[Federal Register Volume 84, Number 70 (Thursday, April 11, 2019)]
[Notices]
[Pages 14660-14662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07168]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1388]


Responsible Innovation in Dietary Supplements; Public Meeting; 
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following public meeting entitled ``Responsible 
Innovation in Dietary Supplements.'' The purpose of the public meeting 
is to give interested parties an opportunity to present ideas for 
facilitating responsible innovation in the dietary supplement industry 
while preserving and strengthening FDA's ability to efficiently and 
effectively protect the public from unsafe and unlawful products.

DATES: The public meeting will be held on May 16, 2019, from 8:30 a.m. 
to 4 p.m. Eastern Time. Submit either electronic or written comments on 
this public meeting by July 15, 2019. See the SUPPLEMENTARY INFORMATION 
section for registration date and information.

ADDRESSES: The public meeting will be held at Food and Drug 
Administration, Center for Food Safety and Applied Nutrition, Wiley 
Auditorium, 5001 Campus Dr., College Park, MD 20740.
    FDA is establishing a docket for public comment on this meeting. 
You may submit comments as follows. Please note that late, untimely 
filed comments may not be considered. Electronic comments must be 
submitted on or before July 15, 2019. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of July 15, 2019. 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

[[Page 14661]]

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-2019-N-1388 for ``Responsible Innovation in Dietary Supplements; 
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 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 
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, Food and Drug 
Administration, Center for Food Safety and Applied Nutrition (HFS-009), 
5001 Campus Dr., College Park, MD 20740, 240-402-1731, email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    On February 11, 2019, FDA announced new efforts to strengthen the 
regulation of dietary supplements by modernizing and reforming FDA's 
oversight (see Statement from FDA Commissioner Scott Gottlieb, M.D., on 
the Agency's new efforts to strengthen regulation of dietary 
supplements by modernizing and reforming FDA's oversight, available at 
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631065.htm). FDA's announcement acknowledged the need to ensure that 
our regulatory framework is flexible enough to adequately evaluate 
product safety without unnecessarily restricting innovation. We invite 
public input about whether and how we should adjust our current dietary 
supplement regulatory approach to better allow for innovation and 
growth in the dietary supplement marketplace while maintaining and 
strengthening our ability to efficiently and effectively evaluate 
product safety and protect the public health.
    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) and defined ``dietary supplement,'' in part, as a product 
(other than tobacco) intended to supplement the diet that bears or 
contains one or more of the following dietary ingredients:
    (A) A vitamin;
    (B) a mineral;
    (C) an herb or other botanical;
    (D) an amino acid;
    (E) a dietary substance for use by man to supplement the diet by 
increasing the total dietary intake; or
    (F) a concentrate, metabolite, constituent, extract, or combination 
of any ingredient described in clause (A), (B), (C), (D), or (E).
    Section 201(ff)(1) of the FD&C Act (21 U.S.C. 321(ff)(1)).
    DSHEA clarified that dietary supplements are generally subject to 
regulation as foods under the FD&C Act but also included dietary 
supplement-specific adulteration and misbranding provisions. Among 
other things, DSHEA provided authority for FDA to establish current 
good manufacturing practice requirements for dietary supplements and 
clarified the statements of nutritional support that can be made in 
product labeling. Dietary supplement manufacturers and distributors are 
responsible for selling products that comply with these requirements. 
FDA is responsible for regulating dietary supplements and has authority 
to take enforcement action when dietary supplements are adulterated or 
misbranded.
    DSHEA also added section 413 of the FD&C Act (21 U.S.C. 350b), 
which defines the term ``new dietary ingredient'' (NDI) and describes 
requirements for NDIs. Among other things, section 413 of the FD&C Act 
requires the manufacturer or distributor of an NDI, or of a dietary 
supplement containing an NDI, to submit a premarket notification to FDA 
at least 75 days before introducing the NDI or dietary supplement into 
interstate commerce, unless the NDI and any other dietary ingredients 
in the dietary supplement have been present in the food supply as an 
article used for food in a form in which the food has not been 
chemically altered (21 U.S.C. 350b(a)(1)).
    DSHEA contemplated a dynamic dietary supplement market with a role 
for innovation. In the 25 years since DSHEA was enacted, the dietary 
supplement market has grown significantly. What was once a $4 billion 
industry comprising about 4,000 products is now an industry worth more 
than $40 billion with more than 50,000--and possibly as many as 80,000 
or even more--products available to consumers. Innovative new products 
involving novel technologies related to ingredients, manufacturing 
processes, and delivery systems represent a substantial portion of this 
growth.
    A robust NDI notification process is an integral part of the DSHEA 
framework and represents FDA's only opportunity to evaluate the safety 
of NDIs in dietary supplements before they become available to 
consumers. Despite the expanded marketplace, however, we have only 
received about 1,200 NDI notifications since DSHEA's enactment. FDA 
recognizes that not every new

[[Page 14662]]

dietary supplement product is subject to the notification requirement, 
so we continue to provide clarifications on when premarket 
notifications are required.\1\ A transparent, common understanding of 
the requirements surrounding dietary ingredient status and 
notification, with predictable expectations regarding compliance and 
consequences for non-compliance, will help our regulatory processes 
operate effectively. Public discussion of these issues will further our 
efforts to strengthen regulation of dietary supplements through 
modernization and reform and help us better protect the public health.
---------------------------------------------------------------------------

    \1\ See, e.g., Draft Guidance for Industry: Dietary Supplements: 
New Dietary Ingredient Notifications and Related Issues (August 
2016), available at https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/dietarysupplements/ucm257563.htm. This draft guidance, when finalized, will represent 
FDA's current thinking on this topic.
---------------------------------------------------------------------------

II. Topics for Discussion at the Public Meeting

    FDA will host a one-day public meeting to provide interested 
parties an opportunity to discuss various issues related to responsible 
innovation in dietary supplements, including the following topics:
    (1) The scope of the phrase ``dietary substance for use by man to 
supplement the diet by increasing the total dietary intake,'' as used 
in DSHEA (section 201(ff)(1)(E) of the FD&C Act);
    (2) Understanding exceptions to the requirement for premarket 
notification, and evaluating whether and how growth in the marketplace 
since 1994 has altered the impact of those provisions;
    (3) Potential commercial or marketing advantages to incentivize 
responsible innovation; and
    (4) Promoting overall compliance with the premarket notification 
requirement through enforcement.
    The issues discussed at the public meeting, including the above 
topics, and any comments submitted to the docket by July 15, 2019, will 
help us evaluate how to proceed with our efforts to modernize and 
reform FDA's oversight of dietary supplements.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the 
following website: https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/ucm632939.htm. Please provide complete 
contact information for each attendee, including name, title, 
affiliation, address, email, and telephone.
    Registration is free and based on space availability. Persons 
interested in attending this public meeting should register by May 6, 
2019, 11:59 p.m. Eastern Time. 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 time and space permit, 
onsite registration on the day of the public meeting will be provided 
beginning at 8 a.m. We will let registrants know if registration closes 
before the day of the public meeting. Please visit the website at 
https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/ucm632939.htm for this information as well as the final meeting agenda.
    If you need special accommodations due to a disability, please 
contact Juanita Yates (see FOR FURTHER INFORMATION CONTACT) no later 
than May 1, 2019.
    Requests for Oral Comments: 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 are seeking a broad 
representation of ideas and issues presented at the meeting. 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 remarks and to request time for a joint comment. After 
registration closes, we will determine the amount of time allotted to 
each participant and the approximate time each oral comment is to begin 
and will select and notify participants by May 10, 2019. All requests 
to make oral comments must be received by the close of registration on 
May 1, 2019. No commercial or promotional material will be permitted to 
be presented or distributed at the public meeting.
    Those without internet or email access can register and/or request 
to participate by contacting Juanita Yates by the above dates (see FOR 
FURTHER INFORMATION CONTACT).
    Streaming Webcast of the public meeting: This public meeting will 
also be webcast. Please visit the following website to register: 
https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/ucm632939.htm.
    FDA has verified the website addresses in this document, as of the 
date this document publishes in the Federal Register, but websites 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 also 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/NewsEvents/WorkshopsMeetingsConferences/ucm632939.htm.

    Dated: April 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07168 Filed 4-10-19; 8:45 am]
 BILLING CODE 4164-01-P


