Urgent Action Alert: The Leahy Bill is BACK!

April 12, 2011
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congressWe 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.

“Adulterated or misbranded”

The bill hangs on the “adulterated or misbranded” language in the FD&C Act, language that is so vague as to be absurd. To our ears, “misbranded” suggests deliberate misstatements about the contents or efficacy of a product. But in the FD&C Act, “misbranding” (section 403) takes on a completely different meaning. It can mean that the producer makes a completely true statement about the product but without FDA permission.

The Act specifically says that misbranding has occurred if a claim is made on the food label, which characterizes the relationship of a nutrient to a disease or a health-related condition. Here’s an example: research from Harvard suggested that cherries could reduce heart attack risk. FDA did not allow cherry producers, sellers, or manufacturers to talk about that research, and sent a cease-and-desist letter to twenty-nine companies telling them to stop making claims about these health benefits or face fines and jail. At least in this instance, the FDA could not threaten a ten-year jail sentence.

Only after a food or ingredient is taken through the New Drug Approval process can a manufacturer educate consumers about the potential of the supplement or food to prevent or treat disease. This is an expensive process—and since food and dietary supplements are natural they cannot be patent protected, which means manufacturers could never hope to recoup the millions (sometimes billions) of dollars necessary to go through the NDA process. Food manufacturers cannot even cite legitimate peer-reviewed science on their website without being guilty of misbranding—and thus subject to up to ten years in prison.

The other word is “adulterated.” To most people, it means that a product doesn’t meet good manufacturing practices, that the supplement itself is somehow tainted or injurious to health, or contains an ingredient that presents a significant risk of illness. But under the FD&C Act, “adulteration (section 402)” says that a dietary supplement is considered adulterated if it does not follow “current good manufacturing practices” (CGMPs)—which are extremely broad, even containing such minor provisions as record-keeping practices. In other words, the FDA could threaten a ten-year jail sentence for minor paperwork errors if the agency took the position that the bill did apply to supplements.

Would the FDA actually try to send someone to jail for ten years, using the new bills’ expanded jail time, for citing science or for paperwork errors? As unlikely as it might seem, the Agency’s past behavior suggests that they would at least threaten it to get food or supplement producers to sign draconian consent decrees.

Where do we go from here?

We would support the Leahy bill if an amendment is offered which addresses its current vagueness and which also carves out certain exemptions in the definition of misbranding and adulteration, or better yet, defines them anew instead of referring to the extremely broad and vague FD&C Act.

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 contact your senators immediately and ask them to amend or stop this bill.

TO SEND YOUR MESSAGE TO CONGRESS

Click THIS LINK to go to the Action Alert page. Once there, fill out the form with your name and address, etc., and customize your letter. We have a suggested message for you, but please feel free to add your own comments to the letter.

We’d also love to hear your comments about this article—just add your thoughts below—but remember that the messages below are only seen by our ANH-USA readers and not Congress, the FDA, etc.

65 Responses to “Urgent Action Alert: The Leahy Bill is BACK!”

  1. Dave Buckingham says:

    The note I sent went only to my senators so it won’t do anything to stop my representatives from passing the same bogus legislation. Please correct this emailing problem.

       1 likes

  2. Vicky Rowe says:

    Sadly, we get the government (and thereby the agencies) that we deserve. Until more than 15-18% of the people turn out to vote, we will continue to get sub-standard officials, because the American public does not stand up and take back their government.

    The ‘good’ (not really, but read on) thing about this blatant disregard for the safety of the American public is that sooner or later (hopefully sooner), something will happen that will tip the balance and make people wake up to what is happening. Then we will see a trend towards greater health, rather than towards cheaper more processed foods.

    We *can* change this. We outnumber the corporations and the government. There are over 400 *million* Americans. If we truly wish to change this, we can, but it will take *numbers* and action.

    Speak up, early and often. Vote with your pocketbook. Buy local and organic. If enough people stop purchasing the processed crap, then changes will happen. If no one uses GMO products, it will not be profitable to use them.

    Corporations, the government and the FDA are driven by profit. The most effective method of getting their attention, and to force them to change, is to negatively impact their profits. Do that enough, in great enough amounts, and we get what we want. But it must be consistent, concerted effort to avoid *all* processed food, *all* GMO products, *all* dangerous Big Pharma products, etc. Until we’re willing to spend more money, and commit to avoiding ‘convenient’ foods and meds, nothing will happen.

    We, the people, can change. But first we must change.

       0 likes

    • Lily says:

      Thank you for putting it so well and I hope the American people will stand tall and defend what is right and what is good for all America. Thanks again.

      Lily

         0 likes

    • Carolyn S. Wade says:

      Unfortunately, there will be no intensive testing of any natural ingredients or products, because they cannot be patented.

         0 likes

    • We need Jamie Oliver’s FOOD REVOLUTION to be advirtised more and more on TV—so it reaches more and more people to hear that something CAN be done to stop this if we join together and demand people eat better—because it is PROOVEN that it has a very direct effect on your health. People need to hear this, learn this, be aware of the truth and direct coorelations between the KIND of food you are putting in your body and your health….. People need to ask themselves….gee –WHY has Cancer been on the rise continuously over the years !!!???? Gee, ya think it could be all the garbage most Americans are eating!!!! Not a truer statement then— YOU GET WHAT YOU PAY FOR—- Buy less food, but better quality food and maybe, just maybe you can afford it!!!! Can’t use the excuse—oh, I can’t afford to buy organic—— In my opionion—-you can’t afford NOT TO!!!

         0 likes

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