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NDI draft guidance

NDI draft guidance

The Food and Drug Administration (FDA) has issued its long awaited draft guidance for new dietary ingredients (NDI), and the industry in general is not happy. NutraIngredients-USA has collected analysis and insights from the leading players in the industry, from the trade associations to leading manufacturers and the FDA itself.

UNPA on the NDI draft guidance: ‘The economic cost to industry could be billions of dollars’

In addition to the areas that require clarification, the dietary supplement industry should look carefully and cautiously at the revised draft guidance for new dietary ingredient notifications, specifically at the...

Self-affirmed GRAS omitted from new NDI draft guidance

The devil is in the detail, and one detail easily missed in the new draft guidance for new dietary ingredient notifications is that self-affirmed GRAS is no longer mentioned as...


NDIs: The biggest changes may be on the industry side

The new NDI draft guidance is very similar to the previous version, and yet the howls of outrage heard in 2011 are silent. What’s changed? Well, a lot…

FDA’s new NDI draft guidance: ‘Not much that’s surprising’

The new draft guidance for new dietary ingredient notifications is “more positive than negative”, says Steve Mister, CEO of the Council for Responsible Nutrition.

GRAS route will still be popular with hard line taken in NDI draft on synthetic botanicals

The updated New Dietary Ingredients draft guidance, issued yesterday by the Food and Drug Administration, modifies the agency’s stance on the contentious issue of synthetic, nature-identical compounds. But not by...

It’s here! FDA releases new NDI draft guidance

Master Files and a grandfathered list are among the highlights in the FDA’s new Draft Guidance for New Dietary Ingredient Notifications, released this morning.

AMA warns members about rise of nootropics

A new policy by the American Medical Association on nootropics once again highlights the blurred edges of what can legitimately be called a ‘dietary supplement.’

FDA’s new dietary supplement office should focus on tainted products, GMPs & NDIs, industry leaders say

With the recent elevation of dietary supplement oversight from a division to its own office at FDA’s Center for Food Safety and Applied Nutrition, the agency should renew its focus...

BGG to use new Mexico City office as springboard for Latin America expansion

Chinese supplier BGG is taking a big step to expand the global footprint of its ingredients with recent establishment of an office in Mexico City to go along with a...

News in brief

AlgaeLife successful with NDI petition with FDA for astaxanthin ingredient

BGG subsidiary AlgaeLife Sciences, Inc. has successfully petitioned the US FDA with a New Dietary Ingredients notification (NDI) for its flagship product AstaZine Natural Astaxanthin. 

Pressure mounts for regulatory clarity on CBDs

The recent spate of FDA warning letters on the use of CBD as an ingredient in dietary supplements seems to have done little to dampen formulators’ enthusiasm for its use...

Onset of FSMA to drive continued demand for consulting services, expert says

The demand for consulting services will only continue to rise as new laws come into full implementation, said a consulting company executive.

Five questions for the FDA’s new Office of Dietary Supplements, increasing State actions, and key preparations for an election year: NPA’s Fabricant looks ahead to 2016

The Natural Products Association enters its 80th year as the premier organization dedicated solely to the natural products industry in 2016.  For those 80- years, our top priority has been...

FDA seizes $400,000 worth of kratom products in Illinois

Despite an import ban on the substance, kratom-containing products continue to find their way into the country. In the latest action, the Food and Drug Administration has seized 90,000 bottles...

Guest article

Looking Ahead at 2016? Be Prepared!

What a difference a year makes! Last January at this time, who in the industry would have predicted the New York Attorney General (AG) debacle in February? Or Senator Dick...

There's plenty of room for botanical discovery, especially in finding new ingredients from familiar sources, experts say

What’s the future for botanical ingredient discovery? Experts differ on whether there are wholly new, useful species yet to be discovered, but agree that there are still more ingredients to...

NIU's Transparency Forum to look at post-NYAG landscape

The actions of New York Attorney General Eric Schneiderman have put an unprecedented pressure on the dietary supplement business, especially those companies dealing in herbal products. 

The 10 key events of 2015… Our Editors’ selection

As we enter the twilight days of 2015 the editors of NutraIngredients-USA become a reflective bunch. A lot of things happened this year, and here is our top 10 of...

‘An interesting interpretation’: Does a concentrate of an ODI need an NDI?

A concentrate of an old dietary ingredient may need to file a new dietary ingredient notification, according to a new warning letter from the US Food and Drug Administration about...

Once it gets warmed up, government can wield big hammer, former prosecutor says

The USPLabs case demonstrates the tools investigators and prosecutors can bring to bear when looking into the dealings of a dietary supplement company, a former prosecutor says.

Trade associations unanimous in support of DoJ/FTC/FDA crackdown

Dietary supplement trade associations have universally welcomed the Department of Justice’s nationwide sweep targeting more than 100 makers and marketers of dietary supplements for alleged fraudulent ingredients and illegal claims.

Jarrow Rogovin: ‘This is a period of opportunity for the industry’

Following a recent meeting with high ranking FDA officials, Jarrow Rogovin, President/Founder, Jarrow Formulas, Inc, says that the dietary supplements industry has an historic opportunity to negotiate with the agency....

Special edition: Regulatory Focus

Sharfstein floats new regulatory framework dialing in on safety and backing off on claims

Former FDA official Dr Joshua Sharfstein, MD, has proposed a new paradigm for the regulation of dietary supplements. The underlying shift would be a move from an attitude of “benefit...

FDA's action in picamilon case sets bad precedent, CRN's Mister says

The declaration from FDA on picamilon that formed part of the lawsuit filed by the Oregon Attorney General sets a troubling precedent, said Steve Mister of  the Council for Responsible...

FDA's Welch says it's time to find way to acknowledge industry's GMP successes

Cara Welch, PhD, acting deputy director of the Division of Dietary Supplement Programs at the Food and Drug Administration, signaled a change in emphasis at the agency with a willingness...

Key Industry Events