H.R.7050 –A Bill to protect the future of Homeopathy for everyone

By Susan Beal, DVM

This is a historical time for homeopathy. After nearly ten years of work led by Paola Brown, President, and the crew at Americans for Homeopathy Choice Action (AHCA), the non-partisan bill (H.R.7050 - Homeopathic Drug Product Safety, Quality, and Transparency Act) was introduced in to the House on January 14, 2026. U.S. Rep. Pete Sessions (R-TX) introduced the bill that will at long last clarify the role of homeopathic medicine in American health care. Paola Brown explains, “The bill is the best solution for long-term protection of access to the full range of homeopathic medicines and for addressing the unique nature of homeopathic medicines and the specific conditions and requirements related to their manufacture, labeling, promotion, distribution, and use.”

What is needed now to move the process forward?

It is critical for all legislators to hear from their constituents that the threat is real and that products they need and rely on are being (and have been) removed from the marketplace. Elected officials and their aides like to hear personal stories – and they pay attention to them and to individuals that make all the words on the page real.

They need to know that the removal of homeopathic medicines from the marketplace will affect animal welfare and remove vital tools for herd health from organic dairy farmers’ toolbox. Ensuring access to homeopathic medicines will assist in compliance with the organic certification regulations.

Here’s what you can do:

Contact your elected House representative and ask them to co-sponsor this bill: H.R.7050 - Homeopathic Drug Product Safety, Quality, and Transparency Act.

Go to https://homeopathychoice.org/ for more information, updates and take advantage of their talking points and automated access to legislators. AHCA and their team leaders in your state, can also help you. They provide training about how to communicate with your elected representatives. Membership in the AHCA is open to all and is available at no charge. Becoming a member will ensure that news of the progress of the bill and reactions to it lands on your desk and it will also show larger support to the homeopathic community.

Background information

The process of moving a grassroots-initiated bill forward is long and needs determination and attention to detail. This bill has taken many years to build agreements within the homeopathic community as to content and goals. The AHCA has developed relationships with politicians and their aides, developing one or more champions to guide it though the legislative process. This bipartisan legislation, which includes Rep. Jonathan Jackson (D-IL) and Rep. Mike Kennedy, MD (R-UT) as original co-sponsors, is supported by more than 40+ leading national and state homeopathy organizations, holistic health non-profits, manufacturers, retailers, and advocacy groups. The time to act is now!

Homeopathy is a holistic system of medicine, meaning it focuses on treating the person or animal’s entire lifestyle, not just one individual symptom. The concept of homeopathy is “treating like with like.” Homeopathy aims to use the body’s own self-healing mechanisms to treat disease. Homeopathy is widely used to treat organic livestock.

Betsy Lehrfeld is the general counsel for the AHCA. Her summary of the top goals of this legislation are:

1. The creation of a new section in the Food, Drug, and Cosmetic Act (FDC) to specifically and uniquely cover the manufacture of homeopathic medicines. It will ensure that the manufacture of homeopathic medicines will be protected in legislation, not at the discretion of the Federal Drug Administration (FDA), or their guidance document. The precedent for the creation of a new section of the FDC Act is a new section for biologicals, and dietary supplements. The current proposed bill is being modeled after the new section of the FDC Act that covers dietary supplements.
2. The expansion of the market and increase the legitimacy of homeopathy. Homeopathic products, will be defined by their inclusion in the Homoeopathic Pharmacopoeia of the United States (HPUS), and certified by the National Homeopathic Certification Board (NHCB). NHCB are developing American National Standards Institute (ANSI) standards for the production of homeopathic medicines acceptable to the regulatory authorities.
3. The bill preserves the FDA authority over safe manufacturing, but requires the use of good manufacturing processes that are unique to, and relevant for, homeopathic medicines. This would include the exclusion of the FDA pre-marketing approval for homeopathic medicines. Homeopathic medicines will not be considered as new drugs that require the same validations as new pharmaceutical drugs.
4. The bill simplifies the labelling process by canceling the need for indications on the label of a homeopathic remedy-medicine unless the product is being manufactured for retail sale.
5. The bill clarifies that no further proof of effectiveness of the homeopathic remedy-medicine is required. Currently, according to the FDA guidance document, homeopathic medicines are fraudulent because there are no double-blinded, placebo-controlled studies on record at the FDA.
6. The bill would establish the Homeopathic Drug Product Advisory Committee, a Federal Advisory Committee Act (FACA) committee to advise the FDA on homeopathy. Currently the FDA have no staff homeopath or homeopaths acting as advisors. The ten members of the Homeopathic Advisory Council will include homeopathic manufacturers both large and small, an MD or DO and ND homeopaths with greater than three years of consecutive homeopathic practice; a homeopathic veterinarian; consumer group representatives; a representative from the HPUS, and the commissioner of food and drugs.

Why the bill is needed: Some history

Until recently, homeopathy and the use of homeopathic medicines have been grandfathered into the health system and has been built on a “working gentlemen’s agreements” about their use based both on historical legislation and on personal relationships between members of the homeopathic community and the FDA.

When the FDC Act was introduced in 1938, one of the sponsors was Royal Copeland, an MD homeopath. He was responsible for writing the Homeopathic Pharmacopoeia into the federal legislation that created the Act. The Homeopathic Pharmacopoeia of the US has been in continual publication since 1897 and was based upon a history of publications that focused on standards for the production of homeopathic medicines.

The support for inclusion of homeopathic medicines in the FDC Act was continued by the exceptional work of the Borneman family over the years. John Sr was a homeopathic pharmacist for Boericke and Tafel in the early years then left to start his own homeopathic pharmacy in eastern Pennsylvania in 1910. He was also the pharmacist for, and instructor at, the Hahnemann Medical College in Philadelphia. His son, John Jr, took over the pharmacy in the mid-1950s, and his son, John the 3rd, known as Jack, also a pharmacist, ran Borneman pharmacy until it was sold to Boiron in the mid-1980s. Jack was the president of the Homeopathic Pharmacopoeia Convention of the US (HPCUS). This was the organization that served as the interface between the homeopathic pharmaceutical industry and the FDA. Jack regularly and clearly reminded the folks at the FDA about the inclusion of the HPUS in the FDC Act.

Newly created FDA Guidance documents for industry and staff re: Homeopathic Drug Products

Fast forward to December of 2022 when the FDA released a Homeopathic Drug Products guidance document for FDA staff and industry. Guidance documents, while not law, have historically been (and are) used to dictate policy rather than having the rules appropriately developed through legislative process. Even though every page of this guidance document has the header “Contains Nonbinding Recommendations”, the document clearly states the homeopathic medicines are unapproved drugs. It also outlines the clear steps the FDA intends to take regarding the enforcement and regulatory priorities of this “guidance” and the categories of homeopathic drug products on which it intends to initially focus. Their priority list includes: Products with reports of injury that, after evaluation, raise potential safety concerns; products that contain or purport to contain, ingredients associated with potentially significant safety concerns; products for routes of administration other than oral or topical; products intended to be used for the prevention or treatment of serious and/ or life-threatening diseases or conditions; products for vulnerable populations; products with significant quality issues.

The guidance documents in action:

While some of these priorities make sense (quality issues, for one), the others raise concerns for and within the homeopathy community. For example, the “products with potential safety concerns” could be (and is currently being) interpreted to include any homeopathic medicine made with ingredients that might be, in material doses, toxic. There is also confusion between the H words: homeopathic, herbal, holistic. There are some products on the market that are inaccurately labeled or described as homeopathic even when they really do not contain potentized substances, or they contain potentized substances that are not described in the HPUS, or when the maker describes their action as homeopathic.

The FDA guidance document has been used to remove injectable homeopathic medicines (such as Viscum album) from the market. It’s also been used to remove common eye drops containing potentized ingredients. The next targeted medicines are likely to be those made with poisonous ingredients. Enforcement of that section of the guidance will remove common and useful homeopathic medicines such as Aconite, Belladonna, Nux vomica, Arsenicum album, Mercurius, Lachesis, Phosphorus, and many others from the market. These restrictions are also being applied to products correctly manufactured in other countries that have previously been available in the US. It is also concerning that many of the stores that once retailed homeopathic medicines have taken the guidance to heart and have removed all remedy-medicines from their shelves or have decreased their offerings to only the common mass market medicines (such as Arnica).

The FDA guidance has also affected the homeopathic pharmacies. April Eya, from Hahnemann Laboratories says that the requirements of this guidance involve every homeopathic medicine from the mass market remedy-medicines (such as Arnica and Hypericum) to the common medicines (such as Nux vomica, Arsenicum album, Staphysagria, Pulsatilla, Phosphorus,….) to the multiple and often more obscure medicines (often called small remedies) of the HPUS. She emphasizes that this is particularly important for makers of other than the mass market remedy-medicines.

Every lot of homeopathic medicine produced currently requires the same extensive FDA record keeping as pharmaceutical drugs, beginning at the validation of the parent material, through to the final products, including all ingredients and steps, stability testing, certificates of authenticity, and other documentation. This significant burden has been demanded in the face of already having a clear and concise document that describes the preparation of the homeopathic medicines in the HPUS. While these requirements are burdensome to all manufacturers of homeopathic medicines, they heavily penalize the producers of mass market medicine such as Arnica, and the makers of less common remedies (Wyethia, or Vanilla, or Skatolum, for example). There are relatively few companies that sell single and smaller remedies that are critical to homeopaths, the individuals in their care, and the larger community. The community needs the full scope of medicines in the HPUS available to them. There has been an increase in the number of inspections of homeopathic pharmacies and manufactures and a continually increasing rigor of these inspections as well since the guidance document was published.

A leader in the homeopathic community, in addition to her limited private homeopathic practice, Susan provides educational programs, consulting, and coaching for pet-owners, farmers and ranchers, businesses, and consumer groups. After being in Jefferson County, Pennsylvania for many years, Susan now lives in Elmira, Ontario, Canada working with unique clients in broad geographies to forge creative solutions in regenerative agriculture and health care. She can be reached at Laughing Oak North, alchemy@penn.com.

Posted: to Industry News on Tue, Mar 3, 2026
Updated: Sun, Mar 8, 2026