Todd Harrison01.01.06
Food Allergy Labeling is Here!
As of January 1st companies will be required to comply with the new food allergen labeling law.
By Todd Harrison
With the start of the New Year, companies are busy preparing new label runs and developing new product formulations. Many of these products will contain allergens, and starting this year a new labeling regime comes into existence for foods that contain allergens. The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) was enacted because Congress was extremely concerned that consumers were not able to easily identify the presence of major food allergens by simply reviewing a product label. To remedy this situation, Congress required that a “major food allergen” be clearly disclosed on product labels.
Specifically, FALCPA requires that an ingredient (including a flavor, color or incidental additive) that is a major food allergen be more explicitly identified on the food label. A major food allergen is identified as one of eight foods or food groups (milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans) or an ingredient that contains protein derived from one of the eight foods. Items considered major food allergens DO NOT include highly refined oils derived from any of the eight foods or food groups, or any ingredient derived from such an oil. Additionally, ingredients may become exempt under a statutory exemption process.
Companies have two options for declaring allergens contained in products. They can include a “contains” statement, which must include the names of the food sources of all major food allergens used as ingredients in the food. For example, if the ingredient statement declares whey, caseinate, egg yolk and peanut flavor, the “contains” statement must identify all three allergens (i.e., contains milk, egg and peanuts). That statement must appear immediately after the ingredient statement or adjacent to it. Also, the “contains” statement must appear in the same type and font size as the ingredient statement. Alternatively, companies can opt to list any major food allergen contained in products parenthetically in the ingredient list. For example, sodium caseinate (milk), albumin (egg). (Note: It is important to remember that once a company decides to use a “contains” statement, it must identify all the major food allergens in it.)
Products that include ingredients from tree nuts, fish and crustacean shellfish must list the specific nut or species of fish or shellfish. For example, products containing tree nuts would use the specific nut present in the food (e.g., almonds, pecan or walnuts). In the case of fish and/or shellfish, the specific species would be identified (e.g., flounder, perch, trout, shrimp, lobster or mussels).
It is important to note that the FALCPA does not address cautionary allergen statements such as “This product was manufactured in a facility that processes peanuts” or “This product may contain peanuts.” These statements are primarily used by companies to limit their regulatory or product liability risks. However, FDA has indicated on numerous occasions that such cautionary statements are not a substitute for adhering to current Good Manufacturing Practices (GMPs). Thus, while in-cluding such cautionary statements may be good practice, it is not a substitute for taking the necessary steps to ensure that cross-contamination does not occur.
Failure to comply with FALCPA leaves a company and its management vulnerable to civil sanctions and/or criminal penalties for failing to comply. The offending product will also be subject to a seizure action, however, FDA will most likely request the company issue a voluntary recall of the product before initiating a seizure action.
Finally, it has come to my attention that there may be some confusion whether the FALCPA pertains to dietary supplements. There is little doubt that the FALCPA is applicable to dietary supplements. More specifically, it is clear under the Federal Food, Drug, and Cosmetic Act (the Act) that dietary supplements are considered foods. Thus, unless a specific statutory provision indicates otherwise or is more directly on point, the food provisions of the Act also pertain to dietary supplements. With that said, to the extent that someone could come up with a legal theory to the contrary (which would require a very strained interpretation of the FALCPA and the Act), product liability concerns should counsel supplement companies to provide the necessary allergen information that is consistent with the
FALCPA.
The vast majority of food and supplement manufactures must adopt the regimen set out in the FALCPA and FDA’s guidance document for declaring allergens. The FALCPA and FDA’s guidelines will now become the industry standard, which every product will be judged against. Failure to follow industry practice leaves a company vulnerable to a product liability lawsuit if someone has an allergic reaction, especially if the product contained an allergen of concern and the label did not adequately disclose its presence in the supplement.
Moreover, a manufacturer may not escape liability because it was simply adhering to the wishes of its customer by affixing a label that fails to meet the industry standard. Regardless of whether a company believes the FALCPA is applicable to dietary supplements (which I believe would be foolhardy and subject the company to adverse regulatory action), a company should nevertheless follow the FALCPA and FDA’s guidance on declaring allergens to limit its product liability exposure. NW