SUBSCRIBE

Breaking News on Supplements, Health & Nutrition - North America EU edition | APAC edition

News > Regulation

Read more breaking news

 

 

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

Post a comment

By Hank Schultz

07-Apr-2017

Dr. Rick Kingston of the University of Minnesota and SafetyCall International spoke at a scientific conference in Oxford, MS.  NutraIngredients-USA photo.

Dr. Rick Kingston of the University of Minnesota and SafetyCall International spoke at a scientific conference in Oxford, MS. NutraIngredients-USA photo.

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

Adverse event reports have been part of the dietary supplement industry since 2007.  But what’s new this year is the Food and Drug Administration’s decision to make the data within these files public, something that was done in late 2016.  Rick Kingston, PharmD, a professor of clinical pharmacy with the University of Minnesota. said that the way that has been done gives the impression there is useful information to be gleaned from these files, which in their raw form is simply not the case.

Kingston said that the way their adverse events are entered into the data base conforms to the letter of the law.  But it does not represent a very useable data set. Too much information is missing, and much of what is there is too imprecise.  For example, a consumer might complain that they had chest pain after taking a particular supplement, but decline to be more specific about what kind of pain they experienced.  Was it a true cardiac event?  Heart burn?  Something else?  They might also indicate that they were treated for the complaint but decline to provide information about what kind of treatment or about what the attending physician had to say about the situation. This particular example might entered using standard medical codes as a case of angina, a potentially serious complaint.

Noise clouds signal

“When you look at the events that come in it’s really only about 5% or maybe 6% that signal something that needs to be looked at, Kingston said.  Kingston, who is President, Regulatory and Scientific Affairs at SafetyCall International, spoke with NutraIngredients-USA at the 17th Annual Oxford Conference on the Science of Botanicals put on by National Center for Natural Products Research at the University of Mississippi.  The conference wrapped up on April 6.

Despite the shortcomings of the system, Kingston said it is still a very valuable tool for responsible companies when treated with the proper filters, so to speak.

“The best practice companies actually do analyze their adverse events experience to get a good handle on those types of events that they really need to take a closer look at and the events that are more likely representative of the background noise that you get in all spontaneously reported adverse event management,he said.

Kingston said FDA released some but not all of the data associated with each adverse event report in an attempt to be more transparent to the public.  But without the narrative associated with the event (information that FDA chose not to release), Kingston said it’s hard to get a handle on exactly what role the supplement or ingredient played in the event.

“I don’t think anybody can look at that data set and draw any conclusions. It’s just not amenable to that type of analysis, Kingston said.

For more information on what was on the agenda in Oxford, click here .

Post a comment

Comment title *
Your comment *
Your name *
Your email *

We will not publish your email on the site

I agree to Terms and Conditions

These comments have not been moderated. You are encouraged to participate with comments that are relevant to our news stories. You should not post comments that are abusive, threatening, defamatory, misleading or invasive of privacy. For the full terms and conditions for commenting see clause 7 of our Terms and Conditions ‘Participating in Online Communities’. These terms may be updated from time to time, so please read them before posting a comment. Any comment that violates these terms may be removed in its entirety as we do not edit comments. If you wish to complain about a comment please use the "REPORT ABUSE" button or contact the editors.

Vox Pop: In sports nutrition, 'usually just protein'

Vox Pop: 'Protein, and that's pretty much it actually'

Sports nutrition is a booming industry, with Euromonitor estimating a value of $7.4bn in...

Curcumin may boost recovery and maintain performance during workouts

Curcumin may boost recovery and maintain performance during workouts

Dietary supplements formulated with highly bioavailable curcumin may allow for faster recovery after competition-level...

Potential for Nutrition Facts label delay should not slow compliance

The potential of a delay to Nutrition Facts label changes should not slow compliance efforts

Assuming FDA does not delay the deadline for the new Nutrition Fact label as...

VIDEO: From earthquakes to sourcing strife - the challenges to open the world’s newest omega-3 fish oil refinery

VIDEO: From earthquakes to sourcing strife - the challenges to open the world’s newest omega-3 fish oil refinery

Omega-3 fish oil supplier SeaDragon overcame a raft of challenges to open the world's...

Testing component of specifications often overlooked, expert says

Testing component of specifications often overlooked, expert says

Fit for purpose testing continues to be a challenge for dietary supplement companies, says...

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

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

The carte blanche release of adverse events data could give a skewed view of...

What’s happening with Health Canada’s proposed NHP changes?

What’s happening with Health Canada’s proposed NHP changes?

Health Canada has published its “What we heard” report, which shows differences in opinion...

VIDEO: Why New Zealand’s long-awaited Natural Health Products Bill is needed now more than ever

VIDEO: Why New Zealand’s long-awaited Natural Health Products Bill is needed now more than ever

Trade body Natural Products New Zealand is hoping new industry regulations – which it...

Aloha rebrands to make plant-based nutrition range pop across multiple channels

Aloha rebrands to make plant-based nutrition range pop across multiple channels

Wellness brand Aloha recently underwent a re-branding, re-formulation, and re-categorization of its plant protein...

Nutraceutical innovation around boosting or reducing nitric oxide

Nutraceutical innovation around boosting or reducing nitric oxide

Industry interest in boosting nitric oxide, a potent vasodilator, has been increasing, with companies...

Soup-To-Nuts Podcast: A closer look at protein’s rise to popularity and where it is headed

Soup-To-Nuts Podcast: A closer look at protein’s rise to popularity and where it is headed

Americans’ love affair with protein shows no signs of cooling in the coming years...

Soup-To-Nuts Podcast: Separating fact from fiction with probiotics

Soup-To-Nuts Podcast: Separating fact from fiction when formulating with probiotics

Once restricted to a handful of products, such as yogurt, probiotics are enjoying unprecedented...

Soup-To-Nuts Podcast: 5 trends driving growth in natural & organic

Soup-To-Nuts Podcast: 5 trends driving growth in natural & organic

As US consumers embrace a healthier lifestyle focused on prevention rather than treatment, they...

Overcoming the taboo of vaginal health – the next frontier of probiotics

Overcoming the taboo of vaginal health – the next frontier of probiotics

A paradigm shift is needed to force delicate women’s health issues like vaginal infections...

Lab meat, plant proteins and insects: Which alternative proteins will feed the world?

Lab meat, plant proteins and insects: Which alternative proteins will feed the world?

The quest for alternatives to animal-derived proteins has led to a huge amount of...

African probiotic project reaching 10,000 infants a day

African probiotic project reaching 10,000 infants a day

Professor Gregor Reid

Chair , University of Western Ontario & Human Microbiology and...

UK researcher backs supplements for omega-3 intakes

UK researcher backs supplements for boosting omega-3 intakes

Philip Calder

Professor, University of Southamption

‘You think Red Bull’s just gonna roll over? It’s not gonna happen!’

‘You think Red Bull’s just gonna roll over? It’s not gonna happen!’ Expert warns wannabes

Beverage brand development guru James Tonkin has warned wannabe entrepreneurs that going up against...

Coffee may hydrate athletes just like water: Researcher

Coffee may hydrate athletes just like water: Researcher

Sophie Killer

Doctoral researcher, Loughborough University

Caffeine in small doses and during training may boost performance

Caffeine taken during training and even in small doses may boost sports performance: Researcher

Sophie Killer

Doctoral researcher in exercise metabolism and performance nutrition

Key Industry Events

 

Access all events listing

Our events, Shows & Conferences...