Overlapping federal rules can sometimes create nooks and crannies that the originators didn’t intend. The Council for Responsible Nutrition has identified one such possible loophole in the interplay between the dietary supplement GMP rules (Part 111)...
With surging interest in the potential health benefits of polyphenols around the globe, experts suggest that there are still some major sticking points in the polyphenol success story.
A new method of measuring the heavy metal absorption capacity of foods and food and dietary supplement ingredients has been developed by researcher Mike Adams of the Natural News Forensic Lab. Adams says the method measures the ability of various food...
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 inclusion in the Food Chemicals Codex.
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 they have penetrated the marketplace.
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 nascent guidances on New Dietary Ingredients and liquid dietary supplements as the...
By Michael McGuffin, President of the American Herbal Products Association
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 subjects that demanded our attention in 2013: cGMP compliance, GMO labeling, and...
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.
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 Drug Administration as part of the public...
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 on the back end is inevitably more expensive, said attorney Ivan Wasserman.
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 the ‘robust and reliable technology’, says the CEO of AuthenTechnologies.
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 the compliance issues still basic.
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.
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 much of the industry is not yet ready for this increased scrutiny,...
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 with the product. FDA also it directed the recall...
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.
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 various forms that are on the market: liquids, powders and...
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 questioned the robustness of the methodology.
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 article in The New York Times, is there evidence that progress is being made on...
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 identity verification...
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 is the culmination of a long interaction between...
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 Michael McGuffin.
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 of industry in June of 2010, wasn’t good news for the nation’s forests as manufacturers...
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 could mark ‘the beginning...
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 a stick to beat the entire industry with, despite there being many unanswered...
The Center for Food Safety and Applied Nutrition's (CFSAN) priority to publish guidance to help manufacturers with voluntarily GMO labeling could signal a change in thinking at the agency, says the United Natural Products Alliance (UNPA).
The activities of the US Food and Drug Administration including routine inspections of facilities and the monitoring of imports have ceased following the government shutdown.
A recent lawsuit filed in California points out some of the issues concerning who’s responsible for product claims as a product makes it way to market. Everyone in the chain shares some of the burden for making sure claims are backed up, experts say.
The US Food and Drug Administration (FDA) has issued a warning letter to Oklahoma City-based Pure Energy Products, Inc. for products containing controversial compound DMAA.
The decisions the US dietary supplements industry makes over the next three years will determine the long-term direction of the industry, said CRN's Steve Mister, and then challenged companies to 'decide where they stand'.
‘Qualifying more than one analytical lab’ and ‘using reference materials to evaluate lab proficiency’ are just two of the seven tips for companies when selecting a contract lab, according to an extensive article by highly qualified industry experts.
The American Herbal Products Association has released a guidance for industry to help supplement manufacturers better understand how to comply with organic labeling requirements.
A new raft of warning letters for dietary supplement companies from the US Food and Drug Administration (FDA) shows that current Good Manufacturing Practice (cGMP) and label claims continue to cause problems for companies.
AssetPoint, a provider of maintenance software solutions, helps dietary supplement manufacturers bolster their equipment maintenance record keeping, somethat that can be a weak spot in their Good Manufacturing Practice compliance programs.
A bill reintroduced by Senators Dick Durbin, D-Il and Richard Blumenthal, D-CT to require registration of all dietary supplements with FDA is a solution in search of a problem, according to trade organizations.
Adulteration of Ginkgo biloba is ‘very widespread’, according to industry sources, but as the adulteration becomes more sophisticated new methods are emerging to help industry ensure the quality of this key herbal.
Brad Williams, a 30-year Food and Drug Administration veteran, has joined Ann Arbor, MI-based NSF International as technical manager of the global health organization’s dietary supplement GMP compliance program.
Leading analytical lab Alkemists Laboratories has expanded its service offerings to include a new R&D division focusing on finished product method development, verification & validation.
Identity testing of botanical ingredients continues to be a hot button issue for the Food and Drug Administration. To help companies comply with this aspect of GMP regulations, the American Herbal Pharmacopoeia has instituted a series of eight webinars...
The reporting of adverse events in connection with dietary supplements is woefully inadequate, according to experts who spoke Monday at a gathering of toxicologists in Aspen, CO. There are many complicating factors, the experts agreed, not the least among...
The safety of appetite suppressing Caralluma fimbriata extracts are further supported with the publication of data from ‘comprehensive safety assessments’, say scientists.
A new warning letter from FDA for a company manufacturing products that contained only 5% of declared nutrient levels shows that the agency is stepping up its testing of finished products, say industry experts.
Establishing robust systems for safety surveillance and the reporting of adverse events presents the dietary supplements industry with an opportunity to instill confidence in the products, says Rick Kingston, PharmD, from SafetyCall.
The US Food and Drug Administration has issued warning letters to two dietary supplement companies, as the agency maintains its vigilance of website claims and cGMP compliance.
The US Food and Drug Administration has issued some important warning letters in recent weeks. In this special focus, we revisit the lessons for all companies, from website claims, to the obligations of private label distributors.
A new warning letter illustrates FDA’s stance on the obligations of private label distributors to ‘ensure that all phases of the production of [a] product are in compliance with dietary supplement CGMP requirements’.
The dietary supplement industry is falling behind on GMP compliance, says Loren Israelsen, executive director of the United Natural Products Alliance. Fixing that is a matter of coming up with a new carrot to go with the stick wielded by the Food and...
Weight loss, bodybuilding and sexual enhancement products tainted with unapproved drug ingredients are responsible for 98% of recalls for ‘dietary supplements’, says a new analysis.
The dietary supplements industry is making ‘heartening’ progress on taking a hard look at raw material sourcing, but GMP issues and adulteration issues continue to cause concern, says the CEO of BI Nutraceuticals.
