NDI draft guidance

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.

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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.

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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?

Fucovital, a patented, all-natural 3% fucoxanthin oleoresin is produced and extracted from microalgae.

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.

© Getty Images / jcamilobernal

The 18 things we learned from the IPA’s DC Workshop 2017

By Stephen Daniells

From market sizing to the need for global probiotics standards at Codex, the International Probiotic Association’s second DC workshop in collaboration with the US Pharmacopeia succeeded in providing a venue for sharing knowledge and expertise.

FDA continuing to drill down to provenance of ingredients

FDA continuing to drill down to provenance of ingredients

By Hank Schultz

Recent warning letters show the Food and Drug Administration continues to hone in on the provenance of ingredients, and demonstrate that the tempo of enforcement remains unchanged despite the moves by the Trump Administration to roll back regulations...

Jarrow challenges FDA on probiotics

Jarrow challenges FDA on probiotics

By Hank Schultz

Dietary supplement manufacturer Jarrow Formulas Inc. has filed a lengthy comment challenging FDA’s position on probiotics as set down in the most recent Revised Draft Guidance on New Dietary Ingredients.

AHPA, CRN suggest tweaks, wholesale overhauls of manufacturing regs

AHPA, CRN suggest tweaks, wholesale overhauls of manufacturing regs

By Hank Schultz

A call from the U.S. Commerce Department for suggestions on streamlining manufacturing regulations has generated responses from industry trade organizations, with the different tacks the suggestions take reflecting those organizations’ membership.

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