SUBSCRIBE

Breaking News on Supplements, Health & Nutrition - North AmericaEU edition

News > Regulation

Read more breaking news

 

 

Is finished product testing the next big wave in GMP warning letters?

By Stephen DANIELLS , 14-Nov-2012
Last updated on 14-Nov-2012 at 17:47 GMT2012-11-14T17:47:48Z

Is finished product testing the next big wave in GMP warning letters?

Once GMP inspectors from the FDA move beyond the first tier of GMP compliance, the next big wave of warning letters from the agency could be on the issue of finished product testing, says a leading quality and regulatory expert.

Aaron Secrist, Quality & Regulatory Manager for NOW Foods, told NutraIngredients-USA at the SupplySide West show in Las Vegas last week that, as the inspectors gain more experience and move beyond the first tier GMP compliance issues, they are going to start ask a whole new set of questions.

“Instead of, ‘Are you are doing finished product testing?’ the questions will be, ‘How are you testing? What are you testing? What are you not testing? What is your rationale for not testing?’” said Secrist.

We’ve already seen warning letters from the FDA this year for basic GMP non-compliance issues, and so is the industry ready for the next tier of inspections?

“I think some in the industry are more ready than others,” said Secrist. “I think one of the issues we face in this industry is a real lack of analytical methods and even some standards. Everything in analytical chemistry comes back to the standards.”

“Without the standards and methods in place, it is going to be very hard for the Agency to test these products and determine if they are meeting their finished products specifications.”

“The FDA needs to look at categories of products and start doing a lot of their own work to determine whether or not these products meet their specifications.

“It’s going to require a significant amount of development work on their end, since you don’t find these published in the literature.

“The other difficulty they are going to run into is that every company’s products are slightly different. The make-up of the product, the matrix, is different. Yes, they’re all multivitamins, but some have botanicals and some don’t, all of those things can make it very difficult for companies as well as the agency to test these products.”

Vox Pop: Consumers had this to say about GMO labeling...

Vox Pop: Consumers had this to say about GMO labeling...

On the heels of President Barack Obama signing into law a federal bill requiring...

DNA barcoding is still a science project: BI Chief

DNA barcoding is still a science project: BI Chief

The dietary supplements industry has done a great job coming together to address raw...

What’s hot in functional beverages? Omega-3s, prebiotics and probiotics

What’s hot in functional beverages? Omega-3s, prebiotics and probiotics

Interest in probiotics is skyrocketing and the friendly bugs are increasingly turning up in...

Edible insects beyond whole cricket powder at IFT

Will the edible insects market move beyond whole cricket powder?

Milled whole cricket powder is probably the best known bug-derived food ingredient aside from...

It's time to put whey and casein back together, exec says

It's time to put whey and casein back together, exec says

Cutting milk proteins apart has been all the rage in recent years. But Benoit...

Consumer vox pop on anti-aging ‘beauty from within’ supplements

Vox Pop: What does ‘beauty from within’ mean to consumers?

Stopping several unsuspecting passers-by in downtown Chicago, we gathered some consumer thoughts on the...

Personalised nutrition: Listening to the gut microbiome

Personalised nutrition: Listening to the gut microbiome

Tal Korem

Professor, Weizmann Institute of Science

Personalised nutrition held back by ‘lack of trust and transparency’

Personalised nutrition held back by ‘lack of trust and transparency’

Nard Clabbers

senior business developer, personalised nutrition and health , TNO

Lallemand’s Lafti L10 may aid URTI symptoms in elite athletes

Probiotics in sports nutrition? Lallemand’s Lafti L10 studied for immune support in athletes

A double-blind, placebo controlled study on elite athletes found that the dairy-derived Lactobacillus helveticus...

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

Psychobiotics can feed gut-brain health axis: 'It’s really an exciting frontier,' says professor

Psychobiotics can feed gut-brain health axis: 'It’s really an exciting frontier,' says professor

Professor John Cryan

Chair and head of the Department of Anatomy and Neuroscience,...

Algatech: Functional food on astaxanthin horizon

Algatech: Functional food on astaxanthin horizon

Israeli firm Algatechnologies will work towards gaining approval for its astaxanthin as a novel...

Key Industry Events