On November 26, 2012, Newman’s Own voluntarily recalled batches of its Lite Honey Mustard Dressing because the product label on the bottle did not mention the fact that the dressing contained milk, a major food allergen. Individuals who are allergic to milk should not consume the Lite Honey Mustard Dressing because doing so could cause a serious or life threatening reaction. Newman’s Own initiated the recall after learning that the 16-fluid ounce bottles of its dressing were labeled with an incorrect back label failing to include milk as an ingredient of the product. The recalled batches of products were sold in stores from the eastern to midwestern United States. See Newman’s Own, Inc. Issues Voluntary Recall of Newman’s Own Lite Honey Mustard Dressing Due to Undeclared Milk, FDA Press Release, November 23, 2012. The Food Allergen Labeling and Consumer Protection Act of 2004 (“FALCPA”) requires manufacturers to clearly label any food product containing a “major food allergen” on food labels. A “major food allergen” is defined by the law as an ingredient that is one of the following foods or has any ingredient containing protein from one of the following foods:

  1. milk
  2. eggs
  3. fish
  4. crustacean shellfish
  5. tree nuts
  6. peanuts
  7. wheat and
  8. soybeans

The FALCPA requires manufacturers to identify on product labels that the product contains one or more of these major food allergens. The law applies only to packaged foods, including products imported into the United States, but excludes from regulation poultry, meat, and egg products. The label must either:

  1. disclose the name of the food source of the major food allergen in parentheses after listing the ingredient’s common name or
  2. next to or immediately after listing the ingredients, put the word “contains” and then the name of the major food allergen

If the food label does not adequately disclose the presence of the allergen, the food product may be recalled by the company or FDA. Other penalties for failing to comply with the FALCPA include civil sanctions, criminal penalties, and the seizure of food products. The Food Allergy & Anaphylaxis Network (“FAAN”) estimates that as many as 15 million people in the United States have some type of food allergy. Approximately nine million, or four percent, of adults have food allergies, while approximately six million, or eight percent, of young children have food allergies. The prevalence of food allergies has been on the rise; the Centers for Disease Control and Prevention noted in a 2008 study that an 18% increase in food allergies was seen between 1997 and 2007. The eight foods regulated by the FALCPA—milk, eggs, peanuts, tree nuts, wheat, soy, fish, and shellfish—account for 90% of all food allergies. See Food Allergy Facts and Statistics for the U.S., The Food Allergy & Anaphylaxis Network. Read more about the FALCPA.

This article was prepared by Megan Engel (mengel@fulbright.com / 512 536 2491) from Fulbright’s Health Care Practice.