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.
The US Food and Drug Administration has requested a $4.7 million dollar budget for fiscal year 2014, an increase of $821 million, or 21%, over FY 2012. The biggest chunk of that increase is due to the Food Safety Modernization Act and almost all of that...
A new guidance document made public by the Food and Drug Administration serves as a reminder to industry to review their FSMA registration status, experts say.
To go with an expanding membership, the American Herbal Products Association has expanded its staff with the addition of Jane Wilson in the newly created role of director of program development.
A breakdown in communication between Beehive Botanicals and its GMP certifier NSF International created the situation in which Beehive received an FDA Warning Letter over GMP violations. And, from Beehive’s point of view, receiving a favorable judgment...
FDA enforcement of the current good manufacturing practices (cGMP) regulations is ‘a huge opportunity for the dietary supplements market’, says Frank Jaksch, CEO of Chromadex.
NSF International has responded to an article in NutraIngredients-USA on the FDA Warning Letter received by Beehive Botanicals after having GMP audits conducted by NSF. A Beehive Botanical company official expressed dismay at getting the letter even...
Beehive Botanicals Inc. has received an FDA Warning Letter even though the company had received a successful GMP audit by NSF International and had NSF review the changes it made to its operations to address FDA concerns.
Former officials of a peanut company have been indicted in criminal court on charges of food violations, mail fraud and conspiracy. The indictments are not a surprise, said a prominent lawyer, but should serve to put the food and dietary supplement industries...
The American Botanical Council has given its annual ABC Norman R. Farnsworth Excellence in Botanical Research Award to professor De-an Guo, PhD, of Shanghai, China.
USPlabs, the maker of the DMAA-containing sports supplement Jack3d, has received a warning letter over drug claim violations and GMP deficiencies, the Food and Drug Administration confirmed Friday.
Four dietary supplements have received independent warning letters from the Food and Drug Administration for alleged GMP violations, as the agency maintains its focus on compliance.
The Food and Drug Administration (FDA) has sent a warning letter to New York based NX Generation Ltd for ‘serious violations’ of the current Good Manufacturing Practice (cGMP) regulation for dietary supplements.
NSF International announced a significant expansion of its footprint in Latin America with the acquisition of INASSA Group of Lima, Peru. INASSA provides technical analysis, laboratory and sanitation services. In particular, the move means NSF will be...
Utah-based Food for Health International, LLC, says it is ‘much stronger’ following a recent FDA audit and the changes necessitated by a subsequent warning letter.
ChromaDex has announced a partnership with a Dutch company to distribute a line of isotope-labeled plant products and phytochemicals, taking a step forward in the company’s aggressive program of expanding its testing offerings and capabilities.
Utah-based Food for Health International, LLC, has received a warning letter from the Food and Drug Administration (FDA) for alleged disease claims and GMP violations.
GMPs, NDIs and FSMA will top the list of most-frequently mentioned acronyms in the regulatory sphere for dietary supplements and functional food ingredient companies in the coming year, industry experts agree.
A recent teleseminar put on by the American Herbal Products Association on GMP compliance made it clear that there is still a significant portion of the dietary supplement industry that is confused about who is responsible for what when a marketer hires...
In January, NutraIngredients-USA raised its head above the parapet and made some predictions for 2012. As the year draws to a close, we look back on what did and didn’t come to pass.
The American Botanical Council’s Mark Blumenthal has called for more self-regulating from industry and regulating from FDA to combat adulteration, as the ABC-AHP-NCNPR Botanical Adulterants Program lines up black cohosh and pomegranate extracts as the...
Health Technology, Inc., from Dawson, Georgia, has received a warning letter from the Food and Drug Administration for alleged GMP violations, and failing to include contact details on the labels of some of its products.
It has been a busy couple of weeks for the Food and Drug Administration, with the Agency filing another injunction, and sending warning letters for GMP violations and product claims.
GMP compliance, Prop 37, market opportunities, hot ingredients and many more dominated this year’s discussions at SupplySide West. In this special newsletter, NutraIngredients-USA round-ups its exclusive coverage of the event.
The industry’s big names have been complying with GMP regulations for years, but low barriers to entry have made it easy for less serious companies to do business with low GMP compliance, says the chief of BI Nutraceuticals.
Current compliance levels to good manufacturing practice (cGMP) are ‘all over the place’, but ‘for the most part there is an increase in compliance’, says the CEO of Alkemists Laboratories.
Dietary supplement companies have six weeks to ensure they have registered their facilities with FDA to comply with FSMA, an issue that is easy to fix for the industry, says Steve Mister, President and CEO of the Council for Responsible Nutrition (CRN).
Supplement manufacturers – particularly smaller companies – need a ‘cultural shift’ to cope with the demands of good manufacturing practices (GMPs), says a former associate chief counsel with FDA.
The practice of dry labbing in the industry is continuing, and the practice is becoming more sophisticated, increasing the need for continued vigilance, says Frank Jaksch, CEO of Chromadex.
Once GMP inspectors from the FDA move beyond the first tier of GMP compliance, the next big wave of warning letters from the agency could be on the issue of finished product testing, says a leading quality and regulatory expert.
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...
Scientists from the US Food and Drug Administration (FDA) have developed a rapid procedure to screen for adulterants in weight-loss products, which could benefit the industry by impacting the ‘rate at which these adulterated products find their way to...
An Oregon herb and supplement manufacturer has been slapped with a permanent injunction for disease claims on products, while a NY supplement manufacturer has agreed to stop activities following repeated cGMP violations, as the FDA continues to use the...
Concerns over tainted dietary supplements are extending to products promoted for pain/inflammation and diabetes, beyond the ‘classic’ sectors of erectile dysfunction, weight loss and bodybuilding, said the new head of CFSAN at FDA.
Marlyn Nutraceuticals Inc., a Phoenix-based contract manufacturer, has successfully completed an NSF GMP for Sport certification program, the company announced recently.
Good responses to 483 can avoid a warning letter. Including in those responses key elements of organization and documentation can improve the chances for success, an experts say.
Lack of good record keeping forms the lion’s share of mentions on the warning letters companies receive from FDA after a GMP inspection, a consultant said in an industry meeting recently.
Good Manufacturing Practices inspections have been a fact of life in the dietary supplement industry for more than five years now, and still some companies struggle with compliance. An event to be held this week by a Colorado-based consultancy aims to...
Bodybuilding supplement manufacturer Parrillo Performance has received a warning letter from the FDA for an ‘inadequate response’ to an FDA 483 for alleged cGMP violations.
The $8.1 million in total fines for Bodybuilding.com and the DeLuca brothers should serve as a reminder for retailers as well as manufacturers of their responsibility to ensure dietary supplements really are dietary supplements, says a US Attorney.
A probe into dietary supplements published in the September 2012 edition of Consumer Reports misleads and insults consumers and smears the industry, claims the Natural Products Association (NPA).
