FDA updates draft guidance on allergen cross-contact for food manufacturers
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Key takeaways:
- The guidance explains how to prevent cross-contact and ensure proper allergen labeling.
- Guidance is provided for voluntary allergen advisory statements when appropriate as well.
The FDA has updated its draft guidance for preventing cross-contact between major food allergens in manufacturing facilities and ensuring that the ingredients in finished products are properly labeled.
This guidance is designed to help food facilities comply with requirements for current good manufacturing practices (CGMPs) and preventive controls for human food, the FDA said in a press release.
“The FDA is looking for opportunities that could help consumers who are allergic to sesame and other major food allergens find foods that are safe for them to consume,” FDA Commissioner Robert M. Califf, MD, said in the press release.
“We encourage manufacturers to follow the guidelines in the draft guidance updates ... to prevent allergen cross-contact and ensure proper labeling,” Califf continued.
Specifically, Chapter 11—Food Allergen Program of the draft guidance explains how manufacturers can protect food from major food allergen cross-contact and ensure proper allergen labeling.
The chapter also provides examples of how manufacturers can significantly minimize or prevent allergen cross-contact and undeclared allergens by using CGMPs and preventive controls.
Noting that labeling errors are the cause of most FDA food allergen recalls, the FDA said that the chapter includes guidance for monitoring or verifying that allergens are properly declared as required and that the product label is correct.
Acknowledging that cross-contact sometimes cannot be completely avoided despite adherence to appropriate CGMPs and preventive controls, the chapter also provides options that manufacturers may consider in these circumstances, such as voluntary allergen advisory statements when appropriate.
The Food Allergy Safety, Treatment, Education, and Research (FASTER) Act requires manufacturers to disclose when sesame is included in a food product and to implement controls that significantly minimize or prevent cross-contact with sesame.
However, the FDA said, some manufacturers are intentionally adding sesame to products that did not previously include it and including sesame on their ingredient labels instead of taking measures to prevent cross-contact with it.
Whereas this may keep manufacturers in compliance with the law, it also limits options for consumers with sesame allergy, which the FDA said it does not support.
Rather than continuing to add sesame to products that did not previously include sesame, the FDA said, it is encouraging industry to follow its new draft guidance and review the examples that it provides.
“We recognize there are challenges with ensuring products are free of allergens and we are engaging with stakeholders on this issue,” Califf said.
“The agency is interested in finding solutions, within our authorities, that meet the needs of consumers with food allergies,” he continued. “Updating this draft guidance with the new allergen chapter provides one tool to help manufacturers meet this goal.”
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Perspective
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We are disappointed that these updates do not go far enough to protect the 1.6 million Americans with a sesame allergy, as the FDA does not prohibit the practice of intentionally adding sesame to previously safe baked products. It appears that by not taking a firm stance against this practice, the FDA is ignoring congressional intent when it overwhelmingly passed the FASTER Act in 2021.
The updated guidance for food allergen controls in Chapter 11, which is a revision to the 2016 edition, is needed because of the FASTER Act requiring sesame labeling. The update also provides the FDA’s current thinking on food allergen controls.
Yes, FARE supports FDA and Congress to do more to stop and prevent baking companies from intentionally adding sesame to previously safe food products. By allowing this practice to continue, the FDA is providing a loophole for industry to follow that undermines the Food Allergen Labeling and Consumer Protection Act and is providing a roadmap for food manufacturers to follow when the next allergen is labeled.
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