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F.D.A. Survey Finds Faulty Listings of Possible Food Allergens
Greg Winter, 
New York Times April 3, 2001

An investigation of dozens of food companies by the Food and Drug Administration has found that in spite of strict labeling laws, as many as 25 percent of manufacturers failed to list common ingredients that can cause potentially fatal allergic reactions.  

The mislabeling poses a threat to the roughly seven million Americans who suffer from food allergies and who rely on a product's packaging to keep them safe, according to the F.D.A.

In recent years, there has been a sharp increase in the amount of food recalled from store shelves for containing allergy-provoking ingredients like peanuts and eggs that were not listed on the product's label. Worried about the trend, the F.D.A. enlisted the support of state regulators in Minnesota and Wisconsin to undertake a series of inspections at food plants over the last two years, trying to grasp the extent of the problem and correct it at the source.

The agency examined 85 companies of all sizes that were likely to use common allergy triggers in abundance: cookie makers, candy companies and ice cream manufacturers. Its report, which was completed earlier this year, found that a quarter of the companies made products with raw ingredients like nuts, but omitted them from the labels describing the food.

Perhaps more surprising, only slightly more than half of the manufacturers checked their products to ensure that all of the ingredients were accurately reflected on the labels, the report said, making it all the more difficult for consumers to know which foods might cause allergic reactions that are often life-threatening.

"The fact that ingredient listings can be dead wrong certainly points to major shortfalls in food safety," said Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest. "The accuracy of a label can really save a life."

Although the cause of food allergies is still something of a mystery, they are the most common cause of anaphylaxis, a severe reaction in which the skin itches, the throat swells and breathing becomes short. In the most serious cases, blood pressure falls, the heart beat fluctuates and some victims die.

The F.D.A. report does not discuss the prevalence of food allergies, but every year, 30,000 people are rushed to emergency rooms because of them, according to the American Academy of Allergy, Asthma and Immunology. As many as 200 of them die.

Many of these illnesses occur at restaurants or in homes, and are not necessarily the fault of a food manufacturer. Some schools have removed peanut butter from their cafeterias and several airlines have taken steps to accommodate passengers who have food allergies, including banning peanuts as the traditional after-takeoff snack.

It is not clear how many allergic consumers have fatal reactions to mislabeled products, but even when they do, the manufacturer may not be liable for them. Last August, a Wisconsin jury ruled against the family of Joshua Ramirez, a 21-year-old junior at a bible college who had a lifelong allergy to peanuts and who died in 1996 after eating chocolate chip cookies from the vending machine in his dormitory.

During the trial, the company, Slettin Vending Inc., acknowledged that the cookies contained peanut residue, although the nuts did not appear on the list of ingredients.

Still, only a small amount of peanuts were found in the cookies. It may have been enough to provoke a fatal reaction in Joshua, the company concedes, but it was not sufficient for a jury to deem the product unreasonably dangerous to the average consumer. That is the standard of proof necessary in many product liability cases.

"People are convinced that with allergies you just get itchy, watery eyes," said Dixie G. Ramirez, Joshua's mother. "They do not believe they can be fatal." 

After suffering an allergic reaction, consumers can be treated with a shot of epinephrine, and they are often encouraged to carry the drug with them. But there is no medical treatment to prevent allergic reactions to food from occurring. Even patients who receive epinephrine may need additional treatment, so clear and accurate labels may be the only thing standing between a susceptible consumer and a trip to the hospital.

As awareness of the problem grows, manufacturers say they are paying more attention to what goes into their products, but it is often difficult for them to know when ingredients that can provoke a reaction, called allergens, slip into the food chain undetected.

In fact, many of the "hidden" allergens found in the F.D.A. study were not deliberately added, but wound up in sweets because bakers routinely used the same utensils to stir separate mixes, or reused baking sheets without washing them between batches. Slettin, for example, used the same pan liners in its bakery from one day to the next.

In some factories, parchment papers were used as many as 10 times before being replaced, the F.D.A. found. In at least one plant, conveyor belts that coated candies in chocolate were cleaned only once a year, allowing peanut residue to get into products that as far as the manufacturer was concerned, contained nothing risky at -all.

Such cross-contamination may seem incidental. But for people with food allergies, ingesting as little as one five-thousandth of a teaspoon of an allergen can induce a fatal reaction within minutes, according to Dr. Hugh A. Sampson, director of Mount Sinai School of Medicine's food allergy institute.

Current F.D.A. rules require companies to list everything that goes into their products, but allow trace amounts of "natural" ingredients to be omitted from labels.

To close those loopholes, a coalition of attorneys general in nine states, from New York to Wyoming, petitioned the F.D.A. last May to issue new regulations. If enacted, the new rules would require manufacturers to warn consumers that their products might contain allergens, even if they are not deliberately add- ed as ingredients.

Turning the petition into new regulations could take years, since manufacturers would have ample opportunity to fight them. For now, the F.D.A. says it is having more success persuading the industry to make voluntary changes. In fact, the agency found that most of the companies it inspected were willing to overhaul their manufacturing.

But the F.D.A. cannot afford to visit all food companies, prompting some lawmakers to push for legislation with stricter standards. Representative Nita M. Lowey, Democrat of New York, has introduced legislation in Congress to require manufacturers to act to prevent unintentional contamination of products, some- thing the law does not now require.

It also calls upon food companies to list allergens by their "common English" names. Even when they do appear on labels, many ordinary allergens are referred to by their for- mal names, like "casein" for milk or "albumin" for eggs.

"To the lay person, these terms are Greek," said Anne Mu–oz-Furlong, founder of the Food Allergy and Anaphylaxis Network. "The labels are written for scientists, not for consumers."