AJHM Summer 2015 51
Volume 108 Number 2
Homeopathic Product Regulation: Evaluating the Food
and Drug Administration’s Regulatory Framework after
a Quarter Century — A Public Hearing
Current Events
O
n April 20
th
and 21
st
, 2015 the United States Food
and Drug Administration (FDA) conducted historic
hearings concerning the regulatory framework around
homeopathic drug products. The event took place at the
FDA White Oak campus in Silver Spring, Maryland and
was open to the public. These hearings were held as the
first step of broader review process. A similar evaluation
was last undertaken in 1988 and resulted in FDA’s Compli-
ance Policy Guide (CPG) 400.400 – a set of rules that has
regulated the manufacture and sale of homeopathic drug
products since that time.
A month prior to the hearings, the FDA posted on its
website a series of questions which it said should guide
speakers’ presentations. These questions touched on sev-
eral topics, including consumer and practitioner attitudes
towards homeopathic drug products, consumer and prac-
titioner knowledge of homeopathic products and available
data sources to evaluate safety and efficacy of these prod-
ucts.
In total, forty five people were allotted time to speak,
either as individuals or as part of a group. Speakers rep-
resented a broad array of stakeholder groups, including
manufacturers, practitioners, patients and public advocacy
groups. Presenters were given between five and twenty
five minutes to speak. Presentations were followed by
a five minute question and answer period during which
members of the panel (who were FDA employees) could
interact with the speakers. The entire hearings (audio and
video) were broadcast live on the web and a recording was
made available shortly thereafter. The recording will re-
main accessible online for the foreseeable future.
Here we are publishing the testimony given at these
hearings on behalf of the American Institute of Home-
opathy. The AIH was given twenty five minutes to make
its presentation on Tuesday, April 21
st
at 1:30 pm. Four
presenters spoke successively—Ronald Whitmont, MD,
Bernardo Merizalde, MD, David Riley, MD and Michelle
Dossett, MD, PhD, MPH. In addition, we are including
the testimony of Karl Robinson, MD (a member of the
AIH who spoke as an individual practitioner and member
of the Texas Society of Homeopaths). Finally, we present
the testimony of Alvin J Lorman, a food and drug attorney
who has represented homeopathic industry groups in FDA
regulatory matters.
Christopher Johnson, ND
Editor-in-chief,
AJHM
Testimony of Ronald Whitmont, MD
American Institute of Homeopathy
Good Morning! It is my pleasure to speak to you today.
My name is Ronald Whitmont and I am the current
President of the American Institute of Homeopathy (AIH).
I received my medical training at SUNY Downstate (HS-
CAB) Medical Center in Brooklyn, New York. I am board
certified in internal medicine and a founding Diplomat of
the American Board of Integrative Holistic Medicine. I
have 25 years of clinical practice experience as a medical
officer in the United States Navy, and as a solo physician in
private practice in New York State. I am past president of
the Homeopathic Medical Society of the State of NewYork
(founded in 1862) and am currently an Assistant Clinical
Professor of Family and Community Medicine at New
York Medical College.
I have included the use of homeopathy in my clinical
practice for the last 20 years. As a second-generation phy-
sician and homeopath, I came to homeopathy by direct
personal experience and added my conventional medi-
cal training to that background. I have a very thorough
understanding of the important role that these medicines
play in providing safe, effective therapeutic choices for my
patients.
Today I am speaking to you as President of theAmerican
Institute of Homeopathy (AIH). Established in 1844, the
AIH is the oldest extant national professional medical so-
ciety in the United States. For the past 171 years, the AIH
has been the voice of the professional homeopathic medi-
cal community. Our mission includes the safeguarding of
the homeopathic medical profession as well as promoting
and supporting the practice of homeopathic medicine. As
the use of homeopathic medicine becomes increasingly
popular, we share the concerns of the FDA with regard to
the regulation of homeopathic drug products for the protec-
tion of public safety. Our concern about the importance of
regulations was evident in 1938 when three term then-US
Senator Royal S. Copeland, a homeopathic physician and
former President of AIH sponsored the Food, Drug and
Cosmetic Act. We are here today to continue this work and
to help safeguard our patients and this profession.
All AIH members are well-trained and licensed health-
care providers who choose to use homeopathy alongside
their conventional medical specialties. In the many con-
versations and interactions I have had with AIH members, I
