13 July 2004

Allergic Reactions

Next week the House of Representatives will vote On the evening of July 21, the House of Representatives approved a law requiring new package design standards that may save lives.

From The New York Times, July 10, 2004:

Allergic“Each year, some 30,000 Americans are rushed to emergency rooms because of severe allergic reactions to food. Roughly 200 people die yearly from such reactions. Sound public health legislation passed by the Senate, and heading for House action before the Congressional recess, aims to lessen that toll by requiring that food labels clearly and accurately disclose the presence of the eight most common allergens in various additives: peanuts, eggs, milk, soy, tree nuts, fish, shellfish and wheat.

The bipartisan measure fills a hazardous gap in Food and Drug Administration rules, which do not require that these allergens in spices, flavorings, coloring and other additives be listed on labels even though ingesting the slightest amount can be fatal for some people. And the allergens that are listed on a label are frequently identified only by their formal names instead of in everyday English — as ‘whey’ instead of ‘milk product,’ for example.

The food industry adopted voluntary guidelines to try to fend off legislation. But although some companies now list allergens in clear terms, others still don’t. The government needs to make compliance universal.

First introduced four years ago by Representative Nita Lowey, Democrat of New York, and championed in the Senate by Edward Kennedy, a Massachusetts Democrat, and Judd Gregg, a New Hampshire Republican, the measure also has important backing from the Bush administration. Its expected passage by the House this week, and subsequent signing by the president, will give food manufacturers until 2006 to refashion their labels to list allergens more clearly. It will also give Americans an all too rare example in this election year of bipartisan cooperation to serve the public good.”

The FDA publicly recognized fatal food allergies in 1994, and in 1996 acknowledged the need to label foods containing allergenic substances. However, they were unable to require the labeling because

“Section 403(i) of the [Food, Drug, and Cosmetic Act] provides that spices, flavorings, and colorings may be declared collectively without naming each one. Secondly, FDA regulations (21 CFR 101.100(a)(3)) exempt from ingredient declaration incidental additives, such as processing aids, that are present in a food at insignificant levels and that do not have a technical or functional effect in the finished food.”

The new bill is the result of grassroots pressure and several medical and academic studies on the effects of allergens and interpretations of commercial food labeling.

This study on label interpretation is even cited in the text of House bill.

The Center for Science in the Public Interest also takes some credit, remarking that:

“A major impetus for the legislation was a 2001 article in CSPI’s Nutrition Action Healthletter that publicized a study by the Food and Drug Administration showing that about 25 percent of candy, ice cream, and baked goods from plants in Minnesota and Wisconsin had products with undeclared egg or peanut ingredients.”

I note that the CSPI’s influential document was in part a repackaging, redesign, and republishing of information already available from the FDA.

The Food Allergen Labeling and Consumer Protection Act (FALCPA, or S. 741) was approved by the House Energy and Commerce Committee on June 24, 2004. It was passed by the U.S. Senate on March 8, 2004. The bill now goes to President Bush for his signature.

The new allergen info is likely to be added to the Nutrition Facts label.

Updated July 21, 2004