Cooking Up the New Food Label

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, many 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. (See "Good Reading for Good Eating.")

"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.

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

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.

Healthier Products Encouraged

In developing the regulations, FDA wrote rules that would not limit manufacturers' incentive to produce healthier products in the future, Scarbrough explains. For example, a manufacturer of cooking oils could not label products with claims of reduced risk of heart disease because oil is not a low-fat food. However, if the manufacturer produced a cooking oil lower in saturated fat than its other products, it could make a comparative claim for the nutrient content, calling attention to what the saturated fat level really was.

Soy sauce is another product that would not qualify for a health claim because it has a high sodium content. But under the regulations, a manufacturer could make a "light" soy sauce, making it clear on the label that "light" referred to a reduced sodium content, if that were the case, and if its sodium content were sufficiently reduced from its regular product.

When NLEA was written, says Scarbrough, Congress decided that such information would be useful to consumers--it would balance the picture so that consumers could make choices. Although it may create a cluttered label, the principle is to give complete disclosure about the food and to encourage nutrition information, versus not allowing some products to make any claims at all.

FSIS rule-makers wanted nutrition labeling to facilitate the development of lower-fat meat and poultry products. "Meat and poultry products are good foods," Glavin says. "The descriptors helped us capture the characteristics unique to meat and poultry on the nutrition label," she says.

In its advanced notice of proposed rule-making, FSIS asked for comments on descriptors for meats. The American Heart Association comment suggested definitions for the descriptors so that consumers could rely on the descriptive terms to help them select meat and poultry products with different levels of fat, saturated fat, and cholesterol. FSIS proposed the AHA-suggested definitions for "lean" and "extra lean." FDA adopted those definitions for the products it regulates, including fish and game meat.

"What neither agency wanted to do was to tell consumers exactly what they should be eating," says Scarbrough. "Industry is very creative describing and promoting their products, and I'm sure manufacturers will come up with ways of doing that without cluttering the label and still stay within the law."

Many Resources Tapped

The effort to get NLEA ready for implementation touched almost everyone in FDA's Center for Food Safety and Applied Nutrition, from scientists to secretaries. Field offices throughout the country were involved also. Charity Singletary, public affairs specialist for FDA's Baltimore district office, says that at a recent national convention of dietitians held in Washington, D.C., "almost every other person who visited our exhibit asked about NLEA." She says from early spring of 1992, all of her public affairs activities, such as exhibits at national meetings and talks to consumer groups and schools, were about NLEA.

In FSIS, staffers devoted thousands of hours, over more than two years, to the label reform effort. "It was hard work, but because we were working together with equally committed FDA staff, it was also satisfying work," Wade says.

In addition, FDA and FSIS relied on a great number of outside resources. Both used the expertise of scientists within their own agencies and from the National Institutes of Health and the national Centers for Disease Control and Prevention, and reviewed a number of scientific studies, including some from the National Academy of Sciences.

"We listen very carefully to the NAS because it's made up of scientists that come together from all parts of the country," Scarbrough says. "They have prestige and carry a certain amount of 'scientific authority' in the public view. If an NAS committee agrees on something, that's about as close as you can get to the 'general scientific agreement' that NLEA requires. NAS has also worked on

Recommended Dietary Allowances for many years and has a lot of experience in that area. And NAS has put together a committee on food labeling with a number of scientific disciplines."

Industry and Consumer Groups React

Scarbrough says FDA worked closely with industry. "In general, the food industry was quite supportive because it knows that nutrition information is important to consumers, and it sells products," Scarbrough says. "The advantage for industry is that everyone now plays by the same rules."

E. Toni Guarino, vice president and general counsel of the Grocery Manufacturers of America, called the number of regulations required by NLEA and the time frame for issuing them "extraordinary." She said the FDA staff responded with "a high level of dedication and professionalism."

"The FDA and food industry cooperative consumer research project to test nutrition label formats is a particularly good example of FDA's commitment to involve all interested groups in the process of developing well-reasoned food labeling rules that achieve FDA's goals," she says.

FSIS sought to be responsive to industry without conflicting with the public interest. In doing so, FSIS extended the time frame for implementation of its rules, giving industry time for compliance and minimizing costs to consumers. FSIS also made exemptions for firms that met its "small business" definition.

"Consumer groups are generally happy with the law," Scarbrough says. "They'd like us to go even further and be more restrictive with what we're allowing," he says.

Public Voice spokeswoman Patti Morris says her group is pleased that ingredient listings will now be required on standardized foods and that nutrient content claims will be defined.

"FDA, as usual, is trying to strike that balance between consumer interests and what's fair to industry," Scarbrough says. "In general," he adds, "I think both consumer and industry groups support our labeling effort, but each has its own viewpoint about how the effort could have been better or have been done a little differently."

How Final Are the Final Regulations?

Final regulations can be modified. "Industry, or anyone, can petition us to change a regulation," explains Scarbrough. "And NLEA gives us a time frame to react to those petitions."

"With new processed foods coming on the market all the time and changes in eating habits," he says, "I think we'll be readdressing serving sizes for a long time. The same applies with new health claims or terms a manufacturer would want to use on the label. Food labeling is a subject we'll continue to revisit for many years to come."

Judith E. Foulke is a staff writer for FDA Consumer.