NDI draft guidance

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Speaker Boehner was receptive to Jarrow Formula's concerns about the FDA's NDI draft guidance during a meeting in LA last month, claim its regulatory attorneys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Jarrow Formulas has raised its concerns about the FDA’s draft guidance on new dietary ingredients (NDIs) with House Speaker John Boehner as part of its campaign to alert members of Congress to the dangers the “fatally flawed”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FDA: We’re not enforcing NDI draft guidance; GMPs are the biggest issue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FDA: We’re not enforcing NDI draft guidance; GMPs are the biggest issue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The Food & Drug Administration is not preparing to enforce its controversial draft guidance on new dietary ingredients (NDIs), but companies can expect more inspections, more injunctions, and more product seizures related to current good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Is the DMAA crackdown an enforcement of the NDI draft guidance?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.

IPA co-founder: EU probiotic approach is “dirty pool”

Disptaches from Microbiota 2011

IPA co-founder: EU probiotic approach is “dirty pool”

By Shane Starling

Jarrow Rogovin, never a man to mince his words, says it is high time the IPA and other trade groups stepped up to the plate to defend a sector that has been under regulatory siege on both sides of the Atlantic for several years.

ABC: Solvents white paper could help inform NDI debate

ABC: Solvents white paper could help inform NDI debate

By Elaine Watson

An authoritative new guide to 23+solvents used in the production of botanical extracts for dietary ingredients could help inform the debate on ‘chemical alteration’ at the heart of the FDA’s draft guidance on new dietary ingredients (NDIs), says the American...

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