A newly introduced bill in Congress would rein in FDA overreach, restore legal clarity for homeopathic medicines, and protect Americans’ right to choose safe, natural healthcare options. Action Alert!
THE TOPLINE
- H.R. 7050 would formally recognize homeopathic medicines as a distinct category under federal law, reversing the FDA’s 2022 guidance that effectively labeled them “unapproved new drugs.”
- The bill creates a clear, commonsense regulatory framework without imposing pharmaceutical-style requirements.
- By restoring legal certainty, the legislation protects patient access, preserves innovation, and prevents the quiet elimination of homeopathic products from the marketplace.
For more than 200 years, Americans have safely used homeopathic medicines as an affordable option for everyday health concerns. Yet in recent years, the FDA has moved to undermine this time-tested system—not through public rulemaking, but through guidance documents that effectively declare homeopathy “illegal” and place the entire category at risk.
Now, finally, Congress has stepped in.
A newly introduced bill, H.R. 7050, the Homeopathic Drug Product Safety, Quality, and Transparency Act, would restore clarity and common sense to federal regulation of homeopathic medicines. It needs our support.
How We Got Here
In December 2022, the FDA finalized a guidance claiming that all homeopathic medicines are “unapproved new drugs.” Because no homeopathic product has gone through—and realistically can go through—the pharmaceutical New Drug Approval (NDA) process, the agency effectively asserted that nearly every homeopathic medicine on the market is being sold illegally.
The FDA promised “enforcement discretion,” saying it would focus only on certain products. But once the FDA labels something illegal, the sword of Damocles hangs overhead. Simply by creating an uncertain regulatory environment for homeopathic products, the agency can cause retailers to back away and manufacturers to stop innovating and developing new products. The end result? Compromised access for consumers.
That’s why we initiated a lawsuit against the FDA in 2024—and we’ll have more news on our progress in this legal action next week.
But we need a fallback. That’s why we’re supporting H.R. 7050, the brainchild of our friends at Americans for Homeopathy Choice, which addresses these core problems.
A Clear Path Forward for Homeopathy
The Homeopathic Drug Product Safety, Quality, and Transparency Act, introduced by U.S. Rep. Pete Sessions (R-TX), will create a new section of the Food, Drug, and Cosmetic Act that formally recognizes homeopathic medicines as a distinct category, separate from pharmaceutical drugs. This simply restores what Congress originally intended when it enacted the Food, Drug, and Cosmetic Act in 1938, which explicitly distinguished drugs listed in the Homeopathic Pharmacopoeia of the United States (HPUS) from conventional pharmaceuticals.
The bill has five main goals to create a legal pathway for homeopathic medicines to be sold:
- Formally recognize homeopathic medicines as a distinct category under federal law, ending their treatment as “unapproved new drugs.”
- Modernize definitions to include HPUS-listed remedies and internationally recognized homeopathic standards.
- Apply good manufacturing practices that ensure safety and quality without imposing pharmaceutical-style requirements.
- Establish clear labeling standards that allow appropriate indications without triggering FTC enforcement.
- Create a dedicated FDA advisory committee with homeopathic expertise to guide oversight.
Importantly, the bill withdraws the FDA’s December 2022 guidance, which destabilized the market without public accountability. Guidance documents may claim to be “nonbinding,” but in practice they function as law—without the transparency or legal safeguards of rulemaking.
The Bottom Line
This legislation provides homeopathy with a clear legal pathway —one that respects its unique nature, long safety record, and the rights of consumers to choose natural, non-toxic healthcare options.
If Congress fails to act, the FDA will continue to eliminate homeopathic medicines quietly, one product at a time, just as it has done with other natural health products that compete with drugs.
Action Alert!
