Losing Sleep Over AERs

Written By:
Kaylynn Chiarello-Ebner
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December and January aren’t just times for celebrating and making resolutions; these months are prime time for predicting the happenings of the coming year.

Many times, projections are positive and kind of fun. I heard from one company (Sensient Flavors) that 2013 flavor trends could include the sweet and smoky variety, cross-berry notes (blue honeysuckle berry or tropical mango–banana-esque pawpaw anyone?), comfort foods inspired (watch out for good old PB&J and French toast…yes, please!) and savory herb and spice blends.

There’s more. The Non-GMO Project says non-GMO foods comprised the fastest growing market area in 2012, and it is expecting the growth to continue into 2013. SPINS predicted several interesting trends for the New Year including vegan protein and nutrition-boosted gluten-free products, as well as hot ingredients like chia, monk fruit and coconut.

While no one can know with 100% certainty what’s in store for us this year, I think groups like these that monitor the industry can make some pretty good guesses. That’s why I was so concerned when expert after expert interviewed for our Lobbying Tips article (see page 60) expressed deep concern over one certain issue that could have a huge effect on the supplement industry.

What the Experts Say
All the trouble centers around adverse event reports (AERs), and a report that could come out in the first part of this year from the U.S. Government Accountability Office (GAO). First, some history.

Back in November 2011, Senator Dick Durbin (D-IL) and Representative Henry Waxman (D-CA) requested that the GAO figure out if the current AER for dietary supplements system is functioning well. So, Congress officially asked the GAO to determine how many AERs are coming from dietary supplements, the nature of the reports, who is submitting them and other information. A draft report has been floating around, but the final version could come to fruition soon.

According to experts interviewed, the biggest finding from the report might include a recommendation that reports of all events—not just serious ones—be filed. While this may seem like a subtle change, it’s not. Right now, “serious” is defined in a June 2009 guidance from the U.S. Food and Drug Administration (FDA) to include inpatient hospitalization, death or a life-threatening experience. Take out the “serious” element, and we’re talking about anything under the sun. Simply “feeling off” after taking Herb X would go on the books. Even anticipated events (skin flushing from niacin or diarrhea from very large doses of vitamin C) would be filed.

This would require a huge amount of time and effort from companies, with little gain to consumers’ safety. It’s unlikely FDA would have the staffing numbers to pull off any meaningful evaluation of AERs. Could it even cloud the informative reports that come through the current Medwatch system, or delay FDA’s attention in other important areas like facility visits? One expert I interviewed for the lobbying story said the situation was enough to make for many sleepless nights.

What We Can Do
So, if the report comes through in 2013, and if there are recommendations that could have such significant effects as those described, the lesson from the lobbying article is to get involved. Get behind any actions your trade group organizes to fight aggressive, restrictive and unwarranted proposed regulations. And most importantly, take the initiative to do your own company-specific activities, whether it’s calling on your own legislators in your own district or just writing letters/e-mails to lawmakers about how you feel. There are a lot of pointers for what to do in this issue.

The point is to do something. We can’t afford to let a few people on Capitol Hill determine the future of the supplement industry while we just stand idly by and watch. WF

Kaylynn Chiarello-Ebner
Editor/Associate Publisher

Published in WholeFoods Magazine, March 2013