Food allergen labeling has now been mandated by law, and food labels will have to feature disclosure statements beginning in January 2006. Packaging components containing allergens from packaging components are covered.
This allergy thing has been serious business for years. For one thing, it has been a source of important issues for business litigation. For example, I just got done working on a lawsuit in which our client, a food processor and supplier, was asked by one of its big customers to pay it back for costs of recalling and relabeling a food product. The food's label hadn't revealed the presence of allergens in the flavorings used. Our client paid the customer, but then turned around and sued the guys who sold them the company for not revealing the need to change that label, which was a breach of their contract for sale of the business.
And here's the thing: this all happened before the law required allergens to be revealed on the label. Still, the companies knew it was an important safety matter and of interest to many consumers.
That case settled. The next case might involve your company. And now your failure to list allergens on a food label could be a violation of federal law and Food and Drug Administration regulations, as well as a basis for civil liability for breach of contract with your customer, and product liability to an injured consumer.
For several years, food industry groups had voluntary guidelines in place under which manufacturers would indicate the presence of allergens even when it wasn't strictly required by law.
Evidently, there wasn't enough compliance with these voluntary guidelines to satisfy Congress. So, in mid-2004, Congress passed a law called the Food Allergen Labeling and Consumer Protection Act.
The principle behind the law, and the voluntary guidelines, is to alert consumers of the presence of allergens before they eat foods, so they can make informed choices. You can't cure a food allergy, so you just have to avoid the food involved, or try to treat the sometimes serious symptoms afterwards. Avoiding foods you're allergic to is often a simple matter of checking the ingredient list on packaged food, but if allergens are present in flavorings, colorings or other additives, they are not required by law to be named with specificity, so the information an allergic person needs might not be there. So the allergen would be "hidden," even from a consumer who takes the time to read the label.
Also, even when ingredients are listed by their common or usual name, as required by law and regulation, consumers may not be sufficiently familiar with those names to alert them of the presence of an allergen.
Primary culprits for causing about 90 percent of food allergies are these eight: milk, eggs, peanuts, tree nuts, fish, shellfish, soy and wheat.
The new law itself cites the statistics that inspired Congress. Annually, "roughly 30,000 individuals require emergency room treatment and 150 individuals die because of an allergic reactions to food," says Congress.
The law requires foods containing a major food allergen to state on their label, "contains," followed by the name of the food source from which the major food allergen is derived. This statement must be placed immediately after or next to the list of ingredients in a type size no smaller than the one used for a list of ingredients. "Major food allergen" is defined as any of the major eight food categories, or any food ingredient containing a protein derived from any of those foods.
Alternatively, you can list the common or usual name of the major food allergen in the list of ingredients and follow it in parentheses by the name of the food source from which is it derived, unless the common or usual name of the ingredient uses the name of the food source, or the name of the food source, appears elsewhere in the ingredient list and that name signifies a major food allergen.
The law requires foods, if they contain a major food allergen, to state on their label, "contains," followed by the name of the food source from which the major food allergen is derived.
The law specifically says that flavorings, colorings or incidental additives containing major food allergens are subject to this labeling requirement. And "incidental additives" include substances migrating into food from packaging. So if you make packaging, customers may ask you to identify allergens in your packaging materials.
Exemptions are provided for situations in which the public is otherwise appropriately protected, but a specific FDA finding to this effect is required and must be published in the Federal Register. If you can provide scientific evidence that demonstrates that your food ingredient doesn't contain allergenic protein, you can also be exempted through a petition process.
The labeling requirement is effective January 1, 2006, which is to say it applies to any food that is labeled on or after January 1, 2006.
The law also requires FDA to inspect food facilities to ensure that they are operating in such a way as to reduce or eliminate cross contamination of major food allergens into foods in which they are not ingredients, and to ensure that food allergens are properly labeled. These issues have been an area of focus for FDA food inspectors in recent years anyway. Now, though, the law backs it up with a new provision that can be cited against manufacturers and labelers.
In recognition of the related problem of persons with celiac disease—the treatment of which involves avoidance of glutens in foods—the law also calls on FDA to develop a proposal to "define, and permit use of, the term 'gluten-free' on the labeling of foods." Watch for that to be developed in the next two years with the final rule issuing in four years.
But the allergen labeling requirement is coming at the start of next year. That means you'd better start thinking right now about what label changes it may mean for your company.
Eric F. Greenberg is principal attorney with Eric F. Greenberg, PC, with a practice concentrated in food and drug law, packaging law and commercial litigation. Visit his firm's website at www.ericfgreenbergpc.com. Contact him by e-mail at [email protected], or by phone at 312/977-4647.