Why Support Adverse Event Reporting for Dietary Supplements

One trait that makes the natural products industry such a powerful grassroots force is the willingness of our retailers to go to bat for issues that are important to our industry. But it is this very passion, characteristic of both our retailers and their customers, that some have sought to exploit in recent years through misinformation campaigns and scare tactics. For instance, last summer’s alarmist message was that international regulations would force dietary supplements off store shelves and result in massive closures of health food stores by August. Of course, the passage of time eventually disproved this rumor, but not before causing many retailers to become fearful about their future.

The latest industry scare is adverse event reporting (AER) legislation for dietary supplements. According to critics of this bill, although the details may differ, the bottom line remains the same: dietary supplements will be forced out of the marketplace and health food stores will have to shut their doors. If you’re a member of the Natural Products Association (NPA), then you already know we support S. 3546, the Dietary Supplement and Non- Prescription Drug Consumer Protection Act (or the “AER bill”) and believe it will benefit, not harm, the industry. We stand alongside two of the dietary supplement industry’s most ardent supporters, Sens. Orrin Hatch and Tom Harkin, who co-sponsored the bill. Both these senators, who were also responsible for the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994, made sure that important safeguards were included in the AER legislation, particularly for retailers.

Two important facts retailers should be aware of. First, this bill does not require retailers to report adverse events to the Food and Drug Administration (FDA). In fact, retailers who do not sell product under their own name are not required by this bill to do anything. Those retailers who have private label lines are also not required to report adverse events and can simply refer any customer complaints to the manufacturer of the product. Second, the AER bill only requires reporting of serious adverse events. Those conditions that would qualify as serious are well defined in the bill and do not include minor health problems like an upset stomach or headache.

The NPA supports this bill because it would:

After 70 years of representing the natural products industry, we have a strong track record in supporting legislation that helps our members thrive while keeping attempts to over-regulate at bay. Those who were active in the industry in the early 1990s may remember that there were people who felt DSHEA would be bad for the industry. As we all know now, nothing could have been further from the truth.

Ultimately, we believe the AER bill will benefit the industry in two important ways: Answering critics of the dietary supplement industry who say it is not well regulated; and, over time, substantiating what many in the industry have known all along—that the safety record of dietary supplements is exemplary. And finally, safety reporting is the right thing to do. A responsible industry puts consumers first. By doing so, we will increase consumer confidence and earn the corresponding benefits.

Share this article: Email, Slashdot, Digg, Del.icio.us, Yahoo!MyWeb, Windows Live Favorites, Furl
Add this article feed to: RSS, My Yahoo, Newsgator, Bloglines

Read Comments [0]