President, Strategic Communications, LLC

Tuesday, August 28, 2012

Will FDA Preempt Prop 37 and the Dance of Legislation?

In our crazy quilt of food law, pepperoni pizza is regulated by the USDA and cheese pizza is regulated by the FDA. Food labeling requirements promulgated by the USDA preempt all state labeling on meat products, since the Federal Meat Act contains explicit preemption language. Not so, for the Federal Food Drug and Cosmetic Act, although many food law experts believe FDA has implicit authority to preempt state labeling requirements that the Agency believes is not in the public's best interest.

California voters this November will cast a ballot on whether foods containing GMO ingredients should bear a consumer warning, the equivalent of a skull and cross bones, notwithstanding that every public health agency in the world have found these foods to be safe. And, in Europe and in other countries where labeling is required, the politicians and regulators will tell you the decision to label had nothing to do with science but everything to do with the power of the "Green" political movement. Fear of political retaliation, not science forced the decision.

Since 1986 California has been the chief cause of concern about preemption and the chief stumbling block for food industry attempts to have Democratic and Republican Administrations' FDAs create a uniform market for labeling.

Despite the law and practice, the reason why we do not have one uniform national market is the simple political truth -- California has too many electoral votes to mess with.

So, the scientific community, the activists in California and the food industry have been performing a "who will blink first" ballet for years. Each side has honed their skills through endless litigation, rehearsals and intense lobbying.

One example of this foolishness involved the birth defect warning required under Proposition 65, the so-called Consumer Warning Initiative, passed in 1986, which required the state of California to warn consumers of "chemicals known to the state to cause cancer or birth defects." The warnings would be on product labeling and be a figurative skull and cross bones.

In its review of chemcials, the Proposition 65 Scientific Advisory Board (SAB) came across Vitamin A. To make a long story short, it turned out the amount of Vitamin A added to milk sold to school children would have triggered a birth defect warning. Now, this raised a huge problem and the ballet started.

At the end of Act II, the SAB did not want to look like fools to their peers and they were loathe to list Vitamin A but the law is demanding. The dairy industry was aghast, to say the least. The FDA  made it clear it would be very unhappy. Legislation began to move in Congress to preempt the Proposition.

Then, near the end of the production, it dawned on the activists that they may have created a monster, one which will devour them. Federal preemption would kill the California law. As deadlines inched closer, as both sides looked over the precipice, a solution appeared -- the activists agreed to be quiet if Vitamin A magically disappeared from its birth defect warnings list. Presto, chango, Vitamin A was gone. Both sides shifted from warp speed to impulse power.

Then a few years later, FDA was confronted with a similar challenge. This time from rBST, a natural hormone which allows milking cows to produce more milk. Milk produced with rBST is identical in every was to milk produced without rBST. There is no laboratory test that can distinguish between the milk. Ben and Jerry were appalled. Small dairy states besieged the FDA with plans to label milk produced with cows not taking rBST. FDA, as always, took the petitions under advisement.

Lots of time passed. Legislation was introduced, the orchestra began to play the overture and then in a stroke of biblical genius, FDA arrived at a solution. It cut the baby in half, just like King Solomon. It allowed the dairies that did not use rBST to make a factual statement that they did not use it but, the Agency required that a new sentence, a science based disclosure that said, "it didn't matter."
So, today, for example, Special Request Skim Plus milk marketed by Farmland Dairies in Wallington, NJ carries a side panel declaration stating:
*Delicious 100% real milk [as opposed to unreal milk] produced from cows not treated with rBST. The FDA has found no significant difference from milk derived from rBST treated cows and those not treated."

The orchestra stopped.

If President Obama wins reelection and Prop 37 passes, the food industry may once again strike up the tune. FDA will be reluctant, as always, to act, but with GMOs in 80% of processed food they really will not have much of a choice? Perhaps King Solomon will be called on again.

However, now may be the best time since 1986 for the food industry to strike. With the "Knuckle Draggers" as Speaker John Boehner (R-OH) fondly calls his Tea Party Caucus, firmly in control of the House, preemption legislation could zip ripe through. The GOP Leader in the Senate would jump at the chance to give FDA and the Obama Administration more problems that either one of them need. Of yes, California Sen. Barbara Boxer will scream, but who cares -- California's electoral votes will not be in play for three years.

If Gov. Romney gets elected, an order to FDA to preempt is certainly possible.

In the spirit of transparency, I do not have a dog in this fight - yet.

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