NDI draft guidance

Industry lawyers gathered at the 12th annual ACI-CRN Legal, Regulatory and Compliance Forum on Dietary Supplements at the American Bar Association in New York City from June 24 to 26, 2024

Lawyers talk evolving risk in modern supplement industry

By Asia Sherman

In a constantly evolving marketplace, dietary supplement companies are exposed to a constantly evolving risk profile determined by off-script influencers, generative AI, elongated supply chains and the proliferation of new ingredients and manufacturing...

ODSP Director Cara Welch and NutraIngredients-USA's Danielle Masterson.

ODSP’s Welch: NDIN 'guidances are not enforceable'

By Danielle Masterson

FDA’s director of the Office of Dietary Supplement Programs (ODSP), Cara Welch, PhD, stopped by SupplySide East to present an overview of the agency’s FY23 activities related to dietary supplements and FY24 plans as well as an update on the pending Human...

CRN’s Steve Mister on NDI enforcement: 'That needs to change'

CRN’s Steve Mister on NDI enforcement: 'That needs to change'

By Danielle Masterson

SupplySide East just wrapped up, and attendees were buzzing about a number of issues ranging from restrictive laws to NDI guidance to DSHEA. NutraIngredients-USA caught up with CRN’s President and CEO Steve Mister Wednesday in Secaucus, NJ to discuss...

© Frank Armstrong / Getty Images

FDA issues draft guidance on NDIN Master Files

By Stephen Daniells

The Food and Drug Administration (FDA) has released draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.”

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Fresh off a new Draft Guidance release, many are hopeful that Master Files would provide clarity on NDI filing requirements and provide protections for intellectual property.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.

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