83 FR 16369 - Highly Concentrated Caffeine in Dietary Supplements; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 73 (April 16, 2018)

Page Range		16369-16370
FR Document		2018-07836

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry, ``Highly Concentrated Caffeine in Dietary Supplements.'' FDA considers some dietary supplements that consist of only or primarily pure or highly concentrated caffeine to be adulterated. FDA is issuing this document to provide guidance to firms that manufacture, market, or distribute dietary supplement products that contain pure or highly concentrated caffeine, or are considering doing so. This guidance should help such parties determine whether their products are or would be adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and to help them understand how to reduce the likelihood that their products will be considered adulterated.

Federal Register, Volume 83 Issue 73 (Monday, April 16, 2018)

[Federal Register Volume 83, Number 73 (Monday, April 16, 2018)]
[Notices]
[Pages 16369-16370]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-07836]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1189]

Highly Concentrated Caffeine in Dietary Supplements; Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a guidance for industry, ``Highly Concentrated Caffeine
in Dietary Supplements.'' FDA considers some dietary supplements that
consist of only or primarily pure or highly concentrated caffeine to be
adulterated. FDA is issuing this document to provide guidance to firms
that manufacture, market, or distribute dietary supplement products
that contain pure or highly concentrated caffeine, or are considering
doing so. This guidance should help such parties determine whether
their products are or would be adulterated under the Federal Food,
Drug, and Cosmetic Act (FD&C Act) and to help them understand how to
reduce the likelihood that their products will be considered
adulterated.

DATES: The announcement of the guidance is published in the Federal
Register on April 16, 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-1189 for ``Highly Concentrated Caffeine in Dietary
Supplements; Guidance for Industry; Availability.'' 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 Office
of Dietary Supplement Programs, Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740. Send two self-addressed adhesive labels to assist that office
in processing your

[[Page 16370]]

requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Sibyl Swift, Office of Dietary
Supplement Programs, Center for Food Safety and Applied Nutrition, Food
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-1455.

SUPPLEMENTARY INFORMATION:

I. Background

We are announcing the availability of a guidance for industry
entitled ``Highly Concentrated Caffeine in Dietary Supplements.'' We
are issuing this guidance consistent with our good guidance practices
(GGP) regulation 21 CFR 10.115. In accordance with 21 CFR Sec.
10.115(g)(2), we are issuing this guidance without prior public comment
because we have determined that prior public participation is not
feasible or appropriate in light of the threat to the public health
that is posed by pure and highly concentrated caffeine products, which
have been linked to several deaths in recent years. Although this
guidance is immediately in effect, it remains subject to comment in
accordance with FDA's GGP regulation.
In this guidance, we are announcing that we consider some dietary
supplements containing high concentrations of caffeine to be
adulterated and informing industry about characteristics that are
likely to lead to products being considered adulterated. A dietary
supplement is adulterated under section 402(f)(1)(A) of the FD&C Act
(21 U.S.C. 342(f)(1)(A)) if it presents a significant or unreasonable
risk of illness or injury under the conditions of use recommended or
suggested in the labeling or, if no conditions for use are suggested or
recommended, under ordinary conditions of use. In recent years, we have
seen the emergence of powdered and liquid dietary supplement products
containing high concentrations of caffeine marketed directly to
consumers. These products are often sold in bulk containers with
hundreds or thousands of servings in the container, and even a small
dose can be toxic or deadly. The consumer is required to measure out a
small, precise serving from what is often a potentially lethal amount
of product. These products pose a significant or unreasonable risk of
illness or injury.
When formulated appropriately, caffeine can be an ingredient in a
dietary supplement that does not present a significant or unreasonable
risk of illness or injury. The guidance provides suggestions on how
manufacturers can formulate safer dietary supplements containing
caffeine that do not present a significant or unreasonable risk of
illness or injury.
The guidance represents our current thinking on dietary supplements
containing high concentrations of caffeine. 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.

Dated: April 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07836 Filed 4-13-18; 8:45 am]
BILLING CODE 4164-01-P

16370 Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices

requests. See the SUPPLEMENTARY dietary supplements containing caffeine 1101 Wootton Parkway, Suite 750,
INFORMATION section for electronic that do not present a significant or Rockville, MD 20852, (240) 453–8200.
access to the guidance document. unreasonable risk of illness or injury. SUPPLEMENTARY INFORMATION: Notice is
FOR FURTHER INFORMATION CONTACT: The guidance represents our current hereby given that HHS has taken final
Sibyl Swift, Office of Dietary thinking on dietary supplements action in the following case:
Supplement Programs, Center for Food containing high concentrations of
caffeine. It does not establish any rights H.M. Krishna Murthy, Ph.D.,
Safety and Applied Nutrition, Food and
for any person and is not binding on University of Alabama at Birmingham:
Drug Administration, 5001 Campus Dr.,
FDA or the public. You can use an Based on evidence and findings of an
College Park, MD 20740, 240–402–1455.
alternative approach if it satisfies the investigation conducted by UAB, ORI’s
SUPPLEMENTARY INFORMATION: review of UAB’s investigation, and
requirements of the applicable statutes
I. Background and regulations. This guidance is not additional evidence obtained and
subject to Executive Order 12866. analysis conducted by ORI in its
We are announcing the availability of oversight review of UAB’s investigation,
a guidance for industry entitled ‘‘Highly II. Electronic Access ORI found that Dr. H.M. Krishna Murthy
Concentrated Caffeine in Dietary (Respondent), former Research
Supplements.’’ We are issuing this Persons with access to the internet
may obtain the document at either Associate Professor, Department of
guidance consistent with our good Vision Sciences, UAB, committed
guidance practices (GGP) regulation 21 https://www.fda.gov/FoodGuidances or
https://www.regulations.gov. research misconduct in research
CFR 10.115. In accordance with 21 CFR supported by PHS grants, specifically
§ 10.115(g)(2), we are issuing this Dated: April 11, 2018. NIAID, NIH, grants R01 AI051615, R01
guidance without prior public comment Leslie Kux, AI032078, and R01 AI045623; NHLBI,
because we have determined that prior Associate Commissioner for Policy. NIH, grants P01 HL034343 and R01
public participation is not feasible or [FR Doc. 2018–07836 Filed 4–13–18; 8:45 am] HL064272; and NIDDK, NIH, grant R01
appropriate in light of the threat to the DK046900.
BILLING CODE 4164–01–P
public health that is posed by pure and
highly concentrated caffeine products, Falsified and/or fabricated research
which have been linked to several was reported in:
DEPARTMENT OF HEALTH AND
deaths in recent years. Although this HUMAN SERVICES • Nature 444:221–225, 2006 (hereafter
guidance is immediately in effect, it referred to as ‘‘Nature 2006’’); retracted in:
remains subject to comment in Office of the Secretary Nature 532:268, 2016 April 14
accordance with FDA’s GGP regulation. • J. Biol. Chem. 274:5573–5580, 1999
Findings of Research Misconduct (hereafter referred to as ‘‘J. Biol. Chem.
In this guidance, we are announcing
1999’’); retracted in: J. Biol. Chem.
that we consider some dietary 284:34468, 2009
supplements containing high AGENCY: Office of the Secretary, HHS.
• Proc. Natl. Acad. Sci. USA 101:8924–8929,
concentrations of caffeine to be ACTION: Notice. 2004 (hereafter referred to as ‘‘PNAS
adulterated and informing industry 2004’’); Editorial Expression of Concern in:
about characteristics that are likely to SUMMARY: Notice is hereby given that on PNAS 107:6551, 2010 April 6
lead to products being considered April 2, 2018, the Department of Health • Biochem. 44:10757–10765, 2005 (hereafter
adulterated. A dietary supplement is and Human Services (HHS) Debarring referred to as ‘‘Biochem. 2005’’)
adulterated under section 402(f)(1)(A) of Official, on behalf of the Secretary of • Proc. Natl. Acad. Sci. USA 103:2126–2131,
HHS, issued a final notice of debarment 2006 (hereafter referred to as ‘‘PNAS
the FD&C Act (21 U.S.C. 342(f)(1)(A)) if
based on the findings of research 2006’’); Editorial Expression of Concern in:
it presents a significant or unreasonable PNAS 107:6551, 2010 April 6
risk of illness or injury under the misconduct made by the Office of
Research Integrity (ORI) against H.M. • Acta Cryst. D55:1971–1977, 1999 (hereafter
conditions of use recommended or referred to as ‘‘Acta Cryst. 1999’’); retracted
suggested in the labeling or, if no Krishna Murthy, Ph.D., former Research in: Acta Cryst. D66:222, 2010
conditions for use are suggested or Associate Professor, Department of • J. Mol. Biol. 301:759–767, 2000 (hereafter
recommended, under ordinary Vision Sciences, University of Alabama referred to as ‘‘J. Mol. Biol. 2000’’);
conditions of use. In recent years, we at Birmingham (UAB). retracted in: J. Mol. Biol. 397:1119, 2010
have seen the emergence of powdered Dr. Murthy engaged in research • Cell 104:301–311, 2001 (hereafter referred
misconduct in research supported by to as ‘‘Cell 2001’’)
and liquid dietary supplement products
U.S. Public Health Service (PHS) grants, • Biochem. 41:11681–11691, 2002 (hereafter
containing high concentrations of referred to as ‘‘Biochem. 2002’’)
caffeine marketed directly to consumers. specifically National Institute of Allergy
• Protein Data Bank (PDB) identification
These products are often sold in bulk and Infectious Diseases (NIAID),
codes 2HR0, 1BEF, 1RID, 1Y8E, 2A01,
containers with hundreds or thousands National Institutes of Health (NIH), 1CMW, 2QID, 1DF9, 1G40, 1G44, 2OU1,
of servings in the container, and even a grants R01 AI051615, R01 AI032078, and 1L6L (the PDB is funded in part by
small dose can be toxic or deadly. The and R01 AI045623; National Heart, NIH)
consumer is required to measure out a Lung, and Blood Institute (NHLBI), NIH, Falsified and/or fabricated research results
small, precise serving from what is often grants P01 HL034343 and R01 also were referenced in the following PHS
a potentially lethal amount of product. HL064272; and National Institute of grant applications:
These products pose a significant or Diabetes and Digestive and Kidney • 1 R21 AI056224–01 submitted to NIAID,
unreasonable risk of illness or injury. Diseases (NIDDK), NIH, grant R01 NIH
srobinson on DSK3G9T082PROD with NOTICES

When formulated appropriately, DK046900. The administrative actions, • 1 R01 AI064509–01 submitted to NIAID,
caffeine can be an ingredient in a including ten (10) years of debarment, NIH
were implemented beginning on April • 1 R01 AI64509–01A1 submitted to NIAID,
dietary supplement that does not NIH
present a significant or unreasonable 2, 2018, and are detailed below.
• 1 R01 AI051615–01A1 submitted to NIAID,
risk of illness or injury. The guidance FOR FURTHER INFORMATION CONTACT: NIH
provides suggestions on how Wanda K. Jones, Dr.P.H., Interim • 1 R03 TW006840–01 submitted to Fogarty
manufacturers can formulate safer Director, Office of Research Integrity, International Center (FIC), NIH

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Document Created: 2018-04-14 02:19:08
Document Modified: 2018-04-14 02:19:08

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		The announcement of the guidance is published in the Federal Register on April 16, 2018.
Contact		Sibyl Swift, Office of Dietary Supplement Programs, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240- 402-1455.
FR Citation		83 FR 16369

83 FR 16369 - Highly Concentrated Caffeine in Dietary Supplements; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 73 (April 16, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration