SUBSCRIBE

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

News > Regulation

Read more breaking news

 

 

Fabricant on GMPs: ‘There is not a clear indication there will be a drop in non-compliance anytime soon, and that concerns us’

By Stephen Daniells , 13-Nov-2012
Last updated on 13-Nov-2012 at 14:37 GMT2012-11-13T14:37:26Z

Fabricant on GMPs: ‘There is not a clear indication there will be a drop in non-compliance anytime soon, and that concerns us’

Strong enforcement from FDA on cGMPs (current good manufacturing practices) will continue, says FDA’s Dr Daniel Fabricant, but given that many GMP basics are still not being met and the Agency's limited resources, many of the issues seen today may still be around in 5 or 10 years. 

Speaking with Stephen Daniells at the recent SupplySide West show in Las Vegas, Dr Fabricant, Director of FDA’s Division of Dietary Supplement Programs, said that the industry will see a lot more strong GMP enforcement action like injunctions and seizures.

“It sends a good message if we can take swift, effective, strong enforcement action. I hope it gives those people [who are flouting GMP regulations] a moment of pause.”

“I can’t emphasize greatly enough that I hope people move away from the mentality that FDA is just a traffic cop handing out tickets.”

Commenting on the potential next wave of potential issues related to GMPs, Dr Fabricant said that finished product testing and reference materials are issues that he expects to see a lot more of in the future.

“We’re five years out [from the introduction of GMPs]. This didn’t happen yesterday. The other question you ask is, ‘What were people doing before? Shouldn’t there have been level of products meeting spec?’

“Given that we’re still not finding the basics being adhered to in a lot of these cases, I fear that in five to ten years, given our limited resources and priority challenges, we may still be seeing some of the same issues.”

'Social retailing' model used to popularize fiber/probiotic blend

'Social retailing' model used to popularize fiber/probiotic blend

Regular Girl, a prebiotic-probiotic blended product, is debuting on the market via a “social...

Consumers willing to pay more for bioavailability enhancements, consultant says

Consumers willing to pay more for bioavailability enhancements, consultant says

There is an opportunity for companies to use bioavailability enhancement to differentiate their products,...

Research on holes in diet informed Dr Low Dog's formulation of new line of Megafood multis

Research on holes in diet informed Dr Low Dog's formulation of new line of Megafood multis

Multivitamin manufacturers are all about differentiation.  How do you stand out from the multitude?...

Ingredient supplier applies Ayurvedic principles to new line of finished products

Ingredient supplier applies Ayurvedic principles to new line of finished products

The principle of synergy embodied in Ayurveda figured into the formulation of a new...

At Expo West 2016, RiceBran Technologies launches NukaCha smoothie

Expo West 2016 Debut: RiceBran Technologies launches smoothie-on-the-go NukaCha

Riding the wave of smoothie enthusiasm, Arizona-based RiceBran Technologies launches… powder in a bottle?

Ayurvedic expert advocates strongly for using plants in whole form

Ayurvedic expert advocates strongly for using plants in whole form

Ayurvedic principles and ingredients are increasingly accepted in North America among product formulators. But...

GNC’s CEO: Raw material GMPs are “absolutely a great solution for the industry”

GNC’s CEO: Raw material GMPs are “absolutely a great solution for the industry”

Supplement heavyweight GNC’s industry initiative to boost supply chain integrity and defend consumer confidence...

Protein could give endurance athletes an extra edge, says Arla Foods

Protein could give products for endurance athletes an extra edge, says Arla Foods Ingredients

A new fast absorbing protein from Arla Foods Ingredients could help crack open the...

Firm has automated solution to ease GMP documentation burden

Firm has automated solution to ease GMP documentation burden

Complying with the paperwork required by full GMP compliance has proved to be a...

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...