Food Allergen Labeling & Consumer Protection Act Become Law
By: RICHARD J. WEGENER
August 2004
Food Industry Prepares of January 1, 2006 Effective Date; European Initiatives Also Move Forward
On August 2, 2004, President George W. Bush signed the Food Allergen Labeling and Consumer Protection Act (S. 741) into law. The bill requires food manufacturers to clearly state if a product contains any of the eight major food allergens responsible for 90% of all allergic reactions: milk, eggs, peanuts, tree nuts, fish, shellfish, wheat, and soy. In addition, it requires that the Food and Drug Administration conduct inspections and issue a report within 18 months to ensure that food manufacturers comply with practices to reduce or eliminate cross-contact of a food with any major food allergens that are not intentional ingredients of the food. The bill also directs the FDA to issue final regulations defining and permitting the label claim "gluten-free" no later than 2008. Gluten, a protein, is found in such grains as wheat, rye, and barley.
Background
Some 11 million Americans suffer from food allergies. Over six million are allergic to fish and shellfish alone. Some food allergies, particularly peanut allergies, can be fatal. Each year, over 250 Americans die due to the ingestion of allergenic foods, and 30,000 receive life-saving treatment in emergency rooms. Eight food groups are responsible for most allergic reactions: Crustaceans such as crab and lobster; peanuts, eggs, fish, milk, soy, tree nuts such as almonds and walnuts; and wheat.
Changing Cultural Values and Minnesota Study Supported Passage
The new law is relatively uncontroversial because the culture of food has shifted due to public awareness of life-threatening food allergies. And the food industry has not been totally unresponsive. As a precautionary measure, ingredients lists on packaged foods have become more detailed in the past five years. But as a key FDA study recently pointed out, more remains to be done.
A two-year FDA study of food manufacturers in Minnesota revealed that allergens were not being properly listed on food labels. Working with state inspectors, the agency focused on peanut and egg allergies and found that as many as 25% of manufacturers of all sizes failed to label products properly. Most of the mislabeled products were cookies, ice cream, and candy. In most cases, the offending ingredients found their way into food because of processing errors, such as using the same utensils to stir different mixes or using the same baking sheets for different batches. The study also found that almost half the companies did not check their products to be sure labels accurately reflected all ingredients present.
Current Law Requires Ingredient Labeling, But Allergens Are Often Masked
The public is not sufficiently able to discern the allergens which are part of required ingredient disclosures. For example, a number of technical terns refer to milk (whey, casein, etc.), soy (miso or textured vegetable protein, etc.) and other commonly understood food ingredients. In addition, allergens may be present in natural or artificial flavoring, additives and colorings.
European Initiatives Also Move Forward
Food allergen labeling is not unique to the United States. Last year Europe also issued a new directive - 2003/89/EC - that requires food manufacturers to list twelve potentially allergic ingredients and their derivatives including celery, mustard, sesame seed and sulphites.
Next Steps: Ending Cross-Contamination and Application to Food Service Providers
While supported by consumers and industry alike, nonetheless there remain some areas of key concern: cross-contamination and application to food service providers. The FDA is directed to use its inspection actions to make sure manufacturers avoid cross-contact (in which small amounts of allergens are transferred on food production lines used for different products) and develop guidelines on preparing allergy-free foods in restaurants, delicatessens, bakeries and school cafeterias. Both are legitimate areas of concern and likely to test the continuing support of food manufacturers and food service operators.