FDA Changes Food Label Rules
January 2006
Some changes in the works:
· The FDA will require that food packages and some supplements list the amount of trans fat on the label.
· The FDA will require labeling for the eight allergen groups: tree nuts, milk, eggs, fish, crustacean shellfish, peanuts, soybeans, and wheat.
· The FDA is expected to define the term “whole grain” for labels in 2006.
· In 2006, companies may tout the health benefits of green tea or tomatoes.
With the arrival of the new year, a host of additions and changes are in store for food labels. The presence of eight major allergens and the amount of trans fat in a product will have to be disclosed on labels as of Jan. 1. But that’s just the start.
Among the other changes on the horizon, the Food and Drug Administration, which oversees most food labels, is considering giving calories more prominence on the food label – by increasing the type size of the calorie listing, for example – and requiring that nutrition information be spelled out for an entire package, not just for “servings.” Also in 2006, the FDA will likely update suggested requirements for nutrients like vitamins to reflect new scientific reports from the National Academy of Sciences.
“It’s going to be a very busy year,” says Alison J. Kretser, senior director of scientific and nutrition policy at the Grocery Manufacturers Association.
The flurry of label activity reflects several factors, from regulatory changes such as the implementation of a 2004 allergen law to food companies’ own efforts to court health-conscious consumers. Consumer activists have met with some success in their quest for more informative labels. Meanwhile, certain health issues have gained more attention, such as food allergies and obesity.
In response, food companies are investing billions of dollars to reformulate products and update their labels. And some are going further, in search of niche markets. Makers of cereals and brads are pushing new lines of “whole grain” products tied to whole grains’ increased importance in the government’s latest dietary guidelines.
But the transition to more informative labels is likely to bring some confusion, too. The FDA is allowing companies to continue labels that were printed before 2006 – without allergen declarations. And it has promised to extend deadlines for some companies having difficulty complying with the trans-fat rule.
Here are some of the changes in the works.
§ Trans Fat
Trans fat, found both naturally in animal-based foods and in processed food such as vegetable shortening, raising LDL, or “bad,” cholesterol and increases the risk of heart disease. As of Jan. 1, food packages and some dietary supplements must list the amount of trans fat on the label. Within three years, the trans fat labeling will prevent 600 to 1,200 coronary heart-disease cases and 250-300 deaths a year, says Scott Gottlieb, the FDA’s deputy commissioner for medical and scientifical affairs.
But there’s one exception: Companies can skip the labeling and declare the food “not a significant source of trans fat,” if the package has less than 0.5 grams of total fat per serving and makes no claims on fat, fatty acids or cholesterol. Also, if the amount of trans fat is less than 0.5 grams, the FDA allows companies to list it as zero.
As the deadline looms, some food companies, restaurants and supermarkets have been reformulating their products and changing cooking materials to get rid of the bad name.
ConAgra Foods Inc. said recently that it will eliminate trans fat in the Orville Redenbacher’s and ACT II microwave brands beginning in February. Kellogg Co., maker of Special K cereal and Cheez-It crackers, says it will switch to oil made from specially bred soybeans to reduce or eliminate trans fat in some products early next year. And restaurant chain Ruby Tuesday started frying with only trans-fat free canola oil last month.
§ Dietary Guidelines and MyPyramid
The Agriculture Department last spring replaced the iconic food pyramid with the Web-based MyPyramid, which modifies food recommendations based on a person’s age, gender and physical activity. In October, the department, which oversees meat, poultry and egg products, issued guidelines clarifying how the new food pyramid applied to food labels.
For instance, MyPyramid now distinguishes between whole grains and refined grains. The USDA allows food makers to use statements such as “Made with Whole Grain Spaghetti” and “Made with 100% Whole Grain brown rice.” But, echoing an FDA decision, the USDA says food makers shouldn’t use labels that imply a specific levels of whole grains in the product, such as “good source” or “excellent source” of whole grain. The FDA is expected to define the term “whole grain” in 2006, says Mr. Gottilieb.
If food companies can squeeze more information in the fine print, the USDA says it will approve statements like the following: “One whole grain ounce equivalent per serving, MyPyramid recommends at least 3 one-ounce equivalents of whole grain.”
§ Allergens
Beginning January 1, food makers are required by law to label in “plain language” the eight allergen groups: tree nuts (including almonds, walnuts, and pecans), milk, eggs, fish, crustacean shellfish, peanuts, soybeans and wheat. Labels must either use parenthesis to clarify that, for instance, “whey” or “casein” is a milk product, or must note at the end of the list that the product “contains” a specific allergen.
While more than 160 foods have been known to cause food allergies, the FDA says those eight allergens cause 90% of all documented food allergies in the U.S. But because the FDA hasn’t set up threshold levels for those allergens, some food makers have listed them even if they only exist in tiny amounts. The agency is developing a rule which may allow such language as “may contain” or “processed in a facility that also processes” the allergens.
§ Qualified Health Claims
In 2006, the FDA will begin allowing companies to tout the health benefits of drinking green tea or eating tomatoes – even though the scientific basis for such claims isn’t conclusive. But the statements must be highly qualified. For instance, the following is approved:
“Two studies do not show that drinking green tea reduces the risk of breast cancer in women, but one weaker, more limited study suggests that drinking green tea may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of breast cancer.”
The agency started permitting food companies to make some qualified claims to years ago, following court rulings that the FDA couldn’t block companies from putting true statements on labels. It has, for instance, said the packages of nuts may say: “Scientific evidence suggests but does not prove that eating 1.5 ounces per day of most nuts as part of a diet low in saturated fat and cholesterol may reduce the risk of heart disease.
But after an agency survey showed that such qualified claims confused consumers, the FDA said it will take a second look at the whole issue. The agency is drafting a ranking system for both authorized and qualified health claims, and in 2006, the FDA may issue guidance explaining how it reviews scientific evidence to approve health claims, spokesman Michael Herndon says.
§ Gluten
For millions of people, gluten, a protein found in wheat, barely and rye, triggers an autoimmune reaction, attacking the small intestine. Sometime before August 2006, the FDA will issue a proposal to allow voluntarily use of the words “gluten free” on food labels, though the rule isn’t likely to be finalized until 2008. But companies already are using their own definitions to label their products as “gluten free” based on their own definition.
At Wal-Mart, gluten-free means free of wheat, oats, barley, rye and tricale, a cross between rye and durum wheat. Wegmans Food Markets Inc. relies on suppliers to assure that ingredients contain no gluten. And at Whole Foods Market, the standard is no more than 50 parts per million.
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