With an increasing focus on “holistic wellness” in both the US and globally, the dietary supplement industry is playing a more and more important role for U.S. consumers. As such, the spotlight on dietary supplement Good Manufacturing Practices (GMPs) shines brighter than ever before – with increased attention being paid by industry, regulators and enforcers. As GMP standards evolve, industry uncertainty about the specifics of the regulations result in numerous FDA observations and Warning Letters a year.

This Boot Camp will provide dietary supplement companies and their counsel with a thorough understanding of 21 CFR 111 and other statutory GMP requirements which are applicable to all companies who manufacture, label, pack or hold dietary supplements for sale in the United States, including those who engage in the testing, quality control and distribution of supplements.

Topics of discussion will include:

• Breaking down 21 CFR 111: outlining the full scope of regulations for dietary supplements in the United States
Understanding the core responsibilities imposed on supplement brand owners, manufacturers, packers, labelers and holders of dietary supplements Practical guidance on how to apply current GMP requirements at your company/facility Analyzing the latest trends in FDA Form 483 observations and warning letters being issued to dietary supplement companies
• What are the most commonly cited issues?
• Exploring recent FDA enforcement activity against dietary supplement companies stemming from GMP violations