[Federal Register Volume 83, Number 73 (Monday, April 16, 2018)]
[Notices]
[Pages 16369-16370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.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.
    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


