Do not transfer one category’s history or notification to another use.
Educational reference—not medical advice, a supply promise or a universal manufacturing procedure.
The intended use matters
The same botanical name can sit within different legal questions depending on preparation and intended use. Review species, plant part, extraction process, composition and conditions of use together. A food-additive authorization, GRAS conclusion, supplement notification and cosmetic ingredient listing are not interchangeable forms of permission. Avoid an unqualified approved ingredient label.
US and EU examples illustrate the boundary
FDA describes an NDI notification process for certain new dietary ingredients in supplements and separately explains GRAS food uses under intended conditions. The European Commission catalogue notes that a history exclusively in supplements does not automatically cover new uses in other foods. These are starting points for review, not a determination about any product listed on this website.
Track drafts and current requirements
The linked FDA pages distinguish draft guidance from final procedural guidance. Its GRAS overview also describes a 2026 proposed rule, which must not be called a final rule. Record the check date and ask a qualified regulatory reviewer to confirm current requirements, the exact preparation and proposed label before commercial decisions. No universal compliance conclusion is made here.
Review handoff
Give the regulatory reviewer the full material description and intended use, not just a common name or a supplier claim.
Confirm species, plant part and starting-material traceability
Record solvent, carrier, form and analytical method
Set acceptance criteria for the actual formulation and destination market
Make decisions using written specifications and genuine batch evidence. The checks described here are not claims of tests already performed or certificates held by ZL Botanicals; equipment and process explanations do not assert our manufacturing capabilities.
References and scope
Sources checked: . Source titles are retained as published. Status reflects this check, not a substitute for pre-market review.
US dietary supplements. Official index lists final procedural guidance (2024) separately from draft guidance (2016, 2022, 2024). Notification is not general product approval.
US food uses under specified conditions. FDA describes an August 10, 2026 proposed rule: proposal, not final rule. Recheck the docket before relying on procedural requirements.