FDA Regulation of Dietary Supplements Under DSHEA

The regulation of dietary supplements by the FDA under the Dietary Supplement Health and Education Act of 1994 (DSHEA) emphasizes the responsibility of manufacturers and distributors to ensure their products are safe and accurately labelled. Here are some key points regarding recent updates and resources related to dietary supplements:

Recent Developments in Dietary Supplements
  1. Consumer Alerts: The FDA regularly issues updates on new dietary supplement products, including those that have been recalled or are under investigation for safety concerns. Keeping an eye on these updates helps consumers stay informed.
  2. Guidelines for Reporting Issues: Consumers, healthcare practitioners, and others can report problems with dietary supplements. This can include adverse reactions or misleading labelling. The FDA provides guidelines for submitting complaints, which can help improve product safety.
  3. Industry Resources: For manufacturers and distributors, the FDA offers various resources, including application guidelines for new dietary ingredients and information on structure/function claims. These resources are essential for compliance and understanding regulatory expectations.
  4. Adulteration and Misbranding: The FDA has the authority to take action against any dietary supplement that is found to be adulterated or misbranded, which underscores the importance of adherence to safety and labeling standards.
  5. Industry Resources
Guidelines for Manufacturers: The FDA offers applications, guidelines, and resources for industry participants, including information on new dietary ingredients and structure/function claims. These resources are essential for compliance and to understand regulatory expectations. How to Stay Informed
  • Links to Updates: The FDA provides access to constituent updates, press releases, and actions taken against non-compliant products, allowing consumers and industry participants to stay informed.
  • Reporting Problems: If you encounter a dietary supplement that seems unsafe or is misbranded, you can report it to the FDA through their designated channels, ensuring that potential issues are addressed.
    Guideline for Dietary supplements: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-new-dietary-ingredient-notification-master-files-dietary-supplements
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