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 …

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 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

EPA changes in pest management regulatory reporting programsIt 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 …

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 …