SUBSCRIBE

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

News > Regulation

Read more breaking news

 

 
Insights from SupplySide West

Adverse event reporting can provide valuable data to companies, expert says

By Hank Schultz

16-Oct-2014
Last updated on 16-Oct-2014 at 17:30 GMT2014-10-16T17:30:35Z

Adverse event reporting can provide valuable data to companies, expert says

Reporting adverse events is something all dietary supplement companies must prepared to do to be in compliance with the law.  But beyond that basic requirement, companies that fully embrace an AER system can use it to provide valuable market data, an expert says.

Ignorance of what having a functional AER system really means is unfortunately still widespread in the industry, said Rick Kingston, PharmD, president of regulatory and scientific affairs at the consultancy Safety Call International.  Kingston, who is also a professor at the University of Minnesota’s College of Pharmacy, spoke with NutraIngredients-USA recently at the SupplySide West trade show in Las Vegas, NV.

“The compliance has been increasing over the years. But there are still a number of companies that don’t understand the regulation and don’t have a system in place to meet their reporting requirements,” Kingston said.

But beyond that basic level, Kingston said a functional AER system can actually provide companies valuable market intelligence.

“I think it is absolutely vital for companies to understaind their consumers and how they are using their products,” Kingston said.

Kingston said properly collecting data on AER reports and mining that data can yield a wealth of information. It can show what other products consumers might typically be using in conjunction with the product in question, products that might more to blame for the reported stomach ache, for example.  Kingston said companies could use that information to better educate their consumers on the successful use of their products.  A sophisticated system can help companies sort through the ‘background noise’ that is to be expected in reports submitted by consumers (unlike in the drug arena, where most of the data is gathered an submitted by a professional such as a physician or a a pharmacist).  Being able to eliminate that noise to find what could be an emerging signal of a safety or manufacturing issue can put a company in a much better position when explaining to FDA what a set of adverse event reports might mean, Kingston said.

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...

Prebiotic ingredient derives big gut health benefit from small dose

AIDP says prebiotic ingredient derives big gut health benefit from small dose

AIDP is emphasizing the prebiotic potential of its PreticX xylooligosaccharide. The small dosage provides...

Demystify testing for new technology & new players

New technology and new players push labs to demystify testing: Alkemist Labs CEO

Keeping up to date with technological advances, understanding which testing methods are suitable for...

Navigating the regulations around supplements for pets

Navigating the regulations around supplements for pets

While many ingredients and trends for animal supplements are the similar to those found...

Milk protein producer not ready throw in towel to whey

Milk protein producer not ready throw in towel to whey

Milk proteins continue to carve out a strong niche in sports nutrition despite’s whey...

Just Thrive Probiotic chosen for HIV trial, company says

Just Thrive Probiotic chosen for HIV trial, company says

Thrive Probiotic has gathered data on the company’s Just Thrive Probiotic supplement and its...

Patient interest driving increase in supplement use, naturopathic doctor says

Patient interest driving increase in supplement use, naturopathic doctor says

Naturopathic doctors can play a key role in supporting the use of supplements through...

Synbio ingredients have vast market penetration, new list shows

Synbio ingredients have vast market penetration, new list shows

Synthetic biology, or GMO 2.0 as some are calling it, has vastly more penetration...

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...