US Dietary Supplements - Regulatory Compliance Requirements

Description

This training will review the dietary supplement regulations in the USA and explain how to verify that your products are compliant with the most recent regulations and provisions. It covers the FDA regulatory structure and considerations for manufacturing, labeling and advertising dietary supplements.

Why Should You Attend

With the FDA beginning to take a stronger stance on Dietary Supplement enforcement, it is important for companies to verify that their products comply with the latest regulations and provisions.

This 90-minute training will review the dietary supplement regulations and discuss how to verify that your products are compliant while citing differences with food and drug regulations. We will also cover what qualifies material as a dietary ingredient, considerations for manufacturers and distributors, requirements for compliant labeling, and acceptable marketing claims. An update on the FDA’s draft guidance for New Dietary Ingredients and an overview of the Dietary Supplement Labeling Act (both introduced in 2011) will also be discussed.

Dietary Supplement Overview

• What is a dietary supplement?
• Supplements vs. Pharmaceuticals/OTC Drugs/Conventional Foods.

Regulatory Structure

• FDA Structure regarding Dietary Supplements.
• Industry Groups.

History of Dietary Supplement Regulation

• Early History & DSHE.
• Code of Federal Regulations.

Manufacturing/Distributor Considerations

• Company & Facility Registration.
• GMP Requirements.

Dietary Ingredients

• What qualifies as a dietary ingredient?
• Old dietary ingredients vs. New dietary ingredients.
• New Dietary Ingredient Notification (NDIN).
• Updated New Dietary Ingredient Guidance from FDA.

Labeling Considerations

• Display Panels & Layout.
• Supplement Facts Panel Requirements.
• Labeling Claims.
• Health vs. Disease vs. Structure/Function claims.
• Disclaimers/Substantiation.
• Notification of labeling claims to FDA.
• Dietary Supplement Labeling Act.

Advertising Considerations

• FDA vs. FTC jurisdiction & enforcement.
• Expressed vs. Implied Claims.
• Disclosures & Claim Substantiation.
• Testimonials.

Who will benefit

This course will be beneficial to the following personnel in Dietary Supplement manufacturing companies:

• Executives of Dietary Supplement companies
• Regulatory Compliance Professionals
• Quality Assurance Professionals
• Dietary Supplement Manufacturers
• Dietary Supplement Distributors
• Sales/Marketing Personnel

Additional service: (Personalized session)

We also do various similar customized events for our clients and it is specially tailored as per the client's requirement. We arrange calls between clients and our course instructors to better understand the training requirement and accordingly a training program is designed. The course duration ranges between 90 Mins and 12 hours. Most 6 hours and 12 hours of classes are split into 2 to 3 days considering customer convenience.

We have 500+ consultants who are associated with us and each have their own specialization example GxP, GMP,GLP, 21 CFR, Computer system validation, FDA Audit & Inspection, Bioassays, Design Control, Data Integrity, FDA regulation, Clinical compliance, and almost everything that falls under Risk, Quality and Compliance arena in the Life Science industry.

If you think that your team needs some kind of boost, update or refresher in Risk management and Regulatory compliance then let me know and we can design a highly cost efficient program for you.

Personalized session please contact liz@theiqminds.com