The Dietary Supplement AER Bill

American Association for Health Freedom would like to thank Senators Hatch and Harkin for their work on S.3546 the Dietary Supplement and Non-Prescription Drug Consumer Protection Act (the AER bill). We appreciate their long-time support and belief in the right of the consumer to access dietary supplements. Ultimately, after careful review of the bill, we DO NOT support S. 3546.

If S. 3546 becomes law, it will amend the federal Food, Drug and Cosmetic Act to require the reporting of “serious” adverse events for both over the counter (OTC) drugs and dietary supplements to the U.S. Food and Drug Administration.

As the bill has already been voted on by the HELP Committee, we need you to take action today and encourage your contacts to do the same. We must move fast to make our voices heard. Click here to contact Congress.

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.

Because we’re all about the consumers right to choose and be informed, we wanted to let you know that if you decide that this a bill that you want to support, please visit Citizens for Health or National Nutritional Food Association for more information.

Brenna Hill
Executive Director
Health Freedom Foundation and American Association for Health Freedom
4620 Lee Highway, Suite 210
Arlington, VA 22207
1.800.230.2762
Fax: 703.294.6380
www.healthfreedom.net