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Cooking Up the New Food Label
by Judith E. Foulke
     
     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. (See "Good Reading
for Good Eating," on page 7.)
     "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.

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 its products with claims of reduced risk of
heart disease because it is not a low-fat food. However, if the
manufacturer produced a cooking oil that was 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." n

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