Dietary Supplement Adverse Event Reporting and Recordkeeping Requirements under the Dietary Supplement and Nonprescription Drug Consumer Protection Act

Why Should You Attend:

Manufacturers, packers and distributors of dietary supplements and nonprescription drugs in the United States are required under federal law to submit reports of serious adverse events. Federal law and FDA regulations dictate the precise requirements as to whom, when and how this information must be submitted. In addition, federal law sets forth the recordkeeping requirements for manufacturers, packers and distributors of dietary supplement products.

This session is designed for manufacturers and labelers of dietary supplement products and is designed to aid both domestic and foreign entities in ensuring compliance with FDA regulations. This session will cover the requirements of the Dietary Supplement and Nonprescription Drug Consumer Protection Act and accompanying FDA regulations.

Areas Covered in the Webinar:

• Detailed overview of the Dietary Supplement and Nonprescription Drug Consumer Protection Act
• Overview of the products and parties subject to reporting and recordkeeping requirements under federal law and FDA regulations.
• Examination of how “serious adverse event” and “adverse event” are defined under the law and how understanding this distinction is critical to knowing when reports must be submitted to the Agency.
• How to properly submit a serious adverse event report to the FDA, including an overview of the minimum data elements.
• Detailed explanation of the recordkeeping requirements applicable to all responsible parties.
• What FDA expects from manufacturers and labelers.
• How failure to comply with the guidelines may affect the manufacturing unit.

Who Will Benefit:

• Dietary supplement manufacturers and facilities responsible for packaging, labeling and distributing dietary supplement products
• Regulatory Affairs
• Documentation
• Senior Management
• Risk Managers
• Legal

Instructor Profile:

Ms. Giannamore, principal attorney at the Law Office of Katherine Giannamore, P.A., helps individuals and companies resolve a wide range of regulatory issues. In addition to helping clients ensure compliance with the laws and regulations pertaining to food labeling, she serves an international clientele in the development of an array of compliant marketing materials, including websites, brochures, infomercials and more. In addition to these services, Ms. Giannamore helps companies who have been targeted as a result of non-compliance by working on their behalf to secure the release of seized goods, submission of reconditioning requests, effectuating removals from import alerts and providing responses to warning letters. In addition to foods, Ms. Giannamore provides regulatory assistance to the many different FDA-regulated industries, including medical devices, cosmetics and drugs. Katherine Giannamore is currently licensed to practice law in the State of Florida and is admitted to practice before the United States Courts of Appeals for the Third Circuit and the Eleventh Circuit.

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