Post-market surveillance system for dietary supplements should contain a process for identifying sentinel events, or low-incidence and unusual adverse events that can indicate big problems, says a toxicologist speaking during a recent Council for Responsible Nutrition webinar.
Post-market surveillance for a dietary supplement should include identifying “sentinel" adverse events, low-incidence or unusual reports that can signal major issues such as bacterial contamination or formula counterfeiting, according to toxicologist and industry consultant Rick Kingston.
“Sentinel events are essentially the canary in the coal mine,” said Kingston during a recent Council for Responsible Nutrition webinar.
Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.
Dietary supplements containing estragole may have to be removed from the European Union market due to carcinogenic risk, according to a draft scientific opinion from EFSA that is currently out for consultation.
What's going on with the EU Green Claims Directive? HBW Insight speaks to the European Commission, Parliament and Council to find out why trilogue negotiations seem to have stalled.
Recent warning letters to seven companies marketing products with kratom extract known as 7-OH are FDA’s first in three years referencing unlawful products containing kratom and the first of all its kratom-related warnings to reference extracts from the botanical.
Explaining he was a heroin addict for 14 years more than 40 years ago “because it was so available,” Secretary Kennedy says “our agencies have been asleep in the wheel” but “now we're going to wake up and we're going to start to stop this before it starts.”
What's going on with the EU Green Claims Directive? HBW Insight speaks to the European Commission, Parliament and Council to find out why trilogue negotiations seem to have stalled.
Recent warning letters to seven companies marketing products with kratom extract known as 7-OH are FDA’s first in three years referencing unlawful products containing kratom and the first of all its kratom-related warnings to reference extracts from the botanical.
