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?

No approval needed if the extract will be used at very low concentrations; minor use exempts it from both GRAS and premarket submission requirements

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

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

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