From Challenges to Compliance: Understanding Dietary Supplement Oversight by the FDA

Dietary supplements, including vitamins, minerals and herbs, are regulated differently from drugs, which creates its own compliance challenges. This 90-minute webinar on FDA dietary supplement oversight explains how the agency sets guidelines, monitors safety and acts against deceptive marketing.

You'll review the Dietary Supplement Health and Education Act (DSHEA) of 1994, supplement cGMPs and the New Dietary Ingredient (NDI) notification process, along with the limits of oversight when there is no pre-market approval and FDA resources are limited.

The session also covers ingredient safety, contamination and drug interactions, labeling and advertising rules, adverse event reporting, FDA enforcement actions, and reliable information sources for consumers and healthcare professionals.

• Explain the FDA's role and responsibilities for dietary supplements
• Identify the unique challenges in regulating supplements
• Apply the regulatory framework, including DSHEA, cGMP and NDI notifications
• Assess safety risks such as contamination and drug interactions
• Meet labeling and advertising requirements for claims and disclaimers
• Describe FDA enforcement actions and the consequences of non-compliance
• Point consumers and healthcare professionals to reliable information

Oversight and regulation

• Dietary supplements and how they differ from pharmaceutical drugs
• The FDA's role and responsibilities in supplement oversight
• Challenges in regulating dietary supplements
• The Dietary Supplement Health and Education Act (DSHEA) of 1994
• Current Good Manufacturing Practices (cGMP) for dietary supplements
• The New Dietary Ingredient (NDI) notification process

Safety

• Ingredient safety and potential risks
• Contamination and adulteration issues
• Interactions with medications and other substances

Labeling, claims and enforcement

• Labeling and advertising requirements: nutrition facts, claims, disclaimers and ingredient lists
• Structure-function claims and health claims
• Using terms like "natural" and "organic" on labels
• FDA enforcement: inspections, sampling, warning letters, recalls and potential criminal investigations
• Reliable information sources for consumers and healthcare professionals
• The role of healthcare professionals in counseling patients on supplement use

False claims, harmful ingredients or broken rules can damage both your reputation and people's health. This training explains how supplements are regulated so you can manage risk and stay compliant as the industry grows.

It suits QA and QC staff, regulatory affairs and compliance professionals, product development scientists, supplement marketing and sales teams, consumer advocacy groups, health and wellness coaches, and nutrition educators.

• Quality assurance and quality control personnel
• Regulatory affairs professionals
• Compliance officers
• Product development and formulation scientists
• Marketing and sales professionals in the dietary supplement industry
• Consumer advocacy groups or organizations interested in dietary supplement regulation.
• Health and wellness coaches
• Educators or instructors in the field of nutrition and supplements

Meredith Crabtree has over 25 years’ experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical devices, Cosmetics, Supplements, and Animal Health manufacturing and distribution. Meredith works as a Quality Consultant performing label reviews, 3rd party inspections, Consent Decree, and Recall support. She also performs regulatory assessments and Quality training. Meredith has a degree in Medical Technology and is currently obtaining a degree in Quality Systems.