This webinar is designed to help businesses in the dietary supplement industry understand the elements of current Good Manufacturing Practice (cGMP) regulations (21 CFR 111) that have been the primary focus of FDA inspections. This knowledge will assist businesses in better allocating and directing their compliance resources.

Learn from our panel that includes an industry attorney and scientist, who address legal standards, today’s regulatory environment, and the lawsuit risks and liabilities marketers face if claims are not adequately substantiated. The panel will also include an FTC representative, who provides the agency’s perspective, updates on recent enforcement actions, and a discussion of the level of substantiation respondents in those actions possessed or did not possess.

This AHPA webinar reviews recent changes to CA Prop 65 and how other provisions of this state law apply to the legal cannabis industry, including marketers of hemp-derived CBD products.

Recorded October 29, 2019, this webinar offers expert insights into the nutrition labeling requirements for foods and dietary supplements are scheduled to take effect January 1, 2020 for manufacturers with $10 million or more in annual sales and January 1, 2021 for smaller manufacturers.

Dr. Rick Kingston, an industry expert with more than 35-years of experience, presents on serious adverse event report (SAER) data and observations. Ashish Talati, a partner with Amin Talati & Wasserman and one of the industry’s foremost experts on FDA regulatory matters, joins Dr. Kingston to review dietary supplement legal and regulatory SAER obligations. In addition, AHPA Chief Information Officer Dr. Merle Zimmermann presents an overview of recent FDA recall data.

Congress passed a Farm Bill in 2018 that included historic provisions to legalize hemp, the low THC cultivars of the Cannabis sativa L. species. This landmark legislation changes how hemp and hemp-derived products like cannabidiol (CBD) are regulated in the U.S. To help the herbal products industry understand the new regulatory landscape, AHPA has expanded this Status Report and to answer industry questions about the new legal landscape.

AHPA partnered with the Global Retailer and Manufacturer Alliance (GRMA) to present this free webinar on February 26, 2019 to provide the herbal industry with specific details on the benefits and implementation costs of the new GRMA ANSI-accredited auditing standards.

AHPA partnered with the Hemp Industries Association (HIA) to present a webinar on Feb. 21 aimed at helping the herbal products industry understand the evolving regulatory landscape for hemp and cannabidiol (CBD) products.

Effective January 3, 2020, the Office of Environmental Health Hazard Assessment added cannabis (marijuana) smoke and Δ9-tetrahydrocannabinol (Δ9-THC) to the list of chemicals known to the state to cause reproductive toxicity (developmental endpoint) for purposes of California Proposition 65 (Prop 65). At a public meeting on December 11, 2019, the Developmental and Reproductive Toxicant Identification Committee (DARTIC) in its official capacity as the “state’s qualified experts” determined that cannabis (marijuana) smoke and Δ9-tetrahydrocannabinol (Δ9-THC) were shown to cause reproductive toxicity based on the developmental endpoint.

Two-part webinar will provide data on recent FDA inspections, an overview of emerging compliance issues and strategies for responding to an FDA 483 in order to avoid an FDA warning letter.