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Trends > GMPs, QA & QC
GMPs, QA & QC
The implementation of new safety measures and current good manufacturing practices (cGMPs) are having a huge impact on business. We bring you the latest developments in this increasingly important sector.
Jarrow: Tribune article was ‘designed to encourage Congress into imposing Draconian new regime’ on supplement trade
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.
New bill would ensure anabolic steroids are not misrepresented as legitimate dietary supplements, say backers
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...
News in brief
AHPA: Mojo Nights warning letter ‘clear signal’ that FDA intent on tackling drugs masquerading as supplements
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...
AHPA responds to Sen. Durbin-Blumenthal cGMP questions
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...
FDA files injunction against NY supplements company for GMP violations
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...
AHPA committed to GMP compliance, but learning curve was expected: McGuffin to Durbin staff
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...
Updated: Associations welcome Durbin-Blumenthal cGMP dialogue & FDA explains GMP violation stats
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...
Industry hopes Olympics will torch supplement contamination concerns
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...
Florida firm accused of serious cGMP violations and unauthorized disease claims
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...
Natural Products Association names John Shaw as its new CEO
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).
FDA: All-natural dietary supplement Reumofan Plus contains prescription drugs
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...
Expert dismisses grapefruit seed extract ‘false positive’ explanation
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...
Many ‘Grapefruit Seed Extracts’ adulterated with synthetic disinfectants, says nonprofit research consortium
The majority of products containing 'grapefruit seed extracts' may be adulterated with synthetic additives, according to a new review from a nonprofit research consortium.
Bodybuilding.com steroids spiking guilty plea is a wake-up call for industry, says lab director
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...
Comment
Safety & efficacy – The industry’s mission statement in two small words
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...
‘Phytoforensics’ could help industry avoid most adulteration disasters: Expert
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.
FDA warns of sexual enhancement products and sends yet more letters for GMP violations
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...
News in brief
NAI posts 30% surge in sales in Q3, 2012
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.
Website claims and GMP violations continue to dominate FDA warning letters
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...
Dispatches from AHPA's Botanical Congress
FDA: We’re not enforcing NDI draft guidance; GMPs are the biggest issue
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...
Toxicology expert raises alarm over potential neurotoxins in graviola/soursop
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)...
DMAA fallout: 'The industry is always on the lookout for the next big stimulant', says All American EFX boss
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...
MusclePharm: ‘We made an intentional decision to stay away from DMAA’
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.
Herbalife: It’s important that we take more control of the manufacturing process
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.
Dan Fabricant: FDA ‘somewhat aghast’ at degree of cGMP non-compliance
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....
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