New ingredient approvals

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Bar association panel takes FDA to task over NDI enforcement

By Hank Schultz

A perplexing attitude towards enforcement on the part of federal regulators leaves the dietary supplement industry with little incentive to file New Dietary Ingredient Notifications, participants in a legal panel asserted recently.

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Guest article

Industry needs consensus in 2022, CRN says

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

As the dietary supplement industry turns the corner to 2022, a range of challenges confronts us— supply chain disruptions, staffing shortages, and inflationary pressures, to name a few. Some difficulties must be addressed individually, but I suggest the...

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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 rejects two NDI filings on full spectrum hemp extracts

By Hank Schultz

The US Food and Drug Administration has rejected two New Dietary Ingredient Notifications for CBD ingredients. Industry stakeholders said the fact of the rejections and some of wording used in the letters makes it clear that new legislation is likely...

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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Publishing a revised version of the NDI Draft Guidance has made a list of FDA priorities for the coming year.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...

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CBD novel foods deadline delayed amid last minute applications

By Nikki Hancocks

The FSA (Food Standards Agency) has backtracked on its initial expectation for companies to make their novel foods applications at least five weeks in advance of the deadline and confirmed that it will accept applications up until March 31st, after receiving...

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,...

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News in brief

Kaneka gets GRAS status on baby probiotic

By Hank Schultz

Kaneka has announced self affirmed GRAS status on its Baby Colic probiotic dietary supplement meant to ease babies through gut discomfort episodes.

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EDITOR'S SPOTLIGHT: SCIENCE & REGULATION

CBDepot files Novel Food application for synthetic CBD form

By Will Chu

CBDepot has applied for Novel Food (NF) application for a synthetic form of cannabidiol (CBD) for food supplement use in a move the firm says has a better chance of regulatory approval.

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