Sept. 16, 2008 -- Carefully reading food labels might not be enough to keep food allergy sufferers safe, according to the FDA.
The agency held a public hearing Tuesday on food manufacturers' use of "advisory labeling," which indicates that a product could unintentionally contain trace amounts of an allergen, such as peanuts. Statements like "may contain (allergen)" or "produced on shared equipment that processes (allergen)" are common.
These warnings are voluntary and unregulated, and they may only baffle the consumer who reads them. Another example: "Produced in a facility with an allergy control plan. The possibility of contact with allergenic ingredients has been minimized. May still contain trace amount of (allergen)."
"Advisory warnings are confusing, inconsistent, and do not provide adequate information to make smart and safe decisions," said Scott Mandell, CEO and president of Enjoy Life Natural Brands, which offers gluten-free and allergy-friendly foods.
The FDA said it wants to develop a long-term strategy to help manufacturers use more truthful, clear, and uniform advisory labels. The agency has addressed the inconsistent use of advisory labeling in the past, and different groups have developed some of their own guidelines, but the public hearing represents a push toward a more unified approach.
Demystifying Food Allergy Labels
A 2004 law requires manufacturers to list major allergens used as ingredients in a product, but there is no labeling requirement for separate products that might come into contact with allergens during manufacturing.
Equipment and facilities shared by allergen-containing foods can cause cross-contamination, where trace amounts of an allergen unintentionally end up in a separate product, putting some consumers at risk for allergic reactions. Many choose to avoid these foods altogether, although increased use of vague advisory labels leave consumers with tough decisions to make.
Anne Munoz-Furlong, founder and CEO of the Food Allergy & Anaphylaxis Network (FAAN), said there are more than 30 different formulations of advisory labeling, making it impossible to determine which companies use advisories to truthfully represent risks and which companies put the warnings on virtually every product to avoid liability.
"Physicians, parents, and teens are ignoring these 'may contain' statements because they appear on so many products," she said.
About 2% of American adults and about 5% of infants and young children are affected by food allergies. The FDA estimates that allergic reactions to food cause 30,000 emergency room visits, 2,000 hospitalizations, and 150 deaths each year in the U.S. and indirectly affect millions of families, teachers, and caregivers.
Separate from the advisory labeling, the Food Allergen Labeling and Consumer Protection Act of 2004 requires that FDA-regulated foods labeled after Jan. 1, 2006, list in plain English all ingredients that are, or are derived from, the eight most common food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. Together they account for about 90% of food allergies, according to the FDA.
Industry groups and FDA officials emphasized that advisory labels are not a replacement for "good manufacturing practices" that curb the risk of cross-contamination.
Alison Bodor, vice president of scientific and regulatory affairs for the National Confectioners Association, urged the FDA to establish allergen "thresholds," which attempt to gauge what levels of an allergen can safely be present in a food without causing an allergic reaction.
She cautioned that thorough cleaning or using separate equipment entirely is unrealistic for many manufacturers, and that despite the vagueness of some companies' warnings, people should heed them carefully.
Public advocates also testified about the problems allergy sufferers face daily trying to find safe food for themselves and their families.
Anne Carter of the Food Allergy Group of Northern Virginia said some group members are playing Russian roulette with food labels; teenagers and young adults are especially at risk when they start to make food decisions for themselves, she says.
FAAN member Lisa Punt shared a story about her now-teenaged son, who has a severe nut allergy. She recalled how she made sure to have plenty of candy corn at past Halloweens because it was one of the few foods her son could safely eat. But it soon became impossible to find candy corn without advisory warnings.
"Does candy corn really have walnuts, pecans, or cashews in it? Nobody knows," she said.
The FDA is accepting public comments on the issue through Jan. 14, 2009, to help develop its long-term strategy.
"Once we get all those comments in, that will be a major evaluation for the agency," said Barbara Schneeman, PhD, director of the Office of Nutrition, Labeling and Dietary Supplements at the Center for Food Safety and Applied Nutrition.