Report Says Congress Needs Better Science Analysis

Industry and government scientists will be working overtime to comply with new demand for fuller information on nutrients WASHINGTON--When President Bush signed the Nutrition Labeling and Education Act (NLEA) into law on November 8, 1990, he set in motion a process that's expected to increase the work load for food chemists in government and industry and raise a new set of scientific questions for academic researchers who study nutrition. The new Nutrition Labeling and Education Act does a lot more than require better labels. Framers of the act envisioned labeling so clear and informative that consumers could use it to help plan their total diets, not just learn isolated facts about a particular food. By creating such labels, food researchers say, scientists would get the chance to improve the country's eating habits. "Look at the name of the act," says Food and Drug Administration division of nutrition head John Vanderveen. "It's nutrition labeling and education. That means we need to tackle nutrition education research. "How can labeling help people eat better? We've talked about that, but nobody knows who's going to pose the real questions there and how they're going to get good answers." Sanford A. Miller, dean of the graduate school of biomedical sciences at the University of Texas Health Science Center at San Antonio, adds: "Research on food habits will have to intensify if labels are ever going to say useful things." For example, Miller says, "we need to look at labels in a real-world kind of way, and ask what's the maximum information they can present and the most useful way to present it. Past studies have usually used students, often with nutrition training, on the panel. So label information has been done by people trained in nutrition for people trained in nutrition. "But that's not the bulk of the population. And we know that even with the smaller amount of information on labels now, most people just say, `The hell with it.' So what's the proper way to present even more information so it doesn't cause confusion?" Similarly, Miller says, scientists ought to formulate the new label rules with people's actual eating behavior in mind. For example, he says, industry research has found that people "won't change cold turkey" from a high-salt to a low-salt diet. That means industry food scientists need to develop "interim foods" that are safer and tasty, Miller suggests, while government scientists should try to formulate labeling rules that will encourage industry to do this. Many companies that produce so-called health foods proudly list their ingredients in an effort to attract customers. The aim of the new law, says Vanderveen, is to make that information more accurate and more valuable to the consumer. "Industry's going to need to call on the academic health community to do more work on how nutrients operate so that labels can make health claims, but with responsible scientific backup," he says. All in all, says Miller, the new law should stimulate interest in topics that previously were seen as having little commercial value. "A lot of questions scientists have been interested in for scientific reasons become practical issues when it comes to food labels," Miller says. "Right now, for example, labs only distinguish between saturated and unsaturated fatty acids. But increasing evidence suggests there's a new category that are neutral with respect to cholesterol--they don't raise or lower it. If you're trying to make a label that actually tells the effect of food on the body, research on that sort of issue needs to go forward." --M.C. "A lot of people call this a full-employment act for lawyers," says Food and Drug Administration chemist John Vanderveen, "but it's scientists I see around here [FDA] at all hours. This whole lab's working just about nonstop--nights, weekends, all the time--trying to write the rules for the new labels. No matter what legal and policy battles erupt, the basic science questions are the heart of the matter." The law, which goes into full effect in May 1993, mandates nutritional labeling on virtually all packaged foods; adds items such as total fat, saturated fat, dietary fiber, and complex carbohydrates to the ingredients that must be listed in terms of grams per serving; and greatly expands the number of nutrients for which recommended daily intakes will be specified. New labels must also use a standardized serving size based on ordinary eating habits and expressed in common household measurements, instead of the current manufacturer-determined estimates of serving sizes. Although FDA scientists are the first to feel the crunch, food chemists in state and private labs as well as in the food industry will also see their work loads increase, at least temporarily, as a result of NLEA. At food companies and private testing labs, scientists are preparing now for the massive amount of nutrient analysis and possible product reformulation that must be completed by 1993. After 1993, federal and state labs are likely to see more work on their desks as consumer groups press government regulators to test the label claims. Along with more nutrient analysis for food chemists, all nutrition scientists will have some problems to solve (see story on page 9). These include developing new methods to determine nutrient content, studying the health effects of nutrients, creating user-friendly label formats, and sorting out the roles of state and federal labs in enforcing the new rules. The tidal wave of NLEA-associated projects that struck FDA labs last year has kept scientists busy "practically 24 hours a day" ever since, says Vanderveen, who heads the division of nutrition there. "It's a matter of answering very basic scientific questions and then turning those answers into rules for how nutrients should be listed on labels," he says. "We've needed broad scientific participation in the health messages that are part of the act--on topics like fiber and cancer, calcium and osteoporosis. Besides my staff of 20, we've got 25 or 30 more scientists at NIH [National Institutes of Health] and PHS [Public Health Service] involved at least a few days a month. I've grabbed bodies from anywhere I can find them." Although initial regulations stemming from the new law should be completed by the end of this year, Vanderveen expects his staff to continue working round-the-clock through 1992, handling comments on the regulations. And the priority given to these efforts is taking a toll on the work his lab ordinarily handles, Vanderveen says. "We got only a small increment of resources for all this,~ so we've reprogrammed," he explains. "A lot of things we'd ordinarily do are suffering. We've put lower-priority regulations on the back burner, cut out surveys and some lab research, also. Our review of new food additives has slowed up, and that understandably makes petitioners mad. A lot of research is sitting on the shelves, waiting to be written up." Food processing companies have known for almost a year about some of the requirements the regulations are likely to contain. But a detailed description won't be available until next November. That means food companies and private testing labs will have only six months to carry out the huge volume of chemical analyses needed to revise labels before the May 1993 deadline. The short time frame has caused some companies already to begin to gear up for the big push. Chemist Eugene Gogel is vice president of Strasburger & Siegel, a private food-testing laboratory in Baltimore. He says his biggest challenge so far has been to persuade his industry clients to let him start analysis of their products before the final requirements are known. "The government has sort of created a monster here," Gogel says. "They gave themselves a year to jerk around with the regulations before they finalize them, so a lot of companies don't want to test until they know the specifics. "But if everybody did that--well, I'm sure Hewlett-Packard would be glad to sell us enough analytical instruments, but where in the world would we get all the chemists to interpret the data? Right now, 99 percent of my job is trying to convince companies they have to start now, or not get the job done." Gogel reports, however, that he has been successful in convincing many clients to submit products early for analysis. His company is hiring new scientists and has redirected other staffers' work toward nutrient analysis. "We're riding a very nice wave right now, with more work than we've ever had," Gogel says. "Besides our small clients who don't have their own labs, big food companies are sending stuff to us because their labs are overloaded or tied up with product development. We know this won't last forever. But right now we're not complaining." Analytical chemist Phil Oles, food sciences manager at Lancaster Laboratories in Lancaster, Pa., agrees with Gogel that food processors need to make plans now for the product analyses they'll need. But his larger, multifunction laboratory is taking a more cautious approach to preparation. "This [new law] hasn't translated into a lot of extra business yet for us," says Oles. "We see it on the horizon, and we're consulting with clients about how we'll schedule the work. But since food is only a small section of our lab, we plan to redirect chemists and technicians from other areas for a big push later." But Oles agrees with Gogel that food companies must begin making plans now or risk getting shut out. "If someone came knocking on the door six months or a year from now with a job they wanted quickly, I doubt they could find a lab in the country who could fit them in," Oles says. Looking at a product before the government has decided what information will be required has forced the industry to gaze into its crystal ball. Biochemist Steven Ink, senior manager for nutrition and research at the Quaker Oats Co. lab in Barington, Ill., says his company has begun to develop methods to cover what it considers to be the most likely wording in the upcoming government regulations. "Right now, we can only anticipate the exact label format," Ink says. "But we've been gearing up for this for several years, nonetheless. We're trying to figure out the most likely two or three formats, then get our computer programs ready to deal with those possibilities. We've tried to anticipate what data might be needed and have our chemists start getting it." Format isn't the only question mark for Lancaster Labs' Oles. "Several new analyses are required that were heretofore optional and have historically been difficult to perform," he says. For example, he says, the new law requires a separate listing for saturated fatty acids apart from other fats, as well as a new listing of the vitamin A content of all foods. "[Vitamin A] used to be an optional listing," Oles says, "and it's very difficult to do with some foods. It can easily be pulled out of a cereal, for example, but try pulling it out of a high-fat food matrix like cheese or ice cream." Oles's large lab has been able to commit staff time to developing new methods of performing some of the newly required analyses, and staff members have published papers on several of these processes. For that reason, he says, he's confident his company will be able to do a good job with the new labels. Nevertheless, he says, "methods have not been developed specifically to analyze many types of food that must now be labeled." Although the intent of the new law is to clarify what is already in food, some rules may wind up changing what we eat. That will happen, say experts, if the new listings cast an unflattering light on a particular product. And such reformulations will create even more work for industry food chemists, experts say. For example, the new regulations may define "sugars" more broadly, including more complex carbohydrates such as corn sweeteners under that heading as well. Such a change is likely to push sugars to the top of the ingredient list in some foods, says Elwood Caldwell, director of scientific services at the American Association of Cereal Chemists. "If sweeteners come out a fraction of a percent ahead of flour when listed by amount, it's no good from a marketing standpoint," Caldwell says. "So food chemists will be asked, `Can we change the percentages without changing the product's characteristics?' "Product development and improvement will be big areas for food scientists under the new law." State analytical chemistry labs may also find themselves with more to do, some scientists say, though few are likely to become involved until the law goes into effect in 1993. State lab directors pondering the law's implications for their already-overburdened facilities say the main issues for them are whether public demand for accurate labels will be strong enough to justify spending state funds and how state and federal laboratories can cooperate to enforce the law without duplication of effort. Michael Wehr, an analytical chemist who heads Oregon's Department of Agriculture labs, says most states will do little to enforce NLEA unless "public-interest groups really begin to perceive that there's misinformation on the labels. The question is limited resources. Public health and safety are higher priorities than nutrition, and most states have a hard enough time paying for those." But R.D. Sowards, who heads the food branch of the Texas Department of Health, says he expects his state to take on a more prominent role in enforcing truth-in-nutrition labeling. "This state has always been aggressive in investigating health claims," he says. "We would trust most companies up to a point, as long as they've got lab data to back it up. But when we start seeing health claims like `low fat' and `cholesterol free,' that triggers questions." But where nutrition labeling is concerned, the lab data that companies present may be of questionable quality, Wehr says: "One big problem is that there aren't any lab accreditation programs in food chemistry. You have to rely on the lab's integrity. There are good lab practices from other areas, like pesticide- residue testing, that are applicable to nutrient work; but a lot of small labs that do mainly food analysis don't have those programs in place." James Sevchik, chief inspector for the New York Department of Agriculture's Division of Food Safety, envisions an increased need for state labs to check nutrition claims. He says state and federal food agencies need to work out a specific work-sharing plan. "There's a lot of work out there to be done," Sevchik says, "and federal labs can't handle all of it. We need to figure out how states and the FDA can cooperate without duplicating work. There'll be a great demand to accept analytical data from other labs." Some state food officials, like John Misock of the Wyoming Department of Agriculture, say state labs may even find themselves having to create some of the new nutrition labels. "It's an economic issue," Misock says. "Companies with at least $500,000 in yearly revenue will have to label. Those aren't big companies. As a state government, we're trying to figure out how to keep our small businesses above water. "That may mean our labs will take on the burden of what small firms can't afford to hire private labs to do." (The Scientist, Vol:5, #22, pg. 9, November 11, 1991) (Copyright, The Scientist, Inc.)

Report Says Congress Needs Better Science Analysis

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