The Alliance for Natural Health
4/12/2011
We fear that the vague language and ten-year jail term in the bill will be misused by the FDA to threaten innocent natural health food and dietary supplement producers. Please take action to amend or stop it.
Last year’s bill to increase criminal penalties for “misbranding” or “adulterating” foods from a maximum of one year in jail to a maximum of ten has been reintroduced. The problem lies in how these terms are defined. And the bill’s on a fast track.
In the previous session of Congress, Sen. Patrick Leahy (D-VT) introduced S.3767, the Food Safety Accountability Act. We opposed the bill, in part because it established fines and/or imprisonment for up to ten years if one were to:
(1) introduce or deliver for introduction into interstate commerce any food that is adulterated or misbranded; or
(2) adulterate or misbrand any food in interstate commerce.
The big sticking points were the way FDA defines “adulterated” or “misbranded,” and the fact that the bill originally didn’t require there be any intent to harm—so that a paperwork error could be treated just as harshly as a corporation that knowingly sells tainted food.
Working with Congressional leaders, we were successful in getting the language changed so that “with conscious or reckless disregard of a risk of death or serious bodily injury” was included. This wasn’t perfect, since the FDA could claim any intent it wants to—better to require actual harm of at least some kind. And the problematic “adulterated” or “misbranded” terminology remained. Fortunately our readers and others took action and the bill died.
Now the bill has been re-introduced in the Senate as S.216. The language is better. First, the jail term now is for violators of specific sections of the Federal Food, Drug, and Cosmetic Act (FD&C) who knowingly and intentionally defraud or mislead and do so with conscious or reckless disregard of a risk of death or serious bodily injury. And second, the jail term applies to food violations, which the Senate Judiciary staff confirmed with ANH-USA would in this instance exclude dietary supplements, although based on their past behavior the FDA may not interpret it that way.
In addition to the risk that the FDA will interpret this bill in whatever way it wishes, a risk that could be fixed with more explicit language, there is a further major problem…
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