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4. HOMEOPATHY IN UNITED STATES OF AMERICA

4.1. Introduction:

 Homeopathy is an alternative medical practice that was developed in

the late 1700s.

 Historically, homeopathic products have been identified through

“Provings” in which substances are administered to healthy volunteers
in concentrations that cause symptoms. Symptoms experienced by
volunteers are recorded to indicate possible therapeutic uses for the
substances .

 In other words, if a substance causes a particular symptom,

individuals experiencing that symptom would be treated with a diluted
solution made from that substance.

 Homeopathy is natural because its remedies are produced according

to the United States Food and Drug Administration recognized
Homeopathic Pharmacopoeia of the United States from natural
sources, whether vegetable, mineral, or animal in nature.

4.2. History:

 Homeopathy was introduced into the United States of America by

Hans Burch Gram in 1825. It developed largely through immigration
of German homeopaths. The first homeopathic medical college was
established in Allentown, in 1835.

 The American Institute of Homeopathy (AIH) was founded in 1844.

 The American Medical Association was founded in 1847 and pursued

policies hostile to homeopathy from the outset.

 The International Hahnemannian Association split from the American

Institute of Homeopathy in 1880. The Flexner Report of 1910 resulted
in many homeopathic medical colleges being closed down.
Homeopathy in the United States of America was in steep decline from
the 1920s to the 1960s but has had a strong recovery since the
1970s.

4.3. Federal recognition of homeopathic medicine:

 Officially recognized under the 1938 Food, Drug, and Cosmetics Act,
the 1965 Medicare Act and the 1987 FDA Compliance Policy
Guidelines, these safe, gentle but deep-acting medicines can be used
to treat persons experiencing many kinds of medical conditions. It
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would be wise, nonetheless, to discuss with the prospective

homeopathic practitioner his/her experience with one’s particular
complaint or problem.

4.4. Labelling of homeopathic products:

 There are no FDA-approved products labeled as homeopathic; this

means that any product labeled as homeopathic is being marketed in
the United States of America without FDA evaluation for safety or
effectiveness to approved prescription and nonprescription products,
and are sold online and major retail stores.

 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.

 Products labeled as homeopathic generally include:

 The word “Homeopathic”

 The ingredients listed in terms of dilution, e.g. 1X, 6X, 2C

 FDA requires that the label on the product, outer container or

accompanying leaflet include at least one major indication (i.e,.
Medical problem to be treated), a list of ingredients, the number of
times the active ingredient was diluted, and directions for use.

 The US Food and Drug Administration) requires the following

information:

 Name and place of business (manufacturer, packer, or distributor)

 Directions for use
 Statement of identity
 At least one major OTC indication for use
 Satement of ingredients (quality and potency the product, e.g. 3x)
 Documentation must be provided to support that those products or
 ingredients which are not recognized officially in the HPUS are
generally
 recognized as homeopathic products or ingredients
 Established name (English names are obligatory, Latin names can
also
 provided)
 Container size and net quantity
 Warning statement.
 The Homeopathic Pharmacopeia of the United States (HPUS) (6)
requires:
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 Directions for use

 Statement of identity
 Potency of the homeopathic medicine
 Net contents
 Name and place of business of the manufacturer, packer or
distributor
 National Drug Code (NDC) number or FDA establishment number
 “Homeopathic” designation (and possibly “HPUS” if made according to
 An existing HPUS monograph and methods)
 Adequate directions for use

4.5. Safety of homeopathic products:

 While products labeled as homeopathic are generally labeled as highly

diluted, some of these products have been found to contain
measurable amounts of active ingredients and therefore could cause
significant patient harm. Additionally FDA has tested products that
were improperly manufactured, which can cause incorrect dilutions
and increase the potential for contamination.

 Further, some products labeled as homeopathic are marketed to treat

serious diseases or conditions.

 Examples of FDA concerns include:

 FDA alerts consumers of Kadesh Incorporation’s voluntary nationwide

recall of Puriton eye relief drops due to non-sterile production
conditions.

 FDA alerts consumers of Sprayology’s voluntary nationwide recall of

homeopathic water-based medicines due to microbial contamination.

 Liquid homeopathic products may contain alcohol. The FDA allows

higher levels of alcohol in these homeopathic drugs than in
conventional drugs.

 If a homeopathic product claims to treat serious disease such as

cancer, it must be sold by prescription. Only products for minor
health problems, like a cold or headache, that go away on their own,
can be sold without a prescription.

4.6. Regulations of homeopathy in United States of America

 Under the Federal Food, Drug and Cosmetic Act, homeopathic

products are subject to the same requirements related to approval,

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adulteration and misbranding as other drug products. There are

currently no homeopathic products approved by FDA.

 In 1988, the FDA issued Compliance Policy Guide (CPG) 400.400,

entitled “Conditions Under Which Homeopathic Drugs May be
Marketed”, which described the agency’s enforcement policy.

 On October 4, 2019, FDA withdrew CPG 400.400 because it is

inconsistent with risk-based approach to regulatory and enforcement
action.

 FDA also issued a revised draft guidance: Drug products labeled as

homeopathic, for public comment. Since homeopathic drug products
have not been approved by FDA for any use, they may not meet
modern standards for safety, effectiveness, and quality.

 The FDA allows homeopathic products that meet certain conditions to

be marketed without agency preapproval.

 Many homeopathic products will likely fall outside the risk-based

categories described in the revised draft guidance.

 FDA intends to focus its enforcement authorities on the following

kinds of products:

1. With reported safety concerns;

2. That contain or purport to contain ingredients associated with

potentially significant safety concerns;

3. For routes of administration other than oral or topical, e.g. for use as
an injection or taken nasally;

4. That claim to treat or prevent serious and/or life-threatening diseases

and conditions, such as cancer;

5. Marketed to vulnerable populations, including children, pregnant

women and the elderly; or

6. With significant quality issues.

4.6.1. Revised draft guidance: Drug Products Labeled as

Homeopathic:

 This draft guidance describes how FDA intend to prioritize

enforcement and regulatory actions for homeopathic drug products
marketed in the United States without the required FDA approval.

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FDA has developed a risk-based approach under which the agency

intends to prioritize enforcement and regulatory actions involving
certain categories of such products that potentially pose a higher risk
to public health.

 In general, FDA’s guidance documents do not establish legally

enforceable responsibilities. Instead, guidances describe the agency’s
current thinking on a topic and should be viewed only 4as
recommendations, unless specific regulatory or statutory are cited.
The use of the word agency guidance means that something is
suggested or recommended, but not required.

4.6.2. Compliance Policy Guide 400.400:

In may 1988, the Center for Drug Evaluation and Research(CDER)

issued Compliance Policy Guide(CPG) 400.400 entitled “Conditions
Under Which Homeopathic Drugs may be Marketed”. As stated in
the1988 CPG, it “delineate those conditions under which homeopathic
drug products may ordinarily be marketed”, including conditions
regarding ingredients, labeling, prescription status, and current Good
Manufacturing Practices.

4.6.3. FDA’s Re-examination of its Enforcement Policies:

 In light of the growth of the industry and passage of more than 2

decades since the issuance of CPG 400.400, FDA announced on
March 27, 2015, that it was evaluating its regulatory framework for
homeopathic drug products. In April 2015, FDA held a public hearing
to obtain information and comments from stakeholders about the
current use of homeopathic drug products, as well as the Agency’s
regulatory framework for such products. FDA sought broad public
input on its enforcement policies related to homeopathic drug
products in an effort to better promote and protect the public health.

 Since the issuance of CPG 400.400, the Agency has encountered

multiple situations in which homeopathic drug products posed a
significant risk to patients. Such products either caused or could have
caused significant harm, even though the product labeling and
ingredient formulation appeared to meet the conditions of CPG
400.400.

 For example, in 2016, FDA’s search of the FDA Adverse Event

Reporting System (FAERS) database identified 99 cases of adverse
events consistent with belladonna toxicity, including reports of infant
deaths and seizures, possibly related to teething products. Multiple

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homeopathic drug products were identified as associated with this

safety concern. Further investigation revealed that the poisonous
belladonna alkaloids in some of the products far exceeded the labeled
amounts, raising a serious safety concern.

4.6.4. FDAs Enforcement Policy:

 FDA is not required, and generally does not expect, to give special
notice that a drug product may be subject enforcement action.
However, this guidance is intended to provide notice that any
homeopathic drug product that is being marketed legally is subject to
FDA enforcement action at any time.

4.6.5. Enforcement and Regulatory Priorities:

 In developing a risk-based approach, FDA has identified certain

categories of homeopathic drug products marketed without the
required FDA approval as potentially posing higher risks to public
health. FDA generally intends to prioritize enforcement and regulatory
actions with respect to premarket approval requirements involving
homeopathic drug products that are marketed without the required
FDA approval and that fall within the following categories:

 Products with reports of injury that, after raise potential safety

concerns.

 Products that contain or purport to contain ingredients associated

with potentially significant safety concerns.

 Products for routes of administration other than oral or topical.

 Products intended to be used for the prevention or treatment of

serious and/or life-threatening diseases or conditions.

Regulation of homeopathic drugs in United States of America:

Enabling Pre market GMPs Labeling Advertising Indication

legislation approval on
labeling

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FDCA HPCUS 21 21 C.F.R. Prescription: Required

monograph C.F.R. 201, FDA FDA
210 & Compliance Non-
211 Policy Guide Prescription:
400.400 FTC

4.7. Manufacturing of homeopathic products:

 The methods of preparation are rooted in the traditional methods used

by homeopathic physicians since the days of Dr. Samuel
Haahnemann. Homeopathic manufacturers strictly adhere to the
standards established by the Homeopathic Pharmacopoeia of United
States and the regulatory requirements of FDA.

 The homeopathic manufacturing process begins with the creation of

“mother tinctures”, the first homeopathic dilution of raw material.

 Raw materials are either macerated in alcohol, in the case of raw

materials that are not immediately water-soluble, or titrated with
lactose powder then liquefied into tincture.

 When the mother tinctures are completed, they are tested according to
testing procedures outlined in the German Homeopathic
Pharmacopoeia(GHP) which is the international standard adopted by
United States of America manufacturers.

4.8. Certification in homeopathy:

 A certification in homeopathy indicates proficiency in homeopathy to

patients and other practitioners using a known standard. Note that
the certification is not a license to practice homeopathy. Licenses can
only be granted by states.

 The following organizations offer a certification in homeopathy in

North America:

 Council for Homeopathic Certification(CHC): This organization certifies

classical homeopaths.

 American Board of Homeotherapeutics (ABHt): This organization

certifies licensed medical and osteopathic physicians in classical
homeopathy.

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 Homeopathic Academy of Naturopathic Physicians(HANP): This

organization certifies naturopaths.

4.9. Licensure in homeopathy:

 There is no license offered to professionals to practice homeopathy in

the United states, with the exception of 3 states. Those states are
Arizona, Nevada, and Connecticut.

 Usually, individuals licensed to practice medicine or other health care

profession can legally practice homeopathy. In 15 states, a section of
the naturopathic medical board examinations is on homeopathy.

4.10. Homeopathic Pharmacopoeia of United States(HPUS):

 The HPUS is the legal basis for marketing homeopathic drug products
in the United States and many other countries around the world. The
HPUS is officially recognized in the United States Federal Food Drug
and Cosmetic Act and other United States laws. As such, the HPUS is
considered an Official Compendium and drug substances referenced
therein are officially recognized as drugs. The HPUS has been in
continuous publication and revision since 1897. Originally published
by the American Institute of Homeopathy (AIH).

 Today, the HPUS is published online and is continuously updated by

multiple working committees of the Homeopathic Pharmacopoeia
Convention of the United States(HPCUS). The HPUS publishes
standards for identity, quality, safety, manufacturing and testing.
These standards become the basis of activity within individual
manufacturing facilities and the reference for regulatory inspections.

 Drug Good Manufacturing Practices require that all facilities of

manufacturing homeopathic drugs have access to the HPUS and
reference its standards within manufacturing and testing procedures.
All American Association of Homeopathic products (AAHP) members
are required to maintain a subscription to the HPUS. The importance
of the HPUS cannot be overstated for homeopathic manufacturing and
marketing organizations.

4.11. Marketing of homeopathy in America:

The Americas can hold the largest market share till 2023 due to awareness
and its use in treatment of diseases. The sale of prescription drugs and
dietary supplements is a multibillion dollar business in the United States.
While sales of homeopathic drug products are atleast an order of magnitude
smaller, they are among the top 10 best selling non-prescription drugs in
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the speciality analgesics, oral analgesics for children, and cough-cold-flu

categories in the United States out of several hundred products currently
tracked. Industry estimates suggest sales of homeopathic drugs in the
United States in 2003 of between $300 million and $450 milllion, with a
compound average growth rate of approximately 8% per year. Recent data
from National Health Survey(NHS) indicate that 74.6% of Americans have
used CAM as the Centers for Disease Control and Prevention (CDC) defines
it while 3.6% of Americans have used homeopathy. Indeed, simple
calculation of per capita consumption of $450 million in retail sales by 3.6%
of the population yields an annual consumption level of approximately $60
per person, a relatively high value considering that average retail prices of
homeopathic drugs range from $5 to $9 per retail unit.

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