83 FR 27894 - The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 116 (June 15, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 116 (June 15, 2018)
| Page Range | 27894-27895 | |
| FR Document | 2018-12867 |
[Federal Register Volume 83, Number 116 (Friday, June 15, 2018)] [Rules and Regulations] [Pages 27894-27895] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12867] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. FDA-2018-D-1323] The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels; Guidance for Industry.'' The guidance identifies eight specific, additional isolated or synthetic non-digestible carbohydrates that we intend to add to our regulatory definition of ``dietary fiber'' through our regular rulemaking process. In the interim, the guidance also advises manufacturers of our policy for when one or more of these eight non-digestible carbohydrates, present in a food, are included in the declared amount of ``dietary fiber,'' and for the use of a caloric value for polydextrose of 1 kilocalorie per gram (kcal/g). DATES: The announcement of the guidance is published in the Federal Register on June 15, 2018. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment 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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-2018-D-1323 for ``The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels; Guidance for Industry.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 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.'' We will review this copy, including the claimed confidential information, in our 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the guidance to the Office of Nutrition and Food Labeling, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5100 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Paula R. Trumbo, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5100 Campus Dr., College Park, MD 20740, 240-402-2579. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a guidance for industry entitled ``The Declaration of Certain Isolated or Synthetic Non- Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels; Guidance for Industry.'' We are issuing this guidance consistent with our good guidance practices (GGP) regulation (Sec. 10.115 (21 [[Page 27895]] CFR 10.115)). We are implementing this guidance without prior public comment because we have determined that prior public participation is not feasible or appropriate (Sec. 10.115(g)(2)). We made this determination because this guidance sets out compliance policy that reduces burden and is consistent with the public health. Although this guidance document is immediately in effect, it remains subject to comment in accordance with FDA's GGP regulation. Before 2016, FDA regulations did not define the term ``dietary fiber'' for purposes of the Nutrition Facts and Supplement Facts labels. In the Federal Register of May 27, 2016 (81 FR 33742), we published a final rule amending our Nutrition Facts and Supplement Facts Labels regulations (hereafter referred to as ``the final rule''). The final rule, among other things, defines dietary fiber as non- digestible soluble and insoluble carbohydrates (with 3 or more monomeric units), and lignin that are intrinsic and intact in plants; isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human health (Sec. 101.9(c)(6)(i) (21 CFR 101.9(c)(6)(i))). The final rule also identifies seven isolated or synthetic non-digestible carbohydrates, each of which has a physiological effect that is beneficial to human health and that must be declared as dietary fiber on Nutrition and Supplement Facts labels when present in a food. 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). For example, a manufacturer can request FDA to include another added isolated or synthetic non-digestible carbohydrate in the listing of dietary fibers by submitting a citizen petition under 21 CFR 10.30. FDA would review the scientific evidence to determine whether the evidence supports the non-digestible carbohydrate as having a physiological effect that is beneficial to human health. If so, FDA would propose a rule to include the non- digestible carbohydrate in the listing of dietary fibers. Based on our review of citizen petitions that FDA has received requesting that we identify additional isolated or synthetic non- digestible carbohydrates in the listing of dietary fibers, and comments that we have received on a 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 (21 CFR 10.30)'' and an accompanying document titled ``Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates,'' the availability of which we announced in the Federal Register of November 23, 2016 (81 FR 84516 and 81 FR 84595), in addition to our independent evaluation of the available scientific data, we intend to add certain isolated or synthetic non-digestible carbohydrates to the dietary fiber definition in Sec. 101.9(c)(6)(i) through our regular rulemaking process. The eight non-digestible carbohydrates that we intend to add are: Mixed plant cell wall fibers; arabinoxylan; alginate, inulin and inulin-type fructans; high amylose starch (resistant starch 2); galactooligosaccharide; polydextrose; and resistant maltodextrin/ dextrin. One category of non-digestible carbohydrate that we intend to add to Sec. 101.9(c)(6)(i) through our regular rulemaking process-- mixed plant cell wall fibers--encompasses a number of fiber ingredients, such as rice bran fibers, soy fibers, and sugar cane fibers. We have tentatively determined that each of these isolated or synthetic non-digestible carbohydrates has a physiological effect that is beneficial to human health. Several petitions are still pending with FDA and reviewing this information is a very high priority for FDA. Firms also can submit new citizen petitions, and we will review the petitions on a rolling basis. Firms whose non-digestible carbohydrates do not meet our regulatory definition of ``dietary fiber'' and are not one of the eight non-digestible carbohydrates identified in the guidance can still use those non-digestible carbohydrates in foods. Although those non-digestible carbohydrates cannot be listed as dietary fiber in the Nutrition Facts label, they would still be declared as part of the amount of total carbohydrate and listed by name in the ingredients on the food package. In addition, based on our review of the scientific evidence, including evidence we received in a citizen petition, we intend to establish a caloric value for polydextrose at 1 kcal/g in Sec. 101.9(c)(1)(i)(C). Pending completion of the rulemaking process, we are announcing a policy for the eight identified isolated or synthetic non-digestible carbohydrates when one or more are present in food and declared in the amount of ``dietary fiber'' on Nutrition Facts and Supplement Facts labels and when the caloric value of 1 kcal/g is used to determine the calorie contribution of polydextrose. Section 101.9(g) requires manufacturers to make and keep records to verify the amount of non- digestible carbohydrates added to food that do not meet the definition of dietary fiber. Under our policy, when a mixture of dietary fiber and one or more of these eight added non-digestible carbohydrates (that are not currently listed as a ``dietary fiber'' in the definition in Sec. 101.9(c)(6)(i)) are present in a food, we do not expect manufacturers to make and keep records in accordance with Sec. 101.9(g)(10) and (11) to verify the declared amount of one or more of these eight added non- digestible carbohydrates in the label and labeling of food. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. II. Electronic Access Persons with access to the internet may obtain the document at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance. Dated: June 8, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-12867 Filed 6-14-18; 8:45 am] BILLING CODE 4164-01-P
![27894 Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Rules and Regulations
Administration (NARA). For information on instructions for submitting comments. claimed confidential information, in our
the availability of this material at NARA, call Comments submitted electronically, consideration of comments. The second
202–741–6030, or go to: http:// including attachments, to https:// copy, which will have the claimed
www.archives.gov/federal-register/cfr/ibr- www.regulations.gov will be posted to confidential information redacted/
locations.html.
the docket unchanged. Because your blacked out, will be available for public
Issued in Burlington, Massachusetts, on comment will be made public, you are viewing and posted on https://
June 8, 2018. solely responsible for ensuring that your www.regulations.gov. Submit both
Robert J. Ganley, comment does not include any copies to the Dockets Management Staff.
Manager, Engine and Propeller Standards confidential information that you or a If you do not wish your name and
Branch, Aircraft Certification Service. third party may not wish to be posted, contact information to be made publicly
[FR Doc. 2018–12873 Filed 6–14–18; 8:45 am] such as medical information, your or available, you can provide this
BILLING CODE 4910–13–P anyone else’s Social Security number, or information on the cover sheet and not
confidential business information, such in the body of your comments and you
as a manufacturing process. Please note must identify this information as
DEPARTMENT OF HEALTH AND that if you include your name, contact ‘‘confidential.’’ Any information marked
HUMAN SERVICES information, or other information that as ‘‘confidential’’ will not be disclosed
identifies you in the body of your except in accordance with 21 CFR 10.20
Food and Drug Administration comments, that information will be and other applicable disclosure law. For
posted on https://www.regulations.gov. more information about FDA’s posting
21 CFR Part 101 • If you want to submit a comment of comments to public dockets, see 80
with confidential information that you FR 56469, September 18, 2015, or access
[Docket No. FDA–2018–D–1323] do not wish to be made available to the the information at: https://www.gpo.gov/
public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
The Declaration of Certain Isolated or written/paper submission and in the
Synthetic Non-Digestible 23389.pdf.
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Carbohydrates as Dietary Fiber on Submissions’’ and ‘‘Instructions’’).
Nutrition and Supplement Facts read background documents or the
Labels; Guidance for Industry; Written/Paper Submissions electronic and written/paper comments
Availability received, go to https://
Submit written/paper submissions as www.regulations.gov and insert the
follows: docket number, found in brackets in the
AGENCY: Food and Drug Administration,
• Mail/Hand delivery/Courier (for
HHS. heading of this document, into the
written/paper submissions): Dockets
ACTION: Notification of availability. ‘‘Search’’ box and follow the prompts
Management Staff (HFA–305), Food and
and/or go to the Dockets Management
Drug Administration, 5630 Fishers
SUMMARY: The Food and Drug Staff, 5630 Fishers Lane, Rm. 1061,
Lane, Rm. 1061, Rockville, MD 20852.
Administration (FDA or we) is Rockville, MD 20852.
• For written/paper comments
announcing the availability of a final You may submit comments on any
submitted to the Dockets Management
guidance for industry entitled ‘‘The guidance at any time (see 21 CFR
Staff, FDA will post your comment, as
Declaration of Certain Isolated or 10.115(g)(5)).
well as any attachments, except for
Synthetic Non-Digestible Carbohydrates Submit written requests for single
information submitted, marked and
as Dietary Fiber on Nutrition and copies of the guidance to the Office of
identified, as confidential, if submitted
Supplement Facts Labels; Guidance for Nutrition and Food Labeling, Center for
as detailed in ‘‘Instructions.’’
Industry.’’ The guidance identifies eight Instructions: All submissions received Food Safety and Applied Nutrition
specific, additional isolated or synthetic must include the Docket No. FDA– (HFS–830), Food and Drug
non-digestible carbohydrates that we 2018–D–1323 for ‘‘The Declaration of Administration, 5100 Campus Dr.,
intend to add to our regulatory Certain Isolated or Synthetic Non- College Park, MD 20740. Send two self-
definition of ‘‘dietary fiber’’ through our Digestible Carbohydrates as Dietary addressed adhesive labels to assist that
regular rulemaking process. In the Fiber on Nutrition and Supplement office in processing your requests. See
interim, the guidance also advises Facts Labels; Guidance for Industry.’’ the SUPPLEMENTARY INFORMATION section
manufacturers of our policy for when Received comments will be placed in for electronic access to the guidance
one or more of these eight non- the docket and, except for those document.
digestible carbohydrates, present in a submitted as ‘‘Confidential FOR FURTHER INFORMATION CONTACT:
food, are included in the declared Submissions,’’ publicly viewable at Paula R. Trumbo, Center for Food Safety
amount of ‘‘dietary fiber,’’ and for the https://www.regulations.gov or at the and Applied Nutrition (HFS–830), Food
use of a caloric value for polydextrose Dockets Management Staff between 9 and Drug Administration, 5100 Campus
of 1 kilocalorie per gram (kcal/g). a.m. and 4 p.m., Monday through Dr., College Park, MD 20740, 240–402–
DATES: The announcement of the Friday. 2579.
guidance is published in the Federal • Confidential Submissions—To SUPPLEMENTARY INFORMATION:
Register on June 15, 2018. submit a comment with confidential
ADDRESSES: You may submit either information that you do not wish to be I. Background
electronic or written comments on made publicly available, submit your We are announcing the availability of
Agency guidances at any time as comments only as a written/paper a guidance for industry entitled ‘‘The
sradovich on DSK3GMQ082PROD with RULES
follows: submission. You should submit two Declaration of Certain Isolated or
copies total. One copy will include the Synthetic Non-Digestible Carbohydrates
Electronic Submissions information you claim to be confidential as Dietary Fiber on Nutrition and
Submit electronic comments in the with a heading or cover note that states Supplement Facts Labels; Guidance for
following way: ‘‘THIS DOCUMENT CONTAINS Industry.’’ We are issuing this guidance
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ We consistent with our good guidance
https://www.regulations.gov. Follow the will review this copy, including the practices (GGP) regulation (§ 10.115 (21
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![Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Rules and Regulations 27895
CFR 10.115)). We are implementing this Petition (21 CFR 10.30)’’ and an and keep records to verify the amount
guidance without prior public comment accompanying document titled of non-digestible carbohydrates added
because we have determined that prior ‘‘Evaluation of the Beneficial to food that do not meet the definition
public participation is not feasible or Physiological Effects of Isolated or of dietary fiber. Under our policy, when
appropriate (§ 10.115(g)(2)). We made Synthetic Non-Digestible a mixture of dietary fiber and one or
this determination because this Carbohydrates,’’ the availability of more of these eight added non-digestible
guidance sets out compliance policy which we announced in the Federal carbohydrates (that are not currently
that reduces burden and is consistent Register of November 23, 2016 (81 FR listed as a ‘‘dietary fiber’’ in the
with the public health. Although this 84516 and 81 FR 84595), in addition to definition in § 101.9(c)(6)(i)) are present
guidance document is immediately in our independent evaluation of the in a food, we do not expect
effect, it remains subject to comment in available scientific data, we intend to manufacturers to make and keep records
accordance with FDA’s GGP regulation. add certain isolated or synthetic non- in accordance with § 101.9(g)(10) and
Before 2016, FDA regulations did not digestible carbohydrates to the dietary (11) to verify the declared amount of
define the term ‘‘dietary fiber’’ for fiber definition in § 101.9(c)(6)(i) one or more of these eight added non-
purposes of the Nutrition Facts and through our regular rulemaking process. digestible carbohydrates in the label and
Supplement Facts labels. In the Federal The eight non-digestible carbohydrates labeling of food.
Register of May 27, 2016 (81 FR 33742), that we intend to add are: Mixed plant This guidance is being issued
we published a final rule amending our cell wall fibers; arabinoxylan; alginate, consistent with FDA’s good guidance
Nutrition Facts and Supplement Facts inulin and inulin-type fructans; high practices regulation (21 CFR 10.115).
Labels regulations (hereafter referred to amylose starch (resistant starch 2); The guidance represents the current
as ‘‘the final rule’’). The final rule, galactooligosaccharide; polydextrose; thinking of FDA on this topic. It does
among other things, defines dietary fiber and resistant maltodextrin/dextrin. One not establish any rights for any person
as non-digestible soluble and insoluble category of non-digestible carbohydrate and is not binding on FDA or the public.
carbohydrates (with 3 or more that we intend to add to § 101.9(c)(6)(i) You can use an alternative approach if
monomeric units), and lignin that are through our regular rulemaking it satisfies the requirements of the
intrinsic and intact in plants; isolated or process—mixed plant cell wall fibers— applicable statutes and regulations. This
synthetic non-digestible carbohydrates encompasses a number of fiber guidance is not subject to Executive
(with 3 or more monomeric units) ingredients, such as rice bran fibers, soy Order 12866.
determined by FDA to have fibers, and sugar cane fibers. We have
physiological effects that are beneficial II. Electronic Access
tentatively determined that each of
to human health (§ 101.9(c)(6)(i) (21 Persons with access to the internet
these isolated or synthetic non-
CFR 101.9(c)(6)(i))). The final rule also may obtain the document at either
digestible carbohydrates has a
identifies seven isolated or synthetic https://www.fda.gov/FoodGuidances or
physiological effect that is beneficial to
non-digestible carbohydrates, each of https://www.regulations.gov. Use the
human health. Several petitions are still
which has a physiological effect that is FDA website listed in the previous
pending with FDA and reviewing this
beneficial to human health and that sentence to find the most current
information is a very high priority for
must be declared as dietary fiber on version of the guidance.
FDA. Firms also can submit new citizen
Nutrition and Supplement Facts labels petitions, and we will review the Dated: June 8, 2018.
when present in a food. petitions on a rolling basis. Firms whose Leslie Kux,
Interested parties can ask us to list
non-digestible carbohydrates do not Associate Commissioner for Policy.
additional isolated or synthetic non-
meet our regulatory definition of [FR Doc. 2018–12867 Filed 6–14–18; 8:45 am]
digestible carbohydrates in the
definition of dietary fiber in ‘‘dietary fiber’’ and are not one of the BILLING CODE 4164–01–P
§ 101.9(c)(6)(i). For example, a eight non-digestible carbohydrates
manufacturer can request FDA to identified in the guidance can still use
those non-digestible carbohydrates in DEPARTMENT OF HEALTH AND
include another added isolated or
synthetic non-digestible carbohydrate in foods. Although those non-digestible HUMAN SERVICES
the listing of dietary fibers by carbohydrates cannot be listed as
dietary fiber in the Nutrition Facts label, Food and Drug Administration
submitting a citizen petition under 21
CFR 10.30. FDA would review the they would still be declared as part of
the amount of total carbohydrate and 21 CFR Part 876
scientific evidence to determine
whether the evidence supports the non- listed by name in the ingredients on the [Docket No. FDA–2018–N–1894]
digestible carbohydrate as having a food package. In addition, based on our
physiological effect that is beneficial to review of the scientific evidence, Medical Devices; Gastroenterology-
human health. If so, FDA would including evidence we received in a Urology Devices; Classification of the
propose a rule to include the non- citizen petition, we intend to establish Fluid Jet System for Prostate Tissue
digestible carbohydrate in the listing of a caloric value for polydextrose at 1 Removal
dietary fibers. kcal/g in § 101.9(c)(1)(i)(C).
AGENCY: Food and Drug Administration,
Based on our review of citizen Pending completion of the rulemaking HHS.
petitions that FDA has received process, we are announcing a policy for ACTION: Final order.
requesting that we identify additional the eight identified isolated or synthetic
isolated or synthetic non-digestible non-digestible carbohydrates when one SUMMARY: The Food and Drug
sradovich on DSK3GMQ082PROD with RULES
carbohydrates in the listing of dietary or more are present in food and declared Administration (FDA or we) is
fibers, and comments that we have in the amount of ‘‘dietary fiber’’ on classifying the fluid jet system for
received on a draft guidance entitled Nutrition Facts and Supplement Facts prostate tissue removal into class II
‘‘Scientific Evaluation of the Evidence labels and when the caloric value of 1 (special controls). The special controls
on the Beneficial Physiological Effects kcal/g is used to determine the calorie that apply to the device type are
of Isolated or Synthetic Non-Digestible contribution of polydextrose. Section identified in this order and will be part
Carbohydrates Submitted as a Citizen 101.9(g) requires manufacturers to make of the codified language for the fluid jet
VerDate Sep<11>2014 15:57 Jun 14, 2018 Jkt 244001 PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 E:\FR\FM\15JNR1.SGM 15JNR1](https://thefederalregister.org/doc/83_FR_28010/page/2.svg)
Document Created: 2018-11-02 12:00:51
Document Modified: 2018-11-02 12:00:51
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Notification of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on June 15, 2018. | |
| Contact | Paula R. Trumbo, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5100 Campus Dr., College Park, MD 20740, 240-402-2579. | |
| FR Citation | 83 FR 27894 |
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