Lee, Tuberville Introduce Protections for Homeopathic Medicine with FDA Approval Framework

WASHINGTON - U.S. Senators Mike Lee (R-UT) and Tommy Tuberville (R- AL) today introduced legislation building an FDA framework for homeopathic medicine to protect Americans' access to natural health solutions. The Homeopathic Drug Product Safety, Quality, and Transparency Act will provide a pathway for homeopathic medicinal products to gain approval from the Food and Drug Administration without needlessly banning safe products that simply do not fit into the same legal categories as traditional pharmaceuticals. The bill is co-led by Senator Tommy Tuberville (R-AL) and endorsed by several health organizations.

"Americans have a right to manage their own health and choose treatments that are right for them, including homeopathic methods," said Senator Mike 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."

"I've long been an advocate for homeopathic medicine," said Senator Tommy Tuberville. "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."

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The Homeopathic Drug Product Safety, Quality, and Transparency Act is endorsed by Americans for Homeopathy Choice Action, MAHA Action, the CPAC Foundation, the National Health Federation, the Health Freedom Defense Fund, and the National Products Association.

"Americans for Homeopathy Choice Action and the 120,000 consumers we represent are grateful to Sens. Tuberville and Lee for introducing this bill which, when enacted, will ensure continued access to homeopathy for millions of Americans who use it to restore and maintain their health. Homeopathic medicines are also an important nontoxic option for health practitioners including medical doctors, nurses, dentists and others who appreciate this choice when treating patients with both everyday and serious conditions." - Paola Brown, President, Americans for Homeopathy Choice Action

"MAHA Action proudly supports Senator Tuberville's and Senator Lee's legislation to protect and preserve Americans' access to homeopathic medicines. We believe individuals should have the freedom to choose the modalities they use to support and maintain their health. For generations, homeopathy has been an important part of the diverse range of options available to American families. Safe, holistic, and effective homeopathy has been used by billions of people around the world as a non-toxic alternative to big pharma." - Tony Lyons, President, MAHA Action

"CPAC proudly supports H.R. 7050, the Homeopathic Drug Product Safety, Quality, and Transparency Act. Healthcare freedom is a core conservative value, and for too long Washington bureaucrats have used regulatory overreach to strip Americans of their right to make their own healthcare decisions. This bill cuts through the red tape and puts power back where it belongs - with the patient. We commend Senators Tuberville and Lee for their fearless conservative leadership on this legislation. Their commitment to individual liberty and limited government is exactly what the American people sent them to Washington to fight for." - Matt Schlapp, Chairman, CPAC

"Homeopathy needs to be recognized for what it is: a safe and inexpensive way for Americans to manage many of their own health needs. We support this bill for bringing regulatory clarity to a time-honored approach that millions of American families rely on for self-care." - Scott C. Tips, J.D., President, National Health Federation

"Now more than ever, American families want access to natural approaches that support our health and wellbeing. For over two centuries, homeopathy has done just that by providing safe, effective, and affordable healthcare to millions. Homeopathy addresses a spectrum of concerns from coughs and colds, to sprained ankles, and grief. It successfully handled the disease outbreaks that plagued the 18th century. Many of us at Health Freedom Defense Fund have used homeopathy to raise our families and can personally attest to this most amazing medicine. We are thrilled about and wholeheartedly support this bill to ensure that homeopathy is accessible for generations to come." - Leslie Manookian, President & Founder, Health Freedom Defense Fund

"The Natural Products Association supports the Homeopathic Drug Product Safety, Quality, and Transparency Act because the legislation would provide long-overdue statutory clarity for the regulation of homeopathic drug products in the United States. The homeopathic legislation offers a thoughtful and balanced solution. It protects consumers, respects the distinct nature of homeopathic drug products, provides clear rules for industry, and reinforces the importance of a predictable federal regulatory framework. NPA urges Congress to advance the Homeopathic Drug Product Safety, Quality, and Transparency Act and support a regulatory approach that promotes safety, quality, transparency and continued consumer access." - Daniel Fabricant PhD, President and CEO, National Products Association

Background

The Food and Drug Administration (FDA) first recognized homeopathic medicines in the Food, Drug, and Cosmetic Act in 1938 and regulated the manufacture and sale of homeopathic drugs for the following eighty years. However, in 2019 the FDA withdrew this regulatory framework for homeopathic products. This created legal and regulatory chaos for the industry as the viability of homeopathic medicine was brought into question.

Senator Lee signed a letter to the FDA in 2021 urging the FDA to provide guidance protecting consumer access to homeopathic drug products for Americans.

The Homeopathic Drug Product Safety, Quality, and Transparency Act:

• Federally acknowledges that homeopathic drug products are distinct from other pharmaceutical products and, as such, require independent regulatory framework.
• Creates a standard definition for homeopathic drug products and clarifies that they are not a new drug.
• Exempts homeopathic drugs from the traditional approval process established under Section 505 of the Food, Drug, and Cosmetic Act.
• Outlines a method for the Secretary to regulate homeopathy safety and quality standards separate from traditional drugs.
• Exempts finished homeopathic drug products from the required laboratory test to evaluate strength of each active ingredient.
• Clarifies that homeopathic drug products must generally comply with traditional labeling requirements, but that homeopathic drugs may use descriptions/dosage units appropriate to homeopathy and that claims made in compliance with this Act shall not be considered a false advertisement.
• Establishes a Homeopathic Drug Product Advisory committee, which shall trigger consultation with the Secretary and provide recommendations on safety, quality, labeling, and regulatory approaches for homeopathy drug products.
• Requires the FDA to issue final Current Good Manufacturing Practice (CGMP) regulations within three years after enactment.
• Deems any drug or supplement that is not homeopathic but uses the word homeopathy in its labeling as misbranded.
• Applies federal standards for reporting serious adverse effects of nonprescription drugs to homeopathic drug products.
• Clarifies that homeopathic drug products shall not be classified as biosimilars.
• Withdraws the FDA's 2022 guidance that significantly restricted the sale of homeopathic drug product.

Read exclusive coverage by The Daily Caller here.

Access the full bill text here.

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