NattoPharma has been awarded a Canadian patent covering the use of menaquinone (vitamin K2) in foods and supplements for maintaining, optimizing, strengthening or promoting cardiovascular health.
An authoritative new guide to 23+solvents used in the production of botanical extracts for dietary ingredients could help inform the debate on ‘chemical alteration’ at the heart of the FDA’s draft guidance on new dietary ingredients (NDIs), says the American...
The regulatory status and safety of DMAA, a stimulant used in sports and weight loss supplements and reported by some to be a natural constituent of geranium oil, has been challenged again this week.
PepsiCo’s snacks business Frito-Lay has been accused of misleading consumers by making all-natural claims on its products which also contain genetically modified corn and vegetable oils.
Not surprisingly, the FDA's draft guidance on new dietary ingredients (NDIs) is top of the list for most trade associations when asked what is keeping them awake at night as we head into 2012, but it is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.
While it is possible that the FDA could withdraw its draft guidance on new dietary ingredients (NDIs), such a move would be “highly unusual”, according to one leading food law attorney.
Direct selling giant Herbalife says it will appeal last month’s ruling in a commercial court in Brussels stating it had violated Belgian law on unfair commercial practices.
A federal judge has found supplement marketer Lane Labs USA Inc in contempt of a court order barring it from making deceptive health claims, but has also heavily criticized the Federal Trade Commission’s (FTC’s) handling of the case.
Food and Drug Administration (FDA) references to safety concerns over supplements spiked with drugs in the context of the debate on new dietary ingredients (NDIs) are “highly disingenuous”, Jarrow Formulas has argued.
Five years ago the European Union nutrition and health claims regulation (NHCR) became law. Around the bloc, hopeful EU healthy foods and supplements stakeholders submitted more than 44,000 health claim applications.
Requiring supplement manufacturers to submit new dietary ingredient (NDI) notifications will force them to seek confidential information from suppliers in order to file submissions, according to law firm Amin Talati.
The only probiotics that should be subject to new dietary ingredient (NDI) notifications should be “new probiotics derived from GM engineering which have little to no history of safe use”, according to the International Probiotics Association (IPA).
Botanical extracts that have been on the market for years should not automatically be treated as new dietary ingredients (NDIs) just because extraction methods have changed, according to the United States Pharmacopeia (USP).
The five main trade associations for the dietary supplements industry are united in their calls for a ‘timely’ and ‘substantial overhaul’ of the draft guidance, according to a joint statement.
POM Wonderful has failed to convince a federal jury that Ocean Spray Cranberries misled shoppers and deprived POM of potential sales by selling a pomegranate juice product containing only 2% pomegranate juice.
The FDA’s NDI draft guidance sets up a ‘substantial and unprecedented premarket regulatory process’ that is ‘tantamount to obtaining FDA approval for dietary supplement products’, says Atrium Innovations.
The new dietary ingredient (NDI) draft guidance, as it stands, will not help achieve the objective of full and efficient implementation and enforcement of DSHEA, says the United Natural Products Alliance (UNPA), as it adds its voice to calls for FDA to...
Health advocacy group Citizens for Health (CFH) has delivered a petition to the House of Representatives, the Senate and the Food and Food and Drug Administration (FDA) signed by more than 12,000 Americans, calling on the FDA to withdraw its draft guidance...
Health advocacy group the Alliance for Natural Health USA (ANH-USA) is exploring all available “legal remedies” should the Food and Drug Administration (FDA) fail to ditch or substantially revise its draft guidance on new dietary ingredients (NDIs).
The International Scientific Association for Probiotics and Prebiotics (ISAPP) has urged the Food and Drug Administration (FDA) to rethink its approach to live microbial dietary ingredients.
The Food and Drug Administration should tear up its “hugely flawed” draft guidance on new dietary ingredient (NDI) notifications and go back to the drawing board, according to the American Herbal Products Association (AHPA).
The Food and Drug Administration (FDA) should recognize the existing industry list of ‘grandfathered’ or ‘old’ dietary ingredients (ODIs) sold in the US pre-1994 – but work with an expert panel to clarify its contents, according to the American Botanical...
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...
There will be differences in emphasis in comments submitted to the FDA on its draft guidance on new dietary ingredients (NDIs), but the overall message from the supplements industry is clear - and consistent - says the Council for Responsible Nutrition...
The Food and Drug Administration’s (FDA’s) draft guidance on new dietary ingredients (NDIs) can be salvaged, but only if the agency is willing to substantially rewrite the offending document, the Natural Products Association (NPA) has argued.
While the Food and Drug Administration (FDA) will need time to process the expected tidal wave of comments on its draft guidance on new dietary ingredients (NDIs), the supplements industry should not be left in regulatory “limbo” for long, trade associations...
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.
Jarrow Formulas is still waiting for a “substantive response” from the Food and Drug Administration (FDA) to a Freedom of Information Act (FOIA) request submitted more than two months ago about the FDA’s draft guidance on New Dietary Ingredients (NDIs).
Suggestions by Aker Biomarine that Neptune Technologies and Bioressources misrepresented the novelty of the inventions claimed in its newly-granted krill oil patent are “baseless”, Neptune bosses have insisted.
The judge presiding over a high-profile case brought by US vitamin buyers against Chinese firms accused of fixing the price of vitamin C is considering a series of motions filed by the defendants, who claim they were compelled to act as a cartel by the...
Neptune Technologies & Bioressources has bolstered its intellectual property portfolio further after securing a new US patent (No. 8,057,825) awarding it the exclusive use of krill extracts in the US as a method for reducing cholesterol, platelet...
Senator Dick Durbin (D-IL) and Representative Henry Waxman (D-CA) have called on the U.S. Government Accountability Office (GAO) to clarify how the adverse event reporting (AER) system is working.
Proposed amendments to legislation designed to promote ethical conduct in federal employees would unfairly discriminate against trade associations, the Council for Responsible Nutrition (CRN) has argued.
The firm behind controversial weight loss crystals designed to be sprinkled on foods to ‘activate your hunger control switch’ has been hit with a class action lawsuit filed in a Texas district court accusing it of false, misleading and deceptive marketing.
A proposed change to the date defining ‘grandfathered’ dietary ingredients to 2007 shows the industry there are options to the NDI issue, but it should not distract attention from FDA and the upcoming deadline for NDI comment submissions, say leading...
Heart healthy food giants Raisio and Unilever have clashed over proposed changes to the wording of health claims about phytosterols and the risk of coronary heart disease.
Pfizer has joined a growing number of companies calling on the FDA to rethink a controversial December 2010 proposed rule that would ban cardiovascular disease risk reduction claims on supplements containing non-esterified phytosterols.
Supplement maker ProCaps Laboratories has weighed into the row over whether dietary supplements containing ‘free’ non-esterified phytosterols should be allowed to make coronary heart disease risk reduction claims.
New standards to underpin the use of the word ‘natural’ on meat & poultry products and snacks & cereals should be released by the Natural Products Association (NPA) next year as part of its Natural Seal certification scheme.
The leading pan-European food supplements trade group has written to the European Commission in an effort to prevent certain negative European Food Safety Authority (EFSA) health claim opinions reaching the lawbooks in their current form.
The Federal Trade Commission (FTC) has cracked on two firms accused of making false and deceptive claims about the much-hyped weight management ingredient hoodia as part of its “ongoing efforts to stop bogus health claims”.
A change to the rules governing Californian statute Proposition 65 that would allow firms to include “contextual language” on warning labels about lead would go some way to addressing industry frustrations with the legislation, according to the American...
Countries that set maximum levels of vitamins in supplements based on RDAs (recommended dietary allowances) are out of step with the latest science and are violating three different World Trade Organization (WTO) agreements, according to a legal analysis...
In the world of food marketing, perception is everything. Consumers want foods that sound wholesome, friendly, and above all “natural” – although they are rarely able to articulate what this means.
The Food and Drug Administration (FDA) has put supplement makers in an “untenable” position with its move to discontinue an eight-year-old policy of enforcement discretion on health claims about phytosterols, according to the Council for Responsible Nutrition...
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.
It is now increasingly likely that a judgment in the Federal Trade Commission’s (FTC’s) false advertising case against POM Wonderful will not be issued before POM squares up with rival Ocean Spray next month at a trial the cranberry juice giant has unsuccessfully...
The functionality of the New Dietary Ingredient (NDI) guidance can be improved in only six steps, says direct selling giant Herbalife in its comments to the US Food and Drug Administration (FDA).
