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 …

Adverse Event Management Services for Dietary Supplement Companies

By Rick Kingston, President, Regulatory and Scientific Affairs In recent years, the FDA has increased inspections of dietary supplement companies regarding good manufacturing practices (GMPs), which include the processes, procedures and documentation that ensure the product is indeed what appears on the label. During the inspection process, the company’s adverse event documentation and serious adverse event reporting systems (SAERs), or …

CRN Presents Free Webinar on Supplement Safety

Dr. Rick Kington will be the featured presenter during a free webinar for pharmacists and nurse practitioners (NPs) on dietary supplements and adverse event reporting results.  The webinar is sponsored by The Council for Responsible Nutrition (CRN) and will take place on Thursday, March 3, at 1:00pm Eastern.  The webinar is presented exclusively to members of Skipta’s Pharmacist Society and …

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 Exhibiting and Presenting at IFT

SafetyCall International will be exhibiting at the 2014 IFT Annual Meeting, a conference which brings together professionals throughout the food industry, including experts in R&D, product development, and QA/QC.  SafetyCall will be at Booth #100.  Stop by to meet some of our key staff members and learn how we can help support product surveillance for reportable foods and dietary supplements. …

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 …