Food And Drug Administration

Trump, vinpocetine, hemp:  AHPA looks at 2016 events that will affect 2017

Trump, vinpocetine, hemp: AHPA looks at 2016 events that will affect 2017

By Michael McGuffin, president, American Herbal Products Association

Several events in 2016 will impact the industry in 2017 and future years. The 2016 election results tops that list. Like most other industries in the U.S., the herbal products industry will be closely watching the incoming Trump administration and Republican-controlled...

NDI draft guidance needs extensive revision, AHPA asserts

NDI draft guidance needs extensive revision, AHPA asserts

By Hank Schultz

The current NDI draft guidance is unlikely to improve compliance or the quality of submissions and should be rewritten. That’s the opinion expressed by the American Herbal Products Association in comments it filed with FDA.

Image © iStock / frank600

NPA tells DEA that Kratom poses threat to public health

By Stephen Daniells

Adding kratom to the US food supply could lead to serious unintended consequences as the US struggles with opioid addiction, says the Natural Products Association in comments submitted to the US DEA.  

Linnea requests FDA to withdrawal vinpocetine notice

Linnea requests FDA to withdrawal vinpocetine notice

By Stephen Daniells

Ingredient supplier Linnea has added its voice to the vinpocetine issue, submitting comments requesting the FDA to withdraw the tentative conclusion that vinpocetine cannot be used as a dietary ingredient.

Trade groups urge FDA to reconsider stance on vinpocetine

Trade groups urge FDA to reconsider stance on vinpocetine

By Hank Schultz

Trade organizations representing the dietary supplement industry urged the Food and Drug Administration to reverse its tentative conclusion that vinpocetine, despite several successful NDI filings, is no longer a legal dietary ingredient.

© iStock / Jezperklauzen

13 things we learned from the IPA’s DC Workshop

By Stephen Daniells

From market sizing to the positions from FDA and FTC on NDIs and claims substantiation, the International Probiotic Association’s DC workshop succeeded in providing a venue for sharing knowledge and expertise.

Lesser Periwinkle Plant (Vinca minor). Image © Ryan Kaldari

Senator Hatch urges withdrawal of vinpocetine notice

By Stephen Daniells

Dietary supplement champion Sen Orrin Hatch (R-UT) is calling for the withdrawal of a Federal Register Notice that questioned the regulatory status of vinpocetine as a new dietary ingredient.

© iStock / studioportosabbia

Ten things to change about DSHEA

By Stephen Daniells

If you could change one thing about the Dietary Supplements Health & Education Act, what would it be? Ten industry lawyers weighed in…

Photo: iStock/MSPhotographic

OmniActive’s CurcuWIN obtains self-affirmed GRAS

By Adi Menayang

An expert panel granted OmniActive’s CurcuWIN ingredient a self-affirmed GRAS (Generally Recognized as Safe) notification after an evaluation in accordance with US Food and Drug Administration (FDA) safety criteria, the company said.

© iStock

Regulation of Probiotics in the USA: Dietary Supplements

By Ivan Wasserman, counsel to the International Probiotics Association, and partner at Amin, Talati and Upadhye LLP

The United States Food and Drug Administration’s (FDA) regulation of products containing probiotics is complex and largely depends on the claims that are made for the product. For example, they can be regulated as foods, dietary supplements, cosmetics,...

Kratom - Mitragyna speciosa. Image © iStock / frank600

DEA puts kratom on schedule 1 drugs list

By Hank Schultz

The Drug Enforcement Administration has put mitragynine and 7-hydroxymitragynine, the active constituents of kratom, on its list of schedule 1 banned drugs, a list that includes heroin and LSD.

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

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

By Hank Schultz

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 by the Food and Drug Administration seems to cast further doubt...

© iStock / frank600

US Marshals seize $150,000 of kratom

By Stephen Daniells

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

AMA warns members about rise of nootropics

AMA warns members about rise of nootropics

By Hank Schultz

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.’

Experts dispute notion that DSHEA hamstrung FDA

Experts dispute notion that DSHEA hamstrung FDA

By Hank Schultz

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.

FDA developing next-gen toolbox for probiotic products

FDA developing next-gen toolbox for probiotic products

By Stephen Daniells

The US Food and Drug Administration is developing a next-generation toolbox for analyzing live microbial products, including DNA microarrays, metagenomic sequencing and analysis, and a whole genome database development.

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