U.S. Sens. Tommy Tuberville, R-AL, and Mike Lee, R-UT, have introduced legislation aimed at establishing a new Food and Drug Administration regulatory framework for homeopathic medicines, arguing the measure would protect Americans’ access to natural health products while creating a pathway for federal approval.

The legislation, titled the Homeopathic Drug Product Safety, Quality, and Transparency Act, would create a separate regulatory structure for homeopathic drug products, which the senators say do not fit within the same legal framework as traditional pharmaceuticals, according to a news release from Tuberville's office.

The bill comes amid broader efforts tied to the Make America Healthy Again, or MAHA, agenda and has drawn support from several organizations, including Americans for Homeopathy Choice Action, MAHA Action, the CPAC Foundation, the National Health Federation, the Health Freedom Defense Fund and the National Products Association.

Tuberville said the legislation would expand access to alternative treatment options.

“I’ve long been an advocate for homeopathic medicine,” Tuberville said in the release. “The reality is that too many Americans today are hooked on pharmaceuticals when they could be using homeopathic remedies, which are often cheaper and can yield miraculous results. There’s no reason why the FDA shouldn’t be reviewing and approving some of these remedies to help Americans live healthier lives.”

Lee said the current federal system is not designed to evaluate homeopathic products.

“Americans have a right to manage their own health and choose treatments that are right for them, including homeopathic methods,” said Sen. Lee. “The current federal regulatory framework is designed around traditional pharmaceuticals, but it is ill-equipped to review the safety and effectiveness of homeopathic products. So, we are building a new one. Our legislation answers the concerns of thousands of families across the country who have been calling on Washington to find a better way.”

According to the senators, the FDA first recognized homeopathic medicines under the Food, Drug, and Cosmetic Act in 1938 and regulated their manufacture and sale for roughly 80 years. They said the agency withdrew that regulatory framework in 2019, creating uncertainty within the homeopathic industry and raising questions about the future of homeopathic products.

Under the proposed legislation, homeopathic drug products would be formally recognized as distinct from other pharmaceutical products and regulated under an independent framework. The bill would establish a federal definition for homeopathic drug products and clarify that they are not considered new drugs.

The measure would exempt homeopathic products from the traditional approval process outlined in Section 505 of the Food, Drug, and Cosmetic Act. It also would authorize the secretary of the relevant federal agency to regulate homeopathic safety and quality standards separately from conventional drugs.

In addition, the bill would exempt finished homeopathic drug products from laboratory testing requirements used to evaluate the strength of each active ingredient. It would require homeopathic products to generally comply with existing labeling standards while allowing dosage descriptions and units specific to homeopathic practice. Claims made in compliance with the legislation would not be considered false advertising.

The legislation also would create a Homeopathic Drug Product Advisory Committee to consult with federal officials and provide recommendations on safety, quality, labeling and regulatory approaches for homeopathic products.

The FDA would be required to issue final Current Good Manufacturing Practice regulations within three years of enactment. The bill also would apply federal standards for reporting serious adverse effects of nonprescription drugs to homeopathic products.

Other provisions would classify as misbranded any drug or supplement that is not homeopathic but uses the term homeopathy on its labeling, clarify that homeopathic products are not biosimilars and withdraw the FDA’s 2022 guidance that the senators said significantly restricted the sale of homeopathic drug products.

The full text of the bill is available at www.tuberville.senate.gov.