Who’s protecting you? From what?

The FDA, for a long time, has been tinkering with the idea that it ought to be protecting you — from the horrors of using, say, supplements to treat medical symptoms.

Here’s a draft “Guidance” document here that outlines the agency’s “current thinking” on the matter. It boils down to something like this: We, the FDA, say we’re in charge of a whole bunch of things you guys are running around with more or less on your own right now.

They aren’t proposing regulatory changes. They’re just claiming turf; the document outlines their reasoning in the turf claim (this is stuff you eat; this is stuff you use to address certain medical conditions).

Here’s the comment that I’ve submitted:

Hi. Given that resources are limited, I think it’s a poor use of the FDA’s time to expand its mandate to cover relative innocuous substances like probiotics. You have more important things to do, such as preventing the contamination of produce with feces, as one example, or figuring out how to trace cows that die of mad cow disease.

I am also concerned that expanding your mandate as outlined by this document strays dangerously close to suggesting that you should be regulating the use of foodstuffs, if they’re ingested to promote health or address medical symptoms. So, if I eat carrots and that improves my night vision, have I suddenly rendered myself subject to FDA oversight? How about if I switch to whole wheat bread for constipation? It’s a gray area; the functional line between drugs and foodstuffs is bound to become more & more blurred as science increasingly links diet and health, and I believe strongly that the FDA should exercise extreme discretion in formulating any wording that might serve to pervert an individual’s right to modify his diet for health reasons, or that might make it more onerous for healthcare providers to advise individuals on these issues.

I object to your suggestion that probiotics should be listed as “biological agents.” Does this give you the right to regulate the critters that occur naturally in the gut? How about in breast milk? Are you staking out territory that may one day mean I can’t culture yogurt, unless I promise I’m eating it just for the taste?

Last but not least, alternative health care is in many cases much more affordable than mainstream health care, and I’m concerned in general at the potential for overregulation to make it less affordable. The relative affordability of alternative HC is, in my opinion, an incentive for people to use it; insofar as it helps some people adopt healthier lifestyles and address symptoms before they’ve reached a more critical stage, it helps reduce the overall societal cost of healthcare in the US. If you make it more expensive, this benefit will be blunted, if not lost completely.

Please leave “CAM” alone. You’ve got better things to do, and the alternative healthcare industry is managing quite well without you getting more involved than you already are.

If you want to get in on the conversation, here’s where you can submit your comment. Deadline is April 30.

[tags] FDA Draft Guidance for Industry on Complementary and Alternative Medicine Products [/tags]

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2 Responses to Who’s protecting you? From what?

  1. If I might be so bold as to summarize your VERY well-written and well thought through comment into a “bumper sticker” snippet, it would be, “It ain’t broke, so butt out of trying to fix it!”

    I think I’ll submit that as MY comment, and then reference yours!

    John

  2. Kirsten says:

    What I really want to know, John, is what you think about FSAs . . .

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