The US FDA and Dietary Supplement Oversight" explores the crucial role of the U.S. Food and Drug Administration (FDA) in regulating the rapidly growing dietary supplement industry. This training provides a deep understanding of FDA oversight, challenges faced, and key regulations.
The dietary supplement industry, comprising vitamins, minerals, herbs, and more, presents unique regulatory challenges separate from drugs. The training introduces participants to supplement types, FDA responsibilities, and regulations for safety and accurate labeling.
The FDA oversees the industry by establishing guidelines, monitoring safety, and enforcing regulations against deceptive marketing. The training delves into challenges, such as the absence of pre-market approval and limited FDA resources impacting comprehensive regulation. Adverse event reporting and monitoring are highlighted for strengthening oversight.
The focus shifts to regulations, emphasizing the Dietary Supplement Health and Education Act (DSHEA) of 1994, Good Manufacturing Practices (cGMP), and the New Dietary Ingredient (NDI) notification process. Safety considerations, including ingredient safety assessments, risks, contamination, and interactions with medications, are explored to ensure transparency and informed choices.
Labeling and advertising requirements are crucial for consumer understanding. The training covers nutrition facts, claims, disclaimers, and ingredient lists. Enforcement actions by the FDA, including inspections, warning letters, recalls, and potential legal consequences for non-compliance, are discussed to emphasize the importance of compliance programs.
The training concludes by highlighting reliable information sources, such as the FDA's website and guidance documents. Participants are encouraged to use authoritative resources and understand the role of healthcare professionals in providing accurate information for informed decision-making.
In summary, "The US FDA and Dietary Supplement Oversight" equips participants with comprehensive knowledge of the FDA's role, industry challenges, and regulatory compliance, ensuring they can navigate the complex dietary supplement landscape and contribute to consumer safety and transparency.
WHY SHOULD YOU ATTEND?
Stay on top of the rules and keep people safe in the growing dietary supplement industry. Learn all about how the FDA looks after these supplements and what rules they follow. This training will give you the know-how and tools to understand how supplements are regulated, avoid risks, and follow the rules. Don't let false claims, harmful substances, or rule-breaking harm your reputation or people's health. Join us to stay in the loop, protect your business, and make smart choices in the changing world of supplement regulations.
AREA COVERED
- Introduction to dietary supplements and their distinction from pharmaceutical drugs
- Overview of the FDA's role and responsibilities in dietary supplement oversight
- Challenges in regulating dietary supplements.
- Understanding the Dietary Supplement Health and Education Act (DSHEA) of 1994
- Current Good Manufacturing Practices (cGMP) specific to dietary supplements
- New Dietary Ingredient (NDI) notification process
- Safety considerations for dietary supplements, including ingredient safety and potential risks.
- Contamination and adulteration issues in the dietary supplement industry
- Interactions between dietary supplements and medications or other substances
- Labeling and advertising requirements, including nutrition facts, claims, disclaimers, and ingredient lists
- Structure-function claims and health claims
- Considerations for using terms like "natural" and "organic" in labeling
- FDA's enforcement actions, such as inspections, sampling, warning letters, recalls, and potential criminal investigations
- Reliable sources of information for consumers and healthcare professionals regarding dietary supplements
- The role of healthcare professionals in counseling patients about dietary supplement use
LEARNING OBJECTIVES
- Understanding FDA's Role and Responsibilities
- Identifying Unique Challenges in Dietary Supplement Regulation
- Knowledge of Regulatory Framework
- Ensuring Product Safety and Compliance
- Safety Considerations and Risk Assessment
- Labeling and Advertising Requirements
- Consumer Information and Healthcare Professional Guidance
- Promoting Consumer Safety and Transparency
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
Stay on top of the rules and keep people safe in the growing dietary supplement industry. Learn all about how the FDA looks after these supplements and what rules they follow. This training will give you the know-how and tools to understand how supplements are regulated, avoid risks, and follow the rules. Don't let false claims, harmful substances, or rule-breaking harm your reputation or people's health. Join us to stay in the loop, protect your business, and make smart choices in the changing world of supplement regulations.
- Introduction to dietary supplements and their distinction from pharmaceutical drugs
- Overview of the FDA's role and responsibilities in dietary supplement oversight
- Challenges in regulating dietary supplements.
- Understanding the Dietary Supplement Health and Education Act (DSHEA) of 1994
- Current Good Manufacturing Practices (cGMP) specific to dietary supplements
- New Dietary Ingredient (NDI) notification process
- Safety considerations for dietary supplements, including ingredient safety and potential risks.
- Contamination and adulteration issues in the dietary supplement industry
- Interactions between dietary supplements and medications or other substances
- Labeling and advertising requirements, including nutrition facts, claims, disclaimers, and ingredient lists
- Structure-function claims and health claims
- Considerations for using terms like "natural" and "organic" in labeling
- FDA's enforcement actions, such as inspections, sampling, warning letters, recalls, and potential criminal investigations
- Reliable sources of information for consumers and healthcare professionals regarding dietary supplements
- The role of healthcare professionals in counseling patients about dietary supplement use
- Understanding FDA's Role and Responsibilities
- Identifying Unique Challenges in Dietary Supplement Regulation
- Knowledge of Regulatory Framework
- Ensuring Product Safety and Compliance
- Safety Considerations and Risk Assessment
- Labeling and Advertising Requirements
- Consumer Information and Healthcare Professional Guidance
- Promoting Consumer Safety and Transparency
- 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
![ins_img](/Speaker_Pics/MeredithCrabtree.jpg)
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.
Upcoming Webinars
![](https://247compliance.com/Speaker_Pics/planing.jpg )
![](/static/images/default-webinar-info.jpg)
Artificial Intelligence (AI), Machine Learning, and FDA Com…
![](https://247compliance.com/static/images/hr-employee.jpg)
Female to Female Hostility @Workplace: All you Need to Know
![](/static/images/default-webinar-info.jpg)
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
![](/static/images/default-webinar-info.jpg)
2024 EEOC & Employers: Investigating Claims of Harassment &…
![](/static/images/default-webinar-info.jpg)
Transforming Anger And Conflict Into Collaborative Problem …
![](/static/images/default-webinar-info.jpg)
Recruiting is Easy: Using a Sales and Marketing Approach
![](https://247compliance.com/static/images/fatal-errors.jpg)
How to Write Procedures to Avoid Human Errors
![](/static/images/default-webinar-info.jpg)
Dynamic Presentations: Advanced Techniques with PowerPoint …
![](https://247compliance.com/static/images/peer-to-boss.jpg)
![](https://247compliance.com/static/images/fda-ai.jpg)
FDA Regulation of Artificial Intelligence/ Machine Learning
![](/static/images/default-webinar-info.jpg)
Behavioral Issues, Conflict and Incivility in The Workplace…
![](/static/images/default-webinar-info.jpg)
Marketing to Medicare or Medicaid Beneficiaries - What You …
![](/static/images/default-webinar-info.jpg)
Onboarding is Not Orientation: How to Improve Your New Hire…
![](https://247compliance.com/Speaker_Pics/qalification.jpg)
Effective Onboarding: How to Welcome, Engage, and Retain Ne…
![](/static/images/default-webinar-info.jpg)
6-Hour Virtual Seminar on Learning the Highlights of Excel …
![](https://247compliance.com/Speaker_Pics/laboratory-3827743_960_720.jpg)
Impact Assessments For Supplier Change Notices
![](/static/images/default-webinar-info.jpg)
Developing an FDA/ISO Compliant Quality Management System
![](/static/images/default-webinar-info.jpg)
Aligning Your HR Strategy with Your Business Strategy
![](https://247compliance.com/Speaker_Pics/vda.jpg)
Accounting For Non Accountants : Debit, Credits And Financi…
![](https://247compliance.com/static/images/travel-expenses.webp)
Dealing With Difficult People In Life & Work
![](/static/images/default-webinar-info.jpg)
Managing Difficult Employee Conversations
![](/static/images/default-webinar-info.jpg)
I-9 Audits: Strengthening Your Immigration Compliance Strat…
![](/static/images/default-webinar-info.jpg)
Essential Job Functions According to the American with Disa…
![](/static/images/default-webinar-info.jpg)
Pay Equity Changes for 2024! What Employers Need to Know to…
![](/static/images/default-webinar-info.jpg)
![](/static/images/default-webinar-info.jpg)
Leader Branding: How to Communicate with Confidence to Attr…
![](https://247compliance.com/Speaker_Pics/currency-3118767_960_720.jpg)
Why EBITDA Doesn't Spell Cash Flow and What Does
![](/static/images/default-webinar-info.jpg)
Design Verification, Validation and Testing for Medical Dev…
![](https://247compliance.com/Speaker_Pics/oo.jpg)
FFIEC BSA/AML Examination Manual: What Compliance Officers …
![](/static/images/default-webinar-info.jpg)
Project Management for Non-Project Managers - How to commun…
![](/static/images/default-webinar-info.jpg)
Data Integrity and Privacy: Compliance with 21 CFR Part 11,…
![](https://247compliance.com/Speaker_Pics/ver.jpg )
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
![](/static/images/default-webinar-info.jpg)
Employee or Independent Contractor – U.S DOL Announces 2024…
![](https://247compliance.com/static/images/73.jpg)
![](/static/images/default-webinar-info.jpg)
Best Practices in Complaint Management for Regulatory Compl…
![](/static/images/default-webinar-info.jpg)
Ensuring Safe and Effective Pharmaceutical Products: A Comp…
![](https://247compliance.com/Speaker_Pics/laboratory-3827743_960_720.jpg)
![](https://247compliance.com/Speaker_Pics/download.jpg)
Human Factors Usability Studies Following ISO 62366 and FDA…
![](/static/images/default-webinar-info.jpg)
![](/static/images/default-webinar-info.jpg)
Tattoos, hijabs, piercings, and pink hair: The challenges …
![](/static/images/default-webinar-info.jpg)
Gossip-Free: Leadership Techniques to Quell Office Chatter
![](/static/images/default-webinar-info.jpg)
Updated Metro 2®, e-OSCAR and the New Tougher FCRA/CFPB Com…
![](https://247compliance.com/Speaker_Pics/files.jpg)
Form W-9 Compliance to Avoid Penalties: TIN Verification, B…
![](https://247compliance.com/Speaker_Pics/tax-blog1.png)
Understanding and Analyzing Financial Statements
![](/static/images/default-webinar-info.jpg)
Divorce, Adoption and Other Special Tax Topics
![](/static/images/default-webinar-info.jpg)
Setting up Quality System for FDA Regulated Products: Tips …
![](/static/images/default-webinar-info.jpg)
Is Your Culture Working For or Against Your Success? If You…
![](https://247compliance.com/static/images/sick.jpg)
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
![](/static/images/default-webinar-info.jpg)