Regulatory

A First Look at AAHP Summit Speakers

We are thrilled to offer a first look at the speakers and sessions for our upcoming Summit on Challenges and Solutions in Quality & Safety of Homeopathic Drug Products! This unique one-day workshop is designed to help you manufacture safe products while complying within FDA and FTC guidelines. Some of readm more…

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How to Work with FDA on Voluntary Recalls

By Mary Borneman, Sr. Director, Communications & Public Affairs, Standard Homeopathic Company/Hyland’s, Inc.   In April 2019, U.S. Food & Drug Administration (FDA) published a draft guidance* Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C (“the Draft Guidance”). The purpose of this new guidance is “to clarify readm more…

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Initiation of Voluntary Recalls: Draft Guidance for Industry and FDA Staff

By Mark Land, AAHP President   Product recalls are an important tool that manufacturers and the U.S. Food and Drug Administration (FDA) use to minimize exposure to potentially harmful or ineffective products.1 Drug product recalls are voluntary — that is to say, FDA does not have legal authority to recall readm more…

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Overview: Membership Meeting 2019

The membership of AAHP came together on March 8 for the association’s semiannual Membership Meeting. Taking place during Natural Products Expo West in Anaheim, Calif., AAHP members convened to hear updates on projects and initiatives, network, and elect new leadership before hitting the tradeshow floor. Three-Pronged Strategic Approach for 2019 readm more…

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Reduce Risk with Product Substantiation

Susan J. Hewling   When bringing products to market, it is essential to build a platform that allows all information generated to be available for future use,” advised Susan J. Hewlings, PhD, RD, during a preview for her workshop this June at the AAHP Summit in Baltimore. Guest speaker at readm more…

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New Congress, New Landscape: What it Means for the Homeopathic Industry

By Pete Evich, AAHP Government Relations Shutdown Impacts FDA The 116th Congress commenced on Jan. 3 amidst a turbulent backdrop of a partial federal government shutdown. On Jan. 25, after a record-breaking 35-day shutdown, President Trump agreed to sign legislation to fund the impacted federal government agencies until Feb. 15. readm more…

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Outlook 2019: A Letter from the Board

By AAHP Board of Directors 2019 presents a unique crossroad to the homeopathic industry. As consumer demand for our products rises across North America, so does industry growth—and it is poised to continue growing. With this increased visibility comes increased scrutiny from regulatory bodies and potentially unfriendly consumer groups. While readm more…

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Accelerating into the New Year

By Mark Land, AAHP President   As the homeopathic industry continues to grow, AAHP recognizes the need for constant improvement. This year, building on the momentum we gained in 2018, we plan to accelerate our efforts in the areas of advocacy, education, and outreach. All of our efforts aim to readm more…

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Mid-Term Election Results: What the Homeopathic Industry Needs to Know

By Pete Evich, AAHP Government Relations The outcome of the November elections will translate into some significant changes on Capitol Hill over the next two years. In contests for the House of Representatives, a “blue wave” came ashore that will give the Democrats a solid governing majority in the lower readm more…

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2018: A Fast-Paced Year of Advocacy and Education

By AAHP Board of Directors It’s been nearly a year since the U.S. Food and Drug Administration (FDA) published a draft guidance document that would revoke clearly detailed parameters for manufacturing and distributing homeopathic products. The agency proposed a vague, risk-based approach that could hinder, rather than help us produce readm more…

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