CRN meets FDA on NDIs: We won’t budge on synthetics but there may be middle ground elsewhere

10-Feb-2012 - Food and Drug Administration (FDA) officials were “engaged” and “receptive” during a meeting with the Council for Responsible Nutrition (CRN) this week about its controversial draft guidance on new dietary ingredients (NDIs), says the CRN.

ABC paper promises to dispel ‘myth’ of unregulated supplements

07-Feb-2012 - A new paper published by the American Botanical Council (ABC) attempts to dispel the ‘puzzling’ and pervasive ‘myth’ that the US dietary supplements trade is unregulated.

Harvard professor: ‘NDI draft guidance doesn’t go far enough’

27-Jan-2012 - 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as draconian and unworkable, but according to one academic, the Food and Drug Administration’s (FDA’s) controversial draft guidance on new dietary ingredients (NDIs) does not go far enough.

Exclusive interview: Paul Gilner, chief executive, Life Extension

Life Extension CEO: ‘I just hope the trade isn’t hogtied and handcuffed by unnecessary regulation’

25-Jan-2012 - While cynics might raise an eyebrow at the Life Extension Foundation’s ambitious mission statement (“to conquer the aging process within the next decade”), bosses at its supplement arm have every reason to feel optimistic, CEO Paul Gilner tells Elaine Watson

‘Uptick’ in GRAS interest suggests industry looking for NDI alternative

16-Jan-2012 - An increase in GRAS (generally recognized as safe) determinations for an ingredient, and particularly self-affirmed GRAS, suggests that industry is looking at the alternatives to NDI notifications, but what are the consequences?

pTeroPure gains momentum as BlūScience hits shelves at Walgreens

11-Jan-2012 - Momentum behind ChromaDex’s branded antioxidant pTeroPure is continuing to build with growing interest from food manufacturers and new listings for the pTeroPure-based supplement line BluScience at Walgreens.

UNPA: We agree with AHPA on DMAA labeling

10-Jan-2012 - 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.

CRN UK on DMAA: “The law is clear. DMAA is illegal in the EU and should be stripped from shelves”

09-Jan-2012 - Trade in sports products containing the controversial stimulant DMAA (methylhexaneamine/1,3-dimethylamylamine) is illegal in the European Union, and should be brought to an immediate halt by EU and member state authorities, according to the Council for Responsible Nutrition (CRN) UK.

FDA silent on calls from Sen Hatch and Harkin to withdraw NDI draft guidance

06-Jan-2012 - Staff for Senators Harkin and Hatch are still waiting for a response from the Food and Drug Administration (FDA) following calls from the Senators for FDA to withdraw its NDI draft guidance and for January meetings to discuss concerns.

USPLabs: DMAA is from geranium oil – and critics are ‘uninformed’

05-Jan-2012 - USPLabs has insisted that the DMAA (1,3-Dimethylamylamine) in its Jack3d and OxyELITE Pro supplements is from geranium in the wake of continued speculation over the source and regulatory status of the popular stimulant.

Dietary supplements industry is doing better than most: NOW Foods president

05-Jan-2012 - The dietary supplements industry is doing better than many consumer brand industries, despite issues such as NDIs, says the new president of NOW Foods.

Disptaches from Microbiota 2011

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

23-Dec-2011 - 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.

FDA will 'consider whether regulatory action is warranted on DMAA'

22-Dec-2011 - The Food and Drug Administration (FDA) has weighed into the debate over the stimulant DMAA (1,3-Dimethylamylamine, also known as methylhexaneamine or MHA), which has garnered more bad press in recent weeks.

Fabricant on NDI draft guidance: Thanks for your 146,000 pages of comments. We’ll get back to you…

22-Dec-2011 - Those hoping the Food and Drug Administration (FDA) is preparing for a major climb down on its draft guidance on new dietary ingredients (NDIs) will draw little comfort from comments made by the agency's supplements chief yesterday.

Plant proteins, ‘pill fatigue’ and ‘abominable’ weight loss ads: A year in supplements…

21-Dec-2011 - Could 2012 be the year for canola protein to shine? Will a dietary solution to the ticking time bomb of type 2 diabetes finally make it big in the supplement aisles? And are gummies the solution to ‘pill fatigue’?

ABC: Solvents white paper could help inform NDI debate

21-Dec-2011 - 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 Botanical Council (ABC).

The agony and the ecstasy: A year in the life of the trade association…

20-Dec-2011 - Not surprisingly, the FDA's draft guidance on new dietary ingredients (NDIs) is top of the list for most trade associations when asked what is keeping them awake at night as we head into 2012, but it is not the only thing causing sleepless nights.

News in brief

Ullman: NDI draft guidance withdrawal unlikely, but industry deserves timely response

20-Dec-2011 - While it is possible that the FDA could withdraw its draft guidance on new dietary ingredients (NDIs), such a move would be “highly unusual”, according to one leading food law attorney.

Jarrow: FDA's talk of spiked supplements in context of NDI debate is 'highly disingenuous'

14-Dec-2011 - Food and Drug Administration (FDA) references to safety concerns over supplements spiked with drugs in the context of the debate on new dietary ingredients (NDIs) are “highly disingenuous”, Jarrow Formulas has argued.

News in brief

UNPA webinar to explore NDIs ‘what now?’ with FDA

13-Dec-2011 - The United Natural Products Alliance (UNPA) will host a webinar on Wednesday December 21 with FDA’s Daniel Fabricant, PhD, to discuss the 7,000+ comments filed on the new dietary ingredients (NDI) draft guidance.

NDI draft guidance comments

Lawyer: NDI draft guidance raises ‘significant intellectual property issues’

12-Dec-2011 - Requiring supplement manufacturers to submit new dietary ingredient (NDI) notifications will force them to seek confidential information from suppliers in order to file submissions, according to law firm Amin Talati.

NDI comments review: Industry urges FDA back to the drawing board

09-Dec-2011 - One week on from the deadline for submission of comments on the FDA’s new dietary ingredients (NDI) draft guidance, we review the comments.

NDI draft guidance comments

IPA: We do not see NDI draft guidance as 'death sentence' for probiotics industry

09-Dec-2011 - The only probiotics that should be subject to new dietary ingredient (NDI) notifications should be “new probiotics derived from GM engineering which have little to no history of safe use”, according to the International Probiotics Association (IPA).

Novel extraction method should not trigger automatic NDI notification, says USP

08-Dec-2011 - Botanical extracts that have been on the market for years should not automatically be treated as new dietary ingredients (NDIs) just because extraction methods have changed, according to the United States Pharmacopeia (USP).