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Event Details
Recorded: Oct. 1, 2019
Duration: 2 hours
Cost:
- Members - $199
- Non-Members - $399
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Dr. Rick Kingston, an industry expert with more than 35-years of experience, presents on serious adverse event report (SAER) data and observations. Ashish Talati, a partner with Amin Talati & Wasserman and one of the industry’s foremost experts on Food and Drug Administration (FDA) regulatory matters, joins Dr. Kingston to review dietary supplement legal and regulatory SAER obligations. In addition, AHPA Chief Information Officer Dr. Merle Zimmermann presents an overview of recent FDA recall data.
SAERs
The Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 placed new responsibilities on certain companies that sell dietary supplements and nonprescription (over-the-counter) drugs to receive adverse events associated with their products used in the U.S., and to submit to FDA any reports that meet the law’s definition of “serious.” These obligations went into effect in December 2007, and FDA published Guidance for Industry in June 2009 to describe the minimum data elements that should be included when reporting SAERs associated with dietary supplements to FDA.
FDA Recalls
AHPA staff analyzed recent FDA recall data and found that 14 of 803 (1.7 percent) recorded recalls initiated in 2019 involved dietary supplements, and among these, three were Class I recalls (the most serious recall class). FDA is responsible for the safety of most foods including dietary supplements, drugs (both prescription and nonprescription OTC drugs), biologics, medical devices, radiation-emitting products, cosmetics, veterinary products, and tobacco products. These regulatory activities include tracking and reporting on product recalls.
AHPA staff also analyzed the reasons for these recent supplement product recalls and found the most common reasons for conducting a recall were the risk of microbial contamination (29 percent, 4 cases) or mislabeling, including incorrect amounts of ingredients and omitted excipients (21 percent, 3 cases), or the presence of unlabeled allergens, (14 percent, 2 cases).
Answers to your questions
A 20-30-minute Q&A session follows the speaker presentations to answer attendees' specific questions.
Topics
- Your legal obligations under the Dietary Supplement and Nonprescription Drug Consumer Protection Act
- SAER data and observations
- In-depth analysis of recent FDA recall data
Presenters
- Rick Kingston, PharmD., President, Regulatory and Scientific Affairs, SafetyCall International, PLLC
- Merle Zimmermann, Ph.D., Chief Information Analyst, American Herbal Products Association (AHPA)
- Ashish Talati, Esq., Partner at Amin Talati & Wasserman