Buying Safety

 

 

Written By:
Kaylynn Chiarello-Ebner
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Whenever I hear the New Jersey Lottery slogan, “Give your dreams a chance,” I can’t help but imagine what I would do if I won the big jackpot. I have a few earmarks nailed down: the local animal rescue center, college funds for my son and nieces, and my county’s homeless shelter and soup kitchen.

“Who else could really use a handout?” I always find myself asking. Recently, I surprised myself with a name that came to mind: our very own U.S. Food and Drug Administration.

Okay, so maybe I wouldn’t actually mail FDA a check, but I sure wish the U.S. government would!

More Funding? Hey, You Never Know…
As I write this editorial, the politicians in Washington are going back and forth (and back again) on the budget and debt ceiling. Tons of ideas are flying around about which programs and departments will experience the deepest cuts, and FDA is certainly on the chopping block. With a proposed 12% slash in its funding, the agency would have to make do with a lot less cash in Fiscal Year 2012 (and probably subsequent years, too).

You can’t get around the fact that the United States has huge money problems right now, and many departments and programs are going to have to tighten the old belt. But, come on. Does FDA really need to be hit this hard?

Let’s think about this for a moment. FDA oversees 80% of the food supply; I only need to mention the recent E. coli and salmonella outbreaks to convince you that the agency’s hands are spilling over with work. There aren’t enough inspectors to go around, and one could argue that some of those investigators could seriously benefit from more training (but there’s no money for that either). And though it has made strides to issue new and revised guidance documents, many people feel even more regulations are needed. Right now, for instance, FDA is trying to devise new rules to improve produce safety, but would it be able to do so with less cash? Estimates say it would cost $1.4 billion to implement the new food safety law.

I haven’t even mentioned FDA’s other jurisdictions, which include medical devices, drugs, cosmetics, veterinary medicine, tobacco and our very own dietary supplements. While we’re nowhere near where we should be, the agency has been busy creating and proposing all sorts of new guidance documents to ensure public safety in all these areas. In 2011 alone, it has issued recommendations tackling big issues like salmonella and eggs and, most recently, new dietary ingredient notifications (NDIs).

Whether you love it or hate it, one must commend the agency for putting together the NDI guidelines within its required 180-day timeline. And though the language isn’t 100% final at this point (we’re currently in the comment period), a very real likelihood is that the supplement industry will soon be forced to flood the agency with NDI applications for acknowledgement. There could be thousands of submissions before long—and just a small handful of FDA evaluators to manage them. With a shoestring budget, these staffers will be stretched further. How will they ever be able to handle the mountain of work? There’s no point of developing such regulations if the final step in the process (acknowledgement) is stymied.

And, what about FDA’s commitment to inspections? Would we see of drop off of these visitations that are so integral to ensuring food, supplement and drug manufacturing safety?

I believe the FDA budget should be growing, not shrinking. If not, the agency cannot make good on its charge to protect the public. There’s far too much at stake for penny pinching. WF

Kaylynn Chiarello-Ebner
Editor/Associate Publisher

Published in WholeFoods Magazine, August 2011