A Dietary Supplement Labeling Guide: Chapter II. Identity Statement; Guidance for Industry; Availability, 11813-11814 [2016-04948]

Download as PDF Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–P–1189] Canned Tuna Deviating From Identity Standard: Temporary Permit for Market Testing AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) is announcing the extension of temporary permits issued to Bumble Bee Foods, LLC; Chicken of the Sea International; and StarKist Seafood Company (the applicants) to market test products (designated as ‘‘canned tuna’’) that deviate from the U.S. standard of identity for canned tuna. The extension allows the applicants to continue to measure consumer acceptance of the products and assess the commercial feasibility of the products, in support of a petition to amend the standard of identity for canned tuna. We also invite other interested parties to participate in the market test. DATES: The new expiration date of the permit will be either the effective date of a final rule amending the standard of identity for canned tuna that may result from the petition or 30 days after denial of the petition. FOR FURTHER INFORMATION CONTACT: Loretta A. Carey, Center for Food Safety and Applied Nutrition (HFS–820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–2371. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 130.17, we issued temporary permits to Bumble Bee Foods, LLC, 9655 Granite Ridge Dr., San Diego, CA 92123; Chicken of the Sea International, 9330 Scranton Rd. Suite 500, San Diego, CA 92121; and StarKist Seafood Company, 225 North Shore Dr., Pittsburgh, PA 15212, to market test products identified as ‘‘canned tuna’’ that deviate from the requirements of the standard of identity for canned tuna in 21 CFR 161.190 (79 FR 35362, June 20, 2014). We issued the permits to facilitate market testing of products that deviate from the requirements of the standard of identity for canned tuna issued under section 401 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341). The permit covers limited interstate marketing tests of products identified as ‘‘canned tuna.’’ These test products deviate from the U.S. standard of identity for canned tuna (§ 161.190) asabaliauskas on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:37 Mar 04, 2016 Jkt 238001 in that they are labeled without the statement ‘‘Below Standard in Fill’’ as required in § 161.190(c)(4) and § 130.14(b). The test products meet all the requirements of the standard with the exception of this deviation. On September 3, 2015, the applicants asked us to extend the temporary permit so they could have more time to market test the canned tuna products and gain additional consumer acceptance in support of the petition to amend the standard for canned tuna. We find that it is in the interest of consumers to extend the permit for the market testing of canned tuna to gain additional information on consumer expectations and acceptance. Therefore, under § 130.17(i), we are extending the temporary permits granted to Bumble Bee Foods, LLC (141,000,000 pounds (lbs) (63,800,905 kilograms (kgs))); Chicken of the Sea International (77,500,000 lbs (35,067,873 kgs)); and StarKist Seafood Company (182,500,000 lbs (82,579,185 kgs)) to provide continued market testing of the specified amounts of product for each applicant on an annual basis. The test products will bear the name ‘‘canned tuna.’’ The new expiration date of the permit will be either the effective date of a final rule amending the standard of identity for canned tuna that may result from the petition or 30 days after denial of the petition. All other conditions and terms of this permit remain the same. In addition, we invite interested persons to participate in the market test under the conditions of the permit, except for the designated area of distribution. Any person who wishes to participate in the extended market test must notify, in writing, the Supervisor, Product Evaluation Labeling Team, Food Labeling and Standards Staff, Office of Nutrition and Food Labeling, Center for Food Safety and Applied Nutrition (HFS–820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. The notification must describe the test products and the area of distribution, specify and justify the amount requested, and include the labeling that will be used for the test product (i.e., a draft label for each size of container and each brand of product to be market tested) (see § 130.17(c)). The information panel of the label must bear nutrition labeling in accordance with 21 CFR 101.9. Each of the ingredients used in the food must be declared on the label as required by 21 CFR part 101. PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 11813 Dated: March 1, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–04944 Filed 3–4–16; 8:45 am] BILLING CODE 4164–01–P 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. 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: SUMMARY: 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. E:\FR\FM\07MRN1.SGM 07MRN1 11814 Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Notices asabaliauskas on DSK3SPTVN1PROD with NOTICES • 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 https://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 https://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 VerDate Sep<11>2014 18:37 Mar 04, 2016 Jkt 238001 comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://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 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 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?’’ PO 00000 Frm 00077 Fmt 4703 Sfmt 9990 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 https:// www.fda.gov/Food/ GuidanceRegulation/ GuidanceDocuments RegulatoryInformation/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 (§ 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 (§ 10.115(g)). II. Electronic Access Persons with access to the Internet may obtain the guidance at either https:// www.fda.gov/Food/ GuidanceRegulation/ GuidanceDocuments RegulatoryInformation/default.htm or https://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 E:\FR\FM\07MRN1.SGM 07MRN1

Agencies

[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)]
[Notices]
[Pages 11813-11814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 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.

[[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 https://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 https://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: https://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 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 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 https://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 https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/default.htm or https://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
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