Recently, Harvard researchers conducted a study involving dietary supplements, later published in the Journal of Adolescent Health, to review adverse event reports from January 2004 to April 2015 using data from the FDA Adverse Event Reporting System (FAERS). The FAERS is a database that contains line listings of select fields of data from Adverse Event (AE) reports contained in …
SafetyCall Weighs in on Statement from FDA Commissioner on Agency’s New Efforts to Strengthen Regulation of Dietary Supplements
Rick Kingston, PharmD
President, Regulatory and Scientific Affairs & Sr. Clinical Toxicologist
Many SafetyCall clients that manufacturer and distribute dietary supplements have likely seen the recent press release by FDA Commissioner Dr. Scott Gottlieb.
One thing that is clear, the FDA plans to crack down on companies that intentionally adulterate their products with unapproved ingredients. These companies put responsible manufacturers …
Cochrane review of carotenoids’ role
A recent Cochrane review entitled “Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration” provided a useful review of the science on the topic. But, like many studies that review or discuss the use of dietary supplements, the authors qualified the positive data with an often times used cliché suggesting there just “might” be a …
Podcast: Potential Implications of FDA’s AER Database
As previously published and shared on Natural Products Insider.
In an effort to promote transparency, FDA improved access to adverse events reports (AERs) via an online database that provides a variety of information in a search-friendly format. Though the database is intended to be a tool, the type and breadth of information, along with how the information is presented, …
FDA Now Making Data Available from CFSAN’s Adverse Event Reporting System (CAERS)
As part of the FDA’s commitment to transparency, for the first time it has begun posting data from CFSAN’s Adverse Event Reporting System (CAERS) on FDA.gov here and through OpenFDA. It’s downloadable in ASCII format, which is amenable to automated querying.
The database contains information on adverse event and product complaint reports submitted to the FDA for Center for Food …
Changes Coming to the EPA’s Adverse Event Reporting System
By Rick Kingston, President, Regulatory and Scientific Affairs
It has been a number of years since there has been any change to the EPA’s adverse event reporting systems. The last major change came in with passage of the 6(a)(2) provision in 1997, which set forth requirements for reporting of adverse events involving EPA registered products. EPA subsequently put out PR …
Kelly Sioris – Mentor of the Year
A huge congratulations to SafetyCall’s Dr. Kelly Sioris on being recognized as the University of Minnesota College of Pharmacy Mentor of the Year for 2014! Kelly was nominated by her students and was selected out of 450 other mentors to win the award. According to the University’s website, the Mentor of the Year is an individual who has shown support …
Celebrate the Dietary Supplement Health and Education Act with CRN
The Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, invites you to join a month-long celebration of the 20th anniversary of the Dietary Supplement Health and Education Act (DSHEA). The celebratory effort will make strong use of CRN’s online platforms throughout the month of October, and involve consumer education; recognition of …
Adverse Event Reporting Webinar
Title: The Importance of a Robust Adverse Event Reporting System
Date: Wednesday, October 29, 2014
Time: 2:00 PM Eastern / 11:00 AM Pacific
Register here
The What, When, Why and How of Serious Adverse Event Reporting
Serious Adverse Event Reports (SAERs) should be a major concern for dietary supplement companies as adverse events can happen at any time. SAER issues …
Adverse Event Reporting Provides Valuable Data To Companies
Dr. Rick Kingston was interviewed at this year’s SupplySide West about Adverse Event Reporting and the importance of having a system in place to monitor your adverse events. You can view his interview and read more here.
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