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New ingredient approvals

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.

Special edition: Botanicals

Synthetic botanicals standoff likely to continue despite Georgia ruling

Experts expect the existing standoff on synthetic botanicals as voiced by FDA in the most recent draft NDI guidance will continue, despite the consensus from industry being  the agency’s position...

FDA prevails over Hi-Tech on DMAA, but ruling could open door on synthetic botanicals

A federal district court judge in Atlanta has ruled in favor of FDA in its case against Hi-Tech Pharmaceuticals over its use of DMAA. But the ruling potentially weakens agency’s...

AHPA, CRN suggest tweaks, wholesale overhauls of manufacturing regs

A call from the U.S. Commerce Department for suggestions on streamlining manufacturing regulations has generated responses from industry trade organizations, with the different tacks the suggestions take reflecting those organizations’...

Transparency is only way for GMO technology to thrive, exec says

Openness and transparency is the only way for genetic engineering technology to thrive in the supply of dietary ingredients, said an official with a company engaged in the practice.

Company forms to push benefits of sciadonic acid

A new company is coming together around a ‘new’ fatty acid — sciadonic acid, which the developer says has potent anti-inflammatory properties.

NDI guidance would over regulate, weaken supplement industry, Jarrow asserts

The updated New Dietary Ingredients draft guidance is an attempt to over regulate and weaken the dietary supplement industry with no increase in public safety, according to comments filed recently...

'20 to 30 elite sportspeople/teams' involved in ketone research

Oxford researchers behind a novel performance-enhancing ketone drink get around an email a day from sports teams hoping to buy the product – and another 20-30 unnamed professional teams have...

UNPA brands FDA's finished product focus in NDI guidance as unworkable and unlawful

Requiring NDI notifications on almost every new product will create a situation in which few companies will be able to comply with the new draft guidance, the United Natural Products...

NPA urges FDA to back off in applying food additive standards

The Natural Products Association has urged FDA to cease its attempt to apply  food additive standards to dietary ingredients. To do so would create an undue burden on small business,...

Algae ingredient developer fixes on protein as latest path to market

Zivo Bioscience, an algae company long focused on deriving unique bioactives from its proprietary strains, has pivoted to protein as developers realized the potential inherent in the straight, unrefined biomass.

CRN to Health Canada: Don't try to fix NHP system if it ain't broke

The Council for Responsible Nutrition has submitted comments to a Health Canada that urges the agency not to scrap the existing product registration system but rather to further refine it...

Special edition: botanicals

NDI guidance will dampen innovation in botanicals, experts say

The NDI draft guidance as written will squelch innovation in botanical ingredients, experts have said.

NPA asks for NDI comment period extension

The Natural Products Association is asking FDA to add 30 days to the comment period on the updated New Dietary Ingredients draft guidance.

GRAS route will still be popular with hard line taken in NDI draft on synthetic botanicals

The updated New Dietary Ingredients draft guidance, issued yesterday by the Food and Drug Administration, modifies the agency’s stance on the contentious issue of synthetic, nature-identical compounds. But not by...

Onset of FSMA to drive continued demand for consulting services, expert says

The demand for consulting services will only continue to rise as new laws come into full implementation, said a consulting company executive.

Plan by Durbin and Blumenthal for new supplement legislation significant but not unexpected, trade associations say

News that Senators Dick Durbin and Richard Blumenthal plan to introduce legislation for the dietary supplement industry came as no surprise to executives of industry trade associations.

FDA seizes $400,000 worth of kratom products in Illinois

Despite an import ban on the substance, kratom-containing products continue to find their way into the country. In the latest action, the Food and Drug Administration has seized 90,000 bottles...

CRN suggests improvements to national supplement label database

The Dietary Supplement Label Database could be a more useful and comprehensive tool with a few changes, the Council for Responsible Nutrition said.

There's plenty of room for botanical discovery, especially in finding new ingredients from familiar sources, experts say

What’s the future for botanical ingredient discovery? Experts differ on whether there are wholly new, useful species yet to be discovered, but agree that there are still more ingredients to...

NIU's Transparency Forum to look at post-NYAG landscape

The actions of New York Attorney General Eric Schneiderman have put an unprecedented pressure on the dietary supplement business, especially those companies dealing in herbal products. 

Once it gets warmed up, government can wield big hammer, former prosecutor says

The USPLabs case demonstrates the tools investigators and prosecutors can bring to bear when looking into the dealings of a dietary supplement company, a former prosecutor says.

GNC lays out initiative for supplement industry meant to recapture quality narrative

GNC laid out a blueprint for the dietary supplement industry for a quality initiative including pre-market product registration at a meeting last week in Salt Lake City. The initiative builds...

Slow pace of innovation hurts sales as Vitamin Shoppe battles industry headwinds, CEO says

The Vitamin Shoppe CEO Colin Watts said a slow pace of innovation in the supplements industry has hurt the company, which has relied on a rapid pace of new product...

Special edition: Regulatory Focus

Sharfstein floats new regulatory framework dialing in on safety and backing off on claims

Former FDA official Dr Joshua Sharfstein, MD, has proposed a new paradigm for the regulation of dietary supplements. The underlying shift would be a move from an attitude of “benefit...

FDA's action in picamilon case sets bad precedent, CRN's Mister says

The declaration from FDA on picamilon that formed part of the lawsuit filed by the Oregon Attorney General sets a troubling precedent, said Steve Mister of  the Council for Responsible...

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