Document ID: FDA-2015-N-0540-0001
Agency: fda
Document Type: Proposed Rule
Title: Homeopathic Product Regulation: Evaluating the Food and Drug
Administration’s Regulatory Framework After a Quarter-Century;
Public Hearing
Posted Date: 2015-03-27T04:00Z

[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Proposed Rules]
[Pages 16327-16329]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07018]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2015-N-0540]

Homeopathic Product Regulation: Evaluating the Food and Drug 
Administration's Regulatory Framework After a Quarter-Century; Public 
Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
hearing to obtain information and comments from stakeholders about the 
current use of human drug and biological products labeled as 
homeopathic, as well as the Agency's regulatory framework for such 
products. These products include prescription drugs and biological 
products labeled as homeopathic and over-the-counter (OTC) drugs 
labeled as homeopathic. FDA is seeking participants for the public 
hearing and written comments from all interested parties, including, 
but not limited to, consumers, patients, caregivers, health care 
professionals, patient groups, and industry. FDA is seeking input on a 
number of specific questions, but is interested in any other pertinent 
information participants would like to share.

DATES: The public hearing will be held on April 20 and 21, 2015, from 9 
a.m. to 4 p.m. The meeting may be extended or may end early depending 
on the level of public participation. Register to attend or provide 
oral testimony at the hearing by April 13, 2015. See Registration and 
Request to Provide Oral Testimony for information on how to register or 
make an oral presentation at the hearing. Written or electronic 
comments will be accepted until June 22, 2015.

ADDRESSES: The public hearing will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31, rm. 1503A, Silver Spring, MD, 
20993-0002. Participants must enter through Building 1 and undergo 
security screening. For parking and security information, please refer 
to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Lesley DeRenzo, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20903-0002, 240-402-4612, FAX: 301-
847-8747, Lesley.derenzo@fda.hhs.gov; or Cynthia Ng, Center for Drug 
Evaluation and Research, 10903 New Hampshire Ave., Silver Spring, MD 
20903-0002, 301-796-7512, FAX: 301-847-8747, cynthia.ng.@fda.hhs.gov.
    Registration and Request to Provide Oral Testimony: The public 
hearing is free and seating will be on a first-come, first-served 
basis. If you wish to attend or make an oral presentation, see section 
III (Attendance and/or Participation in the Public Hearing) for 
information on how to register and the deadline for registration. If 
you cannot attend in person, information about how you can access a 
live Webcast will be located at https://collaboration.fda.gov/hprapril2015/.
    Comments and Transcripts: You may submit either electronic comments 
regarding this document to http://www.regulations.gov or written 
comments to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You 
should annotate and organize your comments to identify the specific 
questions or topic to which they refer. It is only necessary to send 
one set of comments. Please identify your comments with the docket 
number found in brackets in the heading of this document. Received 
comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday, and will be posted to the 
docket at http://www.regulations.gov.
    Transcripts of the hearing will be available for review at the 
Division of Dockets Management and at http://www.regulations.gov 
approximately 45 days after the hearing. You may submit a request to 
obtain a hard copy or CD-ROM transcript. Send your request to the 
Division of Freedom of Information (ELEM-1029), Office of Management 
Programs, Food and Drug Administration, 12420 Parklawn Dr., Element 
Bldg., Rockville, MD 20857.

SUPPLEMENTARY INFORMATION: FDA is evaluating its current enforcement 
policies for drug products labeled as homeopathic from scientific, 
risk, and process perspectives. The Agency is now soliciting opinions 
about whether and how to adjust the current enforcement policies to 
reflect changes in the homeopathic product marketplace over the last 
approximately 25 years.

[[Page 16328]]

I. Background

A. Homeopathic Products and the Federal Food, Drug, and Cosmetic Act

    The definition of a ``drug'' under the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) includes: (1) Articles recognized in the 
official United States Pharmacopoeia (USP), official Homoeopathic 
Pharmacopoeia of the United States (HPUS); (2) articles intended for 
use in the diagnosis, cure, mitigation, treatment, or prevention of 
disease in man or other animals; and (3) articles (other than food) 
intended to affect the structure or any function of the body of man or 
other animals. See section 201(g)(1)(A) to (C) of the FD&C Act (21 
U.S.C. 321(g)(1)(A) to(C)). Accordingly, an article that meets this 
definition of a ``drug'' is subject to regulation under the FD&C Act, 
regardless of whether it is labeled as homeopathic. An article that 
also meets the definition of a ``biological product'' (as defined in 
section 351(i) of the Public Health Service Act (PHS Act) (42 U.S.C 
262(i))) is subject to regulation under both the FD&C Act and the PHS 
Act.
    The FD&C Act recognizes the HPUS, along with the USP, as an 
official compendium. See section 201(j) of the FD&C Act. The HPUS is 
produced by a non-governmental organization known as the Homeopathic 
Pharmacop[oelig]ia Convention of the United States (HPCUS) and has been 
in continuous publication since 1897 (Ref. 1). The HPCUS determines 
which ingredients, including permissible potency levels, are officially 
monographed homeopathic ingredients. To date, there are over 1200 
officially monographed ingredients in the HPUS. Since 2004, the HPCUS 
has added over 500 new ingredient monographs. The standards set forth 
in the HPUS and the USP affect the naming, quality, and labeling of 
drug products. See e.g., sections 501(b) and 502(g) of the FD&C Act (21 
U.S.C. 351(b) and 352(g)).
    Nothing in the FD&C Act exempts drugs labeled as homeopathic from 
any of the requirements related to approval, adulteration, and 
misbranding, including labeling requirements. If a drug labeled as 
homeopathic is a new drug under the FD&C Act, it is subject to the same 
premarket approval requirements and the same standards for safety and 
efficacy as all new drugs. A new drug is defined, in part, as any drug 
that is not generally recognized, among experts qualified by scientific 
training and experience to evaluate the safety and effectiveness of 
drugs, as safe and effective for use under the condition prescribed, 
recommended, or suggested in the labeling thereof. See section 201(p) 
of the FD&C Act).

B. Homeopathic Drugs and the OTC Drug Review

    In 1972, FDA initiated rulemaking procedures (the OTC Drug Review) 
to determine which OTC drugs are generally recognized among qualified 
experts as safe and effective and not misbranded under prescribed, 
recommended, or suggested conditions of use. See ``Procedures for 
Classification of Over-the-Counter Drugs'' (37 FR 9464, May 11, 1972). 
FDA deferred review of drugs labeled as homeopathic due to the 
uniqueness of homeopathic medicine and stated that FDA would review 
them as a separate category at a later time (37 FR 9464 at 9466). To 
date, FDA has not reviewed this class of products for safety and 
efficacy. Accordingly, there are currently no FDA monographs for drug 
products labeled as homeopathic.

C. FDA's Compliance Policy Guide

    Since 1988, prescription and nonprescription drug products labeled 
as homeopathic have been manufactured and distributed without FDA 
approval under the enforcement policies set forth in FDA's Compliance 
Policy Guide (CPG) 400.400 entitled ``Conditions Under Which 
Homeopathic Drugs May be Marketed'' (see 53 FR 21728, June 9, 1988). 
The CPG defines a homeopathic drug as any drug labeled as being 
homeopathic which is listed in the HPUS, an addendum to it, or its 
supplements. The CPG includes conditions specific to ingredients, 
labeling, prescription status, and current good manufacturing practice. 
The CPG can be found at http://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074360.htm.

D. Growth in the Sale of Drugs Labeled as ``Homeopathic''

    The homeopathic drug industry has continued on an upward growth 
trajectory since FDA issued its CPG in 1988, especially with respect to 
OTC drug products labeled as homeopathic. The CPG noted that, at the 
time of original publication in 1988, the homeopathic drug market was a 
multimillion dollar industry in the United States. In 2007, the 
National Health Interview Survey, conducted by the Centers for Disease 
Control and Prevention's National Center for Health Statistics, 
estimated that adults spent about $2.9 billion on the purchase of 
homeopathic medicine (Ref. 2). Many drugs labeled as homeopathic are 
sold OTC in major retail stores and are often marketed as natural, 
safe, and effective alternatives to other prescription and 
nonprescription products.

E. Safety of Drug Products Labeled as Homeopathic

    Drugs products labeled as homeopathic can contain a wide range of 
substances, including ingredients derived from plants, healthy or 
diseased animal or human sources, minerals, and chemicals (either as 
active or inactive ingredients). As with ingredients in other drug and 
biological products, homeopathic ingredients, even if highly diluted, 
can cause side effects, drug interactions, and allergic or other 
adverse reactions. Negative health effects from drug products labeled 
as homeopathic have been reported through the FDA's Adverse Event 
Reporting System and the National Poison Data System (NPDS), which is 
maintained by the American Association of Poison Control Centers and 
tracks human poison exposure cases. Data in the NPDS pertaining to 
homeopathic drug products is tracked under the category ``Homeopathic 
Agents.'' The 2012 American Association of Poison Control Center Annual 
Report indicated that there were 10,311 reported poison exposure cases 
related to ``Homeopathic Agents,'' with 8,788 of those reported cases 
attributed to children 5 years of age and younger (Ref. 3). Of the 
10,311 reported cases, 697 required treatment in a health care facility 
(Id.).

II. Scope of the Public Hearing

    FDA is seeking broad public input on the current enforcement 
policies related to drug products labeled as homeopathic in an effort 
to better promote and protect the public health. FDA has developed a 
list of questions to facilitate a more productive discussion at the 
public hearing. This list is not intended to be exclusive, and FDA 
encourages comments on other matters related to the development and 
regulation of drug and biological products labeled as homeopathic. 
Issues that are of specific interest to the Agency include the 
following:
     What are consumer and health care provider attitudes 
towards human drug and biological products labeled as homeopathic?
     What data sources can be identified or shared with FDA so 
that the Agency can better assess the risks and benefits of drug and 
biological products labeled as homeopathic?
     Are the current enforcement policies under the CPG 
appropriate to protect and promote public health in light of the 
tremendous growth in the

[[Page 16329]]

homeopathic drug market? Are there alternatives to the current 
enforcement policies of the CPG that would inform FDA's regulatory 
oversight of drugs labeled as homeopathic? If so, please explain.
     Are there areas of the current CPG that could benefit from 
additional clarity? If so, please explain.
     Is there information regarding the regulation of 
homeopathic products in other countries that could inform FDA's 
thinking in this area?
     A large majority of human drug products labeled as 
homeopathic are marketed as OTC drugs. These products are available for 
a wide variety of indications, and many of these indications have never 
been considered for OTC use under a formal regulatory process. What 
would be an appropriate regulatory process for evaluating such 
indications for OTC use?
     Given the wide range of indications on drug products 
labeled as homeopathic and available OTC, what processes do companies 
currently use to evaluate whether such products, including their 
indications for use, are appropriate for marketing as an OTC drug?
     Do consumers and health care providers have adequate 
information to make informed decisions about drug products labeled as 
homeopathic? If not, what information, including, for example, 
information in labeling, would allow consumers and health care 
providers to be better informed about products labeled as homeopathic?

III. Attendance and/or Participation in the Public Hearing

    The public hearing is free and seating will be on a first-come, 
first-served basis. If you wish to make an oral presentation during the 
hearing, you must register by submitting either an electronic or a 
written request by 5 p.m. on April 13, 2015, to Lesley DeRenzo or 
Cynthia Ng (see FOR FURTHER INFORMATION CONTACT). Submit electronic 
requests to CDERHOMEOPATHICPRODUCT@fda.hhs.gov. You must provide your 
name, title, business affiliation (if applicable), address, telephone 
and fax numbers, email address, and type of organization you represent 
(e.g., industry, consumer organization, etc.). You also should submit a 
brief summary of the presentation, including the discussion topic(s) 
that will be addressed and the approximate time requested for your 
presentation. FDA encourages individuals and organizations with common 
interests to coordinate and give a joint, consolidated presentation. 
Registrants will receive confirmation once they have been accepted to 
attend the meeting. FDA may limit both the number of participants from 
individual organizations and the total number of attendees based on 
space limitations. Registered presenters should check in before the 
hearing.
    Participants should submit a copy of each presentation to Lesley 
DeRenzo or Cynthia Ng (see FOR FURTHER INFORMATION CONTACT) no later 
than 5 p.m. on April 13, 2015. We will file the hearing schedule, 
indicating the order and time allotted for each presenter, with the 
Division of Dockets Management (see COMMENTS AND TRANSCRIPTS). FDA will 
post an agenda of the public hearing and other background material at 
least 3 days before the public hearing, along with additional 
information, at: http://www.fda.gov/Drugs/NewsEvents/ucm132703.htm 
(select this hearing from the events list).
    We will mail, email, or telephone the schedule to each participant 
before the hearing. In anticipation of the hearing presentations moving 
ahead of schedule, participants are encouraged to arrive early to 
ensure their designated order of presentation. Participants who are not 
present when called risk forfeiting their scheduled time.
    If you need special accommodations due to a disability, contact 
Lesley DeRenzo or Cynthia Ng (see FOR FURTHER INFORMATION CONTACT) at 
least 7 days in advance of the hearing.

IV. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public 
hearing will be held in accordance with part 15 (21 CFR part 15). A 
presiding officer, who will be accompanied by FDA senior management 
from the Office of the Commissioner and the relevant centers, will 
conduct the hearing.
    Under Sec.  15.30(f), the hearing is informal and the rules of 
evidence do not apply. Only the presiding officer and panel members may 
question any person during or at the conclusion of each presentation 
(Sec.  15.30(e)). Public hearings under part 15 are subject to FDA's 
policy and procedures for electronic media coverage of FDA's public 
administrative proceedings (21 CFR part 10, subpart C) (Sec.  
10.203(a)). Under Sec.  10.205, representatives of the electronic media 
may be permitted, subject to certain limitations, to videotape, film, 
or otherwise record FDA's public administrative proceedings, including 
presentations by participants. The hearing will be transcribed as 
stipulated in Sec.  15.30(b). To the extent that the conditions for the 
hearing as described in this document conflict with any provisions set 
out in part 15, this notice acts as a waiver of those provisions as 
specified in Sec.  15.30(h).

V. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov. (FDA 
has verified all the Web site addresses in this reference section, but 
we are not responsible for any subsequent changes to the Web sites 
after this document publishes in the Federal Register.)

1. The Homeopathic Pharmacopoeia of the United States (HPUS), ``What 
is the HPUS?'', available at http://www.hpus.com/what-is-the-hpus.php (last visited Dec. 23, 2014).
2. Nahin, R. L., P. M. Barnes, B. J. Stussman, and B. Bloom, ``Costs 
of Complementary and Alternative Medicine (CAM) and Frequency of 
Visits to CAM Practitioners: United States, 2007.'' National Health 
Statistics Reports; no 18. Hyattsville, MD: National Center for 
Health Statistics, 2009.
3. James B. Mowry, et al., ``2012 Annual Report of the American 
Association of Poison Control Centers' National Poison Data System 
(NPDS): 30th Annual Report,'' 51 Clinical Toxicology, 949, 1188 
(2013).

    Dated: March 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07018 Filed 3-26-15; 8:45 am]
 BILLING CODE 4164-01-P