Fda

‘A valuable addition to QC’: FDA GutProbe may help verify accurate labelling in commercial probiotics

19-May-2015 By Stephen Daniells

A custom DNA microarray may provide a ‘quick, more accurate, and inexpensive’ method for identifying microbials and probiotics in dietary supplements, say the FDA researchers who developed the technique.

Extending GMPs to ingredient suppliers would fix gap in original rule, stakeholders say

18-May-2015 By Hank Schultz

A recently filed citizen's petition asking FDA to extend GMP requirements to ingredient manufacturers met with a cautious but generally positive reception among industry stakeholders. Having ingredient suppliers stand outside this aspect of the law...

Organic and non-gmo trends

Congress should strengthen FDA’s oversight of GMOs, CSPI leader says

23-Apr-2015 By Elizabeth Crawford

Congress needs to strengthen FDA’s oversight of genetically modified organisms before foreign countries, with potentially lower safety standards, begin genetically engineering crops used in finished products that are imported to the U.S., argues an executive...

FDA: KIND bars do not meet the requirements for use of the nutrient content claim ‘healthy'

KIND LLC working with FDA over string of labeling errors; consumer litigation could follow, predict attorneys

16-Apr-2015 By Elaine Watson

KIND LLC says it is working closely with the US Food and Drug Administration (FDA) to address a long list of concerns raised by the agency in a warning letter over label claims on its bars and its website.

FDA warns consumers against Tri-Methyl Xtreme muscle growth product

14-Apr-2015 By Stephen DANIELLS

The FDA has issued a consumer warning to stop using Las Vegas-based Extreme Products Group’s Tri-Methyl Xtreme following reports of serious liver injury.

Anti-depressant drug fluoxetine continuing to show up as adulterant in weight loss products

20-Mar-2015 By Hank Schultz

There's another pharmaceutical ingredient to add to the list of APIs showing up in products marketed as dietary supplements.  It’s fluoxetine, an antidepressant, and why fly-by-night formulators seem to be using it is something of a mystery.

Industry finds new supporter in meeting with Rep. Ted Lieu, D-CA

09-Mar-2015 By Hank Schultz

The dietary supplement industry received a welcome breath of fresh air in a meeting of industry representatives with Rep. Ted Lieu, the newly elected Democrat in California’s 33rd Congressional District.  The meeting was arranged by Jarrow Formulas and...

Firm gets warning letter for straddling beverage/liquid supplement divide

22-Jan-2015 By Hank Schultz

A recent FDA warning letter to a New York company points again to the danger of mixing metaphors when positioning a product as either a beverage or a liquid dietary supplement.

Where was the dietary supplements industry at yesterday’s Redbook hearing?

10-Dec-2014 By Stephen DANIELLS

Proposed FDA revisions to CFSAN’s Redbook to include dietary supplement ingredients, and therefore regulate them as food additives, has created “real and legitimate” concerns for the industry. But also concerning was the limited presence by dietary supplement...

Internet helps noncompliant retailers ply their trade but also helps FDA find them, expert says

05-Nov-2014 By Hank Schultz

The growth of online retailing has bee decried by some in the dietary supplements business for allowing the rapid appearance of fly-by-night marketers.  But the Internet has a flip side, acting as a powerful and low-cost enforcement tool that the Food...

Is FDA doing enough to stem tide of tainted products? Probably not

28-Aug-2014 By Hank Schultz

A review of recent FDA enforcement actions concerning tainted products marketed as dietary supplements highlights the scope of the problem facing regulators and the limitations they operate under in dealing with it.

FDA removes another DMAA-containing supplement from market

12-Aug-2014 By Hank Schultz

Like a bad penny, DMAA keeps cropping up in the market.  In the most recent instance,  a company called Regenaca Worldwide has recalled diet capsules that contain the ingredient, which FDA has banned from the market.

CRN, NPA submit comments on FDA's proposed changes to food, supplement labels

05-Aug-2014 By Hank Schultz

Both the Council for Responsible Nutrition and the Natural Products Association have submitted a comments on FDA’s proposed revisions for food and dietary supplement labels. 

Proposals don't consider a product's overall nutritional value, says professor

Former FDA commissioner: Nutrition Facts overhaul doesn’t go far enough

21-Jul-2014 By Elaine Watson

FDA proposals to overhaul the Nutrition Facts panel on food labels are “strong” and “likely to make an important contribution”, says former FDA commissioner David Kessler, M.D. “But I believe they don't go far enough.”

Genetic testing & personalization: 23andMe works it way back with new premarket notification

27-Jun-2014 By Stephen DANIELLS

The US Food and Drug agency has accepted for review a premarket notification report from 23andMe, seven months after its genetic testing operations were shut down by the FDA.

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....

FDA prohibition of omega-3 nutrient content claims ‘in no way reflects the well-substantiated benefits associated with EPA & DHA’, says GOED

25-Apr-2014 By Stephen DANIELLS

The US Food and Drug Administration (FDA) will publish on Monday, April 28 a final rule prohibiting certain nutrient content claims for foods that contain the omega-3 fatty acids DHA, EPA, and ALA, drawing criticism from the Global Organization for EPA...

Dewmar’s FDA warning letter a ‘no-brainer’: food and drug attorney

11-Apr-2014 By Maggie Hennessy

The Food and Drug Administration (FDA) has issued a warning letter to Dewmar International BMC Inc., alleging that despite labeling its Lean Slow Motion…Potion beverage as a dietary supplement, the manufacturer is representing it as a conventional food...

Kratom distributor recalls all products in wake of FDA import alert

18-Mar-2014 By Hank Schultz

SNI National has voluntarily recalled all of its products that contain kratom, an ingredient whose legality has been questioned by the Food and Drug Administration.

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...

Ex-FDA official praises GMA call for federal GMO labeling rules, but says asking it to define ‘natural’ is a long shot

14-Jan-2014 By Elaine WATSON

It might have enraged those in favor of mandatory GMO labeling, but a leaked document outlining the Grocery Manufacturers Association’s (GMA’s) ideas for a federally regulated 'voluntary' approach to this issue has been praised by one ex-FDA...

Prochnow: GMPs, NDIs and liquid supplements among prominent regulatory concerns for 2014

09-Jan-2014 By Hank Schultz

Attorney Justin Prochnow has made a career of reading the FDA tea leaves for his clients. As the industry enters 2014, he sees a long-term trend of GMP enforcement and nascent guidances on New Dietary Ingredients and liquid dietary supplements as the...

FDA 'respectfully declines' judges' plea for it to determine if GMOs belong in all-natural products

08-Jan-2014 By Elaine WATSON

The FDA has written to three federal judges handling civil cases vs food manufacturers over natural claims to “respectfully decline” their request to come to an administrative determination of whether GMOs belong in ‘all-natural’ foods.

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.

Researchers tout cholesterol-reducing dark chocolate with phytosterols

03-Jan-2014 By Oliver Nieburg

Phytosterols can be added to dark chocolate to produce a cholesterol-cutting product capable of an FDA health claim, according to a study. 

Finished product testing requirements puts pressure on multiple ingredient products, expert says

16-Dec-2013 By Hank Schultz

Setting specifications for products and testing to make sure the lots going out the door meet those specs is a key facet of meeting GMP requirements.  But if a company has a product that might include many ingredients, how does it formulate a realistic...

Should the definition of ‘whole grains’ be expanded to include whole seeds, beans and legumes?

06-Dec-2013 By Elaine WATSON

As the FDA prepares to conduct consumer research into whole grain labeling statements before it issues finalized guidance for industry, the debate over precisely what should constitute a ‘whole grain’, as well as how the amount of whole grain should be...

23andMe warning letter won't decimate personalized nutrition trend, but will help shape boundaries, experts say

05-Dec-2013 By Hank Schultz

Personalized nutrition is one of the ultimate goals of the dietary supplement and functional foods business. But the FDA warning letter received by high profile genomics testing firm 23andMe is casting a cloud of doubt over the trend. If FDA views the...

FDA issues 'softly worded' draft guidance on acrylamide

15-Nov-2013 By Maggie Hennessy

The US Food and Drug Administration (FDA) has issued a draft guidance for the food industry to help growers, manufacturers and operators work toward reducing levels of acrylamide in certain foods.

Following on Hawaii liver injury reports, USPlabs issues national recall of OxyElite Pro

11-Nov-2013 By Hank Schultz

Sports supplement manufacturer USPLabs has recalled lots of its OxyElite Pro products after receiving a letter directing the action from FDA motivated by reports of liver illnesses in Hawaii associated with the product.  FDA also it directed the recall...

FDA seeks injunction against Oregon supplements firm over disease claims, GMP violations

23-Oct-2013 By Hank Schultz

The Food and Drug Administration is seeking a permanent injunction against James G. Cole Inc., an Oregon-based dietary supplement manufacturer.  As is usually the case with such injunctions, the action is the culmination of a long interaction between...

FDA permits qualified health claim about whole grains and type 2 diabetes, but is the wording so qualified no one will use it?

25-Sep-2013 By Elaine WATSON

The FDA says it will permit qualified health claims on the relationship between eating whole grains and a reduced risk of type 2 diabetes, but is the wording it has proposed so qualified that no food manufacturer will want to use it?

FDA warning letter disallows 14 Metagenics products as medical foods

13-Sep-2013 By Hank Schultz

Metagenics, a prominent California-based dietary supplement manufacturer that specializes in medical foods and supplements sold through the practitioner channel, has received a warning letter in which FDA says a number of its medical foods are mislabeled...

GMOs and natural claims: ‘FDA is losing credibility with industry, consumers and the international community by ignoring key food labeling controversies’, says attorney

12-Sep-2013 By Elaine WATSON

Is it too risky to label products that may contain ingredients from genetically engineered crops as ‘all-natural’? And will the FDA step in and decide this issue so consumer class action lawsuits over this issue stop clogging up the court system?  

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's GMP expert Brad Williams joins NSF staff

23-Jul-2013 By Hank Schultz

Brad Williams, a 30-year Food and Drug Administration veteran, has joined Ann Arbor, MI-based NSF International as technical manager of the global health organization’s dietary supplement GMP compliance program.

AHP 's botanical ID webinar series aims to help boost GMP compliance

11-Jul-2013 By Hank Schultz

Identity testing of botanical ingredients continues to be a hot button issue for the Food and Drug Administration.  To help companies comply with this aspect of GMP regulations, the American Herbal Pharmacopoeia has instituted a series of eight webinars...

Members of Congress ‘concerned’ about speed of progress on NDI draft guidance

09-Jul-2013 By Stephen DANIELLS

Key members of the United States Congress have voiced concern over the speed of progress of revising the controversial draft guidance for new dietary ingredients (NDIs), and called on FDA to produce a revised draft guidance in a 'timely manner'.

More FDA warning letters for website claims and cGMP violations

16-May-2013 By Stephen DANIELLS

The US Food and Drug Administration has issued warning letters to two dietary supplement companies, as the agency maintains its vigilance of website claims and cGMP compliance.

Website content an extension of labeling: FDA warning letter shows companies need to ‘think about their real estate space’

09-May-2013 By Stephen DANIELLS

The FDA has issued a warning letter for a company website that links to articles with disease claims cause products to be drugs (FDA), causing the products linked to such articles to be drugs.

Boxer, DeFazio introduce federal GMO labeling bill

25-Apr-2013 By Hank Schultz

A bill requiring the labeling of GMO ingredients has been introduced at the federal level by Sen. Barbara Boxer, D-CA and Rep. Peter DeFazio, D-OR.  Even though the bill’s chances of passage are uncertain, observers see it as a watershed moment.

Updated: CRN calls on industry to stop manufacturing DMAA-containing products

FDA: 'Information is insufficient to defend the use of DMAA'

12-Apr-2013 By Stephen DANIELLS

After reviewing the response from USPlabs about the use of DMAA as an ingredient in dietary supplements, the FDA has concluded that the evidence is ‘insufficient’, NutraIngredients-USA can report.

Be careful what you 'like'... The FDA is looking at your Facebook page

04-Apr-2013 By Elaine WATSON

Two recent warning letters from the FDA should serve as a reminder to supplement makers that the agency is scrutinizing their activities on Facebook and Twitter just as carefully as it is looking at their corporate websites, say attorneys.

Beehive Botanicals gets GMP warning letter despite clean bill of health from NSF

01-Mar-2013 By Hank Schultz

Beehive Botanicals Inc. has received an FDA Warning Letter even though the company had received a successful GMP audit by NSF International and had NSF review the changes it made to its operations to address FDA concerns.

Noncompliant use of testimonials remains durable feature of supplements business

19-Feb-2013 By Hank Schultz

Regulations regarding how dietary supplement manufacturers can use testimonials to market their products have been on the books for many years now.  But judging from recent warning letters and enforcement actions, many companies still aren’t getting the...

FDA seizes supplements over sibutramine tainting, disease claims

16-Feb-2013 By Hank Schultz

FDA seized tainted dietary supplement products from a Florida company called Globe All Wellness, the agency said Friday.

USPlabs slapped with warning letter over drug claims, GMP failures

16-Feb-2013 By Hank Schultz

USPlabs, the maker of the DMAA-containing sports supplement Jack3d, has received a warning letter over drug claim violations and GMP deficiencies, the Food and Drug Administration confirmed Friday.

Make use of deadline extension to comment on FSMA rules, consultant urges industry

15-Feb-2013 By Hank Schultz

Food consultant Ben England is urging food producers and importers to comment on two proposed rules issued by FDA under FSMA, and the agency has just made that easier by extending the comment period deadline.

Final FSMA administrative detention rule includes no changes suggested in comments

05-Feb-2013 By Hank Schultz

The US Food and Drug Administration has adopted a final rule on its administrative detention authority under the Food Safety and Modernization Act.  In adopting the final rule the agency did not make any of the changes to the interim final ruling that...

NDIs, GMPs, FSMA: The regulation scene in 2013

07-Jan-2013 By Hank Schultz

GMPs, NDIs and FSMA will top the list of most-frequently mentioned acronyms in the regulatory sphere for dietary supplements and functional food ingredient companies in the coming year, industry experts agree.