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.
- Any substance intentionally added to food, or that may reasonably be expected to become a component of food or otherwise affect its characteristics, is subject to the food additive provisions unless an exemption or exclusion applies.
- Such substances may only be used when there is a valid legal basis for the intended use, such as FDA approval or a recognized exemption like GRAS;
- Also, color additives are subject to separate statutory and regulatory requirements and must comply with their own specific approval framework.
- When an ingredient or sub-ingredient required to meet these provisions lacks an appropriate legal status for its intended use, the finished food may be considered adulterated under US law..
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.
