News Feature | April 13, 2015

How To Prepare For FSMA Allergen Legislation

By Isaac Fletcher, contributing writer, Food Online

Food Allergens In FSMA

With undeclared food allergens becoming more-strictly regulated, food companies will need to figure out methods to control allergens both internally and from suppliers.

The Food Safety Modernization Act (FSMA) stipulates that undeclared food allergens will be considered adulterants. This legal change, among others, is one of the key reasons that food companies need to start preparing for the coming FSMA changes and begin increasing attention to allergen control. During the Food Week meeting in Washington, D.C., an event sponsored by the Food and Drug Law Institute (FDLI), regulatory experts convened to urge food companies to begin or continue preparing for FSMA changes prior to the release of final rules starting this year.

According to Robert Lake, a 30-year veteran of the FDA and senior consultant with EAS consulting group, FSMA’s increased emphasis on food allergens is a striking change. Current food allergen regulations focus on enforcing the labeling of the big eight food allergens. However, as congress recognizes that undeclared allergens remain a leading cause for recalls among FDA-regulated products, FSMA will adjust the law to identify undeclared allergens as food-safety and misbranding issues.

Risk Assessment Best Practices & Implementing Preventive Controls

The FDA has included provisions to update Good Manufacturing Practices (GMPs) that aim to prevent food allergen cross contact. Additionally, FSMA’s preventive controls will include a requirement to conduct a hazard analysis of food products. Records of these analyses must be maintained and readily available upon the request of regulatory bodies. Lake explains, “Because undeclared allergens are now a food-safety issue, the FDA will pay more attention to the food-allergy controls food companies are using. This ups the FDA’s focus on food allergens.”

To prepare for the upcoming changes, companies should begin to reevaluate food allergen controls and educating employees about the significance of food label mix-ups and various other control issues that can endanger consumers. Additionally, FSMA may force companies to stop relying on advisory statements such as “may contain” allergens, as this kind of labeling has been frustrating to the food-allergen community. This labeling will need to be rethought and the FDA will be pressured into establishing a clearer policy on the issue.

In order to fully implement effective allergen controls, stricter supplier controls will also need to be put in place. Some of the most-significant recalls the U.S. has experienced have been due to mistakes made by suppliers. However, FSMA’s mandate for food companies to better control suppliers will be difficult, especially for companies that deal with thousands of suppliers on a regular basis. Companies will need to look at each supplier to determine if any significant hazards exist and, if so, how those hazards are being controlled. To help ease into this adjustment, experts urge companies to spend time and effort now to validate suppliers.