NDI draft guidance

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Top 8 takeaways from Regulatory Summit

By Danielle Masterson

This year’s Dietary Supplement Regulatory Summit in Washington, DC, featured updates and insights from top FDA officials, including the Office of Dietary Supplement Programs along with top stakeholders and industry experts. Here are a few key takeaways...

Dr Rob Wildman on NDI submissions, implementing MPL

Dr Rob Wildman on NDI submissions, implementing MPL

By Danielle Masterson

This year’s International Society of Sports Nutrition Annual Conference & Expo marked its 19th year promoting the science and application of evidence-based sports nutrition and supplementation. NutraIngredients-USA was there to hear about the latest...

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Guest article

CRN: Don’t Sell Out DSHEA for CBD

By By Steve Mister, President & CEO, Council for Responsible Nutrition

We all want an expedient solution to the stalemate with FDA over the legal status of cannabidiol (CBD), but the call to allow FDA to set a maximum safe level for CBD is antithetical to the law governing dietary supplements, DSHEA.

Nuseed Nutritional uses a genetically modified form of canola as the raw material for its plant-based omega-3 ingredient. ©Getty Images - alexxx1981

GMO plant-based omega-3 approved as NDI

By Hank Schultz

Nuseed Nutritional US has announced its omega-3 ingredient derived from a genetically modified canola strain has successfully completed a New Dietary Ingredient Notification with FDA.

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FDA lists NDI update among priorities for coming year

By Hank Schultz

Publishing a revised version of the NDI Draft Guidance has made a list of FDA priorities for the coming year. Industry observers welcomed the news, but questioned how much impact it might have if enforcement priorities remain as they are.

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CRN's petition sets 180-day deadline for resolution of NAC issue

By Hank Schultz

The Council for Responsible Nutrition has filed a citizen’s petition with FDA requesting that the Agency reverse its decision that the ingredient NAC is not legal for use in dietary supplements. CRN states that FDA’s ruling on the matter, voiced in warning...

CRN’s Mister on the best solution for CBD, DSHEA 2.0, and more

CRN’s Mister on the best solution for CBD, DSHEA 2.0, and more

By Stephen Daniells

The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act represents ‘the best way’ to deal with the hemp-CBD issue for dietary supplements, says CRN’s Steve Mister, and once that’s clarified then the FDA and industry can address...

NPA’s Fabricant on CBD, NDI-related import alerts, and banned stimulants

NPA’s Fabricant on CBD, NDI-related import alerts, and banned stimulants

By Stephen Daniells

Efforts to move the needle on hemp-CBD at the Federal level are slow, and upcoming exits of key personnel at FDA are unlikely to affect progress much, says NPA’s Dr Daniel Fabricant. “In some ways I think FDA likes the status quo,” he tells NutraIngredients-USA.

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FDA seizes Chinese imports over NDI status

By Hank Schultz

The US Food and Drug Administration has issued an import alert and seized products from two firms that were deemed to be offering New Dietary Ingredients that have not gone through the notification process.

Aker's new ingredient is built on new research about how DHA crosses the blood brain barrier.  Aker BioMarine photo

Aker debuts new ingredient that breaks ground in brain, eye health

By Hank Schultz

Aker BioMarine has debuted a new ingredient developed from krill oil. The new product, which features EPA and DHA bound to a lysophosphatidylcholine (LPC) backbone, is based on cutting edge research and breaks ground in the area of brain and eye health,...

Is FDA open to entertaining an NDI for CBD products?

Is FDA open to entertaining an NDI for CBD products?

By Stephen Daniells

The US Food and Drug Administration may be willing to sit down with a company about a possible NDI submission for full-spectrum hemp extracts, says Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN).

NPA Fabricant on CBD, NDIs, FDA resuming inspections

NPA Fabricant on CBD, NDIs, FDA resuming inspections

By Stephen Daniells

FDA has stated it is making ‘substantial progress’ with CBD, and a new enforcement guidance could be very significant for the industry, said NPA’s Dr Daniel Fabricant, but he said the Agency needs to ‘get in the game’ for NDIs.

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