Excerpted from Packaging Digest, December 1993.
Lifeline, Spring 1993, Vol XI, No 2, pp 1-2
A packager's life can be tough. You watch the regulatory scene, and you think you know what's going on. Then one day things get so complicated that you wonder if you have even a clue. For example, food labeling.
The Food and Drug Administration, which regulates most foods, proposed new rules in November, 1991 on everything from nutrition labeling to serving sizes to product nutrient content claims and health claims. The final versions were due in November '92. FDA made these rules as instructed by a 1990 law, the Nutrition Labeling & Education Act.
And, by golly, the U.S. Dept. of Agriculture, which regulates meat and poultry, climbed on board with FDA, agreeing to coordinate changes in its own rules so that the two systems would mostly match. And the sun would shine, the little birdies would sing and consumers would have new, more informative labels by mid-'93.
Oh, yes, and FDA also would examine the best format for the graphic representation of all this new information on labels. But, heck, that would be mostly cosmetic, right?
Wrong. After four months - really years - of FDA work on the new rules, the final regulations were not in fact published by the November '92 deadline. FDA and USDA got into a squabble over several issues, including the label's format, but also over several issues, including the label's format, but also over what caloric level should be used for reference, the designation for the amount of fat (the impact on meat was a special concern of USDA) and the definition of "light" and "lite."
President Bush reportedly summoned the heads of the two warring departments to Camp David to settle their differences. Secretary Louis Sullivan of Health & Human Services (FDA's parent department) and Edward Madigan of Agriculture negotiated for three weeks past FDA's deadline.
For the three weeks after the deadline passed and before the departments made their peace, the food and packaging worlds were in a state of utter limbo. What would the new rules be? What changes were made to the proposals from last year? When would we see them? If the effective date were a short six months away, wasn't this wasted time only making a tough situation tougher?
And most ominously, didn't NLEA declare that the proposals would automatically become the final rules of FDA didn't meet the November '92 deadline?
NLEA did indeed declare such action, but that was hardly the end of things.
On November 27, almost three weeks past the deadline, FDA announced that its proposed rules were now deemed effective by the operation of law. But packagers couldn't run to print shops yet because FDA announced at the same time that it would soon publish superceding rules to take the place of the final-by-law set. "Soon" in this case meant as soon as the FDA-USDA squabble could be resolved. The superceders would be, one expected, the rules FDA was on the road to publishing in early November until it was sidetracked by the spat with the USDA.
Less than a week later, every major new outlet in the country loudly trumpeted the arrival of the new rules, the end of the "Tower of Babel" in food labeling, and the rescue of the Republic.
The more savvy news outlets also described the just-concluded battles between FDA and USDA. But few reports noted the most relevant fact of all: The regulations weren't available yet! FDA issued some very general summaries, but not until early January were the actual final regulations made public. And even then, they were expected to be published together with an opportunity for public comment (until the end of January) on "technical" matters not previously raised, whatever that means.
Ask anyone involved in making the law that required all these new regulations and they'll tell you this wasn't supposed to happen.
Why, the Nutrition Labeling & Education Act of 1990 was written specifically to be bureaucrat-proof. Congress indicated in extraordinary detail not just the subject matter of the new regulations but what their content should be as well. This was contrary to the usual approach of Legislation, which is to set out general principles and let the agencies work out the details.
FDA's discretion was limited to a number of important respects. Congress dictated for example, what words it should define, not simply that it should define words commonly used in food labels. The lawmakers listed exemptions from the regs right in the law, rather than letting FDA decide what to leave out.
Congress even built in deadlines for making the regulations. FDA was to come up with proposals by November ' 91, then consider public comments on the proposals, redraft as it deemed necessary and publish the final versions in November '92.
Then the cherry top of this legislative sundae: The Hammer. The Hammer - as it become known among the hipsters of the food and drug bar - is the requirement that if FDA failed to meet its deadline for publishing final regulations, the proposed regulations would automatically be deemed final by operation of law. And FDA was required to publicly so state soon after the deadline passed. That's what it did on November 27, '92.
Techniques like The Hammer change the typical relationship between legislators and regulators, and their future use in other laws could mean a fundamental shift in government functions.
When the FDA-USDA peace was achieved in early December, the imminent publication of superseding regulations was expected. FDA summaries prepared on December 10 reveal some details.
Proposed rules from last year will largely remain the same in final versions. Some changes have been made here and there, and if they affect your particular products, they of course will not seem minor at all. However, the framework and many of the details revealed in last year's proposal will remain the same.
FDA estimates that 257,000 labels on 160,000 food products need to be changed. The result in undue economic hardship has persuaded the agency to extend the compliance deadline to may 1994.
May believe the new food label is incomprehensively complex and gives consumers too much information they won't understand. It's hard to disagree, given that nutrient contents will be compared with two different calorie intake standards and the average person has no idea what his or her proper calorie intake should be.
But FDA Commissioner David Kessler touts the dietary context features of the new label as a genuine revolution and a great public health opportunity. Certainly, we can expect to see greater consistency in label contents and claims. But public education about reading the new label will be necessary, and it is questionable whether widespread improvements in public health will really be the long-tern results.
We should expect to see more use of legislative techniques like The Hamme, and not just in food and drug contexts. With each hammer will come a debate and maybe litigation over whether it is constitutional to have Congress usurp some of the executive branch's discretion. And what about agencies that don't want to bother with public comments? With a hammer in place, they could write proposals they like, blithely miss the hammer's deadline and end up with final rules by operation of law that are exactly like what they want!
Clearly, there are many interesting legal issues to debate. Speaking of which, by the time you read this there's likely to have been some litigation started over the food label rules. Whether it is a claim that some provision is unauthorized by NLEA or a suit to compel some procedural step by the FDA, there are so many different affected parties here and so many specific provisions and so many financial consequences to the rules that some type of lawsuit is almost bound to result.
And meanwhile, thousands of packagers are huddling with lawyers and laboratories and designers, preparing to redo their labels.
So much has already happened, but the biggest adventures may lie ahead.
CSA Library Series is a collection of articles that pertain to celiac disease and dermatitis herpetiformis. Most of these articles have appeared in CSA’s quarterly newsletter, Lifeline, which all CSA members receive. Historic articles included in these resources may or may not include updated notes. Updated information indicated in red type. Articles represent the work of the author.