G'!
[*quote*]
The Washington Post
Democracy Dies in Darkness
To Your Health
FDA takes more aggressive stance toward homeopathic drugsby Laurie McGinley December 18
Scott Gottlieb, commissioner of the Food and Drug Administration, testifies in October at a House hearing on the opioid epidemic.
On Monday, Gottlieb proposed a new, tougher approach to regulating homeopathic drugs. The Food and Drug Administration on Monday proposed a tougher enforcement policy toward homeopathic drugs, saying it would target products posing the greatest safety risks, including those containing potentially harmful ingredients or being marketed for cancer, heart disease and opioid and alcohol addictions.
[*/quote*]
continue reading:
https://www.washingtonpost.com/news/to-your-health/wp/2017/12/18/fda-to-target-homeopathic-drugs-that-pose-safety-risks/https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM589373.pdf[*quote*]
Drug Products
Labeled as
Homeopathic
Guidance for FDA Staff
and Industry
DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this draft document should be submitted within ___ days
of publication in the Federal Register of the notice announcing the availability of the draft
guidance. Submit electronic comments to
https://www.regulations.gov. Submit written
comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the
docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this draft document contact the Center for Drug Evaluation and Research
(CDER) at 301-796-2089 or the Office of Communication, Outreach and Development (CBER),
800-835-4709 or 240-402-8010.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
December 2017
Compliance
Drug Products
Labeled as
Homeopathic
Guidance for FDA Staff
and Industry
Additional copies are available from:
Office of Communications, Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
th10001 New Hampshire Ave., Hillandale Bldg., 4 Floor
Silver Spring, MD 20993-0002
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353
Email: druginfo@fda.hhs.gov
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htmand/or
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 71, Room 3128
Silver Spring, MD 20993-0002
Phone: 800-835-4709 or 240-402-8010
Email: ocod@fda.hhs.gov
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htmU.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
December 2017
Compliance
Contains Nonbinding Recommendations
Draft — Not for Implementation
I.
II.
III.
TABLE OF CONTENTS
INTRODUCTION... 1
BACKGROUND ... 1
A.
Compliance Policy Guide 400.400 ................................................................................... 3
B.
FDA’s Reexamination of its Enforcement Policies ........................................................ 3
C.
FDA’s Risk-based Approach ........................................................................................... 3
FDA’s ENFORCEMENT POLICY ............................................................................................. 4
Contains Nonbinding Recommendations
Draft — Not for Implementation
Drug Products Labeled as
Homeopathic
1
Guidance for FDA Staff and IndustryThis draft guidance, when finalized, will represent the current thinking of the Food and Drug
Administration (FDA or Agency) on this topic. 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. To discuss an alternative approach, contact the FDA staff responsible
for this guidance as listed on the title page.
I.
INTRODUCTION
This draft guidance describes how we intend to prioritize enforcement and regulatory actions for
human drug products2 labeled as homeopathic and marketed in the United States without the
required FDA approval. As discussed below, 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. However, the
Agency also recognizes that many products labeled as homeopathic will fall outside the risk-
based categories described below.
Simultaneous with the issuance of the final guidance, we will withdraw Compliance Policy
Guide (CPG) 400.400, Conditions Under Which Homeopathic Drugs May be Marketed issued on
May 31, 1988.
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
as recommendations, unless specific regulatory or statutory requirements are cited. The use of
the word should in Agency guidances means that something is suggested or recommended, but
not required.
II.
BACKGROUND
Homeopathy is an alternative medical practice that has a historical basis in theory and practice
first systematized in the late 1700s. Homeopathy is generally based on two main principles: (1)
that a substance that causes symptoms in a healthy person can be used in diluted form to treat
1
This guidance has been prepared by the Center for Drug Evaluation and Research in cooperation with the Center
for Biologics Evaluation and Research at the Food and Drug Administration.
2
For the purposes of this guidance, all references to drugs and drug products refer to human drugs, including drugs
that are biological products, regulated by CDER or CBER, unless otherwise specified.
1
Contains Nonbinding Recommendations
Draft — Not for Implementation
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”). Proponents claim that a significantly
diluted aqueous solution, consisting mainly of water molecules, retains therapeutic properties
due to a “memory” of the substance diluted in it. Historically, homeopathic drugs have been
identified through “provings,” in which substances are administered to healthy volunteers in
concentrations that provoke overt symptoms. Symptoms experienced by volunteers are recorded
to indicate possible therapeutic uses for the substances. In other words, if a substance elicits a
particular symptom, individuals experiencing that symptom would be treated with a diluted
solution made from that substance.
In 1938, when the Federal Food, Drug, and Cosmetic Act (FD&C Act) was enacted, the bill’s
senatorial sponsor, Dr. Royal Copeland, himself a homeopathic practitioner, added a provision to
the law recognizing the Homeopathic Pharmacopoeia of the United States (HPUS) alongside its
3counterparts, the U.S. Pharmacopeia and the National Formulary. Recent years have seen an
increase in the sale of products labeled as homeopathic. In the past, these products were mostly
prepared by homeopathic physicians for individual patients. Today they are frequently mass
manufactured and widely marketed as over-the-counter (OTC) products.
The definition of “drug” in section 201(g)(1) of the FD&C Act (21 U.S.C. 321(g)) includes
articles recognized in the HPUS or any of its supplements. 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 as safe and
effective (GRAS/E) by qualified experts for use under the conditions prescribed, recommended,
or suggested in the labeling (section 201(p) of the FD&C Act) (21 U.S.C. 321(p)). FDA makes
4GRAS/E determinations for OTC drugs marketed under the OTC Drug Review. The 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, 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 filed
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.
The FDA’s evidence-based systems for the review of drugs under new drug applications
(NDAs), biologics license applications (BLAs), and the OTC Drug Review play an essential role
5in ensuring that drugs are both safe and effective. Drugs marketed without required FDA
approval may not meet modern standards for safety, effectiveness, quality, and labeling. The
3
Section 201(g)(1) of the FD&C Act.
4
See 21 CFR part 330.
5
For instance, during the new drug application approval process the applicant must demonstrate that its
manufacturing processes can reliably produce drug products of expected identity, strength, quality, and purity. 21
CFR 314.50(d)(1)(ii)(a).
2
Contains Nonbinding Recommendations
Draft — Not for Implementation
continued marketing of products that have neither been approved by FDA nor found to be
GRAS/E is a public health concern.
A.
Compliance Policy Guide 400.400
In May 1988, the Center for Drug Evaluation and Research issued Compliance Policy Guide
400.400 entitled “Conditions Under Which Homeopathic Drugs May be Marketed.” As stated in
the 1988 CPG, it delineates the conditions, including ones regarding ingredients, labeling,
prescription status, and current good manufacturing practice, under which homeopathic drug
products may ordinarily be marketed.
B.
FDA’s Reexamination of its Enforcement Policies
In light of the growth of the industry and passage of more than 2 decades since the issuance of
the 1988 CPG, FDA announced on March 27, 2015, that it was evaluating its regulatory
framework for these products.6 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,
7as well as the Agency’s regulatory framework for such products. 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 information obtained as a result of the public hearing, 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 without the
required FDA approval, consistent with FDA’s risk-based regulatory approaches generally.
C.
FDA’s Risk-based Approach
In many instances, FDA uses a risk-based approach to carry out its mandates. For
example, FDA has generally employed a risk-based enforcement approach with respect to
8marketed unapproved new drugs. The Agency historically has prioritized compliance
actions involving unapproved new drug products that have potential safety risks, lack
evidence of effectiveness, are health fraud products, present challenges to the new drug
approval or OTC drug monograph systems under the OTC Drug Review, are violative of
the FD&C Act in other ways, or that are reformulated to evade an FDA enforcement
action.
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 below.
6
80 FR 16327, Homeopathic Product Regulation: Evaluating the Food and Drug Administration’s Regulatory
Framework After a Quarter-Century.
7
Docket No. FDA-2015-N-0540; available at
https://www.regulations.gov/docket?D=FDA-2015-N-0540.
8
See Marketed Unapproved Drugs - Compliance Policy Guide, Section 440.100, September 19, 2011. We update
guidances periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs
guidance web page at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
3
Contains Nonbinding Recommendations
Draft — Not for Implementation
III.
FDA’s ENFORCEMENT POLICY
The issuance of this guidance, when finalized, is intended to provide notice that any product
labeled as homeopathic that is being marketed illegally is subject to FDA enforcement action at
any time. FDA is not required, and generally does not expect, to give special notice that a drug
product may be subject to enforcement action. However, in the listing that follows, we clarify
our approach to prioritizing our enforcement actions with regard to drug products labeled as
homeopathic and marketed in the United States without the required FDA approval.
Enforcement and Regulatory Priorities
In developing a risk-based approach, FDA has identified certain categories of drug products
labeled as homeopathic and marketed without the required FDA approval as potentially posing
higher risks to public health. FDA intends to prioritize enforcement and regulatory actions
involving drug products labeled as homeopathic and marketed without the required FDA
approval in the following categories:
•
Products with reported safety concerns. For example, MedWatch reports or other
information submitted to the Agency can indicate or signal a potential association
between the product and an adverse event, medication errors, or other safety issues.
•
Products that contain or purport to contain ingredients associated with potentially
significant safety concerns. For example, potentially significant safety concerns are
raised by products that contain or purport to contain:
o An infectious agent with the potential to be pathogenic;
o A controlled substance, as defined in the Controlled Substances Act, 21 U.S.C.
812;
o Multiple ingredients that, when used in combination, raise safety concerns due to
possible interactions, synergistic effects, or additive effects of the various
ingredients; and,
o Ingredients that pose potential toxic effects, particularly when those ingredients
are concentrated or in low dilution presentations (e.g., 1X, 2X, or 1C), or are not
adequately controlled in the manufacturing process.
•
Products for routes of administration other than oral and topical. For example,
unapproved injectable drug products and unapproved ophthalmic drug products pose a
greater risk of harm to users due to their routes of administration (e.g., bypassing some of
the body’s natural defenses, differences in absorption) and the potential risk of harm from
contamination.
•
Products intended to be used for the prevention or treatment of serious and/or life-
threatening diseases and conditions. Unapproved products for serious and/or life-
threatening diseases and conditions raise public health concerns, in part, because they
may cause users to delay or discontinue medical treatments that have been found safe and
4
Contains Nonbinding Recommendations
Draft — Not for Implementation
effective through the NDA or BLA approval processes.
•
Products for vulnerable populations. For example, patient populations such as
immunocompromised individuals, infants and children, the elderly, and pregnant women
may be at greater risk for adverse reactions associated with a drug product, even if it
contains only small amounts of an ingredient, due to their varying ability to absorb,
metabolize, distribute, or excrete the product or its metabolites. These populations may
also be at greater risk of harm as a result of foregoing the use of medical treatments that
have been found safe and effective through the NDA or BLA approval processes or under
the OTC Drug Review.
•
Products deemed adulterated under section 501 of the FD&C Act. For example, if a
product purports to be or is represented as a product recognized in an official
compendium but its strength, quality, or purity differs from the standards set forth in that
official compendium (defined by 21 U.S.C. 321 as the official United States
Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, official
National Formulary, or any supplement to any of them), or if there are significant
violations of current good manufacturing practice requirements.
5
[*/quote*]
[killed typo, Yulli]
