Dietary Supplements: New Dietary Ingredient Notifications

The starting point is whether the substance is a dietary ingredient and whether it is new under the statutory framework. Evidence concerning marketing before October 15, 1994, and the food-supply exception require attention to identity and chemical alteration. An ingredient name alone does not establish the position for a differently manufactured preparation. FDA notification overview.

The notification explains the basis for concluding that use of the ingredient can reasonably be expected to be safe. Intake, serving pattern, duration, target population and other ingredients affect that assessment. Published studies must be relevant to the preparation and exposure proposed, rather than merely referring to the same plant species. Submission information.

Section 190.6 identifies the notifier, the ingredient, the supplement and the basis for safety, together with supporting material. Manufacturing information can be important to defining what the safety evidence actually covers. A usable submission connects the ingredient specification, proposed use and evidence rather than presenting an unstructured collection of research papers. Notification regulation.

Where notification is required, it is submitted at least 75 days before introduction or delivery for introduction into interstate commerce. Retain the submitted version, supporting references and FDA correspondence with the product decision. A change in identity or conditions of use should be examined for its effect on the original analysis. FDA submission process.

FDA distinguishes its safety-notification process from approval of a dietary supplement. A response or lack of objection does not remove adulteration, misbranding, CGMP or other responsibilities. Ingredient eligibility and the legality of disease-related claims are also separate questions. The commercial label must not turn a notification into an endorsement. FDA process explanation.

Use section 190.6 and the ingredient-specific facts before selecting a submission route. FDA’s submission page discusses a catch-up notification approach conditionally on finalizing draft guidance. That language should not be treated as an enacted exemption, completed amnesty or assurance for past distribution. Confirm the status of any policy relied upon. Submission page and policy wording.