Food And Drug Administration

EU authorities set to follow US DMAA alarm

30-Apr-2012 By Shane Starling

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.

Improper nutrient content claims cited in new wave of class action suits

19-Apr-2012 By Elaine Watson

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...

SIDI Working Group opens supplier qualification guidelines for comments

18-Apr-2012 By Stephen Daniells

The Standardized Information on Dietary Ingredients (SIDI) working group is calling for comments from industry stakeholders on its new supplier qualification guideline.

Energy drink or supplement? Enforce your own guidance, says Sen Durbin to FDA

06-Apr-2012 By Elaine Watson

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.

US shuts down PA supplements company pending cGMP re-inspection

16-Mar-2012 By Stephen Daniells

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.

CRN welcomes FDA ‘wake-up’ call for GMP compliance

29-Feb-2012 By Stephen Daniells

Many dietary supplement companies are not fully compliant with GMP regulations, putting them at risk of warning letters and more, but resources are available to help companies prepare for an FDA inspection, says the Council for Responsible Nutrition (CRN).

FDA launches probe on 'inhalable' caffeine shot

22-Feb-2012 By Oliver Nieburg

The US Food and Drug Administration (FDA) is to investigate the safety of an inhalable caffeine shot called AeroShot, which only hit US shelves last month.

AHA GRAS attack reaction: Why self-affirmed GRAS is not ‘GRAS lite’

21-Feb-2012 By Elaine Watson

Experts in helping firms navigate the GRAS (generally recognized as safe) process say the American Heart Association (AHA) made some valid points in its recent attack on GRAS, but argue the system is actually working pretty well.

Self-affirmed GRAS under fire as AHA steps up sodium reduction campaign

16-Feb-2012 By Elaine Watson

There are serious weaknesses in the system that allows firms to self-affirm the safety of foods without the approval or knowledge of the Food and Drug Administration (FDA), according to the American Heart Association (AHA).

Time is running out for cardio claims on free phytosterol supplements

10-Feb-2012 By Elaine Watson

Time is running out for firms making health claims about coronary heart disease risk on supplements containing non-esterified or ‘free’ phytosterols.

ABC paper promises to dispel ‘myth’ of unregulated supplements

07-Feb-2012 By Elaine Watson

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 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.

NPF: Many ignorant of disease/drug claim rules and where testimonials fit in

24-Jan-2012 By Elaine Watson

A surprising numbers of companies contacted by the Natural Products Foundation (NPF) about unauthorized disease or drug claims on supplements are unaware that they are breaking the law, according to NPF executive director Deb Knowles.

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

16-Jan-2012 By Stephen Daniells

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 By Elaine Watson

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.

NutraIngredients-USA predicts top industry influences in 2012

04-Jan-2012 By Stephen Daniells

As the New Year begins, NutraIngredients-USA predicts the top issues likely to have the greatest impact on the US dietary supplements industry in the year ahead.

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

22-Dec-2011 By Elaine Watson

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.

USPLabs hit with class action over DMAA in Jack3d and OxyELITE

20-Dec-2011 By Elaine Watson

The regulatory status and safety of DMAA, a stimulant used in sports and weight loss supplements and reported by some to be a natural constituent of geranium oil, has been challenged again this week.

NDI draft guidance comments

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

12-Dec-2011 By Elaine Watson

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 draft guidance comments

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

09-Dec-2011 By Elaine Watson

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).

Infiniti Marketing Group: ‘We are NOT the firm targeted by FDA in ephedrine seizure’

08-Dec-2011 By Elaine Watson

A California-based company with the same name as a firm targeted by the Food and Drug Administration (FDA) in a crackdown on adrenaline-like stimulants says it has been inundated with calls from confused customers, although it has nothing to do with the...

NDI draft guidance comments

ANH-USA: 'Unworkable and irrational’ NDI guidance is rulemaking by the backdoor

06-Dec-2011 By Elaine Watson

Health advocacy group the Alliance for Natural Health USA (ANH-USA) is exploring all available “legal remedies” should the Food and Drug Administration (FDA) fail to ditch or substantially revise its draft guidance on new dietary ingredients (NDIs).

NDI draft guidance comments

Citizens for Health NDI guidance withdrawal petition signatures approach 15,000

06-Dec-2011 By Elaine Watson

Health advocacy group Citizens for Health (CFH) has delivered a petition to the House of Representatives, the Senate and the Food and Food and Drug Administration (FDA) signed by more than 12,000 Americans, calling on the FDA to withdraw its draft guidance...

NDI draft guidance comments

AHPA to FDA: Tear up NDI draft guidance and start again

05-Dec-2011 By Elaine Watson

The Food and Drug Administration should tear up its “hugely flawed” draft guidance on new dietary ingredient (NDI) notifications and go back to the drawing board, according to the American Herbal Products Association (AHPA).

Syntec supplements seized over unauthorized disease claims and serious cGMP violations

05-Dec-2011 By Elaine Watson

The Food and Drug Administration (FDA) says it had no choice but to seize supplements manufactured by Syntec Inc (Syntec Nutraceuticals) after the firm committed serious cGMP violations and ignored warning letters accusing it of making unauthorized disease...

NDI draft guidance comments

ABC: Expert panel should clarify list of grandfathered dietary ingredients

05-Dec-2011 By Elaine Watson

The Food and Drug Administration (FDA) should recognize the existing industry list of ‘grandfathered’ or ‘old’ dietary ingredients (ODIs) sold in the US pre-1994 – but work with an expert panel to clarify its contents, according to the American Botanical...

NDI draft guidance comments

NPA to FDA: Ditch product-specific notifications and accept our grandfathered lists … and NDI guidance could be salvaged

01-Dec-2011 By Elaine Watson

The Food and Drug Administration’s (FDA’s) draft guidance on new dietary ingredients (NDIs) can be salvaged, but only if the agency is willing to substantially rewrite the offending document, the Natural Products Association (NPA) has argued.

GMP inspections show ‘consistent fundamental failures’: Israelsen, UNPA

29-Nov-2011 By Stephen Daniells

The ‘consistent fundamental failures’ of companies in the dietary ingredients and supplement segment for current good manufacturing practices (GMPs) is a ‘topic of disappointment’, says Loren Israelsen.

Jarrow Formulas FOIA request on NDIs: ‘In sum, FDA has told us to drop dead’

28-Nov-2011 By Elaine Watson

Jarrow Formulas is still waiting for a “substantive response” from the Food and Drug Administration (FDA) to a Freedom of Information Act (FOIA) request submitted more than two months ago about the FDA’s draft guidance on New Dietary Ingredients (NDIs).

FDA files permanent injunction against supplement manufacturer

25-Nov-2011 By Stephen Daniells

The US Food and Drug Administration has filed for a permanent injunction against a Pennsylvania dietary supplement manufacturer as the agency turns the GMP compliance screw.

Warning Letters continue as FDA maintains cGMP vigilance

23-Nov-2011 By Stephen Daniells

The US Food and Drug Administration (FDA) has issued two warning letters in November for alleged dietary supplement cGMP violations, as the agency maintains its vigilance.

CSPI calls for St John’s Wort warning labels

14-Nov-2011 By Stephen Daniells

Supplements containing St John’s wort should carry warning labels because of potential interactions with drugs and OTC products, says the Center for Science in the Public Interest (CSPI).

Proposed 2007 grandfathered date change: Limited chance of success and distraction from NDI comment deadline?

10-Nov-2011 By Stephen Daniells

A proposed change to the date defining ‘grandfathered’ dietary ingredients to 2007 shows the industry there are options to the NDI issue, but it should not distract attention from FDA and the upcoming deadline for NDI comment submissions, say leading...

Health Canada eases guidelines on p-synephrine from bitter orange

02-Nov-2011 By Stephen Daniells

Guidelines for us of p-synephrine, the predominant alkaloid in bitter orange, has been redefined by Health Canada, with 1 to 50 mg per day of the compound now classified as not ‘likely to cause any adverse health consequences’.

Poll: Do we need a clearer definition of ‘natural’?

28-Oct-2011 By Elaine Watson

In the world of food marketing, perception is everything. Consumers want foods that sound wholesome, friendly, and above all “natural” – although they are rarely able to articulate what this means.

CRN: FDA’s ‘arbitrary and capricious decision making’ on phytosterol claims has put supplements industry in an ‘untenable’ position

27-Oct-2011 By Elaine Watson

The Food and Drug Administration (FDA) has put supplement makers in an “untenable” position with its move to discontinue an eight-year-old policy of enforcement discretion on health claims about phytosterols, according to the Council for Responsible Nutrition...

Herbalife: Six steps to improve functionality of NDI guidance

18-Oct-2011 By Stephen Daniells

The functionality of the New Dietary Ingredient (NDI) guidance can be improved in only six steps, says direct selling giant Herbalife in its comments to the US Food and Drug Administration (FDA).

Exclusive interview

Fabricant: Gap between NDI numbers and submissions is too big 'no matter how you slice it'

13-Oct-2011

It might be controversial, but the FDA's draft guidance on new dietary ingredients (NDIs) does not mean the end of the dietary supplements trade as we know it, insists Daniel Fabricant in an exclusive interview with NutraIngredients-USA at SupplySide...

NDI guidance prompts unprecedented level of grassroots activism, claims ANH-USA

11-Oct-2011 By Elaine Watson

Attempts by health advocacy group the Alliance for Natural Health USA (ANH-USA) to drum up ‘grassroots’ support for its campaign against the Food and Drug Administration's (FDA’s) New Dietary Ingredient (NDI) draft guidance have prompted an unprecedented...

FDA’s Fabricant: ‘Unreasonable risk’ has nothing to do with efficacy

29-Sep-2011 By Stephen Daniells

The issue of ‘unreasonable risk’ in the NDI draft guidance is not about efficacy, despite what some industry personalities have said, the director of the FDA’s Office of Dietary Supplement Programs tells NutraIngredients-USA.

US structure/function claims under scrutiny as EFSA ups the ante

23-Sep-2011 By Elaine Watson

Firms making structure/function claims about foods and supplements in the US could face difficult questions when the final list of general function claims permitted in Europe is released and it becomes clear that scores of products sold in the US feature...

Jarrow Formulas challenges FDA on NDIs with 128-item Freedom of Information request

16-Sep-2011 By Stephen Daniells

California-based Jarrow Formulas has submitted a 128-item Freedom of Information Request to the US FDA with questions it deems ‘vital’ to any comments it seeks to file in response to the New Dietary Ingredient (NDI) draft guidance.

Sabinsa extends patent portfolio to 66 with new selenium forms

09-Sep-2011 By Stephen Daniells

The US Patent and Trademark Office has granted a patent to Sabinsa for selenodipeptides for cosmeceuticals and pharmaceutical applications.

Health Canada: DMAA is not from geranium

24-Aug-2011 By Stephen Daniells

DMAA, a substance used in sports and weight loss supplements and reported by some to be a natural constituent of geranium oil, is not isolated from plants and products containing it need drug authorization, Health Canada has announced.

Emord on NDI guidance: Politics has prevailed over science and common sense

08-Aug-2011 By Elaine Watson

If sufficient pressure is exerted on key members of Congress, it is not beyond the realms of possibility that the FDA might suspend its draft guidance on NDIs (new dietary ingredients) or even withdraw it altogether, according to food law attorney Jonathan...

Melatonin brownie maker: ‘We’ll sell them as supplements’

04-Aug-2011 By Elaine Watson

The maker of the melatonin-laced ‘relaxation’ brownies at the center of a debate over where a dietary supplement ends and a food begins says it will make “all necessary changes to market and sell the product as a supplement”.

ABC on NDI guidance: ‘We find this problematic’

13-Jul-2011 By Elaine Watson

The American Botanical Council (ABC) has weighed into the debate over the Food and Drug Administration’s (FDA’s) draft guidance document on new dietary ingredient (NDI) notifications.

FDA to publish new rules on how daily values are calculated

13-Jul-2011 By Elaine Watson

The Food and Drug Administration (FDA) is hoping to publish new rules on how daily values on food labels are calculated this year, something that could have broad ramifications for the dietary supplements trade.

Big interview: Vasilios Frankos, Herbalife

Frankos on NDI guidance (part one): Take a deep breath and don’t panic

08-Jul-2011

While many stakeholders seem to believe that the Food and Drug Administration’s (FDA’s) controversial draft guidance document on NDI (new dietary ingredient) notifications could spell Armageddon for the supplements trade, this is actually quite unlikely,...

Big Interview: Vasilios Frankos, Herbalife

Frankos on NDI guidance (part two): This really isn’t a big surprise

08-Jul-2011

While many stakeholders warn that the FDA’s controversial NDI draft guidance will stifle innovation and bury the supplements trade (and the FDA itself) under a hellish mountain of paperwork, they cannot pretend they didn’t see it coming, Herbalife’s Vasilios...