Adverse Events

Deeper dive into CAERS data shows how unlikely it is that white mulberry could have caused death

29-Aug-2022 By Hank Schultz

A further examination of adverse events reports further elucidates how unlikely it is that white mulberry could cause the kinds of problems that led to the tragic death of the wife of a prominent public official.

Adverse events expert says conclusion that white mulberry leaf caused death is mere speculation

26-Aug-2022 By Hank Schultz

The conclusion that the botanical white mulberry caused the tragic death of a lawmaker’s wife—something that has been widely reported in the national media—is supported by almost no data and is highly speculative at best, according to a nationally renowned...

Industry stakeholders say call for separate adverse event system for military is misguided

13-Feb-2022 By Hank Schultz

A recent editorial in a military publication calls for a separate adverse event reporting system to be established for troops who use supplements. Industry observers said that wouldn’t improve safety and could create confusion.

As many as 18% of troops reported supplement adverse events in survey questioned by expert

04-Feb-2022 By Hank Schultz

A large survey of supplement use among US military personnel reported as many as 18% of respondents experienced an adverse event. But methodology questions makes it difficult to take those numbers at face value, an expert says.

AI-based attempt to find supplement safety signals in Twitter critically flawed, expert says

13-Oct-2021 By Hank Schultz

A quintet of bioniformatics experts have taken a stab at devising an AI-powered method to find dietary supplement adverse event information within messages shared on Twitter. But an expert in the field doubts the approach will prove fruitful.

Study finds almost half of active military personnel use sports supplements

09-Sep-2021 By Hank Schultz

A new study by US military health experts found that almost half of active service members use sports nutrition products on a regular basis and there was little risk associated with their use.

Amazon has ‘unique opportunity’ to engage manufacturers on adverse event reports, says expert

12-Mar-2021 By Stephen Daniells

The new dietary supplement specifications from Amazon are comprehensive, but adverse event reporting is not currently part of the picture and that presents challenges for brands and consumers, says an expert.

Study finds caffeine-containing products linked to more serious adverse events

13-Aug-2020 By Hank Schultz

A recent study has found that supplements and energy drinks that contain caffeine are associated with a disproportionately high number of serious adverse events.

FDA cites firm for failing to document adverse event investigations

29-Jun-2020 By Hank Schultz

A recent warning letter reiterates the importance of collecting adverse event reports in order to demonstrate full compliance with federal laws governing the manufacture and sale of dietary supplements.

Post-market surveillance supports safety and tolerability of PlusCBD products

27-May-2020 By Stephen Daniells

Data collected over two years of post-market surveillance offers strong support for the safety and tolerability of PlusCBD products from CV Sciences, with fewer than 0.03% of products producing any kind of adverse event.

FDA gives more time for adverse event reporting in light of coronavirus crisis

25-Mar-2020 By Hank Schultz

Dietary supplement companies may store adverse event reports and submit them after the present crisis is past, the US Food and Drug Administration said recently.

Experts file comment questioning conclusions drawn from poison control center data

11-Dec-2017 By Hank Schultz

A recent commentary published by three experts in the dietary supplement industry cautions against drawing big conclusions from aggregate data from poison control centers.

Study on calls to poison control centers overstates risk, experts say

25-Jul-2017 By Hank Schultz

A study that found a rising tide of reports to poison control centers about dietary supplement exposures reaches some faulty conclusions, say experts familiar with adverse event reporting.

Weight loss and energy products linked to majority of ER visits for supplement users

15-Oct-2015 By Stephen Daniells

An estimated 23,000 emergency department visits may be attributed to adverse events related to dietary supplements every year, says new analysis funded by the Department of Health and Human Services.

Industry experts dispute dietary supplement critic Cohen's call for sweeping new regulations

03-Apr-2014 By Hank Schultz

A long time critic of the dietary supplement industry, Dr Pieter Cohen, MD, has called for a premarket approval regime and a modified adverse event reporting system for dietary supplements in an article published today in the New England Journal of Medicine. Industry...

AERs – A unique opportunity to build confidence in supplements: SafetyCall

24-May-2013 By Stephen DANIELLS

Establishing robust systems for safety surveillance and the reporting of adverse events presents the dietary supplements industry with an opportunity to instill confidence in the products, says Rick Kingston, PharmD, from SafetyCall.

Dan Fabricant: FDA ‘somewhat aghast’ at degree of cGMP non-compliance

26-Apr-2012 By Elaine Watson

The level of non-compliance with dietary supplement cGMP (current good manufacturing practice) regulations has left Food and Drug Administration (FDA) officials “somewhat aghast”, according to the agency’s supplements division boss.

Researcher calls for stimulant herb rethink

24-May-2010 By Shane Starling

US researchers have highlighted increasing numbers of adverse events for products containing extracts of the yohimbe herb which is sold in both the dietary supplement and pharmaceutical channels.

Experts slam calls for vitamins to be OTC

12-Jan-2010 By Stephen Daniells

Vitamins A, E, D, niacin and folic acid should be regulated as over-the-counter (OTC) medicines, according to a review of adverse events from Canada.

GAO supplements report generates mixed response

04-Mar-2009 By Lorraine Heller

Consumer activists claim a GAO report on the oversight of dietary supplements confirms that regulatory loopholes plague the industry, while trade bodies say the report makes unrealistic recommendations to improve regulation of the products.

Implementing adverse events reporting begins, UNPA

08-Jan-2007 By Clarisse Douaud

With the recent signing into law of the adverse events reporting
bill by President Bush, many dietary supplement manufacturers will
need to begin implementing or changing their reporting practices
within the upcoming year before the...

AER missing from FDA guidance

28-Sep-2006 By Clarisse Douaud

The FDA has released a guidance for food facilities to maintain
records of production and distribution that still falls short of
taking a stance on the issue of adverse events reporting.

Industry hails bill on adverse events reporting

22-Jun-2006 By Jess Halliday

An amendment to the Food, Drug and Cosmetic Act that would obligate
supplement manufacturers, packers and distributors to notify FDA of
any serious adverse events reports (AERs) was introduced yesterday,
to the applause of the industry...

Mandatory adverse events reporting for supplements is on the way

15-Nov-2005 By Jess Halliday

Mandatory serious adverse events reporting for dietary supplements
is inevitable and, so long as there are protections in place, will
be good for the industry, according to the three main associations.