Document ID: FDA-2017-D-6580-0001
Agency: fda
Document Type: Notice
Title: Drug Products Labeled as Homeopathic; Draft Guidance for Food
and Drug Administration Staff and Industry; Availability
Posted Date: 2017-12-20T05:00Z

[Federal Register Volume 82, Number 243 (Wednesday, December 20, 2017)]
[Notices]
[Pages 60403-60405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27157]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6580]

Drug Products Labeled as Homeopathic; Draft Guidance for Food and 
Drug Administration Staff and Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for FDA staff and industry 
entitled ``Drug Products Labeled as Homeopathic.'' This draft guidance 
describes how FDA intends to prioritize enforcement and regulatory 
action with regard to drug products, including biological products, 
labeled as homeopathic and marketed in the United States without the 
required FDA approval.

DATES: Submit either electronic or written comments on the draft 
guidance by March 20, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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'').

[[Page 60404]]

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-D-6580 for ``Drug Products Labeled as Homeopathic.'' 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.'' 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 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 draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the 
Office of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Elaine Lippmann, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6238, Silver Spring, MD 20993, 301-796-
3600; or Stephen Ripley, Center for Biologics Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 
7301, Silver Spring, MD 20993, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for FDA 
staff and industry entitled ``Drug Products Labeled as Homeopathic.'' 
This draft guidance describes how FDA intends to prioritize enforcement 
and regulatory action with regard to drug products, including 
biological products, labeled as homeopathic and marketed in the United 
States without the required FDA approval. Simultaneous with the 
issuance of the final guidance, FDA will withdraw Compliance Policy 
Guide (CPG) 400.400, ``Conditions Under Which Homeopathic Drugs May be 
Marketed'', issued on May 31, 1988.
    Homeopathy is an alternative medical practice that has an 
historical basis in theory and practice first systematized in the late 
1700s. Homeopathy is generally based on two main principles: (1) A 
substance that causes symptoms in a healthy person can be used in 
diluted form to treat symptoms and illnesses (known as ``like-cures-
like'') and (2) the more diluted the substance, the more potent it is 
(known as the ``law of infinitesimals'').
    The definition of ``drug'' in section 201(g)(1) of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321(g)(1)) 
includes articles recognized in the Homeopathic Pharmacopoeia of the 
United States (HPUS) or any supplement to it. As such, homeopathic 
drugs are subject to the same regulatory requirements as other drugs. 
Generally, a drug, including a homeopathic drug, is considered a ``new 
drug'' if it is not generally recognized by qualified experts as safe 
and effective (GRAS/E) for its labeled uses (section 201(p) of the FD&C 
Act). FDA makes GRAS/E determinations for over-the-counter (OTC) drugs 
marketed under the OTC Drug Review (see 21 CFR part 330). FDA has not 
reviewed any drug products labeled as homeopathic under the OTC Drug 
Review because the Agency categorized these products as a separate 
category and deferred consideration of them (37 FR 9464 at 9466 (May 
11, 1972)). Under section 505(a) of the FD&C Act (21 U.S.C. 355(a)), 
before any ``new drug'' is marketed, it must be the subject of an 
approved application submitted pursuant to section 505(b) or section 
505(j) of the FD&C Act; however, a biological product with an approved 
license under section 351(a) of the Public Health Service Act (PHS Act) 
(42 U.S.C. 262(a)) is not required to have an approved application 
under section 505 of the FD&C Act. Accordingly, absent a determination 
that a drug product labeled as homeopathic is not a ``new drug'' under 
section 201(p), all drug products labeled as homeopathic are subject to 
the premarket approval requirements in section 505 of the FD&C Act or 
section 351 of the PHS Act. There are no drug products labeled as 
homeopathic that are approved by FDA.
    In May 1988, FDA's Center for Drug Evaluation and Research issued 
CPG 400.400 entitled ``Conditions Under Which Homeopathic Drugs May be 
Marketed.'' As stated in the 1988 CPG, it delineates the conditions, 
including conditions related to ingredients, labeling, prescription 
status, and current good manufacturing practice, under which 
homeopathic drug products may ordinarily be marketed.
    In light of the growth of the industry and passage of more than 2 
decades since the 1988 CPG's issuance, FDA announced on March 27, 2015, 
that it was evaluating its regulatory framework for these products. In 
April 2015, FDA held a public hearing to obtain information and 
comments from stakeholders about the current use of drug products 
labeled as homeopathic, as well as the Agency's regulatory

[[Page 60405]]

framework for such products (Docket No. FDA-2015-N-0540; available at 
https://www.regulations.gov/docket?D=FDA-2015-N-0540). FDA sought broad 
public input on its enforcement policies related to drug products 
labeled as homeopathic in an effort to better promote and protect the 
public health.
    As a result of the Agency's evaluation, including consideration of 
the public input received on this issue, FDA has determined that it is 
in the best interest of public health to issue a new guidance that 
applies a risk-based enforcement approach to drug products labeled as 
homeopathic and marketed in the United States without the required FDA 
approval, consistent with FDA's risk-based regulatory approaches 
generally. The Agency generally intends to apply a risk-based 
enforcement approach to the manufacturing, distribution, and marketing 
of drug products labeled as homeopathic, as described in the draft 
guidance, when finalized. However, the Agency has limited enforcement 
resources and recognizes that many such products likely will fall 
outside the risk-based categories described in the draft guidance.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on drug products 
labeled as homeopathic. 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 draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

    Dated: December 6, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27157 Filed 12-18-17; 11:15 am]
 BILLING CODE 4164-01-P