[Federal Register Volume 82, Number 171 (Wednesday, September 6, 2017)]
[Notices]
[Pages 42098-42100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18812]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4625]


Development of a List of Pre-Dietary Supplement Health and 
Education Act Dietary Ingredients; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
following public meeting entitled ``Development of a List of Pre-DSHEA 
Dietary Ingredients.'' The purpose of the meeting is to give interested 
stakeholders an opportunity to discuss issues related to FDA's future 
development of such a list.

DATES: The public meeting will be held on October 3, 2017, from 8 a.m. 
to 5 p.m. Submit either electronic or written comments on this public 
meeting by December 4, 2017. See the SUPPLEMENTARY INFORMATION section 
for registration date and information.

ADDRESSES: The public meeting will be held at FDA's Center for Food 
Safety and Applied Nutrition, Wiley Auditorium, 5001 Campus Dr., 
College Park, MD 20740.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before December 4, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of December 4, 2017. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

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-2017-N-4625 for ``Development of a List of Pre-DSHEA Dietary 
Ingredients; Public Meeting; Request for Comments.'' Received comments, 
those filed in a timely manner (see ADDRESSES), 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

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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.gpo.gov/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.

FOR FURTHER INFORMATION CONTACT: Juanita Yates, Center for Food Safety 
and Applied Nutrition (HFS-009), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-1731, email: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 12, 2016 (81 FR 53486), we issued 
a notice announcing the availability of a revised draft guidance for 
industry entitled, ``Dietary Supplements: New Dietary Ingredient 
Notifications and Related Issues.'' \1\ The revised draft guidance, 
when finalized, will help industry in evaluating whether to submit a 
premarket safety notification for a new dietary ingredient (NDI), or 
for a dietary supplement containing an NDI, and in preparing such 
premarket safety notifications (also referred to as NDI notifications). 
The Dietary Supplement Health and Education Act of 1994 (DSHEA) (Pub. 
L. 103-417) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
by adding, among other provisions: (1) Section 201(ff) of the FD&C Act 
(21 U.S.C. 321(ff)), which defines the term ``dietary supplement'' and 
(2) section 413 of the FD&C Act (21 U.S.C. 350(b)), which describes 
requirements for NDIs. Under DSHEA, dietary ingredients marketed in the 
United States before October 15, 1994, are not NDIs and therefore are 
not subject to the premarket notification requirements in section 413 
of the FD&C Act. The revised draft guidance addressed, among other 
things, considerations related to determining when a dietary ingredient 
is not new and therefore does not require a NDI notification.
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    \1\ https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/dietarysupplements/ucm257563.htm.
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    In the revised draft guidance, we stated our willingness to compile 
an authoritative list of pre-October 15, 1994, dietary ingredients 
based on independent and verifiable data to be supplied by industry. 
Although we are aware that several trade associations and industry 
groups have independently developed their own unofficial lists of 
ingredients that they believe were marketed before October 15, 1994 
(sometimes referred to as ``grandfathered'' or ``old'' dietary 
ingredients), we are unable to verify the accuracy of those lists and 
therefore have never recognized or sanctioned any of them. We also have 
never compiled our own list.
    An authoritative list would provide benefits to both industry and 
FDA. By providing clarity as to which ingredients do not require 
notifications, it would alleviate the burden on industry of preparing 
and submitting unnecessary notifications. Similarly, by eliminating 
unnecessary notifications, an authoritative list would enable us to 
more efficiently use our limited resources to review notifications for 
truly ``new'' ingredients. In addition, an authoritative list would 
allow us to better focus our enforcement efforts in alignment with our 
strategic priorities of consumer safety, product integrity, and 
accurate information.
    We have received and are reviewing comments on the 2016 revised 
draft guidance. The comments generally support the idea that we should 
develop a list of pre-DSHEA dietary ingredients, but reflect opinions 
both on the standard of evidence for demonstrating that an ingredient 
is pre-DSHEA and on the process by which ingredients should be added to 
the list. We believe that public discussion of these issues will be 
beneficial as we work toward development of a list of pre-DSHEA dietary 
ingredients.

II. Topics for Discussion at the Public Meeting

    The public meeting will have two separate panels. Each panel will 
be followed by an opportunity for open public comment. In addition, 
there will be an opportunity for interested stakeholders to submit 
additional written comments following the meeting.
    The first panel will discuss what standard of evidence is necessary 
to determine that an ingredient was marketed before October 15, 1994. 
This panel may address, among other things, what types and quantity of 
evidence may suffice to demonstrate that a dietary ingredient was 
marketed in the United States prior to October 15, 1994, as well as how 
specifically or generally an ingredient on the list may be identified 
depending on the evidence presented for that ingredient. In addition, 
this discussion may also address whether certain botanical preparations 
can be accepted as ``old'' if the plant is demonstrated to be ``old,'' 
and whether certain classes of ingredients can be considered ``old'' 
based on common documentation. During the open comment period following 
this first panel, we will specifically invite comment about whether 
there are any considerations specific to certain classes or types of 
ingredients that should be taken into account as we develop the list.
    The second panel will discuss issues related to the process that 
should be used to develop the list. This includes, but is not limited 
to, the processes for nominating and reviewing ingredients; whether an 
outside panel should be convened and, if so, the composition and role 
of that panel; how information that is claimed to be confidential 
should be treated; and what the ultimate list should look like.
    The topics discussed at the public meeting, both during the panel 
discussions and during open public comment periods, as well as written 
comments submitted after the meeting, will help us determine how to 
develop this list of old dietary ingredients.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the 
following Web site: https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. Please provide complete

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contact information for each attendee, including name, title, 
affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
meeting must register by midnight Eastern Time on September 25, 2017. 
Early registration is recommended because seating is limited; 
therefore, FDA may limit the number of participants from each 
organization. Registrants will receive confirmation when they have been 
accepted.
    If you need special accommodations due to a disability, please 
contact Juanita Yates (see FOR FURTHER INFORMATION CONTACT) no later 
than September 18, 2017.
    Requests for Oral Presentations: During online registration you may 
indicate if you wish to present during a public comment session and 
which topic(s) you wish to address. We will do our best to accommodate 
requests to make public comments. Individuals and organizations with 
common interests are urged to consolidate or coordinate their 
presentations and request time for a joint presentation. All requests 
to make oral presentations must be received by September 18, 2017. We 
will determine the amount of time allotted to each presenter and will 
select and notify participants by September 25, 2017.
    Streaming Webcast of the Public Meeting: This public meeting will 
also be webcast. Please visit the following Web site to register: 
https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
    FDA has verified the Web site addresses, as of the date this 
document publishes in the Federal Register, but Web sites are subject 
to change over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available on the 
Internet at https://www.fda.gov/Food/DietarySupplements/default.htm.

    Dated: August 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18812 Filed 9-5-17; 8:45 am]
 BILLING CODE 4164-01-P