The Guillotine for Supplement Manufacturers?

T he food police are stepping up their cadence—sounding more like the rock-crushing knell of jackboot-wearing marchers in the streets of Europe during the 30s and 40s. Under a piece of legislation unanimously approved by the U.S. Senate Judiciary Committee on September 24, 2010, certain food safety violations would be felonies, rather than mere misdemeanors. Major felonies. Entry level felony jail sentences start at 1–2 years. The Judiciary Committee is taking about 5–10 times that amount for adulteration and misbranding!

Called the Food Safety Accountability Act (S. 3767), the legislation was introduced just weeks ago by Sen. Patrick Leahy (D-VT), chairman of the committee. If this bill is passed, anyone who knowingly introduces or delivers tainted food into interstate commerce, or contaminates—there are already strong laws to punish anyone who commits this crime—or mislabels any food (or supplement) in the U.S. food-supply chain would be subject to severe penalties. Presently, such violations do not typically result in jail time. But Senator Leahy has said fines and recalls do not seem to be sufficient deterrent to those who produce or supply contaminated food. What is sufficient? Under the proposed law, individuals who flout food safety regulations or dare to make any reference to scientific literature or allude to diagnosis, treatment, cure, or disease would be guilty of misbranding and face steep fines and prison sentences of up to 10 years.

What does misbranding have to do with food safety? This sounds like another example of Congress not wanting to let a good crisis (the recent egg contamination) go to waste. Considering the bill’s shortness, why does its text leave the food safety subject immediately, and move on to misbranding? Realize that the FDA contends that any food or supplement producer who mentions or even hints at the potential of a product to prevent or treat disease is guilty of misbranding. That’s true even if the product has mountains of peer-reviewed published scientific studies associated with it, including papers from research teams at the top institutions in the country. If this is the basis for “misbranding,” which might lead to the prospect that some offenders might spend the rest of their lives in prison, then “something is rotten in the state of Denmark.” The better your science, the more guilty you are.

Assuredly, the FDA will use this new stick to go after its prey by intimidation and harassment. They will unfairly punish. The word “misbranding” has no place in this bill. It vastly increases FDA power over food and supplement producers without enhancing food safety in any way.

Part two of the bill’s problems is the concept of contamination as “adulteration.” The legal definition of adulteration, which like “misbranding,” is highly technical and frequently ambiguous. Consider that the FDA’s current interpretation defines adulteration to include minor and unintended administrative and clerical errors. Are these felonies?

Problem three is that the bill is sloppily written—that’s not new, but this goes beyond the pale—which can be dangerous when the time comes to enforce the law. What exactly does the word “knowingly” mean? If someone “knowingly introduces” the product into commerce, or “knowingly adulterates” it, what does that mean? And, if so, does that deserve a draconian penalty, such as 10 years in prison? Moreover, the bill applies to the seller, but not necessarily the original contaminators (and if that was necessarily intentional).

The original House food safety bill was introduced by Rep. Henry Waxman back in July and included these kind of jail sentences. The Senate Committee on Health, Education, Labor, and Pensions (HELP) rejected them, and at that time, contesters were assured by key senators that the Senate would not allow them to be added in conference with the House. However, the new Leahy bill end-runs around HELP by putting the Senate on the record as being in favor of these jail terms for misbranding and adulteration. In all likelihood, if the Leahy bill passes, it will be combined with the Senate food safety bill, and the final conference bill will then almost certainly contain the long jail terms.

As with the recent McCain bill, it is very possible that Sen. Leahy does not fully understand what his bill is doing. It is also possible that the impetus for the Leahy bill may have come from Congressman Waxman in the House, but this is speculation.

The U.S. has an admirably safe food supply that is the envy of the world, with few contaminations and few attributable illnesses. So how do we rate this kind of legislation? There must be something else involved. Could it be the pharmaceutical industry? They are the largest contributors to Congress. Would they benefit if they didn’t have to compete with the supplement industry (see the article, “Slow Down Brain Shrinkage,” starting on page 11, for what’s going on in Europe). We are in a double dip recession. The new regulators have just knocked out a billion dollar drug (see the sidebar on page 7). There may be desperation involved.

When Sen. McCain proposed an earlier version of this bill last spring, he was talked out of it by Sen. Orrin Hatch. Guess what? Sen. Hatch is on the U.S. Senate Judiciary Committee and if it was truly unanimous (Sen. Hatch was present), he just signed off on Sen. Leahy’s bill, along with the rest of the Committee. To Sen. Hatch’s credit, he has since issued an “opposition” statement, but it is mild and likely to be ineffective. What particularly concerns us at the moment is that the Senate might pass this dreadful legislation right away before leaving to go campaign. That’s why we need everyone to take action without delay.

If this gets to you in time, please write or contact both of to your senators immediately and ask them to stop this bill! Do this now! The life you save may be your own.

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