This webinar will help you understand the new FDA regulations directed to the place of New Dietary Ingredients in the FDA regulatory Scheme.
Why Should You Attend:
Both foods and drugs have been regulated by the Food and Drug Administration (FDA). There has been a class of entities, since 1997 known as new dietary ingredients that had formerly been largely unidentified. This class of extracts and compounds and the like is coming under new scrutiny and regulation. A burden is being placed on those in the food production and distribution network. Don’t learn about these by receiving a warning letter or other formal action from the FDA. Be proactive and identify and reduce or eliminate your production, documentation and legal risks.
The FDA has recently issued draft guidelines interpreting the 1997 rules directed to new dietary ingredients. The risk of seizure and fines based on charges of adulteration and mislabeling are real.
This seminar will help you understand the new FDA regulations directed to the place of New Dietary Ingredients in the FDA regulatory Scheme.
Areas Covered in the Seminar:
A series of guidelines interpreting the original rules, including:
- Brief History of regulation of dietary supplements.
- How to identify a new dietary ingredient?
- When you must notify FDA about a new dietary ingredient?
- What information the FDA notification must contain?
- What kind of safety studies will FDA accept?
- How and when should I conduct and report toxicity research?
Who Will Benefit:
This webinar will provide valuable assistance to all (pharmaceutical and food) companies/ manufacturing sites. Those that would benefit most would be:
- Technical Directors / VP's
- Hazard Analysis Critical Control Point (HACCP) Coordinators
- Food and supplement Operations / Production Managers
- Food and supplement Quality Assurance Managers
Instructor Profile:
Dr. Lindon, has been a pharmacist since 1986 and a practicing attorney since 1997. He completed his baccalaureate degree in pharmacy in 1986 and doctorate degree in pharmacy in 1987 and doctorate degree in philosophy in 1992 from the University of Arizona. He completed his juris doctor degree from Ohio Northern University in 1997. He has practiced pharmacy in a variety of institutional and ambulatory settings. He has represented parties before Boards of Pharmacy and civil and criminal courts. He participates as an author in the WebMD “Ask the Expert” panel dealing the pharmacy law topics. He is also registered to practice patent law before the United States Patent and Trademark Office.
