Challenges to Compliance: Understanding Dietary Supplement Oversight by the FDA

90 Minutes
Meredith Crabtree Instructor:
Meredith Crabtree 
Webinar Id:
6 months

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Price Details
$199 Recorded
$399 Corporate Recorded
Price Detail Options

“From Challenges to Compliance: Understanding Dietary Supplement Oversight by the FDA” is a comprehensive training session designed to provide participants with an understanding of the role of the Food and Drug Administration (FDA) in regulating dietary supplements.

The training aims to clarify the purpose and benefits of dietary supplements, highlight the FDA's authority and responsibilities in overseeing the industry, discuss regulatory requirements, and address emerging issues and challenges.

The training will emphasize the importance of dietary supplements and the need for effective oversight. Participants will gain insights into the different types of dietary supplements available in the market, their benefits, and potential risks. Common misconceptions and challenges in the industry will also be addressed.

The session then dives into the role of the FDA in regulating dietary supplements. Participants will learn about the FDA's authority and the impact of the Dietary Supplement Health and Education Act (DSHEA) on supplement regulation. The training explores the FDA's regulatory framework, including labeling and claims requirements, the New Dietary Ingredient (NDI) notification process, and good manufacturing practices (GMPs) for dietary supplement manufacturers. The FDA's post-market surveillance and adverse event reporting system will also be discussed.

Challenges and concerns in dietary supplement oversight will be explored, including product safety, mislabeling, adulteration, and deceptive marketing practices. The implications of contaminated or adulterated supplements will be highlighted, underscoring the importance of consumer awareness and education in mitigating risks.

The training will have a discussion on future developments and emerging issues in dietary supplement regulation. Participants will explore ongoing efforts to strengthen the FDA's oversight of the industry and examine emerging topics such as CBD and hemp-derived products, novel ingredients, and personalized nutrition. The importance of staying informed about regulatory updates and changes will be emphasized.

Overall, this training aims to equip participants with the knowledge and awareness necessary to navigate the complex landscape of dietary supplement regulation and make informed decisions as consumers or industry stakeholders.

Why should you Attend: Attending this training offers invaluable insights into the intricate landscape of FDA oversight within the dietary supplement industry, providing a comprehensive understanding that is essential for professionals and consumers alike. Firstly, it elucidates the FDA's authority and responsibilities, illuminating the regulatory framework that governs dietary supplements. This knowledge is indispensable for stakeholders such as manufacturers, marketers, retailers, healthcare professionals, and consumers, enabling them to navigate the regulatory landscape confidently and make informed decisions.

Moreover, the training delves into compliance with regulatory requirements, shedding light on labeling, claims, and manufacturing practices mandated by the FDA. Understanding and adhering to these requirements are paramount for avoiding non-compliance penalties, product recalls, or legal entanglements, safeguarding both businesses and consumers.

The training also addresses product safety and quality control, highlighting FDA regulations and guidelines pertaining to product testing, ingredient sourcing, and manufacturing practices. By prioritizing consumer safety and producing high-quality supplements, industry professionals can bolster trust and credibility within the market.

Furthermore, attendees gain insights into risk mitigation strategies, learning to identify and address potential pitfalls such as mislabeling, adulteration, and deceptive marketing practices. This proactive approach not only protects consumers but also upholds the integrity of the dietary supplement industry.

The training also explores emerging issues and trends, equipping participants with knowledge about evolving regulatory landscapes and industry developments. From the regulation of CBD and hemp-derived products to novel ingredients and personalized nutrition, staying informed is crucial for adaptation and decision-making.

For consumers, the training fosters empowerment through knowledge, enabling them to discern reliable products, recognize potential risks, and make informed choices regarding supplement usage.

Areas Covered in the Session:

  • Understanding Dietary Supplements:
    • Definition and purpose of dietary supplements
    • Types of dietary supplements
    • Benefits and potential risks associated with dietary supplement usage
    • Common misconceptions and challenges in the industry
  • The Role of the FDA
    • Introduction to the Food and Drug Administration (FDA)
    • FDA's authority in regulating dietary supplements
    • Overview of the Dietary Supplement Health and Education Act (DSHEA)
    • FDA's responsibilities and limitations in overseeing the industry
  • FDA Regulations and Requirements for Dietary Supplements
    • Labelling and claims requirements for dietary supplement products
    • New Dietary Ingredient (NDI) notification process
    • Good Manufacturing Practices (GMPs) for dietary supplement manufacturers
    • Ensuring product quality and safety
  • Post-Market Surveillance and Adverse Event Reporting
    • FDA's post-market surveillance system for dietary supplements
    • Adverse event reporting requirements and processes
    • FDA's actions in response to reported adverse events
  • Challenges and Concerns in Dietary Supplement Oversight
    • Product safety concerns and regulatory challenges
    • Mislabelling, adulteration, and deceptive marketing practices
    • Implications of contaminated or adulterated supplements
  • Emerging Issues and Future Developments
    • Current trends and developments in dietary supplement regulation
    • CBD and hemp-derived products
    • Novel ingredients and personalized nutrition
    • Staying updated with regulatory changes
  • Promoting Consumer Awareness
    • Importance of consumer education in making informed decisions
    • Identifying reliable products and recognizing potential risks
    • Navigating the dietary supplement market effectively

Who Will Benefit:
  • 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

Speaker Profile
Meredith L. Crabtree has over 30 years’ experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health. This includes manufacturing, packaging, labelling and distribution operations. Meredith is the owner of MLKC Consulting is s a Quality Consultant specializing in product label reviews, 3rd party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality trainings.

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