Cooking Up the New Food Label

by Food and Drug Administration (FDA)

Reading the new food labels required on almost all foods will make planning healthy diets easier for consumers. Writing the regulations that spell out what should be on those labels has been everything but easy for the rule-makers.

Ask any number of Food and Drug Administration and U.S. Department of Agriculture Food Safety and Inspection Service (FSIS) staffers who were involved in writing the regulations. They'll say that in almost every instance, before pen met paper there was a tug-of-war between what the law requires and the many opinions about the most practical way to present nutrition information on the food label. By the time regulations were written, lots of compromises had been made. However, both agencies believe that none of the tradeoffs was at the expense of consumer interests or resulted in an excessive burden to the food industry.

First on FDA's and FSIS' agenda for food label reform was to solicit advice from consumers, health professionals in and out of government, and members of the food industry.

"Having the clear legal authority paved the way for us to write the regulations," says F. Edward Scarbrough, Ph.D., director of FDA's Office of Food Labeling, who coordinated the Nutrition Labeling and Education Act (NLEA) rule-making process in the Center for Food Safety and Applied Nutrition. It also sped up the entire project because it established deadlines. For example, it required FDA to propose regulations by November 1991.

"That was a blessing and a curse," says Scarbrough. "The timetable forced us to get the proposals out without a lot of over- review, re-drafting, and going back and forth, but staffers put in long hours, often working on weekends, to meet the one-year deadline."

By November 1991, FDA had published 26 proposals. At the same time, FSIS published a parallel proposal for the nutrition labeling of meats and poultry.

Although meat and poultry products were not covered by NLEA, FSIS shared FDA's concern for consistent labeling requirements so that all foods would carry the same type of information and labels would appear at about the same time. FSIS Deputy Administrator Margaret O'K. Glavin, leader of USDA's label reform effort for more than three years, says, "The combined effort was a success because of the excellent staff work of FSIS and FDA. That's what made it possible."

In January 1992, FDA and FSIS called a public hearing on the proposals. Ninety-two representatives from the food industry, the scientific community, and consumer groups presented their comments in person to a panel of FDA and FSIS officials. (See accompanying article.)

In addition to the oral comments, FDA received more than 40,000 others in writing, the largest number ever received in response to an FDA proposed regulation. About 30,000 were form letters from organized campaigns.

FSIS received 1,109 comments. "Consumer groups, industry, and medical groups overwhelmingly asked for 'harmonization' of the FDA and FSIS labels," says Cheryl Wade, chief, FSIS Nutrition Branch and coordinator of the rule-making process for FSIS.

Dealing with Details

The details called for by NLEA were often a problem for FDA rule-makers, says Scarbrough. "For example," he says, "the law says 'the label shall have' and named nutrients. One of the nutrients named was complex carbohydrates." In order to enforce the law, Scarbrough says, FDA would have had to come up with a way to measure complex carbohydrates.

"The problem is," he says, "there's no good definition for complex carbohydrates. Had we been working on nutrient list requirements without NLEA, we would not have included complex carbohydrates — we might have made a more general term, such as 'carbohydrates other than sugar'."

FSIS had fewer constraints than FDA because FSIS was not bound by the labeling law. However, in order to provide consistent nutrition information on all foods, FSIS rule-makers stayed in tune with NLEA's restrictive details. "For many years we have used prior label approval — a very different system to regulate labeling," Glavin says. "Also, USDA regulates meat and poultry, so the focus for us was on nutrients such as protein and fat, for example, rather than on fiber," she says.

Troublesome Issues

Most NLEA requirements raised troublesome issues, Scarbrough says. Evaluating health claims as they relate to certain nutrients was one of them. The job was large — FDA received more than 7,000 public comments concerning its proposal on health claims and each comment was considered.

"Some health claims were very specific, and the evidence was rather limited," he said. "Others were broad, and yet we were given a mandate to come up with a general set of principles and apply them to all 10 claims." Of the 10 diet-health relationships the law required FDA to evaluate, seven were approved. (See "Starting This Month, Look for 'Legit' Health Claims on Foods" on page 14.)

FSIS had not finalized a health claims proposal when the final regulations were published, but the agency intends to issue a proposal similar to FDA's final rule.

None of the regulations was easy to write, Scarbrough says. Even when there were general principles that everyone accepted, there were still compromises to be made. The regulation for serving sizes was one such case.

"No one seriously argued that the law shouldn't set serving sizes," Scarbrough says. "But there were arguments with industry about numbers — is it one ounce or an ounce and a half — that sort of thing," he says.

Youngmee Park, Ph.D., of FDA's Office of Special Nutritionals, principal writer of the serving size rule, explains that foods were grouped into 139 categories. The amount of food customarily eaten per occasion, called the "reference amount," was established for each category, and the agency established rules for converting the reference amounts into label serving sizes.

But special consideration had to be given to certain foods, for example shrimp, that naturally vary in size (how many jumbo- sized shrimp are customarily consumed in one meal as opposed to small-sized shrimp?). There was also a difference in serving sizes when products were aerated, such as whipped peanut butter or aerated waffles.

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