81 FR 11813 - A Dietary Supplement Labeling Guide: Chapter II. Identity Statement; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 44 (March 7, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 44 (March 7, 2016)
| Page Range | 11813-11814 | |
| FR Document | 2016-04948 |
[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)] [Notices] [Pages 11813-11814] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-04948] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2004-D-0544 (formerly 2004D-0487)] A Dietary Supplement Labeling Guide: Chapter II. Identity Statement; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a revised guidance for industry entitled ``A Dietary Supplement Labeling Guide: Chapter II. Identity Statement.'' This guidance is part of a longer guidance entitled ``A Dietary Supplement Labeling Guide,'' which covers the most frequently raised questions about the labeling of dietary supplements using a question and answer format and is intended to help ensure that the dietary supplements sold in the United States are properly labeled. We are revising the guidance to correct an inaccurate statement. DATES: Submit either electronic or written comments on FDA guidances at any time. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic 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 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 http://www.regulations.gov. [[Page 11814]] 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-2004-D-0544 (formerly 2004D-0487) for ``A Dietary Supplement Labeling Guide: Chapter II. Identity Statement: Guidance for Industry.'' 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 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. Submit written requests for single copies of the guidance to the Office of Dietary Supplement Programs, Center for Food Safety and Applied Nutrition (HFS-810), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance. FOR FURTHER INFORMATION CONTACT: Cara Welch, Center for Food Safety and Applied Nutrition (HFS-810), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2375. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a revised guidance for industry entitled ``A Dietary Supplement Labeling Guide: Chapter II. Identity Statement.'' We are issuing this guidance consistent with our good guidance practices (GGP) regulation (21 CFR 10.115). As with all FDA guidance, the guidance represents our current thinking 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. In April 2005, we issued a guidance for industry entitled ``A Dietary Supplement Labeling Guide.'' The guidance covers the most frequently raised questions about the labeling of dietary supplements using a question and answer format and is intended to help ensure that the dietary supplements sold in the United States are properly labeled. We recently were made aware that the guidance was inaccurate in one detail. Specifically, in Chapter II, entitled ``Identity Statement,'' question 3 asked ``Can the term `dietary supplement' by itself be considered the statement of identity?'' The response to the question said that it could not, but this response was not consistent with section 403(s)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(s)(2)(B)) and our regulations at 21 CFR 101.3(g). Thus, we are revising the guidance to state that the term ``dietary supplement'' may be used as the entire statement of identity for a dietary supplement and to explain the basis for that conclusion. We are also revising questions 1, 2, and 3 for clarity and consistency with 21 CFR 101.3(g) and FDA's guidance on statements of identity for conventional foods in ``A Food Labeling Guide: Guidance for Industry'' (available at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/default.htm). The guidance announced in this notice revises the guidance dated April 2005. This guidance is being implemented without prior public comment because the Agency has determined that such prior public participation is not feasible or appropriate (Sec. 10.115(g)(2)). The Agency made this determination because this guidance's primary revision of the existing guidance merely corrects an inaccurate statement to make the guidance consistent with the FD&C Act and FDA's regulations, and it would be inappropriate to solicit comment on whether or not a guidance should be consistent with requirements set forth in the statute and regulations. The guidance also contains other clarifying edits to existing guidance that do not set forth initial or changed interpretations of statutory or regulatory requirements. Although this guidance document is being implemented immediately, it remains subject to comment in accordance with the Agency's GGP regulation (Sec. 10.115(g)). II. Electronic Access Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/default.htm or http://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance. Dated: March 2, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-04948 Filed 3-4-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Notices 11813
DEPARTMENT OF HEALTH AND in that they are labeled without the Dated: March 1, 2016.
HUMAN SERVICES statement ‘‘Below Standard in Fill’’ as Leslie Kux,
required in § 161.190(c)(4) and Associate Commissioner for Policy.
Food and Drug Administration § 130.14(b). The test products meet all [FR Doc. 2016–04944 Filed 3–4–16; 8:45 am]
[Docket No. FDA–2012–P–1189] the requirements of the standard with BILLING CODE 4164–01–P
the exception of this deviation.
Canned Tuna Deviating From Identity On September 3, 2015, the applicants
Standard: Temporary Permit for Market DEPARTMENT OF HEALTH AND
asked us to extend the temporary permit
Testing HUMAN SERVICES
so they could have more time to market
AGENCY: Food and Drug Administration, test the canned tuna products and gain Food and Drug Administration
HHS. additional consumer acceptance in
[Docket No. FDA–2004–D–0544 (formerly
ACTION: Notice. support of the petition to amend the 2004D–0487)]
standard for canned tuna. We find that
SUMMARY: The Food and Drug it is in the interest of consumers to A Dietary Supplement Labeling Guide:
Administration (FDA or we) is extend the permit for the market testing Chapter II. Identity Statement;
announcing the extension of temporary of canned tuna to gain additional Guidance for Industry; Availability
permits issued to Bumble Bee Foods, information on consumer expectations
LLC; Chicken of the Sea International; AGENCY: Food and Drug Administration,
and acceptance. Therefore, under
and StarKist Seafood Company (the HHS.
§ 130.17(i), we are extending the
applicants) to market test products ACTION: Notice of availability.
temporary permits granted to Bumble
(designated as ‘‘canned tuna’’) that Bee Foods, LLC (141,000,000 pounds SUMMARY: The Food and Drug
deviate from the U.S. standard of
(lbs) (63,800,905 kilograms (kgs))); Administration (FDA or we) is
identity for canned tuna. The extension
Chicken of the Sea International announcing the availability of a revised
allows the applicants to continue to
(77,500,000 lbs (35,067,873 kgs)); and guidance for industry entitled ‘‘A
measure consumer acceptance of the
StarKist Seafood Company (182,500,000 Dietary Supplement Labeling Guide:
products and assess the commercial
lbs (82,579,185 kgs)) to provide Chapter II. Identity Statement.’’ This
feasibility of the products, in support of
continued market testing of the guidance is part of a longer guidance
a petition to amend the standard of
specified amounts of product for each entitled ‘‘A Dietary Supplement
identity for canned tuna. We also invite
applicant on an annual basis. The test Labeling Guide,’’ which covers the most
other interested parties to participate in frequently raised questions about the
the market test. products will bear the name ‘‘canned
tuna.’’ The new expiration date of the labeling of dietary supplements using a
DATES: The new expiration date of the question and answer format and is
permit will be either the effective date permit will be either the effective date
intended to help ensure that the dietary
of a final rule amending the standard of of a final rule amending the standard of
supplements sold in the United States
identity for canned tuna that may result identity for canned tuna that may result
are properly labeled. We are revising the
from the petition or 30 days after denial from the petition or 30 days after denial guidance to correct an inaccurate
of the petition. of the petition. All other conditions and statement.
FOR FURTHER INFORMATION CONTACT: terms of this permit remain the same.
DATES: Submit either electronic or
Loretta A. Carey, Center for Food Safety In addition, we invite interested written comments on FDA guidances at
and Applied Nutrition (HFS–820), Food persons to participate in the market test any time.
and Drug Administration, 5100 Paint under the conditions of the permit, ADDRESSES: You may submit comments
Branch Pkwy., College Park, MD 20740, except for the designated area of as follows:
240–402–2371. distribution. Any person who wishes to
SUPPLEMENTARY INFORMATION: In participate in the extended market test Electronic Submissions
accordance with 21 CFR 130.17, we must notify, in writing, the Supervisor, Submit electronic comments in the
issued temporary permits to Bumble Bee Product Evaluation Labeling Team, following way:
Foods, LLC, 9655 Granite Ridge Dr., San Food Labeling and Standards Staff, • Federal eRulemaking Portal: http://
Diego, CA 92123; Chicken of the Sea Office of Nutrition and Food Labeling, www.regulations.gov. Follow the
International, 9330 Scranton Rd. Suite Center for Food Safety and Applied instructions for submitting comments.
500, San Diego, CA 92121; and StarKist Nutrition (HFS–820), Food and Drug Comments submitted electronically,
Seafood Company, 225 North Shore Dr., Administration, 5100 Paint Branch including attachments, to http://
Pittsburgh, PA 15212, to market test Pkwy., College Park, MD 20740. The www.regulations.gov will be posted to
products identified as ‘‘canned tuna’’ notification must describe the test the docket unchanged. Because your
that deviate from the requirements of products and the area of distribution, comment will be made public, you are
the standard of identity for canned tuna solely responsible for ensuring that your
specify and justify the amount
in 21 CFR 161.190 (79 FR 35362, June comment does not include any
requested, and include the labeling that
20, 2014). We issued the permits to confidential information that you or a
facilitate market testing of products that will be used for the test product (i.e., a third party may not wish to be posted,
deviate from the requirements of the draft label for each size of container and such as medical information, your or
asabaliauskas on DSK3SPTVN1PROD with NOTICES
standard of identity for canned tuna each brand of product to be market anyone else’s Social Security number, or
issued under section 401 of the Federal tested) (see § 130.17(c)). The confidential business information, such
Food, Drug, and Cosmetic Act (21 U.S.C. information panel of the label must bear as a manufacturing process. Please note
341). The permit covers limited nutrition labeling in accordance with 21 that if you include your name, contact
interstate marketing tests of products CFR 101.9. Each of the ingredients used information, or other information that
identified as ‘‘canned tuna.’’ These test in the food must be declared on the identifies you in the body of your
products deviate from the U.S. standard label as required by 21 CFR part 101. comments, that information will be
of identity for canned tuna (§ 161.190) posted on http://www.regulations.gov.
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![11814 Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Notices
• If you want to submit a comment comments to public dockets, see 80 FR The response to the question said that
with confidential information that you 56469, September 18, 2015, or access it could not, but this response was not
do not wish to be made available to the the information at: http://www.fda.gov/ consistent with section 403(s)(2)(B) of
public, submit the comment as a regulatoryinformation/dockets/ the Federal Food, Drug, and Cosmetic
written/paper submission and in the default.htm. Act (the FD&C Act) (21 U.S.C.
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to 343(s)(2)(B)) and our regulations at 21
Submissions’’ and ‘‘Instructions’’). read background documents or the CFR 101.3(g). Thus, we are revising the
Written/Paper Submissions electronic and written/paper comments guidance to state that the term ‘‘dietary
received, go to http:// supplement’’ may be used as the entire
Submit written/paper submissions as www.regulations.gov and insert the statement of identity for a dietary
follows: docket number, found in brackets in the
• Mail/Hand delivery/Courier (for supplement and to explain the basis for
heading of this document, into the that conclusion. We are also revising
written/paper submissions): Division of ‘‘Search’’ box and follow the prompts
Dockets Management (HFA–305), Food questions 1, 2, and 3 for clarity and
and/or go to the Division of Dockets consistency with 21 CFR 101.3(g) and
and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm.
Lane, Rm. 1061, Rockville, MD 20852. FDA’s guidance on statements of
1061, Rockville, MD 20852.
• For written/paper comments Submit written requests for single
identity for conventional foods in ‘‘A
submitted to the Division of Dockets Food Labeling Guide: Guidance for
copies of the guidance to the Office of
Management, FDA will post your Industry’’ (available at http://
Dietary Supplement Programs, Center
comment, as well as any attachments, www.fda.gov/Food/
for Food Safety and Applied Nutrition
except for information submitted, GuidanceRegulation/
(HFS–810), Food and Drug
marked and identified, as confidential, GuidanceDocuments
Administration, 5100 Paint Branch
if submitted as detailed in RegulatoryInformation/default.htm).
Pkwy., College Park, MD 20740. Send
‘‘Instructions.’’ The guidance announced in this notice
Instructions: All submissions received two self-addressed adhesive labels to
assist that office in processing your revises the guidance dated April 2005.
must include the Docket No. FDA–
2004–D–0544 (formerly 2004D–0487) request. See the SUPPLEMENTARY This guidance is being implemented
INFORMATION section for electronic without prior public comment because
for ‘‘A Dietary Supplement Labeling
Guide: Chapter II. Identity Statement: access to the guidance. the Agency has determined that such
Guidance for Industry.’’ Received FOR FURTHER INFORMATION CONTACT: Cara prior public participation is not feasible
comments will be placed in the docket Welch, Center for Food Safety and or appropriate (§ 10.115(g)(2)). The
and, except for those submitted as Applied Nutrition (HFS–810), Food and Agency made this determination
‘‘Confidential Submissions,’’ publicly Drug Administration, 5100 Paint Branch because this guidance’s primary
viewable at http://www.regulations.gov Pkwy., College Park, MD 20740, 240– revision of the existing guidance merely
or at the Division of Dockets 402–2375. corrects an inaccurate statement to make
Management between 9 a.m. and 4 p.m., SUPPLEMENTARY INFORMATION: the guidance consistent with the FD&C
Monday through Friday. Act and FDA’s regulations, and it would
• Confidential Submissions—To I. Background
be inappropriate to solicit comment on
submit a comment with confidential We are announcing the availability of whether or not a guidance should be
information that you do not wish to be a revised guidance for industry entitled consistent with requirements set forth in
made publicly available, submit your ‘‘A Dietary Supplement Labeling Guide: the statute and regulations. The
comments only as a written/paper Chapter II. Identity Statement.’’ We are guidance also contains other clarifying
submission. You should submit two issuing this guidance consistent with edits to existing guidance that do not set
copies total. One copy will include the our good guidance practices (GGP) forth initial or changed interpretations
information you claim to be confidential regulation (21 CFR 10.115). As with all of statutory or regulatory requirements.
with a heading or cover note that states FDA guidance, the guidance represents Although this guidance document is
‘‘THIS DOCUMENT CONTAINS our current thinking on this topic. It being implemented immediately, it
CONFIDENTIAL INFORMATION.’’ The does not establish any rights for any remains subject to comment in
Agency will review this copy, including person and is not binding on FDA or the accordance with the Agency’s GGP
the claimed confidential information, in public. You can use an alternative
regulation (§ 10.115(g)).
its consideration of comments. The approach if it satisfies the requirements
second copy, which will have the of the applicable statutes and II. Electronic Access
claimed confidential information regulations.
redacted/blacked out, will be available In April 2005, we issued a guidance Persons with access to the Internet
for public viewing and posted on for industry entitled ‘‘A Dietary may obtain the guidance at either http://
http://www.regulations.gov. Submit Supplement Labeling Guide.’’ The www.fda.gov/Food/
both copies to the Division of Dockets guidance covers the most frequently GuidanceRegulation/
Management. If you do not wish your raised questions about the labeling of GuidanceDocuments
name and contact information to be dietary supplements using a question RegulatoryInformation/default.htm or
made publicly available, you can and answer format and is intended to http://www.regulations.gov. Use the
provide this information on the cover help ensure that the dietary FDA Web site listed in the previous
asabaliauskas on DSK3SPTVN1PROD with NOTICES
sheet and not in the body of your supplements sold in the United States sentence to find the most current
comments and you must identify this are properly labeled. We recently were version of the guidance.
information as ‘‘confidential.’’ Any made aware that the guidance was Dated: March 2, 2016.
information marked as ‘‘confidential’’ inaccurate in one detail. Specifically, in
Leslie Kux,
will not be disclosed except in Chapter II, entitled ‘‘Identity
accordance with 21 CFR 10.20 and other Statement,’’ question 3 asked ‘‘Can the Associate Commissioner for Policy.
applicable disclosure law. For more term ‘dietary supplement’ by itself be [FR Doc. 2016–04948 Filed 3–4–16; 8:45 am]
information about FDA’s posting of considered the statement of identity?’’ BILLING CODE 4164–01–P
VerDate Sep<11>2014 18:37 Mar 04, 2016 Jkt 238001 PO 00000 Frm 00077 Fmt 4703 Sfmt 9990 E:\FR\FM\07MRN1.SGM 07MRN1](https://thefederalregister.org/doc/81_FR_11857/page/2.svg)
Document Created: 2018-02-02 15:07:38
Document Modified: 2018-02-02 15:07:38
| 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 | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on FDA guidances at any time. | |
| Contact | Cara Welch, Center for Food Safety and Applied Nutrition (HFS-810), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2375. | |
| FR Citation | 81 FR 11813 |
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