Tuberville, Lee Advocate for Homeopathic Medicine, Champion MAHA Agenda

WASHINGTON - U.S. Senator Tommy Tuberville (R-AL) and U.S. Senator Mike Lee (R-UT) introduced the Homeopathic Drug Product Safety, Quality, and Transparency Act which would build a framework for the Food and Drug Administration (FDA) for homeopathic medicine to protect Americans' access to natural health solutions. Their bill would provide a pathway for homeopathic medicinal products to gain approval from the FDA without needlessly banning safe products that do not fit into the same legal categories as traditional pharmaceuticals.

The Daily Caller first reported about this bill.

"I've long been an advocate for homeopathic medicine," said Sen. 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."

"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."

Americans for Homeopathy Choice Action, MAHA Action, the CPAC Foundation, the National Health Federation, the Health Freedom Defense Fund, and the National Products Association endorsed the bill.

Read full text of the bill here.

BACKGROUND:

The 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.

Specifically, the Homeopathic Drug Product Safety, Quality, and Transparency Act would:

• Federally acknowledge that homeopathic drug products are distinct from other pharmaceutical products and, as such, require independent regulatory framework.
• Create a standard definition for homeopathic drug products and clarifies that they are not a new drug.
• Exempt homeopathic drugs from the traditional approval process established under Section 505 of the Food, Drug, and Cosmetic Act.
• Outline a method for the Secretary to regulate homeopathy safety and quality standards separate from traditional drugs.
• Exempt finished homeopathic drug products from the required laboratory test to evaluate strength of each active ingredient.
• Clarify 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.
• Establish 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.
• Require the FDA to issue final Current Good Manufacturing Practice (CGMP) regulations within three years after enactment.
• Deem any drug or supplement that is not homeopathic but uses the word homeopathy in its labeling as misbranded.
• Apply federal standards for reporting serious adverse effects of nonprescription drugs to homeopathic drug products.
• Clarify that homeopathic drug products shall not be classified as biosimilars.
• Withdraw the FDA's 2022 guidance that significantly restricted the sale of homeopathic drug product.

MORE:

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Senator Tommy Tuberville represents Alabama in the United States Senate and is a member of the Senate Armed Services, Agriculture, Veterans' Affairs, HELP and Aging Committees.

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