AHPA Webinar: Setting Specifications on Strength & Composition

• By: AHPA
• On: 01/18/2023 06:33:52
• In: AHPA News

January 18, 2023

The industry has seen an increase in FDA scrutiny, causing confusion about the FDA's guidance on the strengths and composition of finished dietary supplement products and ingredients. Though there has been no change in regulation, FDA has expressed “concern” that botanical ingredients are not uniformly distributed throughout product batches and wants to see that testing, dictated on the product specification, is conducted to ensure this uniformity. This is a long-standing issue for all companies, big and small. Get a diverse perspective from industry experts and learn how to navigate this conversation with FDA.

Join us for this webinar on February 21, 2023 to learn more about the FDA's guidance on the strengths and composition of finished dietary supplement products and ingredients, including:

• What compliance means under 21 CFR 111.70 and 21 CFR 111.75

• Acceptable documentation to show FDA that specifications on strength & composition are met

• What to do if you disagree with an investigator

• AHPA's resources to help protect your business from this issue

Presenters:

• Staci Eisner, Vice President of Quality and Regulatory Affairs, Cortex Scientific Botanicals

• Tara Couch, Owner, TLC Regulatory and Laboratory Consulting

• Will Woodlee, Partner, Kleinfeld Kaplan Becker LLP

Registration Cost:

• AHPA Members: $199

• Non-Members: $399