[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Notices]
[Pages 57439-57441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23334]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-4611]
Compliance Policy Guide Sec. 400.400 Conditions Under Which
Homeopathic Drugs May Be Marketed; Withdrawal of Guidance
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; withdrawal.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the withdrawal of Compliance Policy Guide Sec. 400.400 (CPG 400.400)
entitled ``Conditions Under Which Homeopathic Drugs May be Marketed,''
which was issued in 1988.
DATES: The withdrawal is applicable October 25, 2019.
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.
[[Page 57440]]
SUPPLEMENTARY INFORMATION: FDA is withdrawing CPG 400.400, entitled
``Conditions Under Which Homeopathic Drugs May be Marketed,'' which was
issued in 1988. CPG 400.400 described an enforcement policy regarding
homeopathic drug products.
Under section 505(a) of the Federal Food, Drug, and Cosmetic Act
(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. The requirements in
section 505 of the FD&C Act apply to biological products regulated
under section 351 of the Public Health Service Act (PHS Act) (42 U.S.C.
262); however, as stated in section 351(j) of the PHS Act, a biological
product with an approved license under section 351(a) of the PHS Act is
not required to have an approved application under section 505 of the
FD&C Act. Accordingly, absent a determination that a homeopathic drug
product is not a ``new drug'' under section 201(p) of the FD&C Act (21
U.S.C. 321(p)), all homeopathic drug products are subject to the
premarket approval requirements in section 505 of the FD&C Act or
section 351 of the PHS Act. There are currently no homeopathic drug
products approved by FDA.
Since the issuance of CPG 400.400, the Agency has encountered
multiple situations in which homeopathic drug products posed a
significant risk to patients. There is a broad misconception that all
homeopathic products are highly diluted and generally composed of
``natural'' ingredients, and that they are therefore incapable of
causing harm. However, as with all drugs, the safety of homeopathic
drugs depends upon many factors, such as the product's intended use,
dosage form, frequency of use, manufacturing quality, intended patient
population, and the quantity and combination of ingredients. CPG
400.400 does not directly address all these important considerations.
For example, FDA has encountered situations in which homeopathic
products either caused or could have caused significant harm, even
though the products, as labeled, appeared to meet the conditions
described in CPG 400.400. In 2016, FDA's search of the FDA Adverse
Event Reporting System database identified 99 cases of adverse events
consistent with belladonna toxicity, including reports of infant deaths
and seizures, possibly related to teething products. Multiple
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. As another example, by 2009,
FDA had received more than 130 reports of anosmia (loss of the sense of
smell) associated with the use of Zicam homeopathic intranasal zinc
products. FDA determined that if the products were used as labeled, a
user would receive significant daily intranasal exposure to zinc,
raising a serious safety concern. These are only two examples among
many. FDA has also, for example, documented many serious violations of
current good manufacturing practice (CGMP) requirements by
manufacturers of homeopathic drug products, raising significant
concerns about the safety of the products made with inadequate process
controls.
The homeopathic drug industry has grown significantly since FDA
issued CPG 400.400 in 1988. According to the National Health Interview
Survey, conducted by the Centers for Disease Control and Prevention's
National Center for Health Statistics, between 2007 and 2012 the use of
homeopathic products increased by approximately 15 percent in U.S.
adults. This growth, and the increased population exposure that it
apparently represents, has contributed to FDA's enhanced focus on the
safety of homeopathic drugs in recent years and the evaluation of the
CPG, which was issued over three decades ago.
In light of the growth of the industry and passage of time 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 (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 homeopathic drug products
to better promote and protect the public health. On December 18, 2017,
FDA issued a draft guidance entitled ``Drug Products Labeled as
Homeopathic; Guidance for FDA Staff and Industry.'' The draft guidance
detailed a risk-based enforcement policy, prioritizing enforcement and
regulatory actions for certain categories of homeopathic products that
potentially pose higher risk to public health.
In response to comments received, we have revised the draft
guidance and are announcing the reissue of it elsewhere in this issue
of the Federal Register to enable the public to review and comment
before it is finalized. In particular, we have added a definition of
``homeopathic drug product'' for purposes of the guidance, added an
additional explanation of some of the safety issues that contributed to
the development of the draft guidance, and clarified the intent to use
risk-based factors to prioritize enforcement and regulatory actions
involving homeopathic products that are marketed without required FDA
approval. In addition, the revised draft guidance removes the statement
that the Agency will withdraw the CPG simultaneous with the issuance of
the final guidance.
As a result of the Agency's ongoing evaluation of its regulatory
framework, including consideration of the public input received on this
issue and the recent growth of safety concerns associated with
homeopathic drug products, FDA believes that it is appropriate to
withdraw CPG 400.400 at this time, rather than waiting for the issuance
of the final guidance. Because CPG 400.400 is inconsistent with the
Agency's risk-based approach to enforcement generally, it does not
accurately reflect the Agency's current thinking. When the draft
guidance is finalized, it will specify the categories of products that
the Agency intends to prioritize for enforcement. In the interim,
before the draft guidance is finalized, FDA intends to apply its
general approach to prioritizing regulatory and enforcement action,
which involves risk-based prioritization in light of all the facts of a
given circumstance. Risk-based enforcement best reflects FDA's public
health priorities.
We note that withdrawing the CPG does not represent a change in the
legal obligations that apply to homeopathic drugs under the statutes
FDA administers. The definition of a ``drug'' under section
201(g)(1)(A) through (C) of the FD&C Act includes: (1) Articles
recognized in the official United States Pharmacopoeia or the official
Homoeopathic Pharmacopoeia of the United States; (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. As such, homeopathic drugs are subject to the same
regulatory requirements as other drugs; nothing in the FD&C Act exempts
homeopathic drug products from any of the requirements in the FD&C Act,
including those related to approval, adulteration, and misbranding.
[[Page 57441]]
Generally, a drug, including a homeopathic drug, is considered a
``new drug'' if it is not generally recognized as safe and effective by
qualified experts for use under the conditions prescribed, recommended,
or suggested in the labeling (section 201(p) of the FD&C Act). CPG
400.400 did not, and legally could not, provide a path for legal
marketing of unapproved new drugs, including those that are
homeopathic. Rather, the CPG merely described an enforcement policy
regarding homeopathic drug products. The Agency does not have authority
to exempt a product or class of products that are new drugs under the
FD&C Act from the new drug approval requirements of the FD&C Act. (See
Cutler v. Kennedy, 475 F. Supp. 838, 856 (D.D.C. 1979); Hoffman-LaRoche
v. Weinberger, 425 F. Supp. 890, 892-894 (D.D.C. 1975). See also Util.
Air Regulatory Grp. v. EPA, 573 U.S. 302, 327 (2014) (``An agency
confronting resource constraints may change its own conduct, but it
cannot change the law.'')).
The Agency's interest in its general risk-based enforcement
approach also justifies withdrawing an outdated policy that does not
reflect that approach. Additionally, withdrawal of the CPG is
appropriate given the recent growth of safety concerns associated with
homeopathic drug products--including concerns regarding products
associated with serious adverse events and otherwise presenting
significant safety risks and serious violations of CGMP requirements--
and the increasing number of consumer exposures due to the continued
expansion of the homeopathic industry since issuance of the CPG.
Dated: October 22, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23334 Filed 10-24-19; 8:45 am]
BILLING CODE 4164-01-P