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Embracing the future: The dietary supplement industry comes of age

Duffy MacKay of CRN argues that there is much in FDA's newly released New Dietary Ingredients draft guidance that represents a step forward for the industry.

Literature from trade show booth puts company in hot water with FDA

A recent FDA warning letter emphasizes the importance of maintaining consistent messaging about a product to avoid crossing the disease claims line.

Twinlab CEO bolsters connection to 'ecosystem' by inviting Utah AG for a visit

There is a thread of rhetoric in the supplement industry about being an ‘above board’ company.  Twinlab CEO Naomi Whittel decided to take that notion to the next level by...

New name would 'improve consumer understanding and promote clear food labeling' says Unilever

Unilever, CSPI support NuTek potassium salt petition, but the Salt Institute urges FDA to reject it ‘in the strongest terms’

Unilever and The Center for Science in the Public Interest (CSPI) have both voiced their support for a citizen’s petition asking the FDA to permit ‘potassium salt’ as an alternate...

UNPA on the NDI draft guidance: ‘The economic cost to industry could be billions of dollars’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areas that require clarification, the dietary supplement industry should look carefully and cautiously at the revised draft guidance for new dietary ingredient notifications, specifically at the...

Self-affirmed GRAS omitted from new NDI draft guidance

The devil is in the detail, and one detail easily missed in the new draft guidance for new dietary ingredient notifications is that self-affirmed GRAS is no longer mentioned as...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The new NDI draft guidance is very similar to the previous version, and yet the howls of outrage heard in 2011 are silent.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FDA’s new NDI draft guidance: ‘Not much that’s surprising’

The new draft guidance for new dietary ingredient notifications is “more positive than negative”, says Steve Mister, CEO of the Council for Responsible Nutrition.

Senator slams FDA final rule on GRAS: ‘a self-graded take home exam that industry doesn’t even have to hand in’

New FDA rules clarifying the process by which ingredients are deemed generally recognized as safe (GRAS) have been welcomed by some stakeholders, but harshly criticized by others, who say any...

Updated FDA marijuana Q&A hems in use of CBD still further

Marketers of CBD-containing dietary supplements have long held out the hope that the status of hemp as a food in the US could provide some regulatory cover. A newly-released clarification...

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.

Ingredient Identity offers pay as you go QA plan for virtual organizations

Consulting firm Ingredient Identity has launched an outsourced quality assurance solution that could help smaller companies demonstrate better—and more cost effective—compliance in this important function.

NPA says input on Puerto Rican supplement regulation will form part of debt review

The Natural Products Association has stepped up its campaign at the national level to blunt the effects of an administrative order in Puerto Rico that puts additional burdens on dietary...

US Marshals seize $150,000 of kratom

US Marshals Service have seized over 100 cases of products labeled as containing kratom in California, the US Food and Drug Administration has announced.

Whey maker gets warning on inflammation claims

A recent warning letter issued by the Food and Drug Administration makes clear the danger marketers run into when using the words “inflammation” and “chronic” in the same breath, even...

New NGS DNA testing methods will replace PCR, predicts Clear Labs

Are ‘GMO-free’ (as opposed to ‘non-GMO’) claims legally defensible?

As the Non-GMO Project states on its website, ‘GMO-free’ claims are “not legally or scientifically defensible due to limitations of testing methodology" coupled with cross-contamination risks. In future, however, that could...

Learning from others’ mistakes: NPA launches warning letter database

The Natural Products Association (NPA) has announced the launch of its warning letter database, giving access to data on GMP violations, technical adulteration, and labeling infringements.

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.’

News in brief

FDA has no objections for GRAS status of Axiom Foods’ rice and pea proteins

The US Food and Drug Administration (FDA) has no objections regarding the generally recognized as safe (GRAS) status of Axiom Foods’ Oryzatein, an organic brown rice protein ingredient, as well...


House approves federal GMO labeling bill that nullifies Vermont law

The US House of Representatives has voted to pass a federal GMO labeling bill (306:117 votes) that would pre-empt and nullify all state-led GMO labeling laws including the one that...

Evo Hemp to expand use of US-grown hemp: 'It's only a matter of time before the federal cultivation ban is lifted'

With 28 US states now allowing farmers to grow industrial hemp – a crop that stubbornly remains on the DEA’s controlled substances list although it has no psychoactive effects –...

Experts dispute notion that DSHEA hamstrung FDA

Despite the tenor of a recent meeting of ex FDA commissioners, DSHEA didn’t tie the hands of federal regulators, experts contacted by NutraIngredients-USA have said.

Vermont GMO-labeling law went into effect, what comes next?

When Vermont’s GMO-labeling law became effective last Friday on July 1, some companies were prepared, while others weren’t.

Consumer survey suggests Vermont GMO labels ‘strongly mislead consumers,’ claims CRA

An industry-backed survey of 1,665 online primary shoppers suggests that Vermont’s mandatory GMO labels “strongly mislead consumers,” claims the Corn Refiners Association (CRA).

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