Earlier this week, FDA issued draft guidance for staff updating the agency’s existing

enforcement policy regarding major food allergen labeling and cross-contact prevention. The updated guidance reflects the addition of sesame as a major allergen, discusses how allergens must be disclosed when used as an ingredient in packaged food, and details the preventive controls provisions in 21 CFR § 117 applicable to preventing allergen cross contact. The updated guidance also details the circumstances in which failure to properly declare allergens or prevent cross-contact render a food misbranded or adulterated. Stakeholders have until July 17^th to submit comments.

Although not included in the guidance, FDA’s press release also makes clear the agency’s position regarding recent industry trends of adding sesame to products and declaring it as an allergen rather than taking steps to remove it from products and facilities. The press release states:

The FDA is aware that some manufacturers are intentionally adding sesame to products that previously did not contain sesame and are labeling the products to indicate its presence. While the draft CPG does not specifically address the issue of industry adding sesame to products that did not previously contain it, the draft CPG does address the FDA’s enforcement policy for labeling and cross-contact controls for major food allergens, including sesame. The FDA is engaged with various stakeholders on this issue. The FDA recognizes that this practice may make it more difficult for sesame-allergic consumers to find foods that are safe for them to consume-an outcome that the FDA does not support. (emphasis added)

So, what’s the takeaway? Although the draft guidance is intended as direction to FDA staff, it also provides helpful clues for industry. The updated guidance is far more detailed than the prior version, reflecting a heightened concern about food allergens and, likely, increased enforcement focus.

To prepare for their next FDA facility inspection, packaged food manufacturers should review labels to ensure that ingredient lists are up to date and allergens are declared as required. In addition, reviewing and updating cross-contact prevention controls, employee training, and recall policies will help the next facility inspection go as well as possible.

For food retailers such as supermarkets and restaurants, although local health authorities are the primary inspectors, the updated guidance also serves as a helpful guide for preparation, particularly in light of the allergen updates to the Model Food Code, which articulate best practices for retail food safety.

FDA Updates Draft CPG Regarding Major Food Allergen Labeling and Cross Contact: What Manufacturers and Food Retailers Should Do Next