Homeopathy Papers

Homeopathic Drug Regulation

The authors outline the legal status history of homeopathy in the U.S. and how it has changed under the FDA’s new and arbitrary “risk based” approach.  The availability of homeopathic remedies is now threatened.

Homeopathic Drug Regulation

Historical Timeline Review

Laura Held, Holly Sullivan, Page Pulliam


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. Substantially different from pharmaceutical drugs in function, ingredients, and formulation, homeopathic medicines are specially prepared dilutions made from commonly available substances and have been used safely for over 200 years. Homeopathic drugs manufactured in accordance with official standards for strength, quality, and purity 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, lacking a clear directive and parameters set by Congress, the FDA has not developed regulations tailored to the unique nature of homeopathic medicines as the agency has done for other health product categories. Even as the demand for homeopathic medicine continues to expand by 12 to 18 percent per year, [4] the agency has relied on guidance documents and the application of pharmaceutical-specific requirements and standards to direct its enforcement activity.

While the FDA has historically recognized homeopathic medicines as a unique and separate category of drugs as set forth in the FD&C Act, requirements and standards for drugs have evolved in response to the changing nature of the pharmaceutical industry which has resulted in an inconsistent and ad hoc approach to the agency’s oversight of homeopathic medicines.

This has led to an increasingly inappropriate and unsustainable regulatory environment for the brand owners and manufacturers of homeopathic products, severely affecting the viability of compliant American companies. This ultimately impacts Americans who rely on access to the full range of homeopathic medicines made available by a diversity of suppliers.

The FDA finalized a new guidance document on homeopathic drug products in December 2022. In the guidance, the agency completely reversed its previous longstanding policy by categorically altering the legal status of homeopathic medicines without citing evidence that properly manufactured and labeled homeopathic medicines pose a safety risk.

This upended the entire industry and has raised accessibility concerns among consumers. The FDA went from formally acknowledging the uniqueness of homeopathic medicines in its policy decisions, as set forth by Congress in the FD&C Act, to making no distinction between homeopathic medicines and pharmaceutical drugs in the guidance document.

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 history of use by consumers and physicians.

Americans for Homeopathy Choice Action (AFHC Action) is a consumer advocacy group seeking legislation that advances the consumer interest in safe and accessible homeopathic medicines. The current regulatory environment for homeopathic medicines significantly threatens the right of all Americans to access these safe 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 continued access to genuine homeopathic medicines, an essential component of health care for a growing number of individuals and families.

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.[5]
    • Congress distinguishes medicines in the HPUS from other drugs in the definition of a drug: [6]
      • “…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: [7]
      • “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.[8] The law required new drugs be tested for safety before marketing, the results of which would be submitted to the FDA in the application.[9] At the time, no homeopathic medicines were considered new drugs or unsafe, so the agency “virtually ignored homeopathy,”[10] eliminating the necessity of official evaluation of a product from which there is no reasonable possibility of danger.[11]

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).[12] FDA noted it “would not act against homeopathic products without the prescription legend which are offered to the laity for minor ailments.”[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 a safety review was required)—additional controlled tests and trials are necessary before a new drug can enter the market.[14]
    • 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.[15]
    • 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.[16] 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.[17]
    • The NDA process, which is designed to regulate novel, potentially dangerous drugs containing pharmacologically active chemicals, was not designed nor intended for homeopathic drugs 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 manufactured in accordance with official standards for strength, quality, and purity 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.[18] 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.[19]
    • 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.[20]
  • 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.[21]

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 drugs, while at times responding to stakeholder feedback requesting accommodation consistent with the FDA’s recognition of the uniqueness of these medicines.
  • In 1972, in response to comments from the American Institute of Homeopathy,[22] homeopathic medicines were exempted by the FDA from the Over-the-Counter (OTC) Drug Review: [23]
    • 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 stability testing requirements in a final FDA rule: [24]
    • “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,[25], 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:[26]
    • “…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:[27]
    • “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.[28] The original bill was never voted on, but when reintroduced in the 96th Congress, the bill passed the Senate.[29] The analysis of the 1978 bill included the following language discussing the proposed exemption of homeopathic medicines from certain requirements:[30]
    • “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.[31] 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: [32]
    • 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: [33]
    • “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”:[34]
    • “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:[35]
    • “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:[36]
    • 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:[37]
    • “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.’”
    • 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 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.[38] 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.[39]
  • The final guidance (“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: [40]
    • “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.”
  • The FDA now considers homeopathic medicines to be “unapproved new drugs” that are “illegally” marketed, a complete reversal and inconsistent with its previous policy that delineated conditions for their legal manufacture and marketing.[41]
    • The 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.
    • Products of FDA-registered manufacturers who comply with existing manufacturing and labeling standards are now subject to arbitrary and capricious removal from the market. This blatantly contradicts the 85-year history during which homeopathic manufacturers legally marketed their products, without citing evidence that properly manufactured and labeled homeopathic medicines pose a safety risk.
  • This means the FDA is limited to using the unapproved new drug designation as an enforcement mechanism for the oversight of homeopathic medicines since the FDA eliminated its de facto regulatory pathway for this product category with the rescission of CPG 400.400. As a result, there is now no recourse available for correction and reintroduction once a product is removed from the market.
  • The vast majority of homeopathic medicines are available OTC in retail stores. There are currently only two regulatory pathways for the legal marketing of OTC/nonprescription drugs: 1) the OTC Drug Review based on therapeutic category; and 2) the product-specific NDA. Homeopathic medicines–because of their uniqueness–were exempted by law from the OTC Drug Review.[42] The requirement of premarket approval for homeopathic medicines via the NDA is neither mandated nor allowed by the FD&C Act.[43]
  • A pressing concern is that FDA’s new interpretation of the law leaves homeopathic medicines without a regulatory pathway to ensure both consumer access and provide the proper safeguards and oversight to manage risk. Furthermore, without Congressional action, the FDA does not have the proper parameters to create an appropriate regulatory pathway in order for homeopathic medicines to be legally brought to market.

The Future of Homeopathic Drug Regulation

  • The FDA has relied heavily on guidance documents and the exercise of enforcement discretion in its de facto regulation of homeopathic products. In doing so, it has acted outside the rulemaking process, now contending that the FD&C Act does not give it the authority to create a regulatory pathway for the legal marketing of homeopathic medicines.[44]
    • In its guidance documents the agency has primarily applied pharmaceutical-specific requirements and standards to direct its enforcement activity. As the regulatory landscape has evolved in response to the changing nature of the pharmaceutical industry, brand owners and manufacturers of homeopathic products face an unsustainable and increasingly inappropriate regulatory environment.
  • Our goal is to work with Congress and the FDA to ensure both consumer access and safety by implementing an appropriate legal and regulatory framework for homeopathic medicines.
    • Other products such as biologics, medical devices, compounding drugs, and dietary supplements have unique and appropriately tailored requirements and standards defined by Congress that fit their particular categories.
    • Utilizing requirements and standards specifically related to the safety and quality of homeopathic medicines will also provide the proper guardrails and oversight to manage risk. This will better serve the goal of balancing consumer access with proper regulatory oversight to ensure safety and quality.
  • It’s time to address holistically the unique requirements of homeopathic regulation with a comprehensive, common-sense legislative solution that ensures both consumer access and safety. Congress should create a clear path forward for the homeopathic medicines that millions of Americans rely on for their health care.



For more information, email [email protected].    


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

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

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

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

[8] Section 505 of the FD&C Act.

[9] Junod, Suzanne White, An Alternate Perspective: Homeopathic Drugs, Royal Copeland, and Federal Drug Regulation, 55 Food and Drug L.J. 161, 176 (2000).

[10] Id.

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

[12] Junod at 176-77.

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

[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 at 177.

[17] 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.

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

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

[20] See, 21 CFR 314.

[21] Junod at 177.

[22] 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.

[23] 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…”

[24] 43 FR 45058 (September 29, 1978).

[25] The stability 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).

[26] 48 FR 14003, 14004 (April 1, 1983).

[27] 50 FR 3264, 3271 (January 23, 1985).

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

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

[30] 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.

[31] 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.

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

[33] 22 FDA Consumer 5 (December 1988-January 1989).

[34] 60 FR 13590 (March 13, 1995).

[35] 30 FDA Consumer 15 (December 1996).

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

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

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

[39] 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.

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

[41] CPG 400.400, supra, note 31.

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

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

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


About the author

Laura Held

Laura Held is a wife, mother, home educator and student at the Academy of Homeopathy Education. As the Grassroots Director for Americans for Homeopathy Choice, Laura is integral to the development and execution of the strategic plan for outreach to Congressional offices both through AFHC Leadership and the grassroots Homeopathy Action Team (HAT). She previously worked for the Federal Reserve Board of Governors and was integral to the development of the U.S. Currency Education Program and training domestic and global stakeholders for the launch of the new-design $100 note.

About the author

Holly Sullivan

Holly Sullivan is a lawyer who chose to stay home to raise her four children. She received her undergraduate degree from Northwestern University and her law degree from Case Western Reserve University. As a passionate supporter of homeopathy, Holly offers her legal skills to support AFHC's important mission.

About the author

Page Pulliam

Page Pulliam is the Alabama State Captain for Americans for Homeopathy Choice Action. She is married to Todd and homeschools their son Robert. She is a 2003 graduate of Rhodes College (B.A., History, cum laude), and 2007 graduate of the University of Alabama School of Law (JD, cum laude). She is a member of the Alabama State Bar Association and has previously served as a deputy district attorney for Tuscaloosa County and the director of admissions for the University of Alabama School of Law. The Pulliams transitioned to homeopathic medicines in spring 2008 for their son's autism battle. The entire family has experienced significant health improvements with homeopathy. Robert continues to progress developmentally. Page is honored to help preserve access to the full range of these precious medicines in the United States.

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