The Food and Drug Administration (FDA) recently released temporary guidance that says if a food manufacturer must make minor formulation changes due to a COVID-19-related supply disruption, it does not have to revise the label to indicate the changes. The FDA said it is providing this regulatory flexibility to help minimize the impact of supply chain disruptions on product availability during the pandemic.
The FDA said that the minor formulation changes should only be 2% or less of the finished product, not a major or characterizing ingredient, and not include any ingredients that could cause any adverse health effects (such as food allergens, gluten, sulfites or other foods known to cause sensitivities).
Advocates for the allergen community responded to the FDA guidance, saying it is putting the one in four Americans who suffer from food allergies at risk. Food Allergy Research & Education (FARE) asked the FDA to require food manufacturers to inform consumers of any changes via their website and social media channels. Some brands have already communicated a commitment to not making substitutions and to total transparency in labeling.
If you have made or plan to make any minor supply chain-related formulation changes to your certified products, please be sure to inform your account representative so they can determine whether the product is still compliant with certification requirements.