Food Safety: How the FDA Regulates Labeling Foods That Contain Allergens

imagesIn 2004, the Food and Drug Administration (FDA) enacted the Food Allergen Labeling and Consumer Protection Act (FALCPA). The goal was to help people suffering from food allergies better understand whether certain food items contained allergens. A main focus was to help children identify, in simple terms, food they were required to avoid due to an allergy. Prior to the enactment of FALCPA, manufacturers did not design labels to provide information about allergens contained in prepackaged foods. Many consumers purchased these foods items not knowing whether the item contained allergens, or had come into contact with allergens during processing or packaging. Consumers were unwittingly forced to play Russian roulette with their food choices; without proper labeling, there was no way to tell if a person with allergies would react to a particular food. For example, in 1999, one review of randomly chosen premade or processed foods showed that 25 percent contained the allergens peanuts or eggs, yet did not list those ingredients on the labels. FALCPA’s passage can help allergy sufferers regain control of their own food safety.

Applying FALCPA

FALCPA applies to any food label created on or after January 1, 2006 and covers both domestically manufactured and imported foods that are subject to FDA regulation. The FDA regulates packaged foods, including infant formulas and foods, medical foods, and vitamins and dietary supplements. FALCPA requires food manufacturers to label foods that contain any ingredients that are, or contain a protein from, any of the major food allergens.

Identifying the 8 Major Food Allergens

Although more than 160 foods have been shown to cause allergic reaction in people, more than 90 percent of all allergic reactions come from eight allergens; peanuts, tree nuts, milk, eggs, shellfish, fish, wheat and soy. FALCPA calls these eight foods, “major allergens” and requires their presence be noted on food labels.

In the case of tree nuts, fish and shellfish, FALCPA requires the type of nut (walnut, pecan), fish (cod, flounder), or shellfish (crab, lobster), to be listed on the label as well.

Allergens in Plain Language 

We’ve all read labels that include names of chemicals and foods we can barely pronounce, let alone identify as a food source. FALCPA addresses that issue by requiring manufacturers to list allergens by their common or usual name and by the name of the food source from which it is derived.

Manufacturers may list allergens in two ways. The first way is to list the food allergen by its common name and then by the food source in parenthesis, such as “whey (milk),” or “lecithin (soy).” This is the most common required way allergens are listed on food packaging labels.

The second way manufacturers may list allergens on labels is by placing the word “contains” somewhere on the label. They then list the name or names of the food source from which the major allergen is derived.

The “Contains” “May Contain” and “Shared Facility” Sections

Below a food label’s main area, which lists the nutritional facts and ingredients, a section called “contains,” “may contain,” or “shared facility” may also be included.

If a “contains” section appears on the label, the names of the food sources from which the allergen, or allergens, are derived must follow, such as “contains peanuts and soy.” This section is not required if the main ingredients section lists any allergen present. Likewise, if the allergen is listed in the “contains” section, there is no requirement to list the allergen in the main ingredients as well, so it’s important to read both lists carefully for the presence of allergens in a food item.

A “may contain” section is similar to the “contains” section. The names of food sources from which an allergen, or allergens, are derived must follow, such as “may contain peanuts and soy.” However, the “may contain” section is different because it is generally used in situations when a food item was not manufactured using any of the major allergens, but was processed in a facility that also processes food items that do contain one or more of the major allergens. In these cases, cross contamination may occur and the section alerts consumers to the possibility that an allergen may be present though not intended.

Some manufacturers use a “shared facility” advisory rather than a “may contain” section. A “shared facility” advisory generally states that the food item in question was not manufactured using any of the major allergens, but was processed in a facility that also processes food items that do contain one or more allergens.

Despite these often-included sections, FALCPA does not require “may contain” or “shared facility” advisories to appear on labels. Discretion to provide that information to consumers is left to the manufacturer.

Items Exempted from FALCPA

FALCPA does not cover several food items, such as food in its whole, natural state. Fresh fruit and vegetables fall into this category. Medications, cosmetics and health and beauty aids such as toothpaste are also not covered by FALCPA because they are not considered food, even though they may be ingested. Other items not covered by FALCPA are:

  • Any food product regulated by the USDA, such as meat and poultry
  • Any product regulated by the Alcohol, Tobacco Tax and Trade Bureau, such as alcoholic beverages, beer, spirits and tobacco products
  • Restaurant foods, fast foods and food/street vendors
  • Kosher labeling
  • Pet food and products

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