Regulatory/Legislation

Homeopathic Promoters to Note FTC is Revising its Guide on Endorsements and Testimonials

August 1, 2022

By Mark Land, AAHP President Of the thousands of homeopathic products in the marketplace, few are ever seen advertised on television – historically, the mass medium to blanket the large U.S. market of consumers with a message. The cost is generally prohibitive for our niche industry. Word of mouth recommendations based on strong satisfaction has…

Your NDC Numbers are About to Change

August 1, 2022

By Eric Foxman, AAHP Secretary FDA has published a proposal that will change the required National Drug Code (NDC) format from 10 to 12 digits. Once finalized, all NDC holders would be required to convert to the new format. Because of the significant burden this may entail, FDA is proposing the effective date be five…

House and Senate Advance FDA User Fee Reauthorization Bills

June 29, 2022

By Pete Evich In the month of June, both the House and Senate advanced separate pieces of legislation that reauthorize FDA’s prescription drug, medical device, biosimilars, and generic drug user fee programs for a five-year period. If Congress does not enact legislation by Sept. 30, 2022, all four user fee programs will expire. Because of…

The Status of Homeopathic Medicinal Products in the European Union

June 7, 2022

By European Coalition on Homeopathic & Anthroposophic Medicinal Products (ECHAMP)   Homeopathic medicinal products have a strong foundation in the EU law. Specific EU legislation for homeopathic medicinal products has deep roots in their broad use in the Member States. Most Member States officially confirm a market in their country, and patients and prescribers use…

A Global Perspective on Effectiveness Standards for Homeopathic Medicinal Products: Is there a “Third Way”?

June 3, 2022

By Robbert van Haselen, Chair, HPCUS Clinical Documentation Committee; Director, World Integrated Medicine Forum   We currently live in an increasingly polarized world, and this is also reflected in the regulation of Homeopathic Medicinal Products (HMPs). Whilst there are common principles, such as ensuring the quality and safety of medicinal products, regulatory frameworks for homeopathic…

FDA Seeks Accelerated Drug Approval, DSHEA, Cosmetics Legislative Reforms

June 3, 2022

By Pete Evich, AAHP Government Relations As part of the President’s FY 2023 Budget proposal, FDA has called upon Congress to take up legislation that would give the agency additional authorities over accelerated approval of drugs and the ability to impose new requirements for dietary supplement makers and cosmetics facilities, among other statutory changes to…

The Regulation of Homeopathic Medicines in 2022

June 3, 2022

By Mark Land, AAHP President   The content in our June 2022 newsletter on regulation turned out quite different than I imagined when we discussed it at an editorial planning committee meeting several months ago. I envisioned the regulatory issue to include several articles from authors around the world, each outlining the regulatory framework for…

Regulation of Homeopathic Medicines in Canada

June 3, 2022

Submitted by David Skinner, Canadian Homeopathic Pharmaceutical Association   Homeopathic medicines (HMs) are regulated in Canada by Health Canada, the federal government department responsible for ensuring the safety, efficacy, and compositional integrity of health care products and medical devices distributed and sold in Canada. Health Canada has formally recognized HMs as pharmaceutical products since 1990,…

Regulatory Status of Homeopathy in the EU & UK: What’s Happened Since Brexit?

June 3, 2022

By Steve Mann, Director of External Regulatory Affairs, Nelsons   To say the world has changed over the last couple of years might just be the understatement of the century – but as we begin to emerge from the shadow of COVID-19, into a trading environment as difficult as we’ve ever had to deal with,…

Be ’Recall Ready’: FDA Wants to Help You Fulfill Your Regulatory Requirements

April 1, 2022

By Eric Foxman, AAHP Secretary Does your company market or distribute an FDA-regulated product? If so, then FDA has a document for you. FDA wants all manufacturers and downstream distribution faculties to be prepared with a recall plan so they can quickly and effectively react if a violative product needs correction or removal from the…

AAHP monitors and reports on current federal regulations, legislation and government policies that affect the homeopathic community. AAHP is often the first to learn of regulatory changes that have both direct and indirect effects on our industry enabling members to stay ahead of the curve in a rapidly changing healthcare environment.

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