Let’s assume you’ve done your homework on your new ingredient and have successfully filed a New Dietary Ingredient notification with the Food and Drug Administration. Can a competitor launching a me-too product come along and trade on that status? It’s...
A Department of Defense safety review of DMAA has concluded that the ingredient poses potential health risks but could not be causally linked to the deaths of four soldiers who died with the ingredient in their bloodstreams. GNC Holdings, the last brick...
Conflicts of interest are “ubiquitous” in GRAS [Generally Recognized As Safe] determinations, while there are major flaws in a system that allows firms to affirm the safety of food ingredients without the approval - or even the knowledge - of regulators,...
A bill reintroduced by Senators Dick Durbin, D-Il and Richard Blumenthal, D-CT to require registration of all dietary supplements with FDA is a solution in search of a problem, according to trade organizations.
The case of a dietary supplement company that became ensnared in an IRS complaint and a potential criminal investigation related to a couple of celebrity politician endorsers points out the possible pitfalls of the practice of hitching your marketing...
New rules from FDA to implement the Food Safety Modernization Act will place significant new burdens on industry, observers say. But the new food importation regime that will result could provide new business opportunities, too.
A Senate committee hearing on energy drinks marketing yesterday uncovered some skeletons in the advertising closets of three companies there as witnesses, suggesting some reexamination of practices is in order, one observer said.
The Food and Drug Administration has enough tools to police the dietary supplement sector. That was the reaction from industry in the wake of yet another negative story about the product category in a high profile publication, in this case, USA Today.
The US Food and Drug Administration has issued a batch of warning letters to companies making diabetes-related claims, as the agency continues its scrutiny of claims on products, websites, and beyond.
Brad Williams, a 30-year Food and Drug Administration veteran, has joined Ann Arbor, MI-based NSF International as technical manager of the global health organization’s dietary supplement GMP compliance program.
A market-driven approach that allows consumers to opt for foods made without genetically modified ingredients is preferable to mandatory labeling via either state or federal statutes, according to the United Natural Products Alliance.
Two leading trade associations representing the natural products and dietary supplements sectors have clarified their stance on GMO labeling this week, with the American Herbal Products Association (AHPA) favoring voluntary disclosure of the absence of...
Identity testing of botanical ingredients continues to be a hot button issue for the Food and Drug Administration. To help companies comply with this aspect of GMP regulations, the American Herbal Pharmacopoeia has instituted a series of eight webinars...
The reporting of adverse events in connection with dietary supplements is woefully inadequate, according to experts who spoke Monday at a gathering of toxicologists in Aspen, CO. There are many complicating factors, the experts agreed, not the least among...
Key members of the United States Congress have voiced concern over the speed of progress of revising the controversial draft guidance for new dietary ingredients (NDIs), and called on FDA to produce a revised draft guidance in a 'timely manner'.
Whole foods supplement manufacturer FoodState has achieved Non-GMO Project verification on five of its MegaFood products. It’s a challenging standard for supplement manufacturers to meet, said FoodState CEO Robert Craven.
The American Herbal Products Association has weighed in on draft proposals to amend California’s Proposition 65. Among the group’s recommendations are changes to the language of the warnings mandated under the law.
In a time of regional regulatory change affecting more than 100 countries, the International Association of Dietary Supplement Associations (IADSA) has emphasised the importance of global guideline setting organisation, Codex Alimentarius, which turns...
Big interview, Gregory Jaffe, Director of Biotechnology, CSPI
The Center for Science in the Public Interest (CSPI) has made a name for itself by tackling the food industry’s big guns on everything from artery-furring entrees to misleading label claims. But where does it stand on genetically modified organisms (GMOs)?
A judge in a federal court in California has ordered the Food & Drug Administration (FDA) to publish all outstanding proposed regulations under the Food Safety Modernization Act (FSMA) by November 30 this year.
Vasilios (Bill) Frankos, PhD and Andrew Shao, PhD are, in a way, the alpha and omega of network marketing giant Herbalife’s increasingly sophisticated commitment to the scientific backing, quality and safety of the company’s nutritional products. Their...
Who is best qualified to provide nutritional counseling? A registered dietitian? A medical doctor? A nutritionist? A nutrition scientist? A sports scientist? You or me?
The Food and Drug Administration moved today to seize more than 1,500 cases of supplements that contain DMAA from a Pennsylvania warehouse belonging to GNC Holdings, Inc.
Beta Labs, a dietary supplements distributor and retailer, has recalled four sports supplement products that contain DMAA. The company said it initiated the recall after “a review of recent FDA communications related to 1,3 dimethylamylamine (DMAA).”
The US House of Representatives Appropriations Committee has sent a stern message to the Food and Drug Administration on the subject of the draft New Dietary Ingredients guidance. The message in a nutshell: Get a move on.
A new government dietary supplement database now provides information on the ingredients thousands of finished products for the benefit of researchers, health care providers and consumers, according to the National Institutes of Health, which hosts the...
Infant formula products that have passed their sell-by-date could soon be considered adulterated if a recently introduced bill – labelled a “no brainer” – can make through the House of Representatives and the Senate.
The campaign for mandatory GMO labeling gained a further boost this week as the Maine House of Representatives voted 141-4 in favor of LD 718, a bill that would require foods made with ingredients from biotech crops to carry the label ‘Produced with Genetic...
A new warning letter from FDA for a company manufacturing products that contained only 5% of declared nutrient levels shows that the agency is stepping up its testing of finished products, say industry experts.
Omega Protein has agreed to a total of $7.5 million in fines and payments to settle an investigation by the US Environtmental Protection Agency into the company’s Virginia fishing operations.
The Center for Science in the Public Interest has called on FDA for a ban on ginkgo products, basing its demand on a government report that industry sources have said is critically flawed. FDA, in response, said the request was 'not scientifically...
US-based foods and supplements manufacturer, Now International, hasn’t sat on its hands since the EU’s new health claim laws kicked into play in 2008 – taking pre-emptive action to keep abreast of the new formulation and health claims landscape.
The proliferation of proposed state GMO labeling laws is a means to an end, according to one longtime advocate. The ultimate goal is a federal law that would require GMO labeling across the US.
When communicating scientific information to a jury in a court proceeding, just remember your bedtime reading skills. Telling a good story well is the key, experts say.
Quality control in the food supplements sector is an ongoing mission that remains top of the agenda at the group that most prominently represents both global and national players – IADSA - especially as new regions adopt GMP rules for the first time.
Food fortification with neural tube defect (NTD)-reducing folic acid is mandatory in 75 nations, but concerns over cancer and other health issues mean Europe lags far behind – a situation that needs to change and quickly, says DSM thinktank, sightandlife.
The legislative pressure on mandatory GMO labeling continues to build, at least on the state front, as the Connecticut State Senate voted 35-1 in favor of SB 802, a bill that would require labeling of products with genetically modified ingredients.
Among recent warning letters sent by the US Food and Drug Administration to supplement manufacturers one stood out from the rest as it bears upon how the agency view the differentiation of beverages and supplements, according to Justin Prochnow, an attorney...
Differing regulatory environments can play havoc with a company's research plans, say consultant Joerg Gruenwald, PhD. But recent, sometimes bitter, experience with the European Food Safety Authority has shed some light on how to negotiate this...
Whether the food industry likes it or not, when it comes to GMO labeling, the “train appears to have left the station”, according to former FDA associate commissioner of foods Dr David Acheson.
Nations and populations are in peril of being swamped by the cost of their healthcare systems unless a severe nutrition policy rethink can occur, says a leading academic.
The US Food and Drug Administration has issued warning letters to two dietary supplement companies, as the agency maintains its vigilance of website claims and cGMP compliance.
The US Food and Drug Administration has issued some important warning letters in recent weeks. In this special focus, we revisit the lessons for all companies, from website claims, to the obligations of private label distributors.
The Vermont House of Representatives has passed H.112, a bill requiring the labeling of all genetically engineered (GE) food sold in Vermont. However, there are plenty of hurdles ahead.
A new warning letter illustrates FDA’s stance on the obligations of private label distributors to ‘ensure that all phases of the production of [a] product are in compliance with dietary supplement CGMP requirements’.
The FDA has issued a warning letter for a company website that links to articles with disease claims cause products to be drugs (FDA), causing the products linked to such articles to be drugs.
The Council for Responsible Nutrition (CRN) has submitted comments to the FDA via international law firm Steptoe & Johnson, LLP, to address when an ingredient is chemically altered such that it would require a separate NDI notification.
The proposed changes by California Gov. Edmund G. Brown Jr. to the state’s controversial Prop 65 law ‘could be helpful to companies that need to deal with this law’, says AHPA's legal counsel.
The five associations representing the dietary supplement industry have asked the Food and Drug Administration (FDA) to issue revised guidance on new dietary ingredient (NDI) notifications, with a specific focus on the information to be included to identify...
Now, almost 20 years after DSHEA became law, some companies seem to be just starting to get the message that the regulations governing health claims language don’t apply just to product labels. Websites are fair game, too, and can form easy pickings for...
