FDA Allergen Controls

Editor’s Note: In September, the author met with three officials from the Food and Drug Administration to discuss current agency initiatives and challenges faced by both the agency and the industry in controlling and identifying allergens in foods. Involved in the discussion were Senior Advisor in the Office of Food Safety Jenny Scott, Food Allergen Coordinator Steven Gendel, and Director of Food Labeling and Standards Staff Felicia Billingslea.

What do consumers really need and what is possible for industry? The sometimes conflicting juxtaposition of the two needs illustrates one of the top challenges that the Food and Drug Administration (FDA) faces and the questions it must consider every time it proposes new guidelines or regulations on food allergens. Each set of needs and capabilities must be reviewed and determined for every regulation and guidance document from advisory labeling to thresholds to the yet-to-be-released preventive controls provisions of the Food Safety Modernization Act (FSMA).

This balancing of both sides has been a challenge, not only in development and passage of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), but for the initial focus on allergens that began back in the 1990s when it became recognized that a number of food recalls were being made because of allergic reactions in consumers.

“We were in the middle. Consumers were saying that labels weren’t giving them enough information, and industry was saying consumers want too much information,” said Director of Food Labeling and Standards Staff Felicia Billingslea, who has been with the FDA for 25 years.

And even after more than 20 years of recognition of the potentially life-threatening impact of allergenic cross-contact, it is still difficult to get everyone in the industry to see it as important, said Office of Food Safety Senior Advisor Jenny Scott. This is due, at least in part, to the low percentage of the population who would have a reaction, making a significant outbreak from an allergenic contamination unlikely. And those who are not connected with anyone with food allergies are often not even aware of an issue.

“There is very little or no tracking of allergic reactions,” said Food Allergen Coordinator Steven Gendel. “No place gathers that information.” The Food Allergy and Anaphylaxis Network (FAAN), a nonprofit organization dedicated to improving awareness of food allergies, maintains a website which is closely tracked by many of those with food allergies. But the larger population is often comfortably unaware of food allergen issues.

The contrast with pathogen-contamination recalls is so great because of the differences between pathogens and allergens. “Pathogens don’t have labeling issues,” Billingslea said. If there’s a pathogen in a food, it is a food safety issue for anyone who may consume it. But allergens are food, and are nutritious and desirable for the majority of the population.

In addition, compared with the length of time for which the government and industry have been dealing with pathogens in food, allergens are still an emerging issue, and they present a different sort of complexity than many other food safety problems. “It is a complex set of interactions, any one of which going wrong can create a problem,” Gendel said, adding that because of this, “a significant percent of the problem is human error.”

“The bad news,” Scott added, “is that there is no kill step for allergens. The good news is that, unlike foodborne pathogens, allergens don’t grow in the food.”

Thus, key challenges facing both FDA and the industry are advisory labeling, communication and understanding, risk management, allergen thresholds, imported foods, and preventive controls.

Advisory Labeling. Although it continues to be a major challenge, advisory labeling is not a new issue. It was, in fact, addressed in a 1996 letter to manufacturers on “Label Declaration of Allergenic Substances in Foods” from Fred Shank, then Director of CFSAN, “Another area of concern is the potential, inadvertent introduction of an allergenic ingredient to a food … FDA is considering options for providing consumers with information about the possible presence of allergens in these foods. The agency is aware that some manufacturers are voluntarily labeling their products with statements such as “may contain (insert name of allergenic ingredient).” FDA advises that, because adhering to good manufacturing practice (GMP) is essential for effective reduction of adverse reactions, such precautionary labeling should not be used in lieu of adherence to GMP. The agency urges manufacturers to take all steps necessary to eliminate cross contamination and to ensure the absence of the identified food. The agency is open to suggestions on how best to address this issue.”

Today, the agency and the industry are still wrestling with how best to address the issue. Currently there is only general guidance that food allergen advisory statements (e.g., “may contain [allergen]” or “produced in a facility that also uses [allergen]”) should not be used as a substitute for adhering to current good manufacturing practices and must be truthful and not misleading. Beyond that, there is little uniformity as to how advisory statements are used.

The issue is of grave concern, Billingslea said, because FDA consumer studies have shown that consumers use advisory labels as permission to buy a product rather than as a warning to stay away. This also has been shown in surveys conducted by FAAN, in which consumers who are, or who have family members who are, food allergic were asked if they would buy products with certain advisory labeling. If a product were labeled “May contain [allergen],” fewer than 10 percent of respondents said they would buy it. However, if labeled, “Manufactured in a facility that also processes [allergen],” more than 35 percent would buy it.

“Consumers want permission to buy the food. So the less risky they determine it to be, the more willing they are to buy it,” she said.

Knowledge and Awareness. As this shows, consumer knowledge and awareness is an important aspect of food safety when it comes to allergens, so FDA works closely with FAAN and has conducted consumer outreach on the topic. However, just as important is the awareness and understanding by the plant workers who are a primary line of defense against allergen cross-contact.

People who have not had personal experience with serious food allergies, or connection with someone who has, often do not understand the potential gravity of allergen contact. “There’s always the people issue,” Scott said. “People make mistakes; some people don’t care; some people don’t see it as important.” But there are ways to get the point across through training.

One example Scott gave was that of companies having food-allergic employees make presentations to others describing what life is like with the food allergy, the precautions they must take, and what happens if the allergen is consumed. Getting a personal, first-hand view can significantly increase awareness—and care.

Another training example, given by Billingslea, is that of training conducted at a facility in which each participant was “assigned” a food to which he or she was said to have a life-threatening allergy. They were given a grocery list and charged with shopping for foods without the allergen. At the end of the session, their purchases were reviewed and they were told whether they lived or died. “It gave them a different viewpoint and they were compelled to be more careful,” she said.

But however you train, Scott said, “You can’t train once and let it go. You have to keep reinforcing all your controls.”

Allergen Thresholds. It is the variation of effects on the food-allergic individual that makes it difficult to set thresholds. One person might experience a reaction if he or she consumes a very tiny amount of the allergen, while others can consume more before experiencing a reaction. “We are very aware of the issues and what potential impact thresholds could have,” Gendel said. Although there is an increasing amount of data on such thresholds, and some will say that every individual has a threshold, he said, “from the FDA viewpoint, we have to look at it for the whole population. We have to be protective of the population as a whole.”

It is not just a matter of the impact of the allergen itself. Even for foods that are common allergens, he added, how the food is used can make a difference in the threshold. “We need quantitative data to make a decision as an agency. Part of that process is to identify the data and its reliability,” Gendel said. “Industry has tried to encourage us to use their threshold levels, but the data needs to be from publicly available sources.”

Additionally, it is difficult for FDA to set thresholds because of the array of factors that come into play, such as labeling rules, standards for approvals for new food additives, etc.—each of which is governed by a different part of the Food, Drug and Cosmetic Act . This was, in fact, the impetus for development of Gendel’s position as food allergen coordinator, in which he acts as liaison between different offices and programs in FDA to reduce duplication and increase partnerships.

Risk Management. Gendel and Scott are both members of FDA’s “reportable foods” risk control and review team. The purpose of the team is to review reports submitted to FDA’s Reportable Food Registry (RFR) and to help determine the root cause of the food problem—where the problem is occurring and what needs to be done about it. This includes reports related to unlabeled food allergens, Gendel said. “Root-cause analysis is used to identify both the issues that are most likely to cause allergen problems and the types of facilities in which they are likely to occur.” One such finding that has been made from the data available through the RFR is that there is a very high occurrence of undeclared milk and egg in bakery products.

Such analysis is valuable not only to the FDA, but also for industry itself, both for the types of facilities identified as most susceptible and for processors sourcing raw ingredients. “It is a very important effort and provides information the industry likes to see,” Scott said.

Another area that was identified from the RFR analysis was that error(s) during product changeover is a significant cause of undeclared allergen recalls, with an emerging issue being that of on-site printing of computer-generated labels. “People aren’t always careful in choosing the proper label,” Gendel said. It can be all too easy to open or delete the wrong file, and end up using an old label on a re-formulated product.

“We may need to provide some guidance on label controls for food allergens,” Scott said.

Imported Foods. Imported foods also can be a challenge because of varying food safety and labeling regulations around the world, Gendel said. A food may be properly labeled at its origin, but not for its destination in the U.S.; or it may require translation, thus the food source of the allergen may not be always listed as required by FALCPA.

Additionally, many of the exotic, foreign foods that consumers seek come from small, niche markets that don’t have a great deal of legal training. Thus, it is not surprising that there will be import error and issues when, as Scott said, “Even domestically, we continue to see allergen recalls from the most savvy companies.” There is general international recognition and agreement of the eight major food allergens, as demonstrated by the labeling standards of the Codex Alimentarius Commission, Billingslea said, but each country may differ in how it handles allergens and what ingredients have to be on the label.

FSMA Preventive Controls. While FSMA’s preventive control regulation had not yet been published at the time of the interview or writing of this article, the act does recognize and list allergens as a hazard for which an evaluation must be made. If allergens are reasonably foreseeable hazards, preventive controls must be identified and implemented “to significantly minimize or prevent the occurrence of such hazards and provide assurances that such food is not adulterated under section 402 or misbranded under section 403(w),” controls monitored, and monitoring records maintained. In defining preventive controls, FSMA further notes that they may include a food allergen control program.

Allergens have long been recognized as a hazard and are, in fact, the primary chemical hazard of concern, Scott said. Because of this, as well as FALCPA regulations and the impact of recalls, facilities that produce allergenic and non-allergenic products generally do take steps to manage allergens, control cross contact, and label products that do or may contain such allergens.

“That’s when it works,” Billingslea said. “When industry is very careful with how they manage allergens, when they have controls in place and information is available for the consumer.”

The author is Editor of QA magazine. She can be reached at llupo@gie.net.