The US Food and Drug Administration (FDA) yesterday said it is extending the comment period for Section 912 of its Amendments Act (FDAAA), which has the potential to radically change the way dietary supplements are regulated in the country.
In a move that has divided industry, the Food and Drug Administration (FDA) has told German pharma giant Bayer in no uncertain terms to cease making disease reduction claims about products that contain both pharmaceutical and nutraceutical ingredients.
Stuart Craig, Danisco's director of Regulatory and Scientific Affairs, North America, explains why Section 912 could have a major impact on the way dietary supplements are regulated in the United States.
The US Food and Drug Administration (FDA) has confirmed that GMP inspection reports are not, in fact, available online, and that the only way to access these is by filing a Freedom of Information request.
A review of the current US dietary guidelines to help improve the nation’s health through proper nutrition is now underway with the appointment of a new panel, which includes experts in probiotics, prebiotics and satiety.
The course of true love never did run smooth. The same could be said of stevia’s road to regulatory approval as a food ingredient. One final concerted effort is needed to ensure approval of this hot ingredient.
An update to this article has been published here.The US Food and Drug Administration (FDA) has published the first round of GMP inspection reports on its website, according to the director of the agency’s Division of Dietary Supplement Programs, Dr Vasilios...
Coffee and tea-based products are free from the caffeine labelling requirements of energy drinks. But is this in consumers’ best interests? Neil Merrett reports.
The successful implementation of new GMP regulations needs to start with the education of upper management on the requirements and implications of the rules, industry heard yesterday.
The American Academy of Pediatrics has doubled its advice on vitamin D intake by children and infants to 400 IU per day, on the basis of clinical evidence for the prevention of rickets and deficiency – and possible links with diabetes and cancer prevention.
The supplements industry continues to fight for its territory just weeks before the US Food and Drug Administration (FDA) is expected to respond to a petition that would reclassify weight loss claims as disease claims.
In the second part of a series on gut health, NutraIngredients examines the way products in this category are regulated – and what types of health claims they can make.
Before reading this you’re probably going to need a coffee, in fact why not have a few? After all who’s to say when enough is enough in our hunt for a caffeine kick.
The Food and Drug Administration (FDA) has come in for criticism from a government watchdog for failing to adequately crack down on false and misleading food labeling.
Dietary supplement manufacturers in the US should inform the nation’s regulator of the cost burden they are likely to incur if proposed labeling regulations are passed, an industry association said yesterday.
The US Food and Drug Administration (FDA) says it is unable to set a safe level of melamine contamination in infant formulas after issuing a wider ruling on the chemical’s presence in food products containing milk.
The issue of whether businesses are solely driven by profits and will not respond to voluntary guidance to improve the health effects of their products is a matter of hot debate in the British Medical Journal this week.
Martek Biosciences Corporation is disappointed but not devastated by the European Food Safety Authority’s rejection of its article 14 DHA/ARA infant nutrition health claim.
The dietary supplements industry is calling for a freer flow of information linked to the adverse event reporting system, in order to be better prepared to address failures.
A trade association has prepared a GRAS notification dossier for its baobab fruit pulp powder in the hope that products could become available in time for the 2010 soccer World Cup in South Africa.
The European Food Safety Authority recently turned in its first health claim verdicts, rejecting eight of nine. European food regulations expert Lorène Courrège explains why EFSA’s tough health claim approach may stifle product innovation.
The US calcium osteoporosis health claim will include vitamin D and be simplified in a number of other ways from January 1, 2010, according to the Food and Drug Administration (FDA).
At the end of last month, the founder of US supplements firm Berkeley Premium Nutraceuticals received the most severe punishment yet to be handed out for fraud in the industry: A 25-year jail sentence and $93,000 from his personal savings. The company...
The US Food and Drug Administration estimates that it will receive only one nutrient content claim notification and two health claim notifications per year, according to a notice to be published in the Federal Register.
There have been 604 adverse event reports (AERs) – including five deaths – in six months, according to the Food and Drug Administration (FDA), which implemented the system last year.
Five US dietary supplement companies are facing lawsuits for marketing cancer cures, while another six firms have settled out of court following a crack down by the nation’s Federal Trade Commission (FTC).
New Zealand dairy group Fonterra is facing criticism over lethal contaminated milk powder supplied through its Chinese joint venture, but says action was delayed as it had to go through the correct procedures in China.
The US Food and Drug Administration (FDA) has issued a public warning that infant formula manufactured in China may not be safe because of concerns over melamine contamination.
Whey and milk-based ingredients specialist, Friesland Foods Domo, has received GRAS status (generally recognized as safe) for its prebiotic ingredient Vivinal GOS from the US Food and Drug Administration (FDA).
Californian ingredient firm BioCell Technology has filed a suit against the contract manufacturer ProTec Laboratory, which it claims has been selling supplements falsely marketed as containing BioCell’s joint health ingredient.
At the end of last month, the founder of a US supplements company received the most severe punishment yet to be handed out for fraud in the industry: a 25-year jail sentence. NutraIngredients is calling for comments on this historic decision.
Regulations governing the omega-3 market vary greatly between regions but in common is the fact there is no official, government-recommended dietary intake (RDI) anywhere in the world and approved health claims are few.
Europe’s health claim assessment process kicked off with the rejection of almost 90 per cent of the first bunch. But industry must accept its shortcomings if credibility is to be the winner.
The founder of Berkeley Premium Nutraceuticals, Steve Warshak, has this morning been handed a 25-year jail sentence and his company ordered to forfeit $500 million by a federal court that found him guilty on 93 counts of conspiracy, fraud and money laundering.
The Canadian regulator is continuing its campaign against the banned weight-loss herbal Ephedra and the anxiety-reliever Kava, yesterday issuing its latest warning to consumers not to use the substances.
Cargill’s barley beta concentrate has received a heart health claim go-ahead, following the publication last week of a final ruling from the US Food and Drug Administration (FDA).
Members of the supplement trade body Council for Responsible Nutrition (CRN) have pledged to follow certain guidelines when marketing products containing the naturally occurring steroid hormone DHEA, in a move designed to tighten industry self-regulation.
Self regulation to ensure that products marketed towards children meet nutritional standards is working, according to The Council of Better Business Bureaus, which has just signed Nestlé up to the scheme.
In the third of a four part series on natural colors, FoodNavigator looks at the regulatory situation in the US and Europe and the challenges this poses for food manufacturers and ingredients companies.
Reclassifying weight loss claims as disease claims will unfairly "disease-ify" many health conditions, according to the Council for Responsible Nutrition (CRN).
Developing harmonised dietary supplements regulations in Latin America was the central topic at a recent meeting in Buenos Aires, Argentina, convened by the International Alliance of Dietary/Food Supplement Associations (IADSA).
The US Food and Drug Administration (FDA) has published guidance to help small companies comply with the labeling of antioxidant products and high potency products.
A group of defendants allegedly involved in selling bogus weight
loss hoodia supplements through illegal spam e-mails have settled
charges with the Federal Trade Commission (FTC).
The prescribing of statins for eight years-olds is tantamount to
saying that food and diet have failed, and that children are
incapable of changing their eating habits and lifestyle.
Sabinsa has gained GRAS status for its coconut water solids
ingredient Cococin, giving an extra layer of assurance that it is
safe for use in food and beverage products, as well as supplements
and cosmetics.
The 'fake' hoodia battle between supplier Stryka Botanics and
customer Certified Natural Laboratories has moved up a notch, after
Stryka filed papers that it says will have the lawsuit thrown out.
Bogus health claims that are "commonplace" on dietary
supplements are now also being adopted by the food industry,
according to consumer group CSPI, which has urged an FDA
clamp-down.
