Regulatory
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Affairs, Standard Homeopathic Company/Hyland’s, Inc. In April 2019, U.S. Food & Drug Administration (FDA) published a draft guidance* Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C (“the Draft Guidance”).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…
Read MoreInitiation of Voluntary Recalls: Draft Guidance for Industry and FDA Staff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…
Read MoreOverview: 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…
Read MoreReduce 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…
Read MoreNew 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…
Read MoreOutlook 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…
Read MoreAccelerating 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…
Read MoreMid-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…
Read More2018: 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…
Read MoreA Brief Regulatory History of Process Validation
By Mark Land, AAHP President Finished product testing is probabilistic and not dispositive of process control; that is why we need process validation. While preparing this article I came across several histories of process validation. One that caught my attention was a book chapter written by Bernard Loftus, formerly readm more…
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