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 safety …

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, could …

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 …

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 …

SafetyCall’s Accepted Poster Presentations at NACCT

Congratulations to SafetyCall’s Drs. Kelly Sioris and Dan Keyler as well as Dr. Rick Kingston, Dr. Dean Filandrinos, and Ryan Seaverson for getting their abstracts accepted to this year’s North American Congress of Clinical Toxicology (NACCT) meeting! Dr. Kelly Sioris and Dr. Dan Keyler submitted an abstract titled, “K2 and K9s.”  K2, or synthetic cannabinoids, have become increasingly prevalent in …

SafetyCall International Issues Statement Regarding Institute of Medicine’s Food and Dietary Supplement Workshop Summary

Additional post-market surveillance is required to accurately determine potential risks of products containing caffeine SafetyCall International today issued a statement in response to the Institute of Medicine’s (IOM) report released last week, “Examining Safety: Workshop Summary of Caffeine in Food and Dietary Supplements.” SafetyCall’s President of Regulatory and Scientific Affairs Dr. Richard Kingston, who participated in the workshop, stated that …