Food and drug administration

FDA warns consumers about mixing supplements and medications

28-Oct-2014 By Stephen DANIELLS

The US Food and Drug Administration has issued a consumer update to warn of the potential interactions between prescriptions and OTC medications and dietary supplements.

Guest article

Goin’ Back in Time with DSHEA

27-Oct-2014 By Steve Mister, president and CEO for the Council for Responsible Nutrition (CRN)

It’s 1994 all over again—The Lion King just came out; everyone is talking about the Nancy Kerrigan incident, and the police are chasing O.J. Simpson’s white Bronco down the L.A. freeway. Meanwhile, back in Washington, Congress is crafting legislation...

Import detentions increasing and likely to accelerate as FSMA kicks into gear, expert says

23-Oct-2014 By Hank Schultz

Import refusals by the Food and Drug Administration are ramping up and are likely to become more common as some of the rules associated with the Food Safety Modernization Act (FSMA) kick into gear in the coming year, said an executive with a labeling...

CRN’s Mister on DSHEA’s ‘monumental anniversary’, companies choosing a side, and the critical role of contract manufacturers for GMP compliance

20-Oct-2014 By Stephen DANIELLS

The 20th anniversary of the Dietary Supplements Health and Education Act (DSHEA) is ‘monumental’, says Steve Mister from the CRN, but the industry shouldn’t rest on its laurels too long. ‘The important thing is to figure out what change is necessary to...

Study finds DMAA-like 'designer stimulant' in 12 of 14 pre workout supplements tested

08-Oct-2014 By Hank Schultz

A recent study has found 1,3-dimethylbutylamine (DMBA), a synthetic stimulant similar to DMAA, in 12 of 14 dietary supplements tested. According to Dr Pieter Cohen, one of the study’s authors, no information exists on the safety and acceptable dosages...

Rock Creek seems to be near end of supplement road as FDA rejects NDI filing

17-Sep-2014 By Hank Schultz

Rock Creek Pharmaceuticals, formerly known as Star Scientific, has hit another pothole in the road in the form of a negative opinion from the Food and Drug Administration on its New Dietary Ingredient Notification (NDIN).

Nutrasource Diagnostics Inc. hails ‘synergistic strategic acquisition’ of GRAS Associates LLC

08-Sep-2014

Ontario-based Nutrasource Diagnostics Inc. has enhanced its core capabilities with the acquisition of Oregon-based GRAS Associates, LLC (GRAS Associates), of Bend, Oregon. The acquisition also expands the service offering for GRAS Associates customers.

AHPA's data shows FDA ramping up enforcement on tainted weight loss, sex products

21-Aug-2014 By Hank Schultz

The presence of undeclared pharmaceutical ingredients in products purporting to be dietary supplements is garnering an increasing amount of attention and enforcement from the Food and Drug Administration, databases compiled by the American Herbal Products...

Reaction to FDA's proposed Nutrition Facts updates

AHPA to FDA: Clarify protein labeling

21-Aug-2014 By Maggie Hennessy

Although it generally supports the Food and Drug Administration’s (FDA) proposed Nutrition and Supplement Facts label changes, the American Herbal Products Association (AHPA) urged the agency to adopt the Digestible Indispensable Amino Acid Score (DIAAS)...

Rock Creek suspends Anatabloc sales while it tries to resolve NDI issue

13-Aug-2014 By Hank Schultz

Rock Creek Pharmaceuticals, formerly doing business as Star Scientific, has suspended the sale of its Anatabloc antioxidant dietary supplement based on anatabine, a molecule found in cauliflower and other foods. The company said it is attempting to clear...

China's proposed food safety overhaul lacks clarity and detail, NPA says

06-Aug-2014 By Hank Schultz

China’s proposed changes in its food safety regulations, which also govern dietary supplements, are long on aspiration and short on specifics. That’s the opinion expressed by the Natural Products Association in comments the organization submitted to Chinese...

Particulars of GRAS process leave it open to criticism, expert says

11-Jul-2014 By Hank Schultz

The GRAS process as it stands in the United States is vulnerable to criticism based on possible conflicts of interest and low-quality safety work, said Claire Kruger, PhD, president of Spherix Consulting, a division of ChromaDex.

China

New draft law is a step in the right direction for supps exporters

08-Jul-2014 By RJ Whitehead

A recent draft reform of China’s Food Safety Law, which is now available for public comment, is a great improvement for supplements exporters who have been increasingly frustrated at the time and expense required to gain certification in the country.

News in brief

Federal judge approves consent decree with Mira Health Products

03-Jul-2014 By Stephen DANIELLS

A federal judge in New York has signed a consent decree for permanent injunction between the United States and Mira Health Products Ltd., a dietary supplement manufacturer located in Farmingdale, New York, and Michael S. Ragno and Michael S. Ragno, Jr.

IND guidance unfairly restricts supplement research, VDF FutureCeuticals says

13-Jun-2014 By Hank Schultz

The Food and Drug Administration has overstepped its bounds by ruling that a study’s endpoints, rather than the intended use of the product or ingredient being studies, determines whether an Investigational New Drug application must be filed in the opinion...

Jury's out whether recent data shows improvement in NDI picture

09-Jun-2014 By Hank Schultz

Preliminary figures from the American Herbal Products Association show that one in four recent New Dietary Ingredient notifications went through without objections from the Food and Drug Administration. Whether that represents an improvement in the overall...

Soapbox

Light at the end of the tunnel for China supplement importers

09-Jun-2014 By Jeff Crowther

The regulatory management of China’s dietary supplement industry has always been a controversial issue, especially over the last six years.

Devon Powell joins NPA as Sr VP of member services and COO

12-May-2014 By Stephen DANIELLS

Changes at the top of the Natural Products Association continue with the appointment of seasoned industry executive Devon Powell as its new Sr VP of member services and COO.

Nascent 100% confident in the quality and safety of its PQQ, despite FDA safety concerns

05-May-2014 By Stephen DANIELLS

Nascent Health Sciences has resubmitted a New Dietary Ingredient notification (NDIN) for its PureQQ pyrroloquinoline quinone ingredient following a negative response from the FDA first time around, and the company stands by the safety of its product....

Long strange trip: The evolution of botanicals since the inception of DSHEA

21-Apr-2014 By Hank Schultz

The Dietary Supplements Health and Education Act has given rise to a thriving dietary supplements industry. Botanical ingredients have always been a part of that picture, but the concept of where they fit within that category has shifted over the years...

Industry experts dispute dietary supplement critic Cohen's call for sweeping new regulations

03-Apr-2014 By Hank Schultz

A long time critic of the dietary supplement industry, Dr Pieter Cohen, MD, has called for a premarket approval regime and a modified adverse event reporting system for dietary supplements in an article published today in the New England Journal of Medicine. Industry...

Companies must walk fine line when bringing a supplement to market in US that is a drug elsewhere

27-Mar-2014 By Hank Schultz

A company known as PharmaRoth Labs had to absorb a setback recently when it announced that FDA had objected to a New Dietary Ingredient notification the company filed on its Sucanon ingredient. The incident points out the potential pitfalls of bringing...

Dispatches from the NCA State of the Industry Conference in Miami

US cocoa flavanol health claim nears but ‘not quite there yet’

10-Mar-2014 By Oliver Nieburg

More clinical trials are needed for a US health claim on cocoa flavanols, according to the National Confectioners’ Association’s technical director.

FDA agrees to new deadlines on FSMA final rules

24-Feb-2014 By Hank Schultz

The Food and Drug Administration has agreed to new deadlines for final rules detailing the implementaiton of the Food Safety Modernization Act (FSMA). The agreement comes as part of a settlement in a lawsuit brought by advocacy groups claiming that FDA...

CRN recommends making FSVP rules apply to all importers of dietary supplements

29-Jan-2014 By Hank Schultz

Overlapping federal rules can sometimes create nooks and crannies that the originators didn’t intend. The Council for Responsible Nutrition has identified one such possible loophole in the interplay between the dietary supplement GMP rules (Part 111)...

Observers disagree about whether report of tainted thyroid supplements points to wider problems in market

24-Jan-2014 By Hank Schultz

A recent blog in The New York Times raised questions about some thyroid supplements, but passed over the legitimate role dietary supplements scan have in the support of health thyroid function, observers say.

Federal budget bill boosts FDA funding, according AHPA analysis

20-Jan-2014 By Hank Schultz

The new omnibus appropriations bill that surprisingly sailed through Congress recently contains significant budget increases for the Food and Drug administration. Whether those increases will match FDA’s expanded responsibilities under the Food Safety...

For AHPA, 2014's song remains the same: GMPs, GMOs and inaccurate mainstream news reports

07-Jan-2014 By Michael McGuffin, President of the American Herbal Products Association

The American Herbal Products Association (AHPA) is planning for 2014 with the assumption that the hot button issues for the New Year are likely to include three of the same subjects that demanded our attention in 2013: cGMP compliance, GMO labeling, and...

FDA to assess drug release of medicated chewing gums

07-Jan-2014 By Oliver Nieburg

The US Food and Drug Administration (FDA) is working towards a method to validate the effectiveness and safety of medicated chewing gums such as nicotine gum.

CRN seeks clarification on how FSMA affects ingredient suppliers that are already complying with GMPs

02-Dec-2013 By Hank Schultz

The Council for Responsible Nutrition has suggested additional clarification of the risk-based controls portion of the Food Safety Modernization Act. The suggested clarification, submitted by CRN to the Food and Drug Administration as part of the public...

FDA seizes another $2 million worth of DMAA products

19-Nov-2013 By Hank Schultz

The FDA moved to seize more than $2 million worth of DMAA-containing products from Georgia-based Hi-Tech Pharmaceuticals Inc. US Marshals seized the goods after agency investigators determined they contained 1, 3-Dimethylamylamine HCl (DMAA) or its chemical...

DuPont affirms GRAS status of its Bifidobacterium lactis range with FDA letter

19-Nov-2013 By Stephen Daniells

The US Food and Drug Administration has no questions for DuPont (Danisco) and the generally recognized as safe (GRAS) status of its Bifidobacterium animalis subsp. lactis strains HN019, Bi-07, B1-04, and B420 (B. animalis subsp. lactis strains).

Conclusion that herbal supplements causing more liver injuries disputed by expert

06-Nov-2013 By Hank Schultz

The incidence of liver damage caused on by herbal dietary supplements is on the rise, according to information presented at the annual meeting of the American Association for the Study of Liver Diseases. But those conclusions have been questioned by...

Australia and NZ add to OxyElite Pro’s global woes

23-Oct-2013 By Shane Starling

Australia and New Zealand have jointly issued a warning against pre-workout sports supplement OxyElite Pro following its links to an outbreak of acute non-viral hepatitis in Hawaii that killed one person and affected 29.

AHPA requests 'common sense' change to way FDA issues GMP inspection reports

22-Oct-2013 By Hank Schultz

A petition by American Herbal Products Association to the Food and Drug Administration on GMP inspections is an attempt to facilitate communication between the agency and industry, said AHPA president Michael McGuffin.

Panel of experts proposes monograph system to regulate probiotics claims in US

22-Oct-2013 By Hank Schultz

A paper written by a group coordinated out of the University of Maryland proposes significant changes to the way probiotics are regulated, including using a monograph system similar to what regulators use in Canada to govern the use of the organisms.

USPLabs gets warning letter for Oxy Elite Pro and VERSA-1, but claims aegeline ingredient has a long history of safe use

16-Oct-2013 By Stephen Daniells

The US Food and Drug Administration (FDA) has sent a warning letter to Dallas, Texas-based USPLabs for its OxyElite Pro and VERSA-1 products, claiming the ingredient aegeline is not a lawful dietary ingredient, but the company says the ingredient is a...

FDA investigating liver damage reports potentially linked to products labeled OxyElite Pro

08-Oct-2013 By Stephen Daniells

A federal investigation is underway into reports of acute non-viral hepatitis in Hawaii, with many of the cases being linked to a dietary supplement product labeled as OxyElite Pro.

Reaction to CFSAN's priorities for 2013-14

UNPA: Does CFSAN’s plan for GMO labeling guidance signal a change of thinking at FDA?

08-Oct-2013 By Stephen DANIELLS

The Center for Food Safety and Applied Nutrition's (CFSAN) priority to publish guidance to help manufacturers with voluntarily GMO labeling could signal a change in thinking at the agency, says the United Natural Products Alliance (UNPA).

NDIs, GRAS & GMOs: CFSAN outlines priorities for 2013-14

07-Oct-2013 By Stephen DANIELLS

The Food and Drug Administration's (FDA) Center for Food Safety and Applied Nutrition (CFSAN) has outlined its priorities for 2013-14, with a 'surprising' number relevant to supplements, including NDIs, GRAS, and GMOs.

FDA unable to support the majority of its food safety & nutrition activities following shutdown

02-Oct-2013 By Stephen DANIELLS

The activities of the US Food and Drug Administration including routine inspections of facilities and the monitoring of imports have ceased following the government shutdown.

Synthetic versions of natural ingredients with NDI notifications crop up in marketplace

02-Oct-2013 By Hank Schultz

The question whether an NDI notification opens the door for follow on ingredients has yet to be definitively answered. But sources say the question is a lot clearer when the putative follow on ingredient might not even be the same thing.

Medical foods specialist branches off into dietary supplements

06-Sep-2013 By Hank Schultz

Targeted Medical Pharma, a company that has specialized in medical foods, has announced the formation of a dietary supplement division to reach a new set of consumers, the company’s chief executive officer said.

Website claims, cGMP violations, and label claims: FDA warning letter round-up

04-Sep-2013 By Stephen DANIELLS

A new raft of warning letters for dietary supplement companies from the US Food and Drug Administration (FDA) shows that current Good Manufacturing Practice (cGMP) and label claims continue to cause problems for companies.

FDA clearly ramping up scrutiny of Indian pharma businesses

27-Aug-2013 By RJ Whitehead

With two more warning letters sent by the US drug regulator to Indian companies for violation of acceptable manufacturing practices, America has brought to six the number of India-based drugmaking facilities against which it has taken action over the...

Conflicts of interest are ‘ubiquitous’ in GRAS determinations, alleges study

07-Aug-2013 By Elaine WATSON

Conflicts of interest are “ubiquitous” in GRAS [Generally Recognized As Safe] determinations, while there are major flaws in a system that allows firms to affirm the safety of food ingredients without the approval - or even the knowledge - of regulators,...

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