NDI draft guidance

FDA & Pharmavite join speaker roster for the DSHEA Summit

FDA & Pharmavite join speaker roster for the DSHEA Summit

By Stephen Daniells

Dr Cara Welch, Director of FDA’s Office of Dietary Supplements Programs, and Christine Burdick-Bell, EVP & General Counsel at Pharmavite, have confirmed their participation in the NutraIngredients-USA’s landmark DSHEA Summit.

Courtesy of Aker BioMarine

Aker Biomarine gets NDI nod from FDA for brain health ingredient

By Danielle Masterson

The Norwegian fishing and biotech company has successfully achieved New Dietary Ingredient (NDI) status from the US Food and Drug Administration for its Lysoveta. Under the NDI, Aker BioMarine can market Lysoveta at 1.5 grams/day for the general adult...

Getty Images / Youngvet

All eyes on Dietary Supplement Master Files

By Danielle Masterson

Fresh off a new Draft Guidance release, many are hopeful that Master Files would provide clarity on NDI filing requirements and provide protections for intellectual property. However, some point to issues with the NDI framework and say that must be solved...

NPA’s Fabricant on FDA reorg, HSAs/FSAs, Master Files, NMN and more

NPA’s Fabricant on FDA reorg, HSAs/FSAs, Master Files, NMN and more

By Stephen Daniells

From a proposed reorganization of the Food & Drug Administration to progress (or not) on the NMN situation, there’s a lot going on in the dietary supplements industry. We caught up with Daniel Fabricant, PhD, president and CEO of the Natural Products...

ODSP’s director on NDIs, MPL, and NMN

ODSP’s director on NDIs, MPL, and NMN

By Danielle Masterson

NutraIngredients-USA caught up with Cara Welch, PhD, Director of FDA's Office of Dietary Supplement Programs. Welch talked inspections, made the case for MPL and hinted NDI guidance is on the way.

CRN: NDI guidance is 'doable'

CRN: NDI guidance is 'doable'

By Danielle Masterson

NutraIngredients-USA caught up with CRN’s Steve Mister at SupplySide East to discuss new research, top priorities for the year and what they hope to see from FDA this year.

Lawsuit against FDA on NMN ‘certainly being considered’, says NPA CEO

Lawsuit against FDA on NMN ‘certainly being considered’, says NPA CEO

By Stephen Daniells

The Natural Products Association is hoping the US Food & Drug Administration is responsive to its recent Citizen’s Petition on the status of NMN, but if it’s not then other options are being considered, Dr Daniel Fabricant, NPA’s CEO tells NutraIngredients-USA.

Getty Images / Rawf8

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...

©Getty Images - Klaus Vedfelt

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...

©Getty Images - jetacomputer

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.

©Getty Images - Ildo Frazen

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.

©Getty Images - serggn

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.

© eakgrunge / Getty Images

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.

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