The Food and Drug Administration (FDA) is likely to make the food industry swallow some labeling and packaging reforms as the agency moves forward on its revision of current good manufacturing practices (cGMPs) for food.

After three hearings this summer and the close of the public comment deadline in September, the agency is now chewing over whether it needs to upgrade controls companies must put in place to guard against physical, chemical, and microbiological contamination of food as it is processed and packaged. The GMPs are oriented toward sanitation: Their primary objective is to keep things like allergens, glass fragments, and residue from cleaning solutions out of food. Isolating food from Listeria monocytogenes in ready-to-eat foods is another top priority, too.

Congress was already one step ahead of the agency in one area: food allergens such as peanuts, milk, and fish. Too many food recalls because of food processing line contamination with allergens caused Congress to pass a new law this summer requiring new labeling for foods containing potential allergens. More on this later.

Actually, the GMPs themselves do not address labeling directly—though they do make mention of packaging. The agency does have the authority, for example, under Section 110.93 of the current GMPs, to address “warehousing and distribution” of food in order to protect the food and its container from contamination.

Pressure for temperature indicators

Caroline Smith DeWaal, director of the food safety program for the Center for Science in the Public Interest, wants the FDA to use that authority to require food companies to put time and temperature indicators (TTI) on “refrigerated food products or those that have a shelf life that could be shortened” with significant temperature abuse.

“I have heard from producers that a monitor could be affixed to packages that change color permanently if the product is subject to temperature abuse,” she says in an interview. DeWaal would like to see TTIs on packages all the way from the packaging line to the grocery store shelf. But the FDA clearly does not have the authority to mandate TTIs in a retail setting.

Larry Gordon, president of Cold Chain Technologies, thinks food companies would rebel against any effort by the FDA to mandate use of TTIs. “They don’t want the FDA to tell them how to run their business,” he explains. Cold Chain sells its own TTIs, plus those manufactured by companies such as Temptime Corp. and 3M Company. These can cost anywhere from $1.50 to $4. per tag. They make radio-frequency identification (RFID) tags look positively cheap.

Sebastian Cianci, an FDA spokesman, says the agency has made no decisions on whether to require TTIs on food packages stored in warehouses and shipped in trucks or other conveyances.

The allergen issue

The GMPs have a much more indirect link to food labeling: Companies that allow food products to become contaminated with “outside” ingredients, such as allergens, on unsanitary processing and packaging lines run the risk of ending up with a product on a retail shelf that is mislabeled.

For example, it has become clear over the past few years that some packaged foods reaching consumers have been contaminated with allergens such as milk, egg, fish, shellfish, tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans. Over the past 10 years or so, the food industry has adopted a voluntary practice of putting labels on foods saying the product “may contain” an allergen.

From a language standpoint, these warnings are all over the place. Moreover, Terry Furlong, cofounder and chief operating officer of the Food Allergy and Anaphylaxis Network, argues that too many companies use those statements as an excuse to ignore cross-contamination problems in their processing plants.

But Congress has stepped in here. On August 2, President Bush signed the Food Allergen Labeling and Consumer Protection Act. Jenny Scott, senior director of food safety programs, National Food Processors Association (NFPA), says an examination of food-related recalls in FDA enforcement reports for 2004 suggests that about two-thirds of these were related to unlabeled allergens or sulfites.

How to label allergens

The new law requires companies either to separately list the food source of the allergen next to the list of ingredients on the food label, or to include the common or usual name of the major food allergen in the list of ingredients followed in parentheses by the name of the food source from which the major food allergen is derived. There are a couple of exceptions, such as when an ingredient already listed on the label signals the presence of an allergen.

Regina Hildwine, senior director of food labeling standards at the NFPA, states that some food companies are already in compliance with the new law which becomes effective January 1, 2006—because they comply with voluntary guidelines the NFPA was instrumental in developing in 2001.

Two of the formats suggested in those guidelines parallel the formats dictated by the new law. But Hildwine does not know what percentage of the industry is complying. Moreover, the new Food Allergen law also requires labeling of allergens contained in flavorings and colorings, which currently are listed on labels as “classes.” That now changes.

By way of an example of a change, Hildwine cites a natural flavor that includes milk protein concentrate, an allergen. That allergen will have to be declared on the label. But it is not clear whether the FDA will want companies to declare “milk protein concentrate” or whether “milk” will suffice. Given the very limited real estate on food labels, the difference between adding three new words or one will make a big difference to some companies.

“A lot of companies have questions,” Hildwine states.