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Historical Timeline Review | Homeopathic Drug Regulation

By Laura Held, Holly Sullivan, Esq., and Page Pulliam, Esq.

Background

The estimated $3 billion-dollar homeopathic product industry in America supports small businesses, creates substantial job opportunities, and provides individuals with access to safe, 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.[1]

A sound homeopathic drug regulation framework would reflect the uniqueness of this category of drugs which are part of a system of medicine that is fundamentally different from that of pharmaceutical drugs. Substantially different in function, ingredients, formulation, and intended purposes, homeopathic medicines are specially prepared dilutions made from natural substances, are primarily available over the counter, and have been used safely for over 200 years in the U.S. and around the world. Homeopathic products prepared in accordance with the fundamental principles of the homeopathic pharmacy have a unique and unchanging safety profile without concern for toxicity.

Congress enshrined the right to choose homeopathic medicines in the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act or the Act). The definition of a drug in the FD&C Act expressly distinguishes medicines in the Homoeopathic Pharmacopoeia of the United States (HPUS) and its supplements,[2] the official compendium of standards and monographs for homeopathic drug ingredients, from pharmaceutical drugs in the official United States Pharmacopeia and the official National Formulary.[3] The FD&C Act thus recognizes that homeopathic medicines constitute a unique and separate category of drugs.

However, after over 80 years of regulating the legal sale of homeopathic medicines in the United States, the FDA now interprets the law to say that all homeopathic products are “unapproved new drugs” that are “marketed illegally” and can be removed from the market at will[4]—attempting to categorically alter the legal status of homeopathic products. This has created regulatory and legal chaos, is severely affecting the viability of companies and, of greatest concern, is eliminating access to affordable medicines that Americans rely on.

The FDA historically recognized homeopathic medicines as a unique and separate category of drugs as set forth in the FD&C Act. The agency’s policy decisions and enforcement activities were guided by its longstanding interpretation of the law that “while homeopathic drugs are neither regulated under the monograph system nor subject to [premarket approval via] NDA’s, they are still regulated as drugs under the act.”[5]

Now, the FDA asserts that homeopathic products are “unapproved new drugs” subject to premarket approval and the agency no longer recognizes the unique nature and safety profile of homeopathic medicines in its application of drug requirements and standards. Even as the demand for homeopathic medicine continues to expand by 12 to 18 percent per year,[6] the agency has increasingly relied on guidance documents and the application of pharmaceutical-specific requirements and standards to direct its enforcement activity. Nothing, other than growing consumer interest in homeopathic medicines, has changed. In fact, properly prepared homeopathic medicines have an unchallenged safety record with long-established processes for manufacture and two centuries of continuous use by consumers and physicians.

As a result of the FDA’s new position, homeopathic medicines have been deprived of a defined regulatory path to market, although it cannot have been Congress’s intent to prevent their legal distribution. The FDA’s responses to Congressional letters and informal inquiries, Citizen Petitions, and FOIA requests have made it clear what the agency’s new position means: The FDA needs Congress to define a distinct legal pathway for homeopathic medicines.

Americans for Homeopathy Choice Action (AFHC-A) is a consumer advocacy group seeking legislation to restore consumer access to the full range of safe homeopathic medicines. The current regulatory environment for homeopathic medicines significantly threatens the right of all Americans to access these medicines as one of their health care options.

The FDA has recognized the unique nature of homeopathic medicines throughout the history of drug regulation as set forth by Congress in the FD&C Act—until now. We seek to restore and preserve this recognition to ensure access to the full range of homeopathic medicines, an essential component of health care for a growing number of individuals and families.

Below is a timeline that reviews the historical treatment of homeopathic medicines as a separate and unique category of drugs before the FDA’s new interpretation of the law.

Review of the Historical Treatment of Homeopathic Drugs

1938 Food, Drug, and Cosmetic Act

  • The FD&C Act recognizes as official the drugs and standards in the HPUS and its supplements.[7]
    • Congress distinguishes medicines in the HPUS from other drugs in the definition of a drug: [8]
      • “…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.”
    • Congress also distinguishes the standards for homeopathic drugs as set forth in the HPUS: [9]
      • “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 homeopathic 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.”
      • “Such determination as to [the official compendium standard of] strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium…”
    • In the wake of the Elixir Sulfanilamide drug tragedy of the 1930’s, Congress included a separate “new drug” definition along with the New Drug Application (NDA) requirement to the Act.[10] The law required new drugs be tested for safety before marketing, the results of which would be submitted to the FDA in the application.[11] At the time, no homeopathic medicines were considered new drugs or unsafe, so the agency “virtually ignored homeopathy,”[12] eliminating the necessity of official evaluation of a product from which there is no reasonable possibility of danger.[13]

1951 Durham-Humphrey Amendment

  • The Durham-Humphrey Amendment enacted in 1951 differentiated between drugs that could only be available by a physician prescription and those available for self-medication. In its response to an inquiry as to whether the Durham-Humphrey Amendment applied to homeopathic medicines, the FDA stated that it did not “directly encompass homeopathic preparations as prescription drugs” but the FDA had no objection to their distribution with the prescription legend (Rx).[14] FDA noted it “would not act against homeopathic products without the prescription legend which are offered to the laity for minor ailments.”[15]

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 a safety review was required)—additional controlled tests and trials are necessary before a new drug can enter the market.[16]
    • Similar to 1938, these amendments were the Congressional response to another dangerous drug tragedy—this time, the thousands of children born with severely disabling birth defects due to Thalidomide.[17]
    • If the NDA process were to apply to homeopathic medicines, “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.[18] Thus, the NDA process would create a second unnecessary and unsuitable review process for homeopathic medicines which have already previously been reviewed in accordance with the provisions of the HPUS.[19]
    • The NDA process, which is designed to regulate novel pharmaceutical drugs containing potentially dangerous pharmacologically active ingredients, was not designed nor intended for homeopathic medicines that are by and large available as over-the-counter (OTC) medicines made from unpatentable, natural substances.
      • Unique system of medicine: Homeopathic medicines are part of a system of medicine different from that of pharmaceutical drugs. A conventional medical practitioner may diagnose 10 people with the same condition, prescribing exactly the same pharmaceutical medicine. By contrast, a homeopathic practitioner considers each individual’s unique expression of symptoms including the physical and mental state; thus, patients with seemingly similar conventional diagnoses may receive different homeopathic medicines.
      • Unique safety profile: Homeopathic medicines prepared in accordance with the fundamental principles of the homeopathic pharmacy have a unique and unchanging safety profile without concern 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, just the drug trial costs for FDA approval have an estimated median cost of $19 million. That substantial amount is a small portion of the cost of developing a new drug which runs from $2 to $3 billion on average.[20] This financial investment is not appropriate for products formulated using naturally occurring, commonly available substances such as onion, aloe, elderberry, black tea, and coffee which cannot be patented. Because homeopathic products cannot be patented, and thereby have no financial protection, the pharmaceutical-specific NDA approval process is an impossibility for homeopathic manufacturers.
    • Based in part on these factors, the exemption from NDA requirements for homeopathic drugs remained intact with the 1962 amendments.[21]
    • When the FDA promulgated NDA regulations for pharmaceutical drugs following the 1962 Amendments, it excluded reference to the HPUS but specifically included reference to the United States Pharmacopeia (USP) and the National Formulary (NF). The USP and NF apply to pharmaceutical drugs, not homeopathic drugs. This adoption of the USP and NF (and exclusion of the HPUS) further verifies that the premarket approval process via the NDA was never intended nor appropriately tailored to homeopathic drugs.[22]
  • In 1967, the FDA excluded homeopathic medicines from the prescription drug review known as the Drug Efficacy Study Implementation (DESI). The FDA began DESI in 1966 to meet the 1962 Kefauver-Harris Amendments requirement that all drugs have substantial evidence of efficacy and proof of safety.[23]

Post-1962 FDA Drug Regulations

  • In response to the 1962 Kefauver-Harris Amendments in which Congress sought to address issues within the pharmaceutical industry, the FDA began issuing new regulations tailored to pharmaceutical drugs.
  • Homeopathic medicines had been appropriately subject to homeopathic-specific standards as set forth in the HPUS to ensure safety and quality. Nothing changed about homeopathic medicines. Yet, in an ad hoc fashion, the FDA began applying these new pharmaceutical-specific regulations to homeopathic products, while at times responding to stakeholder feedback requesting appropriately tailored standards consistent with the FDA’s recognition of the uniqueness of these medicines.
  • In 1972, in response to comments from the American Institute of Homeopathy,[24]homeopathic medicines were exempted by the FDA from the Over-the-Counter (OTC) Drug Review: [25]
    • “Because of the uniqueness of homeopathic medicine, the Commissioner has decided to exclude homeopathic drugs from this OTC drug review.”
  • In 1978, homeopathic drugs were exempted from expiration dating and complete stability testing requirements in a final FDA rule: [26]
    • “The Commissioner notes that homeopathic medicine and drugs used for homeotherapeutics are unique and differ substantially from other forms of pharmaceutical products…Because of the unique nature of homeopathic drugs, the Commissioner has reconsidered the value of stability testing and expiration dating for this small class of drug products and concludes the need for expiration dating and complete stability testing, as proposed, are unnecessary in this group…the 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.”
  • In 1983, the FDA initiated a rulemaking proceeding to amend a Current Good Manufacturing Practice (CGMP) regulation for finished pharmaceuticals to exempt homeopathic medicines from laboratory determination for identity and strength. Although the FDA withdrew the exemption in 2004 after being in place for over 21 years,[27] the agency’s language in the original proceeding reaffirmed the authority of the HPUS as applied to homeopathic medicines and further recognized their uniqueness when it stated the following:[28]
    • “…the agency believes the granting of the petition is entirely consistent with the agency’s prior recognition of homeopathic drug products as unique entities.”
    • “…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.”
    • “In the preamble to the final CGMP regulations, (comment 357, in the Federal Register of September 29, 1978; 43 FR 45058), FDA formally acknowledged the uniqueness of homeopathic drug products. Accordingly, they were exempted from expiration dating and from complete stability testing due to the imprecise nature of measuring extremely low levels of active ingredients in homeopathic drug substances and because such criteria as potency, absorption, bioavailability, and other measures of effectiveness do not appear to apply to homeopathic drug products.”
    • “…the agency believes that this objective can be attained for these drug products by adherence to the other requirements of the CGMP regulations and to the quality and production standards of ‘The Homeopathic Pharmacopoeia of the United States.’ Accordingly, the agency tentatively has concluded that exempting homeopathic drug products from the required testing for identity and strength of their active ingredients will not diminish the overall quality of these drug products.”
  • In 1985, a Federal Register notice included the following comment from an FDA review panel:[29]
    • “The regulations in 601.25 (21 CFR 601.25) make no separate provision for homeopathic drugs. FDA may wish to consider this product differently because it is a homeopathic remedy…”

1978 Proposed Drug Regulation Reform Act

  • In 1978, a bill was introduced in the 95th Congress entitled the “Drug Regulation Reform Act” seeking a large reform package to the FD&C Act.[30] The original bill was never voted on, but when reintroduced in the 96th Congress, the bill passed the Senate.[31] The analysis of the 1978 bill included the following language discussing the proposed exemption of homeopathic medicines from certain requirements:[32]
    • “This subpart provides a special set of requirements for the unique type of drugs used in homeopathic medicine. The theory of drug therapy may be divided into two schools of thought: allopathic and homeopathic. The first teaches that drugs provide their benefits through pharmacological action in the body; that is, that the drug produces a biochemical change that ultimately manifests itself in the therapeutic, preventive, or curative effect sought. Homeopathic medicine, on the other hand, is premised on the theory that drugs also operate at dosages well below those needed to produce a pharmacological effect. The mere presence of the drug is sufficient to disturb the natural balance (or homeostasis) of the body, which will respond on its own to restore the balance.”
    • “Homeopathic drugs present a variety of special questions regarding regulatory objectives and controls.”
    • “[Homeopathic products] are rarely labeled as to their intended purposes; instead the homeopathic effects are described in extensive homeopathic literature.”
    • “The consequence of these facts is that homeopathic drugs have never been fully subjected to the requirements of the current FD&C Act, and should be distinguished from allopathic drugs under the Drug Regulatory Reform Act.”

1988-2019 Compliance Policy Guide (CPG) 400.400

  • In May 1988, the Center for Drug Evaluation and Research (CDER) issued CPG 400.400 entitled “Conditions Under Which Homeopathic Drugs May Be Marketed.” The policy referenced both HPUS standards and pharmaceutical-specific regulations to “delineate those conditions under which homeopathic drug products may ordinarily be marketed,” including conditions regarding ingredients, labeling, prescription status, and CGMP.[33] CDER’s development of a guidance apart from the regulatory pathways designed for pharmaceutical drugs substantiates that the FDA recognized their unique nature AND that they are not subject to the OTC Drug Review or premarket approval.
  • The FDA reiterated the legal distinction between pharmaceutical drugs and homeopathic medicines in a September 1988 Talk Paper: [34]
    • “…the law gives FDA no pre-market review of true homeopathic dilutions, [and the authors of the FD&C 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.”
  • In the December 1988-January 1989 issue of FDA Consumer, the agency clarified the legal requirements for homeopathic medicines: [35]
    • “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…”
  • In 1995, the FDA responded to a comment in the promulgation of the regulation entitled “Over-the-Counter Drug Products Intended for Oral Ingestion that Contain Alcohol”:[36]
    • “While homeopathic drugs are neither regulated under the monograph system nor subject to NDA’s, they are still regulated as drugs under the act.”
  • In the December 1996 issue of FDA Consumer, it was noted that:[37]
    • “FDA regulates homeopathic drugs in several significantly different ways from other drugs. Manufacturers of homeopathic drugs are deferred from submitting new drug applications to FDA. Their products are exempt from good manufacturing practice requirements related to expiration dating and from finished product testing for identity and strength.”
    • In that same issue, FDA’s CDER consumer safety expert, Edward Miracco, was quoted as he explained the difference in how homeopathic drugs are regulated: “‘The reasoning behind [the difference] is that homeopathic products contain little or no active ingredients…From a toxicity, poison-control standpoint, [the active ingredient and strength] was deemed to be unnecessary.’”
    • Miracco further stated: “Overall, the disparate treatment has been primarily based on the uniqueness of homeopathic products, the lack of any real concern over their safety because they have little or no pharmacologically active ingredients…”
  • In 2017, FDA drug center chief, Dr. Janet Woodcock, reiterated the differences Mr. Miracco discussed regarding the safety of homeopathic drugs:[38]
    • “It’s important that homeopathic products can stay within those guardrails of what makes them safe even if they’re not tested in the way that prescription or OTC products might be. They’re safe because they don’t have pharmacological activity in their product … and we’re more or less willing to concede that for many, many years.”
  • In 2019, the FDA rescinded CPG 400.400 which effectively eliminated the de facto regulatory pathway that outlined the conditions for their legal manufacture and marketing.

2013 Drug Quality and Security Act and the 2020 CARES Act

  • In 2020, 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 for the District of Columbia restated two examples from the last decade of Congressional recognition of homeopathic medicines as separate and distinct from pharmaceutical drugs. The following comes from his October 23, 2020 memorandum opinion and order:[39]
    • “When Congress enacted new requirements for tracking prescription drugs through the supply chain as part of the Drug Quality and Security Act [DQSA] 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.’”
    • Judge Moss also cited the 2020 CARES Act’s exemption of homeopathic drugs from the OTC Drug 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.’”
  • In the DQSA, Congress again exempted homeopathic medicines based on their uniqueness and confirmed through the language used in the exemption the requirement that homeopathic medicines be provided a path to legal marketing.
  • In the CARES Act, Congress once again exempted homeopathic medicines when it amended the OTC Drug Review program by codifying the original exclusion from the 1972 OTC Drug Review.[40] In so doing, Congress reaffirmed its original intent from 1938 that homeopathic medicines are a unique and separate category of drugs.

2022 FDA Guidance on Homeopathic Drug Products

  • In 2015, the FDA initiated a rulemaking procedure for addressing the regulatory framework for homeopathic medicines but never completed it. Instead, it issued a draft guidance in 2017 (slightly modified in 2019) outlining enforcement priorities based on its risk-based approach. In 2019, the FDA rescinded CPG 400.400 and then finalized the guidance in December 2022.[41]
  • The 2022 final guidance (“final guidance”) reverses course on the FDA’s decades-long historical recognition of homeopathic medicines as a separate and unique category of drugs. The guidance states: [42]
    • “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.”
  • After over 80 years of regulating the legal sale of homeopathic medicines in the United States, the FDA now interprets the law to say that all homeopathic products are “unapproved new drugs” that are “marketed illegally” and can be removed from the market at will—attempting to categorically alter the legal status of homeopathic products.
    • The final guidance disregards the long-established legal distinction between homeopathic medicines and pharmaceutical drugs.
    • This substantial policy change was not handled pursuant to the rulemaking requirements of the Administrative Procedure Act, which are intended to safeguard public participation in the administrative process.
    • o Products manufactured or distributed by FDA-inspected companies that comply with existing manufacturing and labeling standards are now subject to arbitrary removal from the market. Despite the 80-plus year history during which homeopathic companies legally marketed their products, the agency now removes products without citing evidence that properly prepared homeopathic medicines pose a safety risk.
  • This means the FDA has eliminated its longstanding regulatory pathway for homeopathic products with the rescission of CPG 400.400 and no longer recognizes the unique nature of homeopathic medicines in its application of drug requirements and standards.
  • The FDA now contends that the FD&C Act does not give it the authority to have a distinct regulatory pathway for the legal marketing of homeopathic medicines.[43]
  • Homeopathic medicines—because of their uniqueness—were excluded by law from the OTC Drug Review which is a regulatory pathway based on therapeutic categories.[44] Premarket approval via a product-specific NDA, the other primary pathway, is neither mandated nor permitted by the FD&C Act for homeopathic products[45]—it was designed to regulate novel pharmaceutical drugs containing potentially dangerous pharmacologically active ingredients.
  • As a result of the FDA’s new position, homeopathic medicines have been deprived of a defined regulatory path to market, although it cannot have been Congress’s intent to prevent their legal distribution.
  • The FDA’s responses to Congressional letters and informal inquiries, Citizen Petitions, and FOIA requests have made it clear what the agency’s new position means: The FDA needs Congress to define a distinct legal pathway for homeopathic medicines.

The Future of Homeopathic Drug Regulation

  • We are asking Congress to preserve our access to homeopathic medicines and provide a clear directive and an appropriate framework for their regulation by adopting comprehensive, common-sense legislation that ensures both consumer access and safety.
    • Our goal is to modernize the law regarding the regulation of homeopathic medicines in order to provide a clear, consistent, and stable framework that serves the needs of the growing number of Americans who rely on homeopathic medicines to restore and maintain their health.
    • This framework should ensure safety while preserving consumer and practitioner access to the full range of homeopathic medicines from a diversity of suppliers in a resilient and competitive marketplace.
    • Establishing requirements and standards tailored to the unique nature of homeopathic medicines, as has been done for other health product categories such as biologics, medical devices, compounded drugs, and dietary supplements, will provide the proper safeguards and oversight to ensure safety and quality.

 

[1] Goldberg, Burton, Larry Trivieri, and John W. Anderson. “Homeopathy.” Alternative Medicine: The Definitive Guide. Berkeley: Celestial Arts, 2002. Print.

[2] The HPUS has been in continuous publication since 1897.

[3] As defined in Section 201(j) of the FD&C Act: “The term ‘official compendium’ means the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, official National Formulary, or any supplement to any of them.”

[4] Homeopathic Drug Products Guidance for FDA Staff and Industry, December 2022.

[5] 60 FR 13590 (March 13, 1995).

[6] Various research firms project sales growth in the homeopathic products market to be between 12 and 18 percent per year worldwide.

[7] Sections 201(g)(1) and 501(b) of the FD&C Act.

[8] Section 201(g)(1) of the FD&C Act.

[9] Section 501(b) of the FD&C Act.

[10] Section 505 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] Id.

[13] Weitzman, Stephen, Drug, Device, Cosmetic?—Part I, 24 Food, Drug, Cosmetic L.J. 226, 248 (1969).

[14] Junod at 176-77.

[15] Id. at 177, footnote 126. (“Administration Information letter N. 269 July 3, 1953, 500.13 (homeopathic drugs classified as prescription drugs under Durham-Humphrey Amendment).”)

[16] Public Law 87-781, October 10, 1962.

[17] 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).

[18] Junod at 177.

[19] Harrison, Todd A. and Claudia A. Lewis, “The FDA’s Flipped Stance on Homeopathic Drugs,” Insights, Venable, LLP (Dec. 22, 2017) (homeopathic active ingredients are individually evaluated for safety and effectiveness according to a scientifically sound process prior to inclusion as an official drug in the HPUS). https://www.venable.com/insights/publications/2017/12/the-fdas-flipped-stance-on-homeopathic-drugs.

[20] Johns Hopkins, Bloomberg School of Public Health, News Release, September 24, 2018.

[21] Food and Drug Admin., Talk Paper No. T-88-68 (Sept. 15, 1988).

[22] See, 21 CFR 314.

[23] Junod at 177.

[24] The American Institute of Homeopathy, established in 1844, is the oldest extant national medical association in the United States. Membership is open to licensed physicians and other medical providers who have integrated homeopathic medicine into their practice.

[25] 37 FR 9466 (May 11, 1972). Paragraph 357, 43 FR 45058 (September 29, 1978), notes “…the Commissioner has exempted homeopathic drugs for the [OTC] Drug Review…”

[26] 43 FR 45058 (September 29, 1978).

[27] The identity and strength testing exemption rulemaking was also referenced in CPG 400.400 in 1988. The FDA withdrew the exemption in 2004 even though manufacturing processes related to ensuring the safety and quality of homeopathic medicines had not changed. See, 69 FR 68834 (Nov. 26, 2004).

[28] 48 FR 14003, 14004 (April 1, 1983).

[29] 50 FR 3264, 3271 (January 23, 1985).

[30] S. 2755 and H.R.12980 – 95th Congress; Drug Regulation Reform Act of 1978.

[31] S.1075 – 96th Congress; Drug Regulation Reform Act of 1979.

[32] Section-by-Section Analysis to Accompany Proposed Legislation, Drug Regulation Reform Act of 1978, S. 2755 and H.R.11611, March 24, 1978; Part B, Subpart 8.- Homeopathic Drug Entities and Drug Products.

[33] See Conditions Under Which Homeopathic Drugs May be Marketed – Compliance Policy Guide, Section 400.400 (“CPG 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.

[34] Food and Drug Admin., Talk Paper No. T-88-68 (Sept. 15, 1988).

[35] 22 FDA Consumer 5 (December 1988-January 1989).

[36] 60 FR 13590 (March 13, 1995).

[37] 30 FDA Consumer 15 (December 1996).

[38] Wang, Beth, “Drug Center Chief Calls Out Homeopathic Industry,” InsideHealthPolicy.Com’s FDA Week 23, no. 20 (2017): 4–5.

[39] MediNatura, Inc. v. FDA, 496 F. Supp. 3d 416 (D.D.C. 2020), aff’d, 998 F.3d 931 (D.C. Cir. 2021).

[40] Coronavirus Aid, Relief, and Economic Security Act, Pub. L. No. 116-136, § 3853, 134 Stat. 281, 454 (2020).

[41] The 2019 draft guidance was submitted to the Office of Management and Budget (OMB) on November 18, 2022 (3 business days before Thanksgiving), and was approved as final by December 7, 2022. See 87 FR 75054 (Dec. 7, 2022). More specifically, the draft guidance was sent to the Office of Information and Regulatory Affairs (OIRA). AFHC Foundation requested and scheduled an EO 12866 Meeting with OIRA within the required time frame. Although OIRA’s website says it “remains committed to hearing the views of outside parties,” the scheduled meeting was unilaterally canceled by OIRA prior to the 10-day window for scheduling because the FDA Homeopathic Drug Guidance was finalized before the meeting date.

[42] Homeopathic Drug Products Guidance for FDA Staff and Industry, December 2022.

[43] MediNatura, Inc. v. FDA, 496 F. Supp. 3d 416, 455 (D.D.C. 2020), aff’d, 998 F.3d 931 (D.C. Cir. 2021).

[44] Coronavirus Aid, Relief, and Economic Security Act, Pub. L. No. 116-136, § 3853, 134 Stat. 281, 454 (2020).

[45] Food and Drug Admin., Talk Paper No. T-88-68 (Sept. 15, 1988).

 

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