NDI draft guidance

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.

FDA photo

Cancer institute head named acting FDA chief

By Hank Schultz

Dr Ned Sharpless, MD, who is the current head of the National Cancer Institute, will be the interim head of the Food and Drug Administration when Dr Scott Gottlieb, MD, leaves next month.

Getty Images

From the editor's desk

What should DSHEA 2.0 look like? Here are a couple of suggestions

By Hank Schultz

On Monday FDA Commissioner Scott Gottlieb put forward some ideas about where the regulation of dietary supplements should go in the coming years. This is an opportunity that should not be missed. What should be tops on the industry’s wish list?

© Getty Images / Aleksandr_Kravtsov

Top FDA official: ‘Anyone who thinks CBD is lawful is mistaken’

By Stephen Daniells

“Just because we haven’t taken enforcement action people seem to think it [CBD] is OK,” said Steven Tave, director of the FDA’s Office of Dietary Supplement Programs, at a recent industry conference. “Anyone who thinks it is lawful is mistaken.”

© Getty Images / jcamilobernal

20 things we learned at the 2018 IPA DC Workshop

By Stephen Daniells

The Nagoya Protocol, the big changes coming for Lactobacillus classification, and how to boost your chances of success with an NDI notification were just some of the topic covered during the third annual IPA Workshop in DC.

© Getty Images / Pat_Hastings

Opinion

Ease of market entry poses risk for entire industry

By Hank Schultz

Does DHSEA contain within it the seeds of the industry’s downfall? The freewheeling marketplace this regulation created has placed the barriers to entry so low that less than reputable companies have room to maneuver, creating risk for the whole industry.

Are dietary supplements getting better?

Commentary

Are dietary supplements getting better?

By Hank Schultz

Are dietary supplements getting ‘better?’ Or are the new products that come onto the market merely a matter of churn, replacing tired packaging and marketing concepts with updated versions?

Algatech receives NDI for new microalgae ingredient

Algatech receives NDI for new microalgae ingredient

By Mary Ellen Shoup

Algatechnologies has launched Fucovital, a fucoxanthin oleoresin produced and extracted from microalgae, available in the US and Japan with launches in other markets to follow.

Some shady ingredients find home in nootropics category

Special edition: Nootropics

Some shady ingredients find home in nootropics category

By Hank Schultz

Nootropics is an area of the dietary supplement industry burgeoning with new ingredients. But at the ragged fringe of the category are drug-like substances that just won’t go away.

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