NDI draft guidance

Hiring an attorney early is cheaper than hiring one late, expert says

Dispatches from SupplySide West 2013

Hiring an attorney early is cheaper than hiring one late, expert says

By Hank Schultz

As dietary supplement firms prepare for their initial (or follow up) GMP compliance inspections, it pays to have the advice of a consultant and/or a lawyer up front. Fixing problems on the back end is inevitably more expensive, said attorney Ivan Wasserman.

UNPA chief agrees with FDA that GMP compliance far from uniform

Dispatches from SupplySide West 2013

UNPA chief agrees with FDA that GMP compliance far from uniform

By Hank Schultz

Adverse event reporting, amphetamine-like substances showing up in products and NDI notifications are all prominent blips on FDA’s radar, said Loren Israelsen, president of the United Natural Products Alliance.

NDIs, GRAS & GMOs: CFSAN outlines priorities for 2013-14

NDIs, GRAS & GMOs: CFSAN outlines priorities for 2013-14

By Stephen DANIELLS

The Food and Drug Administration's (FDA) Center for Food Safety and Applied Nutrition (CFSAN) has outlined its priorities for 2013-14, with a 'surprising' number relevant to supplements, including NDIs, GRAS, and GMOs.

AHPA expands staff with program development position

AHPA expands staff with program development position

By Hank Schultz

To go with an expanding membership, the American Herbal Products Association has expanded its staff with the addition of Jane Wilson in the newly created role of director of program development.

GRAS status will boost benfotiamine, XSTO says

GRAS status will boost benfotiamine, XSTO says

By Hank Schultz

Benfotiamine, a form of thiamine or vitamin B1, has been on the market for decades.  So what makes BenfoPure, a branded form of the ingredient now represented by XSTO Solutions, special? The differentiator, said XSTO’s Dan Murray, is in the details.

2012’s regulations in pictures: GMPs, NDIs, and energy drinks

2012’s regulations in pictures: GMPs, NDIs, and energy drinks

By Stephen Daniells

As 2012 comes to a close, NutraIngredients-USA looks back on an action packed year. In the second of our series of galleries capturing the year’s main events, we take a look at the regulatory issues that made the headlines.

2012’s predictions: How did we do?

2012’s predictions: How did we do?

By Stephen DANIELLS

In January, NutraIngredients-USA raised its head above the parapet and made some predictions for 2012. As the year draws to a close, we look back on what did and didn’t come to pass.

FDA: Inflammation and diabetes raising red flags for tainted products

FDA: Inflammation and diabetes raising red flags for tainted products

By Stephen Daniells in Laguna Beach

Concerns over tainted dietary supplements are extending to products promoted for pain/inflammation and diabetes, beyond the ‘classic’ sectors of erectile dysfunction, weight loss and bodybuilding, said the new head of CFSAN at FDA.

Speaker Boehner was receptive to Jarrow Formula's concerns about the FDA's NDI draft guidance during a meeting in LA last month, claim its regulatory attorneys

Jarrow calls for Congressional hearings to address NDI guidance woes

By Elaine Watson

Jarrow Formulas has raised its concerns about the FDA’s draft guidance on new dietary ingredients (NDIs) with House Speaker John Boehner as part of its campaign to alert members of Congress to the dangers the “fatally flawed” document presents to the...

FDA: We’re not enforcing NDI draft guidance; GMPs are the biggest issue

Dispatches from AHPA's Botanical Congress

FDA: We’re not enforcing NDI draft guidance; GMPs are the biggest issue

By Stephen Daniells

The Food & Drug Administration is not preparing to enforce its controversial draft guidance on new dietary ingredients (NDIs), but companies can expect more inspections, more injunctions, and more product seizures related to current good manufacturing...

ANH-USA: 'If DMAA is unsafe, it should be removed... If it is an NDI, it should go through the NDI notification process... But let’s stop this nonsense about it being illegal because it’s a synthetic botanical. That is not a requirement of DSHEA...'

Is the DMAA crackdown an enforcement of the NDI draft guidance?

By Elaine Watson

In warning letters sent as part of its recent crackdown on DMAA, the FDA says “synthetically produced DMAA is not a dietary ingredient and, therefore, is not eligible to be used as an active ingredient in a dietary supplement”.

Hemo Rage Black is one of several supplements containing DMAA cited in class action lawsuits filed this week in California

FDA DMAA crackdown prompts fresh wave of class action lawsuits

By Elaine Watson

UPDATED May 3 - All 10 recipients of FDA warning letters over supplements containing DMAA (1,3-Dimethylamylamine) have now been targeted in a new wave of class action lawsuits in California alleging their products contain DMAA in a synthetic form that...

Dr Fabricant addressed attendees at the IPA World Congress

Dispatches from the IPA World Congress

'Master Files' top list of NDI comments of note… so far

By Stephen Daniells in Universal City, CA

The proposal to use Master Files for IP protection and to expedite the notification process is attracting attention within FDA, as the agency considers comments submitted in response to its controversial NDI draft guidance.

Dr Cohen: 'In my opinion, the current regulatory framework creates a facade of safety for all supplements. This creates perverse incentives to introduce poor quality and even illegal products.'

Harvard professor: ‘NDI draft guidance doesn’t go far enough’

By Elaine Watson

It might have been roundly slammed by the trade as draconian and unworkable, but according to one academic, the Food and Drug Administration’s (FDA’s) controversial draft guidance on new dietary ingredients (NDIs) does not go far enough.

UNPA: We agree with AHPA on DMAA labeling

UNPA: We agree with AHPA on DMAA labeling

By Elaine Watson

The United Natural Products Alliance (UNPA) says it agrees with the AHPA that supplement makers should not label the stimulant DMAA (1,3-Dimethylamylamine) as geranium oil or as any part of the geranium plant.

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