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The Food & Drug Administration is not preparing to enforce its controversial draft guidance on new dietary ingredients (NDIs), but companies can expect more inspections, more injunctions, and more product seizures related to current good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.
GMP compliance and enforcement is good for the industry, but it is also good for business for suppliers that focus on quality, says George Pontiakos, president and CEO of BI Nutraceuticals.
The analytical community knows which companies are involved in dry labbing, says a leading analytical expert, and the practices of a minority of labs are harming the whole industry.
The Food and Drug Administration (FDA) is taking the information seriously from Dateline NBC’s exposé on dry labbing in the dietary supplements industry, NutraIngredients-USA has learnt.
The recent Dateline NBC investigative section on unsafe supplements and ‘dry labbing’ was “misleading” and “not representative of the responsible supplement industry”, says the American Herbal Products Association (AHPA).
Yesterday's airing of a Dateline NBC exposé on dry labbing practices in dietary supplements represents an opportunity for industry to tackle the problem head on, says Frank Jaksch, CSO and co-founder of ChromaDex.
PTeroPure maker ChromaDex has posted a 7% rise in revenues to $8.1m in the fiscal year ending December 31, 2011, but notched up a net loss of $7.9m compared with a net loss of $2.1m in 2010.
The United States has entered a consent decree against a Pennsylvania dietary supplement company to cease operations following numerous current good manufacturing practice (cGMP) violations.
Twinlab is preparing to unveil a new range of sports nutrition products under the Clean Series brand to tap into growing demand for products with ‘cleaner’ labels.
Many dietary supplement companies are not fully compliant with GMP regulations, putting them at risk of warning letters and more, but resources are available to help companies prepare for an FDA inspection, says the Council for Responsible Nutrition (CRN).
Germander is still being used as a substitute for skullcap in dietary supplements, despite ongoing attempts to raise awareness about the problem, according to a new paper published by the American Botanical Council (ABC).
Experts in helping firms navigate the GRAS (generally recognized as safe) process say the American Heart Association (AHA) made some valid points in its recent attack on GRAS, but argue the system is actually working pretty well.
A new paper published by the American Botanical Council (ABC) attempts to dispel the ‘puzzling’ and pervasive ‘myth’ that the US dietary supplements trade is unregulated.
So much for easing gently into the New Year. Just days into 2012, the supplements trade was wrestling with a big spiking story on Dr Oz, more difficult questions about DMAA and calls for even tougher NDI guidance…
An analysis of recent Food and Drug Administration (FDA) warning letters has exposed several ‘ten ton elephants in the room’ and ‘time bombs waiting to go off’ when it comes to cGMP (current good manufacturing practice) compliance, according to one leading...
A monograph for American Ginseng – claimed to be one of the most widely adulterated herbs on the market - has been released by the American Herbal Pharmacopoeia (AHP).
Dangerous stimulants in so-called ‘bath salts’ and plant food could make their way into the supplements trade this year if firms do not maintain their vigilance, according to one expert in the analytical testing field.
Anaheim-based GMP Laboratories of America Inc has been Certified for Sport by NSF International, as the company met stringent certification requirements, including testing for more than 150 banned substances.
The FDA published a handful of warning letters in late December, with cGMP violations and claims on websites and social media sites continuing to catch the FDA’s eye.
The Food and Drug Administration (FDA) has weighed into the debate over the stimulant DMAA (1,3-Dimethylamylamine, also known as methylhexaneamine or MHA), which has garnered more bad press in recent weeks.
Not surprisingly, the FDA's draft guidance on new dietary ingredients (NDIs) is top of the list for most trade associations when asked what is keeping them awake at night as we head into 2012, but it is not the only thing causing sleepless nights.
A California-based company with the same name as a firm targeted by the Food and Drug Administration (FDA) in a crackdown on adrenaline-like stimulants says it has been inundated with calls from confused customers, although it has nothing to do with the...
The FDA claims US Marshals have seized $70,000 worth of raw materials for dietary supplements containing ephedrine alkaloids, as enforcement action in the dietary supplement industry continues.
Syntec Inc (Syntec Nutraceuticals) says it is “fully co-operating” with the Food & Drug Administration (FDA) after supplements made at its facility in Wisconsin were seized following allegations of serious cGMP violations and unauthorized disease...
The Food and Drug Administration (FDA) says it had no choice but to seize supplements manufactured by Syntec Inc (Syntec Nutraceuticals) after the firm committed serious cGMP violations and ignored warning letters accusing it of making unauthorized disease...
The owner of two New Jersey-based dietary supplement companies guilty of criminal contempt of court relating to GMP violations has been sentenced to prison for 40 months.
The ‘consistent fundamental failures’ of companies in the dietary ingredients and supplement segment for current good manufacturing practices (GMPs) is a ‘topic of disappointment’, says Loren Israelsen.
The US Food and Drug Administration has filed for a permanent injunction against a Pennsylvania dietary supplement manufacturer as the agency turns the GMP compliance screw.
The US Food and Drug Administration (FDA) has issued two warning letters in November for alleged dietary supplement cGMP violations, as the agency maintains its vigilance.
Products manufactured by Robinson Pharma Inc can carry the respected NSF Mark following NSF cGMP certification for its dietary supplement manufacturing facilities.
The dietary supplements industry should keep an eye on GMP compliance, and not be distracted by discussions over NDIs, because enforcement may move beyond handing out paper if warning letters are ignored, said FDA’s Dr Daniel Fabricant.
The industry may be on the verge of facing up to potential ‘dry labbing’ issues, which could bring the issue to the forefront and ‘hopefully get this problem fixed’, says ChromaDex’s Frank Jaksch.
The U.S. Food and Drug Administration (FDA) found no deficiencies or areas where corrective action notices following a cGMP (current Good Manufacturing Practices) inspection of its facility in Utah.
EuroPharma is planning to launch a probe into commercially available curcumin supplements to establish whether products purporting to contain exclusively natural extracts in fact contain cheaper, synthetic raw materials.
ChromaDex has signed a deal with the Association for African Medicinal Plants Standards (AAMPS) to sell and market its botanical standards and the African Herbal Pharmacopoeia.
Scientists with the US Department of Agriculture (USDA) have developed a ‘simple, fast, and easy’ method to test for adulterants in skullcap herbal formulations, a timely development given potential short-comings with formulations currently on the market.
So-called Class 1 solvents such as benzene and carbon tetrachloride have no place in the manufacture of herbal products, the American Herbal Products Association (AHPA) has said.
The FDA should calculate how much complying with its guidance on new dietary ingredients (NDIs) will cost before forcing the supplements industry to embark on a “giant paperwork exercise” that will not make consumers any safer, according to the first...
