{"abstract":"The Food and Drug Administration (FDA or we) is reopening the comment period for the document requesting scientific data, information, and comments entitled \"Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates\" that appeared in the Federal Register of November 23, 2016 (81 FR 84595). In the document, we requested scientific data, information, and comments to help us determine whether a particular isolated or synthetic non-digestible carbohydrate should be added to our definition of \"dietary fiber\" for purposes of being declared as dietary fiber on a Nutrition Facts or Supplement Facts label. We also announced in the document the availability for comment of a scientific literature review document that we conducted that summarizes clinical studies associated with 26 specific isolated or synthetic non- digestible carbohydrates. We are taking this action in response to requests to allow interested persons additional time to submit comments.","action":"Notice; reopening of comment period.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2017/01/13/2017-00725.html","cfr_references":[],"citation":"82 FR 4348","comment_url":null,"comments_close_on":"2017-02-13","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments by February 13, 2017.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-3389"],"dockets":[{"supporting_documents":[{"title":"02-320 Resistant starch type 4-enriched diet lowered blood cholesterols and improved body composition in a double blind cross-over intervention  re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; R","document_id":"FDA-2016-N-3389-0388"},{"title":"Reference 02-319 Fermentable fibers do not affect satiety or food intake by women who do not practice restrained eating re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments","document_id":"FDA-2016-N-3389-0322"},{"title":"Reference 02-303 Gastrointestinal effects of resistant starch, soluble maize fibre and pullulan in healthy adults re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments","document_id":"FDA-2016-N-3389-0306"},{"title":"Reference 02-264 Food amylose content affects postprandial glucose and insulin responses re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments","document_id":"FDA-2016-N-3389-0267"},{"title":"Reference 02-246 Digestions and physiological properties of resistant starch in the human large bowel re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments","document_id":"FDA-2016-N-3389-0249"},{"title":"Reference 02-244 Glycemic responses to sweetened dried and raw cranberries in human with type 2 diabetes re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments","document_id":"FDA-2016-N-3389-0247"},{"title":"Reference 02-234 Polydextrose its impact on short-term food intake and subjective feelings of satiety in males – a randomized controlled cross-over study re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments","document_id":"FDA-2016-N-3389-0237"},{"title":"Reference 02-232 Postprandial effects of polydextrose on satiety hormone responses and subjective feelings of appetite in obese participants re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments","document_id":"FDA-2016-N-3389-0235"},{"title":"Reference 02-226 Studies on the effects of polydextrose intake on physiologic functions in Chinese people re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments","document_id":"FDA-2016-N-3389-0229"},{"title":"Reference 02-225 Consuming polydextrose in a mid-morning snack increases acute satiety measurements and reduces subsequent energy intake at lunch in healthy human subjects re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments","document_id":"FDA-2016-N-3389-0228"}],"agency_name":"FDA","documents":[{"comment_count":36,"comment_start_date":"2017-01-13","updated_at":"2023-02-28T19:25:49.868-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2016-N-3389-0408","allow_late_comments":null,"id":"FDA-2016-N-3389-0408","comment_end_date":"2017-02-14","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":411,"id":"FDA-2016-N-3389","title":"Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates"}],"document_number":"2017-00725","effective_on":null,"end_page":4349,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/01/13/2017-00725.xml","html_url":"https://www.federalregister.gov/documents/2017/01/13/2017-00725/evaluation-of-the-beneficial-physiological-effects-of-isolated-or-synthetic-non-digestible","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-00725?publication_date=2017-01-13","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-01-13/2017-00725/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":960,"last_updated":"2026-08-25 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-01-13/pdf/2017-00725.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-00725.pdf?1484228798","publication_date":"2017-01-13","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/01/13/2017-00725.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"02-320 Resistant starch type 4-enriched diet lowered blood cholesterols and improved body composition in a double blind cross-over intervention  re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; R","document_id":"FDA-2016-N-3389-0388"},{"title":"Reference 02-319 Fermentable fibers do not affect satiety or food intake by women who do not practice restrained eating re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments","document_id":"FDA-2016-N-3389-0322"},{"title":"Reference 02-303 Gastrointestinal effects of resistant starch, soluble maize fibre and pullulan in healthy adults re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments","document_id":"FDA-2016-N-3389-0306"},{"title":"Reference 02-264 Food amylose content affects postprandial glucose and insulin responses re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments","document_id":"FDA-2016-N-3389-0267"},{"title":"Reference 02-246 Digestions and physiological properties of resistant starch in the human large bowel re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments","document_id":"FDA-2016-N-3389-0249"},{"title":"Reference 02-244 Glycemic responses to sweetened dried and raw cranberries in human with type 2 diabetes re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments","document_id":"FDA-2016-N-3389-0247"},{"title":"Reference 02-234 Polydextrose its impact on short-term food intake and subjective feelings of satiety in males – a randomized controlled cross-over study re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments","document_id":"FDA-2016-N-3389-0237"},{"title":"Reference 02-232 Postprandial effects of polydextrose on satiety hormone responses and subjective feelings of appetite in obese participants re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments","document_id":"FDA-2016-N-3389-0235"},{"title":"Reference 02-226 Studies on the effects of polydextrose intake on physiologic functions in Chinese people re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments","document_id":"FDA-2016-N-3389-0229"},{"title":"Reference 02-225 Consuming polydextrose in a mid-morning snack increases acute satiety measurements and reduces subsequent energy intake at lunch in healthy human subjects re Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments","document_id":"FDA-2016-N-3389-0228"}],"comments_count":36,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-N-3389","supporting_documents_count":411,"docket_id":"FDA-2016-N-3389","document_id":"FDA-2016-N-3389-0408","regulation_id_number":null,"title":"Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates","checked_regulationsdotgov_at":"2023-03-01T00:25:48Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":4348,"subtype":null,"title":"Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request For Scientific Data, Information, and Comments; Reopening of Comment Period","toc_doc":"Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates","toc_subject":"Requests for Information:","topics":[],"type":"Notice","volume":82}