cGMP Responsibilities for Own Label Distributors and Brand Owners

Presented by Shelly Blackwell

December 18, 2025, 1pm (eastern)

Own Label Distributors (OLD) in the dietary supplement industry often question their responsibilities for complying with current Good Manufacturing Practices (cGMP’s) required by FDA regulations. They sometimes incorrectly think that GMP responsibilities fall on the Contract Manufacturing Organization (CMO) alone. However, recent FDA enforcement has emphasized that brand owners, or “Own Label Distributors” (OLD’s) are ultimately responsible for the quality of their products, even when the products are manufactured by a CMO. This seminar will help you understand how to meet the requirements of an Own Label Distributor and comply with FDA regulations.

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About the Presenters

Shelly Blackwell

Senior Director for Dietary Supplement and Tobacco Services

Shelly Blackwell brings over 22 years of quality and compliance experience in highly regulated environments to the EAS Consulting Group. After starting her career as a Microbiologist, she gained expert knowledge of a variety of domestic and international regulations while holding senior leadership positions in the dietary supplement, pharmaceutical, and medical device industries. These positions include 7 years as the Quality Assurance Director for GNC / Nutra Manufacturing and most recently leading the Quality Systems and Compliance Team at Bausch and Lomb in Greenville, SC.

Shelly’s accomplishments while leading Quality teams include developing supplier qualification programs, sourcing and implementing electronic QMS systems, implementing inspection readiness programs resulting in improved regulatory standing, risk-based quality system development, data integrity program development, and numerous successful continuous improvement initiatives. She has lead FDA and other regulatory inspections throughout her career and is also a lead auditor herself, auditing raw material suppliers and finished product manufacturers all over the world. Shelly holds certifications from the American Society of Quality and the Institute of Food Technology and has a Biology degree from James Madison University.