A firm plans to introduce a novel plant extract not previously used in foods. Which FDA approval pathway is most appropriate and what immediate requirements should the company expect to fulfill?

• A. No approval needed if the extract will be used at very low concentrations; minor use exempts it from both GRAS and premarket submission requirements
• B. File directly for a Temporary Emergency Use Authorization which the FDA grants automatically for new colorants and novel flavorings without data if economic benefit is demonstrated
• C. Claim GRAS status without public disclosure because any company can declare a substance generally recognized as safe based on internal opinion without submitting evidence to FDA
• D. Premarket food additive petition: submit safety data including analytical detection methods, animal toxicology studies, and evidence of efficacy because the substance is novel and not historically recognized as safe

Answer: (D)