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.
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.
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.
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).
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...
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.
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.
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”).
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...
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”.
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.
The Food & Drug Administration is not preparing to enforce its controversial draft guidance on new dietary ingredients (NDIs), but companies can expect more inspections, more injunctions, and more product seizures related to current good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...
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.
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...
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.
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.
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.
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”.
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...
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).
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.
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.
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”.
The level of non-compliance with dietary supplement cGMP (current good manufacturing practice) regulations has left Food and Drug Administration (FDA) officials “somewhat aghast”, according to the agency’s supplements division boss.
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.
A coalition six organizations including vitamin giant DSM has petitioned the FDA to allow corn masa flour to be fortified with folic acid in a bid to decrease neural tube defects in the Hispanic community.
With class action lawsuits alleging labeling violations now “filed almost daily in California”, food manufacturers are spending “hundreds of thousands of dollars in legal fees and settlement amounts” to resolve cases that are entirely avoidable, according...
Both sides are claiming victory in a legal dispute over Muscle Milk nutritional bars and beverages after a federal judge ruled a false advertising lawsuit could proceed but dismissed most of the claims made by the plaintiff.
The boss of a leading online retailer accused of selling dietary supplements spiked with steroids just wants to “put this matter behind himself and continue to move the company forward”, says his attorney.
ChromaDex has secured its first patent covering the cardiovascular health benefits of pterostilbene, an antioxidant found in blueberries and grapes that the California-based firm has synthesized to produce a nature identical branded ingredient called...
The row over the legal line between liquid dietary supplements, conventional beverages and energy drinks hit the headlines again this week with Senator Dick Durbin calling on the Food and Drug Administration (FDA) to enforce its own guidance.
ConAgra Foods says there is “ample scientific evidence” to support a qualified health claim about whole grain consumption and a reduced risk of type II diabetes.
Select members of the highly influential House Energy & Commerce Committee have written to FDA calling for a 'significant reworking' of the controversial new dietary ingredient (NDI) draft guidance.
The EU crackdown on health claims is unlikely to impact on US regulators, but it could provide ammunition to opportunistic plaintiffs’ attorneys this side of the Atlantic, experts have warned.
GMP compliance and enforcement is good for the industry, but it is also good for business for suppliers that focus on quality, says George Pontiakos, president and CEO of BI Nutraceuticals.
LycoRed has “very strong evidence” that Indian firm EID Parry and Valensa International – which distributes Parry's natural tomato lycopene in the US - are infringing three of its patents, its bosses have claimed.
The Food and Drug Administration (FDA) is taking the information seriously from Dateline NBC’s exposé on dry labbing in the dietary supplements industry, NutraIngredients-USA has learnt.
A German court has rejected global CoQ10 leader Kaneka’s charge that rival Zhejiang Medicine Company (ZMC) and its European Distributor, Kyowa Hakko GmbH Europe, infringed its patent – a ruling ZMC hopes will influence pending actions.
Natural Alternatives International (NAI) has settled its patent infringement case vs BPI Sports and Image Sports (trading as Image Nutrition) over their use of sports nutrition ingredient beta-alanine.
The United States has entered a consent decree against a Pennsylvania dietary supplement company to cease operations following numerous current good manufacturing practice (cGMP) violations.
A Food and Drug Administration (FDA) qualified health claim about green tea and the risk of breast and prostate cancer is so strongly worded that it “effectively negates” the claim it is designed to qualify and violates the first amendment, a judge has...
Implementing better growing and manufacturing processes along with increasing the use of modern analytical techniques and greater international regulation would ‘undoubtedly’ reduce the issues surrounding the quality of herbal extracts, say researchers.
Jarrow Formulas has submitted a formal appeal to the Food & Drug Administration objecting to its “incomplete response” to a Freedom of Information Act (FOIA) request about its controversial draft guidance on New Dietary Ingredients (NDIs).
The FDA’s warning letter to the maker of melatonin-laced Slowtivate Relaxation Drink has reignited the debate over the legal line between liquid dietary supplements and conventional beverages - and should make some firms very nervous - say lawyers.
The court handling a patent infringement lawsuit filed by Neptune Technologies and Bioressources against Israeli nutritional lipids supplier Enzymotec has agreed to stay proceedings until a re-examination of the krill oil patent at issue is completed.
The firm behind ‘breathable’ caffeine shot AeroShot Energy has promised to amend its marketing to make it clear that it should be ingested – and not inhaled – following a warning letter from the Food and Drug Administration (FDA).
The makers of the QuickTrim weight loss supplements endorsed by reality TV stars the Kardashians are making false, misleading and unsubstantiated claims about their efficacy, according to a class action lawsuit.
