If raw materials aren’t fully FDA-compliant but EU compliant, can we still sell the product in the US ? This question comes up often with complex formulations. From an FDA perspective, the logic is simple. Pointing to approval in other jurisdictions, relying on a long history of use elsewhere, or assuming that a low use level or a so-called “minor” ingredient will be overlooked is not a good argument or approach to access the US market. These factors may feel reassuring, but they do not establish legal status under FDA rules. What does work is a disciplined regulatory approach by mapping each ingredient and sub-ingredient to its US regulatory status, verifying that the intended use levels and conditions of use are covered, and reformulating where no valid approval or GRAS pathway exists. I have prepared this illustration that summarizes the decision logic used to determine a substance’s regulatory and legal status, and shows where compliance ultimately leads to the need for food additive authorization. If you find it useful and choose to share it, attribution would be appreciated. If you have questions, feel free to reach out anytime. We support food businesses with food labeling compliance, risk assessment and management, and food system compliance with the FDA. If you have questions about what FDA registration means for your facility, which regulations apply to your operation, or how to design compliant food labels and build a compliant HACCP and Food Safety Plan for the US and EU market, DFK Safe Food Environment provides regulatory consulting, FSPCA training, and FSMA compliance support for domestic and international food businesses.