SUBSCRIBE

Breaking News on Supplements & Nutrition - North AmericaEU edition

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.”

New gut models facilitating microbiome research

New gut models facilitating microbiome research

The understanding of what happens within the human digestive system has always been hampered...

Collaboration among stakeholders needed for probiotics research to move forward, experts say

Collaboration among stakeholders needed for probiotics research to move forward, experts say

The immediate future of the probiotics space is clouded by regulatory uncertainty but is...

Pivotal study on effect of gut microbial makeup on brain activity changed course of researcher's career

Pivotal study on effect of gut microbial makeup on brain activity changed course of researcher's career

The dawn of inexpensive, rapid genetic sequencing has opened up new avenues for explaining...

Can gut microbes affect eating behavior?  It's an intriguing field of research, expert says

Can gut microbes affect eating behavior? It's an intriguing field of research, expert says

Evidence continues to mount that the gut microbiome affects gut health in a number...

Ganeden BC30 boosts performance, recovery in weight lifting test, attendees at event are told

Ganeden BC30 boosts performance, recovery in weight lifting test, attendees at event are told

A study detailed at the Probiota Americas gathering in San Diego showed how supplementation...

US market is faster, but not lower quality or less ethical than Europe, consultant says

US market is faster, but not lower quality or less ethical than Europe, consultant says

In the wake of the New York Attorney General affair, one question that has...

ABC taps into European herbal insights via new advisory board member

ABC taps into European herbal insights via new advisory board member

Europe, and especially Germany, has historically been a hotbed of herbal lore, science and...

Ismail says omega-3s industry needs to take high road when it comes to bad press

Ismail says omega-3s industry needs to take high road when it comes to bad press

An article in late March in The New York Times called the efficacy of omega-3s into...

NYAG affair will have implications for probiotics suppliers, exec says

NYAG affair will have implications for probiotics suppliers, exec says

According to one prominent executive, for the probiotics industry, the fallout from the NYAG...

Blackmores: We wanted to see krill sustainability with our own eyes

Blackmores: We wanted to see krill sustainability with our own eyes

Richard Henfrey

Chief Operating Officer, Blackmores

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...

Fed up: Probiotic research veteran issues global call to action

Fed up: Probiotic research veteran issues global call to action

Veteran probiotic researcher professor Gregor Reid is not a happy man. It’s time the...

Industry concerned about data abuse as EFSA fans transparency wings

Industry concerned about data abuse as EFSA fans transparency wings

Euros Jones

Director of regulatory affairs, European Crop Protection Association (ECPA)

Key Industry Events