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Trends > GMPs, QA & QC

USP proposes monograph on specific bacillus coagulans probiotic strain

For the first time, the United States Pharmacopoeia is proposing a monograph on a probiotic organism as a food ingredient in the latest series of draft monographs put forward for...

Lawsuit drives home real damage tainted weight loss products can cause

Cases of sibutramine tainting in weight loss products are nothing new.  But a recently-filed lawsuit drives home the real harm such products can cause, and the insidious way in which...

Prochnow: GMPs, NDIs and liquid supplements among prominent regulatory concerns for 2014

Attorney Justin Prochnow has made a career of reading the FDA tea leaves for his clients. As the industry enters 2014, he sees a long-term trend of GMP enforcement and...

For AHPA, 2014's song remains the same: GMPs, GMOs and inaccurate mainstream news reports

The American Herbal Products Association (AHPA) is planning for 2014 with the assumption that the hot button issues for the New Year are likely to include three of the same...

We’re moving into omega-3 testing next, says Alkemist Labs CEO following successful 2013 and rebranding

Costa Mesa-based Alkemist Labs is expanding its testing capabilities into the omega-3 sector, with the success of its label claim verification/ R&D division allowing for continued reinvestment.

2013’s top regulatory, policy & enforcement news

From warning letters to GMO labeling and FSMA, it’s been a busy year for the regulatory people. In this special gallery we review the top regulatory, policy & enforcement headlines...

CRN seeks clarification on how FSMA affects ingredient suppliers that are already complying with GMPs

The Council for Responsible Nutrition has suggested additional clarification of the risk-based controls portion of the Food Safety Modernization Act.  The suggested clarification, submitted by CRN to the Food and...

Dispatches from SupplySide West 2013

Hiring an attorney early is cheaper than hiring one late, expert says

As dietary supplement firms prepare for their initial (or follow up) GMP compliance inspections, it pays to have the advice of a consultant and/or a lawyer up front. Fixing problems...

The next 2-3 years will see a huge shift towards DNA barcoding for botanicals: AuthenTechnologies CEO

DNA barcoding for botanicals has a bright future, despite comments that it may not yet be fit for purpose, and the next 2-3 years will see a ‘huge shift’ towards...

Chloramphenicol debacle points out need to have recall procedures at the ready

The recent massive recall of products containing enzymes contaminated with an antibiotic points out the need for companies to think out recall procedures in advance, experts say.

Dispatches from SupplySide West 2013

FDA’s Dr Fabricant: GMP violations are staying the same, and that’s a concern

One year on and 'GMPs' and 'concern' continue to be used together by Dr Daniel Fabricant, Director of the Division of Dietary Supplement Programs at the agency, with many of...

Dispatches from SupplySide West

Industry not ready for increased scrutiny for finished products testing: Alkemists’ CEO

Finished product testing has been predicted to be a key focus for regulatory enforcement as FDA inspectors gain more experience and move beyond the first tier GMP compliance issues, but...

News in brief

FDA extends comment period on medical foods guidance

The comment period on FDA’s recently updated draft guidance on medical foods will be extended through Dec. 16, 2013, thje agency announced today.

Following on Hawaii liver injury reports, USPlabs issues national recall of OxyElite Pro

Sports supplement manufacturer USPLabs has recalled lots of its OxyElite Pro products after receiving a letter directing the action from FDA motivated by reports of liver illnesses in Hawaii associated...

I-522 effort a victory regardless of outcome, says Stonyfield Farms chairman

I-522 is a victory for the proponents of GMO labeling, no matter how the final polls might turn out, attendees on a United Natural Products Alliance webinar were told yesterday.

Updated: ABC calls for retraction of paper

Contamination & substitution present in many herbal products, but is DNA barcoding of herbals fit for purpose?

Many North American herbal products may contain contaminants or substitute ingredients that are not listed on their labels, says a new DNA barcoding analysis, but a leading analytical lab has...

Level of actives varies widely among saw palmetto products, researchers find

Is saw palmetto what it seems?  A recent study published in the open access journal Nutrients found big differences in the amount of fatty acids and phytosterols (the active ingredients) in the...

News in brief

UNPA to hold post I-522 GMO labeling webinar tomorrow

Wednesday is the last day to register for a webinar being put on by the United Natural Products Alliance on GMO labeling.  Whether or not Washington state’s genetically modified organism...

Special Edition: Botanicals

Despite bad publicity, adulteration picture slowly improving, experts say

The extent of adulteration of herbal supplements has been a question for as long as the products have been on the market.  In light of damaging publicity, such as Monday’s...

Guest article

Former FDA inspector offers insight into identity testing procedures

Tamika Cathey, a former FDA inspector and current independent regulatory consultant at EAS Consulting Group discusses identity verification regulations and methodologies. Cathey and 15 other industry experts will discuss botanical...

FDA seeks injunction against Oregon supplements firm over disease claims, GMP violations

The Food and Drug Administration is seeking a permanent injunction against James G. Cole Inc., an Oregon-based dietary supplement manufacturer.  As is usually the case with such injunctions, the action...

AHPA requests 'common sense' change to way FDA issues GMP inspection reports

A petition by American Herbal Products Association to the Food and Drug Administration on GMP inspections is an attempt to facilitate communication between the agency and industry, said AHPA president...

Integrated data systems help cut cost of GMP compliance, providers say

GMP compliance has been a steep hill to climb for the dietary supplement industry by some accounts. And the advent of the regulations, which took full force for all sectors...

Nutravigilance program marks ‘the beginning of a new era of adverse event reporting’

A new verification program called Nutravigilance, launched by Supplement Safety Solutions, LLC, is promising to exceed current regulatory requirements related to safety and adverse event surveillance, monitoring and reporting, and...

Comment

The ‘shady supplements industry’ vs ‘legitimate medicine’: A tragic tale often told

Acute non-viral hepatitis is tragic, whether it’s potentially linked to a product labeled as a dietary supplement or not. It is also tragic when critics of supplements use it as...