“CRN is pleased that FDA has announced the formal release date for the long-awaited NDI draft guidance document and made the pre-publication version available for review,” said Steve Mister, president and CEO, CRN. “The dietary supplement industry has eagerly awaited this guidance in the hope that it will provide clarity and an appropriate framework for introducing new ingredients and products into the supplement marketplace.
“As FDA has reminded us, this draft guidance document describes the agency’s interpretation of the requirements for NDIs—it is not a new regulation and does not create new rights or responsibilities for the industry,” he continued. “Nevertheless, this draft guidance does represent an important step for the dietary supplement industry—and for the agency—as it demonstrates further implementation of the requirements of the Dietary Supplement Health and Education Act (DSHEA) and will give companies clearer understanding of FDA’s expectations under the law.”
CRN will review the guidance and will respond accordingly, said Mr. Mister. “This guidance has potential for short- and long-term implications for our industry and for our consumers’ ability to have access to in-demand products and we want to be sure the guidance is appropriate, reasonable and practical for industry and the more than 150 million consumers who use dietary supplements year after year.”