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Is “May Contain” a Trigger for Inspections and Audits?

A “May Contain” advisory statement on the label of a food product can be a valuable warning to consumers of the potential of an unintentional, unavoidable allergen in a product … or it can be a pretext for the lack of allergen controls in a food facility. In either case, it not only advises consumers of the potential of allergenic cross-contact in your facility, but it also informs federal inspectors and third-party auditors of the same.

While no specific statements have been made by FDA or third-party auditors (e.g., GFSI) that an advisory statement would instigate an inspection/audit, there is little doubt that it could prompt them to look more closely at your allergen control program and practices during the inspection or audit. FDA has continually stated that “the advisory statement is not to be used instead of current good manufacturing practices (CGMPs)”; that FDA regulations “require adequate control of allergen cross-contact”; and that “manufacturers cannot just place an advisory statement on a product without first taking measures to prevent allergen cross-contact to the best degree possible.”

Applying action to the statements, the FDA Investigations Operations Manual specifically includes requirements for inspectors to evaluate packaging, packing and labeling operations (Sec., noting that “If the products contain allergens, ensure that the firm has controls in place to accurately identify the label declaration and procedures to ensure proper application to the final packaging.” Given that, the inclusion of a “May Contain” advisory statement essentially mandates that the inspector focus in on your allergen controls.

As listed in the manual, practices for the protection against allergenic cross-contact that are to be inspected include:

  • Note whether employees are wearing outer garments suitable to the operation in a manner that protects against allergen cross contact.
  • Cleaning and sanitizing of utensils and equipment must be conducted in a manner that protects against allergen cross-contact.
  • Equipment must be constructed, handled, and maintained during manufacturing, processing, packing, and holding in a manner that protects against allergen cross-contact.
  • All operations must be conducted in accordance with adequate sanitation principles – under such conditions and controls necessary to minimize the potential for allergen cross-contact.
  • Fans and other air-blowing equipment should operate in a manner that minimizes the potential for allergen cross-contact.
  • Raw materials and ingredients must be stored under conditions that will protect against allergen cross-contact.
  • Material scheduled for rework must be identified and held to protect against allergen cross-contact.
  • Chemical, microbial, or extraneous-material testing procedures must be used where necessary to identify sanitation failures or possible allergen cross-contact.
  • All food-contact surfaces must be cleaned as frequently as necessary to protect against allergen cross-contact.
  • Appropriate quality control operations must be employed, with determination of which quality controls are critical for the safety of the finished product, including allergen control points.

FDA is also very direct in stating that “Advisory statements such as ‘may contain [allergen]’ or ‘manufactured on equipment that also processes [allergen]’ cannot be used as a substitute for current good manufacturing practices (cGMPs) intended to prevent allergen cross-contact.” In fact, if FDA does find evidence of inadequate allergen cross-contact controls, the agency may deem a product adulterated “even when the product bears an allergen advisory statement.”

Despite all the above, there are times that cross-contact is unavoidable, or avoidance is unfeasible, which is the reason that advisory statements are allowed and are even encouraged in specific cases. While these statements limit product choice for allergenic consumers, it is preferable that they are informed of the potential allergen than that they consume the product and have a reaction.

But, if you are considering the use of an advisory statement, you should always conduct an operational risk assessment first, to evaluate the hazard and determine if changes could be made to prevent potential, unintended allergenic cross-contact, thus avoiding the need for an advisory statement. With cross-contact becoming an increased risk in bakeries across the country with sesame becoming the new “ninth major allergen,” TAG has been working with several bakeries and other facilities to assist in risk assessments and operational improvements to prevent the risk.

In the absence of regulatory allergen thresholds, other than for gluten, the regulatory agencies, especially FDA, continue to exert strong oversight for allergens at any level in food products. The new requirements around sesame do appear to have put more of a regulatory focus on precautionary labeling. So even if you have been using such a strategy for some time with no problems, we urge you to take a good look at your programs to ensure they are adequate. Better you do it before FDA does it for you!

If you’re currently using, or considering the use of, any advisory statements, give TAG a call. We can help assess your operations to determine if practices can be implemented to avoid use of the statement, thus increasing consumer choice, and reducing the potential of excessive inspection focus.


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