Historical Review | Homeopathic Drug Regulation

By Laura Held & Holly Sullivan, J.D.

Background

The estimated $1.2 billion dollar homeopathic drug industry in America supports small businesses, creates substantial job opportunities, and provides individuals with access to safe, effective, nontoxic, and affordable homeopathic drugs to restore and maintain one’s health. Homeopathic medicine is a complete system of medicine used by nearly 250,000 physicians and over 500 million people worldwide. Substantially different from pharmaceutical drugs in nature, ingredients, and formulation, homeopathic drugs are specially prepared dilutions made from commonly available substances and have been used safely for over 200 years.

A key aspect of sound homeopathic drug regulation is the understanding that without pharmacological activity as seen in pharmaceutical drugs, homeopathic drugs made in accordance with the standards for strength, quality, and purity have a unique and unchanging safety profile without concerns for toxicity.

From 1938 until 2017, the FDA appropriately treated homeopathic drugs and pharmaceutical drugs as unique and separate areas of regulation as set forth in the Food, Drug, and Cosmetic Act of 1938 (FD&C Act) which recognizes as official the drugs and standards in the Homeopathic Pharmacopeia of the United States (HPUS) and its supplements. With the FDA’s recent 2017 draft guidance on drug products labeled as homeopathic (slightly revised in 2019), the agency reversed its policy and threw the entire industry into upheaval without any direction as to how homeopathic products can legally be marketed and remain accessible to consumers who depend on them. 

Americans for Homeopathic Choice (AFHC) is a consumer advocacy group which formed to assist the FDA and foster inclusion of the consumer voice in policy decisions on homeopathic medicine. AFHC is concerned about this substantial policy change because it significantly impacts the individual’s right to access health care. 

Below is a review of the FDA’s 80-year treatment of homeopathic drugs that has been in keeping with the framework and intent established by Congress with the FD&C Act of 1938 and continued through today—regulating homeopathic drugs as unique and separate. 

Overview of Historical Treatment of Homeopathic Drugs

  • From 1938 until 2017, the FDA appropriately treated homeopathic drugs and pharmaceutical drugs as unique and separate areas of regulation as set forth in the FD&C Act which recognizes as official the drugs and standards in the HPUS and its supplements. Some examples include:
    • The FDA excluded homeopathic drugs from the 1967 Prescription Drug Review Drug Efficacy Study Implementation (DESI), a program begun by the FDA in 1966 to fulfill the requirement in the 1962 Kefauver-Harris  Amendments that all drugs have substantial evidence of efficacy as well as proof of safety.
  • In 1972, homeopathic drugs were exempted by the FDA from the Over-the-Counter Drug Review: 

“Because of the uniqueness of homeopathic medicine, the Commissioner has decided to exclude homeopathic drugs from this OTC drug review.”[1]

  • In 1978, homeopathic drugs were exempted from expiration dating requirements in a final FDA rule:

The Commissioner notes that homeopathic medicine and drugs used for homeotherapeutics are unique and differ substantially from other forms of pharmaceutical productsthe fact that factors such as potency, absorption, bioavailability and other measures of effectiveness do not appear to be applicable to homeopathic drugs, have convinced the Commissioner that requiring an expiration date for such products would be a burdensome requirement that would not result in any added assurance of drug quality to the user. [2]

  • In 1983, the FDA finalized an amendment to a proposed regulation, applying certain good manufacturing practice rules to drugs, saying that: 

…the Agency believes that the quality controls required by the other portions of the CGMP regulations and the requirements of “The Homeopathic Pharmacopoeia of the United States” are sufficient to ensure the quality of homeopathic drug products. [3]

  • In May 1988, following the principle that homeopathic drugs are unique and to be regulated as separate from the NDA process, the Center for Drug Evaluation and Research (CDER) issued Compliance Policy Guide (CPG) 400.400 entitled “Conditions Under Which Homeopathic Drugs May be Marketed,” in accordance with the law and affirming FDA policy. The 1988 CPG “delineate[d] those conditions under which homeopathic drug products may ordinarily be marketed,” including conditions regarding ingredients, labeling, prescription status, and CGMP. [4] FDA regulated homeopathic drugs in accordance with CPG 400.400 until 2019.
  • In the December 1988-January 1989 issue of FDA Consumer, the agency clarified the legal requirements for homeopathic drugs and stated the following:

These substances are exempt from the requirement of the Federal Food, Drug, and Cosmetic Act that drugs must be proven safe and effective before they can be marketed. They are, however, subject to other requirements of the law and must meet the following guidelines…[5]

  • In 1995, the FDA stated the following in response to a comment in the promulgation of the regulation entitled “Over-the-Counter Drug Products Intended for Oral Ingestion that Contain Alcohol”:

“While homeopathic drugs are neither regulated under the monograph system nor subject to NDA’s, they are still regulated as drugs under the act.” [6]

  • Since the passage of the FD&C Act in 1938, Congress has consistently recognized homeopathic drugs as distinct from pharmaceutical products including two examples from the last decade. In the case of MediNatura vs. FDA (a homeopathic drug manufacturer blocked from importing homeopathic products under the FDA’s 2019 draft guidance), Judge Randolph D. Moss of the United States Federal District Court of the District of Columbia restated these Congressional recognitions in his October 23, 2020 memorandum opinion and order:[7]
    • “When Congress enacted new requirements for tracking prescription drugs through the supply chain as part of the Drug Quality and Security Act in 2013, for instance, it exempted homeopathic prescription drugs from those provisions by excluding from the definition of ‘product’ any ‘homeopathic drugs marketed in accordance with applicable guidance under this chapter.’”
    • The 2020 CARES Act exempts homeopathic drugs from review under its provisions. Judge Moss writes: “Likewise, when amending the OTC Drug Review program in the CARES Act, Congress exempted from its new regulatory scheme ‘any nonprescription drug . . . which was excluded by the Food and Drug Administration from the Over-the-Counter Drug Review in accordance with the paragraph numbered 25 on page 9466 of volume 37 of the Federal Register, published on May 11, 1972.’” The full reference is as follows: Coronavirus Aid, Relief, and Economic Security Act, Pub. L. No. 116-136, § 3853, 134 Stat. 281, 454 (2020).

1938 Food, Drug, and Cosmetic Act

  • The FD&C Act recognizes as official the drugs and standards in the HPUS and its supplements. [8]

Whenever a drug is recognized in both the United States Pharmacopoeia and the Homoeopathic Pharmacopoeia of the United States it shall be subject to the requirements of the United States Pharmacopoeia unless it is labeled and offered for sale as a homoeopathic drug, in which case it shall be subject to the provisions of the Homoeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia. [9]

  • Congress defined drugs to include: 

articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them.” [10]

  • Congress also added a separate “new drug” definition along with new drug application (NDA) requirements in direct response to a tragedy involving the drug Elixir Sulfanilamide. The application required that the applicant provide full reports of investigations to show the drug was safe for use. [11]
    • Under the definition of a new drug, “a ‘drug’ is a ‘new drug’ if it is not generally recognized as safe [or effective] or one for which no new drug application is in effect. The exception for drugs recognized as safe and effective from this definition, eliminates the necessity of official evaluation of a product from which there is no reasonable possibility of danger.”[12]
  • Due to the unique safety profile of homeopathic drugs, the FD&C Act exempted them from NDA requirements. [13]

1962 Kefauver-Harris Amendments

  • In 1962, Congress passed the Kefauver-Harris Amendments which added a proof of efficacy requirement to the NDA. A new drug must now be shown to be both safe and effective (previously only safety review was required) and additional controlled tests and trials are necessary as substantial evidence before a new drug can enter the market. [14] 
  • Similar to 1938, these amendments were Congress’ response to a dangerous drug tragedy—this time, the thalidomide tragedy where thousands of children were born with severely disabling birth defects. [15]
  • When considering the inclusion of homeopathic drugs in the new NDA requirements, “homeopathic drugs would have to be evaluated for efficacy by homeopathic experts according to homeopathic standards” in adherence with the recognition of the HPUS in the FD&C Act.  [16] The new NDA would create a second and unnecessary review process for homeopathic drugs. 
  • Additionally, the NDA process, designed to regulate novel, potentially dangerous drugs containing pharmacologically active chemicals, is not appropriate for homeopathic drugs for the following reasons:
    • Unique system of medicine: Homeopathic drugs are part of a system of medicine different from the system that includes pharmaceutical drugs. Where conventional medical practitioners might diagnose ten people with the same condition and prescribe exactly the same medicine, a homeopathic practitioner would consider each individual’s unique collection of symptoms. This often results in a different medicine recommended for ten people with the same underlying condition (as it would be diagnosed by a conventional practitioner). An NDA seeks to determine whether a drug is safe and effective in its proposed use(s), in other words, for common diagnoses across large groups of people. Therefore, the NDA is not an appropriate tool to evaluate homeopathic medicines which practitioners choose, not based on a conventional diagnosis, but based on the individual’s unique collection of symptoms and overall physical and mental state.
    • Unique safety profile: Without pharmacological activity as seen in pharmaceutical drugs, homeopathic drugs made in accordance with the standards for strength, quality, and purity have a unique and unchanging safety profile without concerns for toxicity.
    • Financial investment: The expanded NDAs required by the 1962 amendments set forth an expensive process of controlled safety and efficacy studies.  As of 2018, drug trial costs for FDA approval have an estimated median cost of $19 million—just less than 1% of the estimated $2 to $3 billion average total cost of developing a new drug. [17] This financial investment does not make sense for products formulated using commonly available substances such as onion, aloe, elderberry, black tea, and coffee that cannot be patented.
  • Considering all of these factors, the exemption from NDA requirements for homeopathic drugs remained intact with the 1962 amendments. [18]

Legal Framework for Homeopathic Drugs

  • For 80 years consumers, practitioners, and homeopathic drug manufacturers have relied on a legal framework which outlines the requirements for manufacturing homeopathic drug products in accordance with standards that ensure safety and quality. This framework:
    • provides the agency with the standards by which to regulate homeopathic drugs as a separate and unique category.
    • provides manufacturers with a clear pathway to market their products.
    • protects consumers from products that are adulterated, misbranded, or improperly labeled as homeopathic.
    • ensures consumers and practitioners access to products which meet homeopathic standards for quality, purity, and dilution.
  • With the passage of the 1938 FD&C Act, the FDA supported including the HPUS and its supplements in the Act to give it the tools to regulate homeopathic drugs as a unique and separate category of drugs. [19] The Act provides the FDA with the authority to enforce standards that separate and safeguard legitimate homeopathic products while permitting swift action against products that are adulterated, misbranded, or improperly labeled as homeopathic. Within this framework the FDA is able to ensure both consumer access and safety.
  • The FDA reiterated this legal distinction in a 1988 Talk Paper which states the following:

the law gives FDA no pre-market review of true homeopathic dilutions, [and the authors of the Food, Drug, and Cosmetic Act] wrote into the law a recognition of any product listed in the Homeopathic Pharmacopeia of the United States. This exempted homeopathic products from safety review, but that was of little concern at the dilutions being used. The 1962 drug amendments left the homeopathic exemption intact, so that while regular drugs are scientifically tested and reviewed for safety and effectiveness, homeopathic products are checked for neither. [20]

  • While homeopathic drugs are not reviewed according to the requirements of the NDA due to the recognition of HPUS in the FD&C Act, they are individually evaluated for safety and effectiveness according to a scientifically sound process before being listed as an official drug in the HPUS.
  • As with any drug manufacturer, the FDA inspects homeopathic production facilities to ensure that CGMP and labeling standards are met in accordance with FDA regulations and as required by the FD&C Act.

FDA Draft Guidance on Drug Products Labeled as Homeopathic

  • In 2017, the FDA issued a draft guidance on drug products labeled as homeopathic which outlines enforcement priorities based on its risk-based approach.
  • The guidance reverses course on the 80-year legal framework for homeopathic drugs. Not only does the guidance disregard the distinction in the law between homeopathic and pharmaceutical drugs, but it also fails to make the critical distinction between products which meet homeopathic standards and those which may be adulterated, misbranded, or improperly labeled as homeopathic. The guidance states the following:

Absent a determination that a homeopathic drug product is not a “new drug” under section 201(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. [21]

  • Both of these above distinctions are paramount to a sound regulatory framework that protects the public from potential harm when products do not meet homeopathic standards while ensuring continued access to the full range of safe, effective, nontoxic, and affordable homeopathic medicines.
  • A thorough assessment and understanding of homeopathic manufacturing shows that ONLY those products that violate homeopathic standards and which thus cannot legitimately be labeled as homeopathic pose a potential risk to public health.
  • However, according to the guidance, ALL products labeled as homeopathic—properly manufactured and labeled or not—are to be treated as “unapproved new drugs” and subject to the NDA requirements or removal from the market at any time without notice. [22]
  • In other words, the products of FDA-registered manufacturers who comply with standards for quality, purity, and proper dilution are subject to removal from the market despite 80 years of a legal framework that allowed homeopathic manufacturers to legally market their products—products which are nontoxic by their very nature when made according to those standards.
  • Additionally, the draft guidance lacks direction on how to properly produce and market homeopathic products, inviting unscrupulous operators into the marketplace.
  • The FDA has a crucial role in protecting public health and ensuring that products which do not meet homeopathic standards are not labeled as homeopathic and are subject to enforcement action. However, the draft guidance does not outline conditions under which homeopathic drugs may be marketed, only how to take enforcement action against these “unapproved new drugs.” This raises serious concerns about the future stability of the market and the quality and availability of homeopathic drug products.
  • The actions as outlined in the draft guidance treating all homeopathic drug products as “unapproved new drugs” fall outside of the purview of drug regulation as set forth in the FD&C Act.
  • AFHC’s goal is to work with Congress and the FDA to restate the longstanding, clear distinction in the law between homeopathic and pharmaceutical drugs and to guide FDA enforcement policies to distinguish between products which meet homeopathic standards and those which may be adulterated, misbranded, or improperly labeled as homeopathic. This will ensure continued access to homeopathic medicine, an essential component of health care for a growing number of individuals.

 

[1] 37 FR 9466 (May 11, 1972).
[2] 43 FR 45058 (September 29, 1978).
[3] 48 FR 14004 (April 1, 1983).
[4] See Conditions Under Which Homeopathic Drugs May be Marketed – Compliance Policy Guide, Section 400.400; available at https://web.archive.org/web/20191020010940/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-400400-conditions-under-which-homeopathic-drugs-may-be-marketed
[5] 22 FDA Consumer 5 (December 1988-January 1989).
[6] 60 FR 13590 (March 13, 1995).
[7]  MediNatura, Inc. v. FDA, 496 F. Supp. 3d 416 (D.D.C. 2020).
[8] Sections 201(g)(1) and 501(b) of the FD&C Act.
[9]Section 501(b) of the FD&C Act.
[10] Section 201(g)(1) of the FD&C Act.
[11] Junod, Suzanne White, An Alternate Perspective: Homeopathic Drugs, Royal Copeland, and Federal Drug Regulation, 55 Food and Drug L.J. 161, 176 (2000).
[12] Weitzman, Stephen,  Drug, Device, Cosmetic?—Part I, 24 Food, Drug, Cosmetic L.J. 226, 248 (1969).
[13] Food and Drug Admin., Talk Paper No. T-88-68 (Sept. 15, 1988).
[14] Public Law 87-781, October 10, 1962.
[15] Hutt, Peter Barton and Robert Temple, Commemorating the 50th Anniversary of the Drug Amendments of 1962, 68 Food and Drug L.J. 449, 451 (2013).
[16] Junod, Suzanne White, An Alternate Perspective: Homeopathic Drugs, Royal Copeland, and Federal Drug Regulation, 55 Food and Drug L.J. 161, 177 (2000).
[17] Johns Hopkins, Bloomberg School of Public Health, News Release, September 24, 2018.
[18] Food and Drug Admin., Talk Paper No. T-88-68 (Sept. 15, 1988).
[19] Junod, Suzanne White, An Alternate Perspective: Homeopathic Drugs, Royal Copeland, and Federal Drug Regulation, 55 Food and Drug L.J. 161 (2000).
[20] Food and Drug Admin., Talk Paper No. T-88-68 (Sept. 15, 1988).
[21] Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry, Draft Guidance, October 2019 (lines 78-81).
[22] Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry, Draft Guidance, October 2019.

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