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US Focus: Regulatory Pathways for Dietary Ingredients and Types of Claims

FREE
Erik Hedrick
Tuesday , 17th Dec 2024
Burdock Group
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Background

In the United States, dietary supplements play a significant role in the health and wellness market, providing consumers with a wide range of products designed to support overall health. The regulatory landscape for dietary supplements is shaped by the Dietary Supplement Health and Education Act (DSHEA) of 1994, which establishes the framework for how these products are defined, marketed, and regulated. Unlike drugs, companies are responsible for ensuring that the dietary supplements they sell are safe and properly labeled. Understanding this regulatory environment is crucial for manufacturers aiming to succeed in this competitive market.

In this webinar, ChemLinked has invited Erik Hedrick, EVP and Director of Toxicology at Burdock Group, to discuss the complexities of dietary supplement regulation. The session will cover essential topics, including regulatory agencies, categories, definitions, labeling, claims, and compliance requirements for new dietary ingredients. Additionally, participants will learn about the differences between food additives and GRAS (Generally Recognized as Safe) reviews, and which compliance options may be the most effective for their products.

Notes:

  • Please feel free to send us questions before, during or after the webinar;

  • The webinar livestreaming is freely available to all users. You are welcome to register for and participate in the webinar.

  • The webinar will use the Web conferencing service 'Webex,' and we recommend downloading the client for optimal viewing.

  • Kindly be aware that the access to the slides, recording, and Q&A collection is limited to ChemLinked premium members only [Upgrade now].

Contents

Part 1 Dietary Supplements Definition

Part 2 Competent Authority & Regulatory Framework

Part 3 Compliance for A Dietary Ingredient

Part 4 Labeling and Claims

Contact Information

If you have any questions about this webinar, please contact us at:

EMAIL: contact@chemlinked.com

TEL: +86 (0) 571 8609 4444

Speaker
  • Erik Hedrick
    Director of Toxicology
    Erik received his Ph.D. in Toxicology in 2016 from Texas A&M University and has seven years of post-doctoral experience from Texas A&M University and the Lerner Research Institute of the Cleveland Clinic. With fourteen years of molecular toxicology, medical oncology, cell/molecular biology and biochemistry experience, Dr. Hedrick has acquired extensive experience utilizing in vitro and in vivo molecular, biochemical, and analytical techniques as well as animal husbandry in the field of molecular toxicology and oncology. He has published over 20 peer reviewed publications and has received a Merit Scholars Fellowship, National Institute of Health (NIH) Ruth L Kirschstein National Research Service Award (NRSA), and Early Investigator Research Award through the Prostate Cancer Research Program. He has presented at over 20 scientific conferences including annual SOT meetings. Here at Burdock Group, Erik's role is to ensure the safety and regulatory compliance of a client’s product before it comes out onto the market. His experience in toxicology has equipped him with the toolset to understand the unique safety requirements for an ingredient and what tests are needed to demonstrate safety. He is also familiar with specific regulations pertaining to the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) within the United States as well as with the European Food Safety Authority (EFSA) within the European Union (EU).
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