Health Canada has approved Bio-K Plus International Inc’s patented Bio-K+ probiotic formula to help reduce the risk of Clostridium difficile (C. diff) infections in hospitalized patients.
After a tidal wave of lawsuits and months of heated debate about the regulatory status of the stimulant DMAA (1,3-Dimethylamylamine), USPLabs has agreed to settle a nationwide class action suit challenging the legality and safety of its top-selling DMAA...
Two US senators and a member of the House of Representatives have sent letters to 14 energy drink companies seeking information about their products. The letters ask the companies to respond to detailed questions about their products’ ingredients and...
While the headlines yesterday could be summarized as ‘FTC one, POM zero’, legal experts say the 54-page opinion from FTC Commissioners on the FTC’s false advertising case vs POM Wonderful could have troubling implications for the food and supplement trade...
The Council for Responsible Nutrition has submitted comments to the Codex Alimentarius Commission recommending substantive changes to the proposed draft standards for fish oils, the organization announced yesterday.
Herbalife Inc. fought back against negative press about its business model in a presentation for analysts Thursday that ran more than two hours. The company sought to refute in detail allegations made by hedge fund manager William Ackman in December...
The recent announcement by USP of a proposed new standard for krill oil could help boost customer and consumer certainty about the ingredient, experts said.
Nestlé has refused to comment on reports that it is working with financial advisory group Rothschild to sell more than $1bn of Latin American assets in an effort to win regulatory approval for its acquisition of Pfizer Nutrition.
New Mexico has joined Washington and California to become the latest US state asked to consider mandatory labeling for foods containing genetically engineered ingredients.
Supporters of a Washington State ballot initiative that would require GMO labeling have turned in more than 340,000 signatures to the secretary of state’s office, well in excess of the number required for certification, the campaign said. Supporters said...
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.
The Food and Drug Administration has created new dockets for new dietary ingredient notifications (NDINs) and structure-function claim notification letters.
A recent ruling by the US appeals court protecting free-speech relating to off-label use of pharmaceuticals may have ‘far reaching effects’ for the nutritional supplement business, says a leading industry figure.
The energy beverage sector had a lively 2012, marked by a high-profile wrongful death suit against Monster Beverage Co., some high-profile negative press and even higher-profile attacks from a pair of US Senators. 2013 is shaping up, if anything, to be...
The planned acquisition of Super Supplements, a Seattle-based chain, by Vitamin Shoppe Inc. appears to be in question after the Federal Trade Commission’s decision to extend its investigation into the transaction past the planned Dec. 31 closing date.
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...
The Truth in Advertising program of the Natural Products Foundation has referred another 26 advertisers on to the Federal Trade Commission for making drug claims on behalf of dietary supplements.
A Washington state ballot initiative that seeks to require GMO labeling is nearing its goal of 320,000 signatures, a goal organizers are confident that it will reach.
FDA announced on Thursday, Dec. 13 that it has in effect granted a month-long grace period for food facility re-registrations required under the Food Saftey Modernization Act (FSMA).
Evidence is growing that many overseas facilities may fail to meet the Dec. 31 Food Safety Modernization Act food facility re-registration deadline. A new consultancy based in Miami aims to help by offering online information in both Spanish and Portuguese.
The year 2012 might not mark the end of the world. But in future years as people look back, it might mark the beginning of the end for the adulteration of botanical materials, according to Mark Blumenthal, executive director of the American Botanical...
FDA has filed a motion to dismiss a lawsuit that sought to prod the agency into faster implementation of the Food Safety Modernization Act (FSMA). But regardless of whether full implementation is accelerated, FSMA has already significantly altered the...
As the formlisation of the main organ (article 13.1 list) of the nutrition and health claims regulation (NHCR) kicks in this week, Professor Ambroise Martin, the new chair of the European Food Safety Authority (EFSA) health claims panel, tells NutraIngredients...
LifeVantage, manufactures of herbal supplement Protandim, recently announced a product recall that reportedly could end up costing the company as much as $7 million before recovery from suppliers.
Research conducted by ingredient developer Futureceuticals has demonstrated the existence of adulterated green coffee bean extract in the marketplace and has also teased out the probable adulterants.
Do firms need at least two randomized controlled trials (RCTs) to convince regulators that they have ‘competent and reliable scientific evidence’ to support advertising claims about the health benefits of foods and supplements?
Working with athletes can provide a way to circumvent some of the challenges of dietary supplement research by offering up a ‘prestressed’ population, experts say.
A large number of foreign food facilities likely will not be in compliance with the Food Safety Modernization Act re-registration guidelines when the deadline passes at the end of the year, a consultant has said.
Australia is the site of the latest battle between Neptune and Aker Biomarine. In addition to patent strife between the two krill majors in American courts, Canadian Neptune has now announced that it filed opposition to an Aker patent application earlier...
The Food and Drug Administration (FDA) has told US Senators Dick Durbin and Richard Blumenthal that is reviewing the safety of energy drinks and may take regulatory action if it finds a health risk.
2012 is turning out to be a very good year for the vitamins sector. Aside from the feel good factor of the essential nutrients turning 100, vitamins have also won a bag of health claims in the European Union to go with those already existing in other...
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.
The manufacturer of Sensa satiety crystals has agreed to settlements in two cases alleging false advertising. In one case the company settled a false advertising lawsuit filed by several California district attorneys. In the other, the company agreed...
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.
Giant of probiotic supply, DuPont, is not afraid to admit its European business has been altered by the rejection of probiotic health claims under the EU nutrition and health claims regulation (NHCR).
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).
The response to the new GRAS Self-Determination Inventory Database (GSID) has been “overwhelmingly positive and supportive”, according to its creator AIBMR Life Sciences, which has helped dozens of firms prepare for GRAS determinations.
Sen. Dick Durbin (D-IL) read a statement on the Senate floor late Thursday calling for FDA action on the safety of energy drinks in apparent reaction to the news that 92 adverse event reports have been received by FDA in the past four years citing 5-Hour...
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.
5-Hour Energy is “unaware of any deaths proven to have been caused” by consuming its top-selling energy shots, distributor Living Essentials has insisted, after the FDA confirmed it has received 92 serious adverse event reports (AERs) citing 5-Hour-Energy...
The results of the recent elections mean that it’s business as usual for the dietary supplements industry, and the defeat of Prop 37 in California is not the end of the genetically engineered food issue, says Steve Mister, President and CEO of CRN.
Despite the ‘NO’ vote on Prop 37, the momentum behind sourcing non-GMO ingredients remains as strong as ever, with non-GMO Project verified sales up 66% and a new class action lawsuit against a major food brand over ‘all-natural’ claims on products containing...
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...
Consumers, market researchers tell us, want foods that are ‘wholesome’, ‘authentic’, and above all ‘natural’, although few of them can articulate what this means. And they are not alone. Regulators have not had much of a stab at defining ‘natural’ either,...
