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 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 …

Webinar: The Buzz on Caffeine

Dr. Kingston will join a group of faculty to present a two hour webinar hosted by the Institute of Food Technologists.  More information on the webinar can be found here: http://www.ift.org/knowledge-center/learn-online/live-webcasts/the-buzz-on-caffeine.aspx “The Buzz on Caffeine: New Developments in Safety, Regulation and Adverse Event Reporting” Caffeine, a methylated xanthine, is the most widely used mild central nervous system stimulant, naturally present …

Dr. Kingston Comments at Institute of Medicine’s Caffeine Workshop

Dr. Rick Kingston provided comments at the Institute of Medicine’s Workshop on Potential Health Hazards Associated with Consumption of Caffeine in Food and Dietary Supplements.  The two day workshop took place on August 5-6 in Washington DC and featured comments and presentations from various experts in the industry. Topics and discussions included: Evaluating the epidemiological, toxicological, clinical, and other relevant …

Manufacturers role in adverse event reporting and postmarket surveillance to be discussed at the Human Performance and Dietary Supplements Summit

Rick Kingston, President, Regulatory and Scientific Affairs and Sr. Clinical Toxicologist at SafetyCall International will speak on the topic of adverse event and post market surveillance related to human performance dietary supplement at the upcoming summit sponsored by the NIH Office of Dietary Supplements, NSCA, and Abbott Laboratories. Dietary supplements to enhance athletic and general human performance are widely advertised …

Adverse Event Reports on the Rise – Is there a Safety Issue?

Does FDA’s expectation of increased serious adverse event reports involving dietary supplements signal a safety issue with these products? In recent months, the U.S. Food and Drug Administration (FDA) has been advising dietary supplement companies to review their SOPs regarding adverse event documentation and reporting of serious adverse events to the FDA. FDA believes that there are good indications that …

Can Your Adverse Event Reporting Practices Affect Your Insurance Rates?

Rick Kingston recently spoke at the Consumer Healthcare Products Association’s Regulatory and Scientific Conference regarding Best Practices in Safety Surveillance. During his presentation, Rick explained how dietary supplement firms and manufacturers with best practices in place for adverse event reporting are most likely to receive the best insurance rates. Rick was quoted in “The Tan Sheet” Vol. 20, No. 22 …

The Importance of Best Practices

As Rick Kingston, President of Regulatory and Scientific Affairs at SafetyCall International, has said on numerous occasions, it is important for dietary supplement manufacturers to not only ‘meet the letter of the law’ in regards to manufacturing regulations, but to also define and follow best practices for compliance with these regulations. Dr. Kingston was quoted in “The Tan Sheet” article …

Best Practices in Regulatory Reporting: Are You Compliant with cGMPs?

As Dan Fabricant, Director of the FDA’s Dietary Supplements Program, states in recent communications with Industry, he views the level of non-compliance of dietary supplement manufactures with cGMP’s (current good manufacturing practices) as astonishing. Based on audits that have been completed by the FDA’s compliance division they have estimated that nearly 70% of dietary supplement manufacturers are currently not up …

Is your Company Compliant? Learn More at our “Best Practices” Webinar

“Best Practices” for post-market surveillance & regulatory reporting of dietary supplement and OTC drug adverse events. Although “Best Practice” AE Processes can be fairly straightforward, there are a variety of challenges a manufacturer must overcome when implementing an AE system. These can include designing a database, developing SOP’s for managing, documenting, analyzing and reporting indicated events, and overcoming internal political …