SUBSCRIBE

Breaking News on Supplements & Nutrition - North AmericaEU edition

Loading...

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 GMT

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.”

Botanical Adulterants Program 'intended to raise the bar of awareness of the problem, and I think we've done that,' Blumenthal says

Botanical Adulterants Program 'intended to raise the bar of awareness of the problem, and I think we've done that,' Blumenthal says

The Botanical Adulterants Program is “raising the bar of awareness of this growing problem among...

McGuffin: DSHEA was about preserving right to direct one's own self care

McGuffin: DSHEA was about preserving right to direct one's own self care

Michael McGuffin, president of the American Herbal Products Association, has a unique perspective on...

‘Some companies claiming they’re strengthening their defense against chondroitin adulterants are not using the right method’: Synutra President

‘Some companies claiming they’re strengthening their defense against chondroitin adulterants are not using the right method’: Synutra President

A unique collaboration of experts worked together to identify an adulterant in the chondroitin...

Israelsen: DSHEA created world's most vibrant supplement marketplace

Israelsen: DSHEA created world's most vibrant supplement marketplace

The dietary supplement business has gone from fighting for its life to enjoying the...

CRN’s Mister on DSHEA’s ‘monumental anniversary’, companies choosing a side, and the critical role of contract manufacturers for GMP complia...

CRN’s Mister on DSHEA’s ‘monumental anniversary’, companies choosing a side, and the critical role of contract manufacturers for GMP compliance

The 20th anniversary of the Dietary Supplements Health and Education Act (DSHEA) is ‘monumental’, says...

New ingredient set to give caffeine a run for its money, supplier says

New ingredient set to give caffeine a run for its money, supplier says

Ingredient supplier Compound Solutions has introduced a nature identical version of theacrine branded as...

GMPs, NDIs, and definitions for GMO and natural: NPA’s Fabricant on industry issues

GMPs, NDIs, and definitions for GMO and natural: NPA’s Fabricant on industry issues

Despite ongoing vacancies in the main office of the Division of Dietary Supplements, companies...

Cargill highlights cavity-fighting effect of Zerose erythritol at SupplySide West trade show

Cargill highlights cavity-fighting effect of Zerose erythritol at SupplySide West trade show

Research by Cargill shows its Zerose brand erythritol does more than just cut calories; ...

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

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...

‘No better place than the nutra-science marketplace for financial investors’: BI Chief

‘No better place than the nutra-science marketplace for financial investors’: BI Chief

Nutraceuticals and dietary supplements are attracting a lot of private equity attention, and it’s...

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)

Unilever: Healthier food choices must be ‘doable’

Unilever: Healthier food choices must be ‘doable’

Hans Zevenbergen

Cross-category nutrition and health director, Unilever