Food additive petition, drug product

The evaluation of the safety of a new excipient as a food additive could be accomplished by the submission of a food additive petition to the United Nations expert panel operating under the auspices of the FAO and the World Health Organization known as the JECFA. A JECFA review could serve as a separate independent safety review to support the new excipient for potential use in drug products. Alternatively, the safety of a new excipient could be evaluated through the food additive petition processes, as currently in practice both in the United States and the EU, assuming that the new excipient can be demonstrated to have a technological function as a food additive. 

The FDA regulations or guidelines prescribe the types of safety tests for a particular product. Sponsors may conduct the studies in their own laboratories or have them performed by a contract laboratory, a university, or some other type of laboratory. The sponsor submits the study reports to the FDA in food and color additive petitions, investigational new drug applications, new drug applications, new animal drug applications, biological product license applications, and other requests for permission to market a product. 

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