Breaking News on Supplements & Nutrition - North AmericaEU edition

New ingredient approvals

Innovation in functional foods is closely linked to the emergence of new ingredients, many of which are already successfully used in the dietary supplement market. We list the latest GRAS and novel foods approvals, which open up an ingredient’s use in the food and beverage market.

AHPA: FDA will be 'laughed out of court' if it sticks to its guns on supplement-specific NDI notifications

The FDA will be “laughed out of court” if it tries to defend enforcement action against supplement manufacturers based on the argument that new dietary ingredient (NDI) notifications should apply...

Hatch NDI guidance meeting: File comments for now, then explore legal avenues …

A range of options – “judicial, administrative and Congressional” – is being explored by the dietary supplements industry should the FDA prove unwilling to make substantial changes to its controversial...

Emord on NDI guidance: Politics has prevailed over science and common sense

If sufficient pressure is exerted on key members of Congress, it is not beyond the realms of possibility that the FDA might suspend its draft guidance on NDIs (new dietary...

Supplements trade: NDI guidance can be salvaged, but give us more time

If stakeholders are granted more time to respond to the FDA’s draft guidance on new dietary ingredients (NDIs), it should be possible to reach a compromise that will satisfy regulators...

NDI guidance public comments: Don't revise it, ditch it

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...

Biotech firm launches mission to commercialize novel prebiotics

A New Orleans-based biotech firm on a mission to commercialize “novel evidence-based prebiotic products” is aiming to bring its first products to market next year.

Dormant antioxidant has ‘unparalleled’ benefits

A Beverly Hills-based biotech firm is planning to launch a series of supplements and functional foods containing ergothioneine, an antioxidant it claims has “unparalleled” benefits that has hidden its light...

New entrant set to shake up algal omega-3 market

A new player is poised to enter the vegetarian omega-3 market with a production process it claims will enable it to make the long chain fatty acids EPA (eicosapentaenoic acid)...

ChromaDex: We’ll do for nicotinamide riboside what we did for pterostilbene

Nicotinamide riboside (NR) - the latest addition to ChromaDex’s bioactive ingredients stable – will follow a similar development path to pterostilbene, a compound found in blueberries it has synthesized to...

‘No logic’ to FDA view on product-specific NDI notifications, says lawyer

There is “no logic” to the FDA’s insistence that NDI (new dietary ingredient) notifications are applicable only to the specific manufacturer that submits them, according to one leading food law...

Lawyer on NDI guidance: FDA is trying to ‘dismantle’ DSHEA

The argument that the FDA has overstepped its legal remit in its draft guidance on new dietary ingredients (NDIs) is gaining ground, with one food law expert claiming the FDA...

Toxicologist: FDA’s NDI guidance is entirely reasonable

Many dietary ingredients used in supplements today bear little resemblance to ingredients that were assumed to be ‘grandfathered in’ post the 1994 Dietary Supplements Health and Education Act, making a...

ABC on NDI guidance: ‘We find this problematic’

The American Botanical Council (ABC) has weighed into the debate over the Food and Drug Administration’s (FDA’s) draft guidance document on new dietary ingredient (NDI) notifications.

Lawyer: FDA line on grandfathered ingredients was not made clear

A leading food law expert and the Food and Drug Administration’s (FDA’s) dietary supplements chief agreed to disagree over several key aspects of the FDA’s draft guidance on new dietary...

Big interview: Daniel Fabricant, Food and Drug Administration (FDA)

FDA on NDI guidance: This is ‘not a doomsday scenario’ for supplements trade

The trade can rail against the Food and Drug Administration's new dietary ingredient (NDI) guidance as much as it likes, but it cannot honestly pretend to be shocked or even...

Big Interview: Vasilios Frankos, Herbalife

Frankos on NDI guidance (part two): This really isn’t a big surprise

While many stakeholders warn that the FDA’s controversial NDI draft guidance will stifle innovation and bury the supplements trade (and the FDA itself) under a hellish mountain of paperwork, they...

Big interview: Vasilios Frankos, Herbalife

Frankos on NDI guidance (part one): Take a deep breath and don’t panic

While many stakeholders seem to believe that the Food and Drug Administration’s (FDA’s) controversial draft guidance document on NDI (new dietary ingredient) notifications could spell Armageddon for the supplements trade,...

Could the trade mount a legal challenge vs NDI guidance?

If the Food and Drug Administration (FDA) does not revise its draft guidance on new dietary ingredients (NDIs) for supplements to reflect industry concerns, the trade might be stuck...

Mister on NDI guidance: ‘We are terribly disappointed.’

The amount of safety data the FDA now says it requires to prove new ingredients in supplements are safe goes well beyond what Congress envisaged when it ratified DSHEA and...

Quality of nano toxicity data is ‘not great’, says expert

The limited nature of many toxicity studies into engineered nanoparticles used in the food and dietary supplements industry makes it very difficult to draw firm conclusions about their safety, according...

Liquid confusion: When does a dietary supplement end and a beverage begin?

There could be serious consequences for industry if the Food and Drug Administration (FDA) decides to start enforcing guidance clarifying the legal dividing line between liquid dietary supplements and conventional...

Ullman on homotaurine: “I do not see any basis in law for what FDA is doing”

Last week the Food and Drug Administration (FDA) denied a petition that sought to have a synthetically manufactured algae extract called homotaurine classified as a new dietary ingredient (NDI).

Folate form gains FDA NDI approval

Italian supplier Gnosis Bioresearch has won New Dietary Ingredient (NDI) approval from the Food and Drug Administration for a synthetic folate salt form.

Burcon gains FDA GRAS for canola proteins

The Food and Drug Administration has issued a letter of no objection to Burcon NutraScience Corporation for its canola protein extracts, an important milestone for further development.

DSM confident about genistein uptake in foods

Ingredient firm DSM says its branded genistein ingredient marketed for menopause and bone benefits could appear in foods sold in the US within the next 12 months, following strong interest...

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