Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments

Federal Register, Volume 81 Issue 226 (Wednesday, November 23, 2016)

Federal Register Volume 81, Number 226 (Wednesday, November 23, 2016)

Notices

Pages 84595-84596

From the Federal Register Online via the Government Publishing Office www.gpo.gov

FR Doc No: 2016-27950

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket No. FDA-2016-N-3389

Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for scientific data, information, and comments.

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SUMMARY: The Food and Drug Administration (FDA or we) is requesting scientific data, information, and comments that would help us evaluate the beneficial physiological effects to human health of isolated or synthetic non-digestible carbohydrates that are added to foods. We are requesting such 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.

DATES: Submit either electronic or written scientific data, information, and comments by January 9, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

Submit electronic scientific data, information, and comments in the following way:

Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comments will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:

Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.''

Instructions: All submissions received must include the Docket No. FDA-2016-N-3389 for ``Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your

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comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Paula R. Trumbo, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2579.

SUPPLEMENTARY INFORMATION:

1. Background

   FDA regulations did not define the term ``dietary fiber'' before 2016. In the Federal Register of May 27, 2016 (81 FR 33742), we published a final rule amending our Nutrition and Supplement Facts label regulation. The final rule, among other things, defines dietary fiber as non-digestible soluble and insoluble carbohydrates (with three or more monomeric units), and lignin that are intrinsic and intact in plants; isolated or synthetic non-digestible carbohydrates (with three or more monomeric units) determined by FDA to have physiological effects that are beneficial to human health (21 CFR 101.9(c)(6)(i)). The final rule also identifies seven isolated or synthetic non-

   digestible carbohydrates that we determined to have beneficial effects for human health when added to foods (Sec. 101.9(c)(6)(i)). The seven isolated or synthetic non-digestible carbohydrates are: beta-glucan soluble fiber (as described in 21 CFR 101.81(c)(2)(ii)); psyllium husk (as described in Sec. 101.81(c)(2)(ii)); cellulose, guar gum, pectin, locust bean gum; and hydroxypropyl methylcellulose. Foods and dietary supplements that contain any of these seven isolated or synthetic non-

   digestible carbohydrates must include the amounts of these dietary fibers in a serving of food in the dietary fiber declarations on the products' Nutrition and Supplement Facts labels.

   Interested parties can ask us to list additional isolated or synthetic non-digestible carbohydrates in the definition of dietary fiber in Sec. 101.9(c)(6)(i) if we determine that the new isolated or synthetic non-digestible carbohydrate meets our dietary fiber definition. For example, a manufacturer who wants FDA to amend the definition of dietary fiber to include another added non-digestible carbohydrate could submit a citizen petition under 21 CFR 10.30. Elsewhere in this issue of the Federal Register, we have published a notice announcing the availability of a draft guidance document entitled, ``Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30): Guidance for Industry.'' The draft guidance describes the type of evidence and the scientific evaluation process we plan to use in determining the strength of the evidence for the relationship between an isolated or synthetic non-digestible carbohydrate that is added to food and a physiological effect that is beneficial to human health.

   In addition to issuing the draft guidance and determining that the seven isolated or synthetic non-digestible carbohydrates identified in the final rule's definition of dietary fibers have physiological effects that are beneficial to human health, we have conducted a scientific literature review of clinical studies associated with 26 isolated or synthetic non-digestible carbohydrates, such as gum acacia, carboxymethyl cellulose, inulin, polydextrose, and xanthan gum, that are not listed as a dietary fiber in Sec. 101.9(c)(6)(i). Our review is consistent with the factors we provide in the draft guidance entitled, ``Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (Sec. 10.30); Guidance for Industry'' to evaluate whether the available scientific evidence is sufficient to support a physiological effect that is beneficial to human health, based on the factors set forth in the draft guidance. We have summarized the clinical studies that we have identified for these 26 non-digestible carbohydrates and have provided summaries of the studies and related references in a document entitled ``Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-

   Digestible Carbohydrates.'' The purpose of this Federal Register notice is to invite interested parties to submit additional scientific data, information, and comments regarding:

   The physiological endpoints that we have addressed in the science review for each of the 26 non-digestible carbohydrates, and

   Other beneficial physiological endpoints and the relevant scientific data for a particular fiber. We have identified the main endpoints, such as cholesterol or glucose levels, but ask for scientific data on additional physiological endpoints (blood pressure) for which a non-digestible carbohydrate may have a beneficial physiological effect.

2. Reference

   The following reference is on display at the Division of Dockets Management (see ADDRESSES) and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at http://www.regulations.gov. FDA has verified the Web site address, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

   1. FDA, 2016. ``Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates.'' Available at: http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm525656.htm.

   Dated: November 14, 2016.

   Leslie Kux,

   Associate Commissioner for Policy.

   FR Doc. 2016-27950 Filed 11-22-16; 8:45 am

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