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).
A recent article in the Chicago Tribune that prompted a wave of negative publicity for the dietary supplements trade unfairly “maligned an industry” according to California-based supplement maker Jarrow Formulas.
A Food and Drug Administration (FDA) warning letter sent to a sexual enhancement supplements maker should serve as a “clear signal that FDA continues its enforcement efforts against illegal drugs or drug alternatives masquerading as dietary supplements”...
New legislation proposed in the Senate this week would help to ensure anabolic steroids are not misrepresented as legitimate dietary supplements by broadening the definition and imposing tougher penalties on firms making and selling them, claim supporters.
The American Herbal Products Association has responded to Senators Durbin and Blumenthal to outline current and future initiatives to support its members’ efforts to comply with current good manufacturing practices (cGMPs).
The learning curve for GMP compliance is to be expected – just look at other FDA-regulated industries, Michael McGuffin, president The American Herbal Products Association (AHPA), told staff for Senator Dick Durbin in a meeting July 13.
The US Food and Drug Administration (FDA) has again shown that it will go beyond just sending warning letters for GMP violations after filing an injunction against a NY supplement manufacturer.
The Natural Products Association (NPA) and the Council for Responsible Nutrition (CRN) have welcomed requests from Senators Durbin and Blumenthal to outline cGMP education initiatives, but questions have been raised as to the numbers cited by FDA officials...
The Olympic Games have in the past brought the food supplements industry to the edge of its collective seat – but not necessarily in fevered anticipation of the world-class sporting fare on offer as anti-doping scrutiny has raised contamination issues.
Private label supplement distributor Caribe Natural has been warned by the FDA that it is still responsible for violations of current Good Manufacturing Practice (cGMP) regulations and making drug claims on product labels, even though its supplements...
Washington DC insider and former administration official John Spitaleri Shaw has been named as the new chief executive and executive director of the Natural Products Association (NPA).
Lab tests on Reumofan Plus, a dietary supplement made in Mexico and marketed as a natural pain reliever, show that it contains at least two prescription painkillers, the Food and Drug Administration (FDA) has warned.
Claims by a leading grapefruit seed extract product manufacturer that the detection of synthetic disinfectants in some products is related to a ‘false positive’ interpretation of analytical data have been rejected by a leading analytical expert.
The majority of products containing 'grapefruit seed extracts' may be adulterated with synthetic additives, according to a new review from a nonprofit research consortium.
News that Bodybuilding.com has pled guilty to selling dietary supplements spiked with steroids - and agreed to pay a $7m fine - proves the FDA is “not blowing smoke” when it says it will crack down on adulterated products, says one analytical testing...
Company mottos and mission statements are marvelous – they talk about lofty goals, commitments to people and the environment, and leaving the planet a better place than how they found it. But boil it all down and there are only two words that companies...
Stakeholders in the dietary supplements industry could avoid massive liability and reduce the rates of adulteration in products by engaging phytoforensic scientists, says a leading industry expert.
Another week, another batch of warning letters from the Food and Drug Administration (FDA): Warning letters for current good manufacturing practice (cGMP) violations continue, and the agency has warned consumers against three sexual enhancement products...
California-based nutritional supplement contract manufacturer Natural Alternatives International (NAI) has posted a 30.3% rise in net sales to $17.4m in the three months to March 31, 2012.
The most recent batch of warning letters from the Food and Drug Administration (FDA) show that the agency continues to monitor closely claims on websites, and GMP violations need to be resolved by actions, not words.
The Food & Drug Administration is not preparing to enforce its controversial draft guidance on new dietary ingredients (NDIs), but companies can expect more inspections, more injunctions, and more product seizures related to current good manufacturing...
A toxicology expert says he is shocked to see firms in the supplements trade developing products containing extracts from the tropical fruit graviola (also known as soursop or Annona muricata) given its association with atypical Parkinson's disease.
With the road ahead now appearing closed - or at least decidedly rocky - for pre-workout stimulant DMAA (1,3-Dimethylamylamine), attention is turning to alternatives. But could they be just as controversial?
MusclePharm “made an intentional decision to stay away from DMAA” when it formulated its pre-workout supplement Assault, say bosses at the Colorado-based sports nutrition expert.
Direct selling supplements giant Herbalife now manufactures almost a third of its products in-house and will significantly increase this percentage in the coming years.
The level of non-compliance with dietary supplement cGMP (current good manufacturing practice) regulations has left Food and Drug Administration (FDA) officials “somewhat aghast”, according to the agency’s supplements division boss.
The Standardized Information on Dietary Ingredients (SIDI) working group is calling for comments from industry stakeholders on its new supplier qualification guideline.