers should be discussing their adverse event reactions (especially “serious adverse events” as per the bill) with their healthcare practitioner rather than just sending a complaint to the manufacturer or retailer. There is a serious potential for abuse of the system and supplements could easily be blamed in place of things as divergent as pharmaceutical drugs, recreational drugs, genetic sensitivities, food intolerances, alcohol abuse, etc. A healthcare professional is crucial to determining the adverse event and ensuring that needless blame is not pointed towards the wrong substance.

Additionally, the FDA is already broken and this bill would just add to its misery. The FDA's own enforcement reports (for drug products) show it to be an agency under increasing pressure to do more with less. The number of warning letters issued to pharmaceutical companies has dropped over the past 10 years even as product recalls have increased. In other words, the agency is allowing more manufacturer product mistakes to reach the market. Adding supplements would reduce enforcement efficiency even more - for both drugs and supplements. This bill is a classic demonstration of the federal government wasting money to protect the public from a relatively small health threat on the part of dietary supplements. In fact, food is actually more dangerous than dietary supplements and cause 5,000 deaths and over 80 million hospitalizations a year in the US, according to the Centers for Disease Control.

We do not wish to discourage the dietary supplement industry in reporting their adverse events and we believe that over-the-counter medications should have a mandatory adverse event reporting process but S.3546 is not what is best for the American dietary supplement consumer."

If you agree, please take action and help us keep nutritional supplements available and affordable to us all.