Adverse Event

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.

Reporting adverse effects of supplements made easier with Nutrivigilance upgrade

22-Feb-2021 By Will Chu

French food authorities have introduced a new online resource that is hoped to streamline the process of reporting adverse effects of supplements and other food products.

Sports nutrition brands have lower SAE rates, expert says

05-Jul-2017 By Hank Schultz

Despite the perception that sports nutrition products tend to include ‘edgy’ ingredients, data suggest that these are among the safest of supplements, already a very safe category, an expert says,

Adverse events database not useful for drawing safety conclusions, expert says

07-Apr-2017 By Hank Schultz

The carte blanche release of adverse events data could give a skewed view of the safety of the dietary supplement industry, one expert says.

FDA releases adverse events data for supplements, foods, and cosmetics

07-Dec-2016 By Stephen Daniells

Motivated by transparency, the US Food and Drug Administration has released tens of thousands of adverse event reports for dietary supplements, but does the data actually allow for any conclusions to be drawn?

Interest in adverse event reporting post AG probe up 15-20%, say experts

08-Apr-2015 By Stephen Daniells

The NY Attorney General’s probe into herbal supplements has prompted an uptick in interest about adverse event reporting (AER) but more needs to be done to ensure companies are fully compliant, expert sources tell NutraIngredients-USA.

Herbalife boosts monitoring of products throughout life cycle

27-Jun-2013 By Hank Schultz

Vasilios (Bill) Frankos, PhD and Andrew Shao, PhD are, in a way,  the alpha and omega of network marketing giant Herbalife’s increasingly sophisticated commitment to the scientific backing, quality and safety of the company’s nutritional products. Their...

FDA on warning letters: ‘We are going to do more than just hand out paper’

24-Oct-2011 By Stephen Daniells

The dietary supplements industry should keep an eye on GMP compliance, and not be distracted by discussions over NDIs, because enforcement may move beyond handing out paper if warning letters are ignored, said FDA’s Dr Daniel Fabricant.

Special edition: DSHEA turns 15

DSHEA veteran: ‘I give DSHEA implementation a mixed grade’

18-Dec-2009 By Shane Starling

Mainstream press bashing. Constant and widespread Congressional opposition. GMP question marks. Steroids. Ephedra. Calls for abolishment. Or amendment.

Supplement labels must include address, confirms FDA

01-Sep-2009 By Lorraine Heller

The US Food and Drug Administration has again updated its guidance for the labeling of dietary supplements, and continues to ‘recommend’ the inclusion of manufacturer contact details for adverse event reporting.

FDA issues AER guidance for supplements

15-Jul-2009 By Lorraine Heller

New FDA guidance to dietary supplements marketers on the reporting of adverse events has been welcomed by industry as being a “helpful” and “useful” resource.

Leading weight loss supplements linked to liver damage

04-May-2009 By Lorraine Heller

The US Food and Drug Administration (FDA) has initiated a massive recall of a top-selling American weight loss supplement brand, after a series of adverse event reports indicated that the products could be linked to serious liver damage.

FDA issues new guidance on AER labeling

09-Dec-2008 By Lorraine Heller

FDA has issued another draft guidance document on the labeling of dietary supplements to facilitate adverse event reporting, despite earlier calls from industry that the guidance should be withdrawn.

More transparency needed for AERs, says industry

01-Oct-2008 By Lorraine Heller

The dietary supplements industry is calling for a freer flow of information linked to the adverse event reporting system, in order to be better prepared to address failures.

Ephedra industry compiles the evidence

11-Dec-2002

An organisation supporting ephedra manufacturers yesterday released
a report containing more than 55 clinical studies backing the
herb's safety and weight loss benefits - the report found no
significant adverse effects were caused...