NDA Versus GRAS Ingredients

September 20, 2011 By Steven Perez

FDA recently issued its highly anticipated guidance regarding new dietary ingredient (NDI) notifications, and several aspects have prompted substantial industry objection and concern. Most would agree that the agency thinking, as captured in the guidance document, will impose an increased burden on supplement companies seeking to comply with applicable regulations.

ISO/IEC 17025 is a company level accreditation based on a standard published by the International Organization for Standardization (ISO) titled “General requirements for the competence of testing and calibration laboratories”. ISO/IEC 17025 is a general umbrella term used to refer to the specific standard; the current version of this standard is ISO/IEC 17025:2017. The standard contains two main sections: management requirements (primarily related to the operation and effectiveness of the quality management system within the laboratory) and technical requirements (primarily related to the competence of staff and calibration of equipment). The standard also gives requirements related to quality management such as document control and corrective action. This standard is the basis for accreditation from an accrediting body.

ADPEN has also been inspected by the US-EPA multiple times with no observations.

NDA Versus GRAS Ingredients

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