Breaking News on Supplements & Nutrition - North AmericaEU edition

Industry enjoys ‘significant victory’ over ‘Durbin amendment’

25-May-2012 - The dietary supplements industry has hailed the defeat of Sen. Richard Durbin's controversial amendment to the pending Food and Drug Administration (FDA) User Fee Act.

‘I’m off to save prostates’: POM goes on offensive with new ads post FTC ruling

24-May-2012 - POM Wonderful has gone on the offensive following a ruling on its legal battle with the Federal Trade Commission (FTC) from an administrative law judge (ALJ) with a bold series of new ads selectively quoting from his 335-page initial decision.

Animal welfare group slams EU organics verdict

24-May-2012 - Compassion in World Farming (CIWF) has criticised the decision to recognise US organic food standards as equivalent to those in the EU.

Industry braced for senate vote on Durbin's controversial dietary supplement registration amendment

23-May-2012 - Industry eyes will be focused on the Senate tomorrow (Thursday) with the vote on Sen. Richard Durbin's controversial amendment to the pending Food and Drug Administration (FDA) User Fee Act scheduled for 2pm EST.

Attorney: POM ruling is a 'stunning rejection' of FTC's stance on 'gold standard' clinical trials to support product claims

22-May-2012 - While POM Wonderful does not emerge from Michael Chappell’s 335-page ruling smelling entirely of roses , it has successfully challenged the accepted wisdom that firms can only make claims about food or supplements if they are backed at least two ‘gold standard’ human trials, say lawyers.

News in brief

FDA should reconsider capital costs of AERs: CRN

22-May-2012 - The Food & Drug Administration’s (FDA) position that dietary supplement adverse event reporting incurs no  capital costs or operating and maintenance costs is wrong and should be reconsidered, says the Council for Responsible Nutrition (CRN).

Both sides claim victory as judge rules in FTC v POM false advertising case

21-May-2012 - Both sides have claimed victory in a bitter legal dispute between Californian juice maker POM Wonderful and the Federal Trade Commission (FTC) over allegations of false advertising.

Dendrobium-containing Craze pre-workout supplement hit with CA class action

21-May-2012 - Tipped by many as the heir apparent to DMAA supplements in the pre-workout category, the dietary supplement Craze is the latest to be hit with a class action in the State of California.

DMAA latest: FDA considers next steps; GNC remains defiant; Nutrex says FDA is 'demonstrably wrong'

18-May-2012 - All 10 recipients of FDA warning letters on DMAA have now written back, although only one - Nutrex Research - has so far revealed what it said (notably that the agency's interpretation of the law is “demonstrably wrong”).

FDA warns of sexual enhancement products and sends yet more letters for GMP violations

18-May-2012 - Another week, another batch of warning letters from the Food and Drug Administration (FDA): Warning letters for current good manufacturing practice (cGMP) violations continue, and the agency has warned consumers against three sexual enhancement products for containing undeclared drug ingredients.

Major League Baseball ‘contaminant’ letter sullied our reputation, claims deer antler velvet supplier

15-May-2012 - Nutronics Labs says a letter sent out by Major League Baseball (MLB) last year warning players to avoid deer antler velvet supplements has sullied its good reputation and caused “extensive and irreparable damage”.

Website claims and GMP violations continue to dominate FDA warning letters

11-May-2012 - The most recent batch of warning letters from the Food and Drug Administration (FDA) show that the agency continues to monitor closely claims on websites, and GMP violations need to be resolved by actions, not words.

Dispatches from AHPA's Botanical Congress

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

10-May-2012 - 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 practice (cGMP) violations.

Academic: DMAA saga ‘perfect example of gaping loophole in DSHEA which needs to closed’

10-May-2012 - The whole “adventure” over DMAA (1,3-Dimethylamylamine) is “a perfect example of a gaping loophole in the Dietary Supplement Health and Education Act (DSHEA) which needs to closed”, according to one academic.

News in brief

Allmax Nutrition, BPI Sports and DynaPep Corp targeted in latest wave of class action suits over DMAA

09-May-2012 - Allmax Nutrition (Razor8Blast Powder); BPI Sports (Roxylean and 1.M.R.); and DynaPep Corporation (DynaPep Energy) are the latest firms to be targeted in class action complaints alleging their products contain DMAA (1,3-Dimethylamylamine) in a synthetic form that is “illegal and dangerous”.

Attorney: Revised green tea health claim another ‘value laden subjective judgment’ from FDA

07-May-2012 - The Food and Drug Administration (FDA) has drafted revised wording for a qualified health claim about green tea and breast/prostate cancer after being taken to task by a judge in Connecticut over the wording of its previous efforts.

DMAA latest: 14 class action suits now filed by CA law firm - but speed may not be of the essence, predicts expert

04-May-2012 - The law firm responsible for the flurry of class action lawsuits against 10 firms named by the FDA in its DMAA crackdown last week has now targeted four other firms selling products containing the stimulant.

Comment

Is the game up for DMAA? Why the FDA crackdown raises more questions than answers…

03-May-2012 - They’ve had the sword of Damocles hanging over their heads for months. So when 10 firms selling DMAA supplements were finally told to put up or shut up by the FDA last week, it looked like the game might finally be up for the controversial stimulant.

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

02-May-2012 - 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”.

FDA DMAA crackdown prompts fresh wave of class action lawsuits

01-May-2012 - 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 is “illegal and dangerous”.

AHPA: If DMAA is in geranium, synthesized version is a lawful dietary ingredient

30-Apr-2012 - If DMAA (1,3-Dimethylamylamine) exists naturally in geranium - which has been in the food supply for years - synthesized DMAA is also a lawful dietary ingredient permitted for use in supplements, says the American Herbal Product Association (AHPA).

EU authorities set to follow US DMAA alarm

30-Apr-2012 - European food and medicines agencies will follow the lead of the US Food and Drug Administration (FDA) which last week issued warning letters to 10 manufacturers over safety and authenticity concerns for DMAA products, an EU food law expert has said.

Updated: FDA cracks down on DMAA - but this is just the start, not the end, of the debate, predicts CRN

27-Apr-2012 - It’s official, says the FDA. “Synthetically-produced DMAA (1,3-Dimethylamylamine) is not a dietary ingredient and is not, therefore, eligible to be used as an active ingredient in dietary supplements”.  

GNC: FDA action on DMAA is ‘factually and legally unfounded’

27-Apr-2012 - There is “no basis” for the Food and Drug Administration’s (FDA’s) decision to crack down on firms making supplements containing the stimulant DMAA (1,3-Dimethylamylamine), says retail giant GNC.