OJ and Cheerios for Breakfast

A good American breakfast: a great way to start the day. And also, perhaps, a great way for a new leadership team at the Food & Drug Administration to start its tenure.

And keep in mind: It is one of the ironies of leadership at FDA that the more the public views the head of the agency as a tough, anti-industry regulator, the more ambitious the agency can be in taking on initiatives that benefit the regulated industries.

Just as a generation ago (18 years being a good regulatory generation), a new young FDA commissioner, David Kessler, used an attack on orange juice labeling to establish the tone for his tenure in the public’s mind, the new Obama Administration FDA leadership – headed in the interim until Margaret Hamburg’s pending confirmation by Deputy Commissioner Josh Sharfstein -- is going after another iconic breakfast food to flex its muscle.

FDA’s warning letter to General Mills attacking Cheerios’ cholesterol claims can be read as a message to all food and dietary supplement manufacturers that make any type of health claims on their products: hew tightly to FDA’s claims regulations and approved language, or else. FDA claims that the reference to specific percentage cholesterol lowering claims push Cheerios labeling in the realm of new drug claims.

But the agency gets more from the action against a product like Cheerios than just a message to the food industry.

Because of the almost universal brand recognition for Cheerios, any action by FDA against the product is certain to stimulate broad public comment – from amusement to agreement. It is a great way to get FDA talked about, in terms of taking an action instead of reacting to an event. The publicity can re-establish FDA in the public’s eye as a force that is willing to take on big commercial products.

This is the agency’s clearest message yet since the administration transition that things are going to work a little differently in the regulated industries than they have over the previous eight years.

General Mills uses a soluble fiber claim the agency approved years ago, but the agency says certain variations in the Cheerios labeling move it over the line. Read an analysis of the warning letter in from “The Tan Sheet.” This is just a warning letter compared to a very large seizure action against the orange juice. But even FDA is not likely to try to take Cheerios out of the hands of toddlers for a labeling issue. That would risk way too much backlash from parents.

Observers who followed FDA in the 90’s are having flashbacks to the tenure of former commissioner David Kessler, who sent a message to orange juice manufacturers that the agency would not tolerate claims that juice made from concentrate was “fresh.” In that case, the agency actually seized a huge quantity of Citrus Hill from Procter & Gamble. At the time, some former FDA officials criticized the fight with P&G as a worthless display of FDA’s power to little public benefit.

The OJ crusade did, however, set the tenure for Kessler’s term and gave him a platform and reputation of decisive regulator from which to undertake a range of initiatives at FDA – including getting user fees for drug approvals and speeding approvals of AIDS drugs.

As FDA says in its official biography of Kessler:

“Early in his tenure, he took action to protect consumers from misleading uses of the term ‘fresh’ in conjunction with processed or partially processed orange juice and tomato products, gaining himself the nickname ‘Elliot Knessler.’”

We know what you’re thinking: will the current leadership be able to earn enforcer nicknames that are anywhere near that awkward?

Suggestions from our staff: Josh Harshstein and Peggy “the Grinder” Hamburg.

Enjoy your bowl of cereal tomorrow and reflect: this strange attack on an American icon may mark the start of something good for regulated industry.--Cole Werble