Food And Drug Administration

Pressure mounts for regulatory clarity on CBDs

21-Mar-2016 By Hank Schultz

The recent spate of FDA warning letters on the use of CBD as an ingredient in dietary supplements seems to have done little to dampen formulators’ enthusiasm for its use in new products. The situation is unprecedented in the herbal products sphere, observers...

List of food, supplement facilities registered with FDA misses firms that avoid filing, expert says

17-Mar-2016 By Hank Schultz

More than half of food facilities currently registered with the Food and Drug Administration are located outside the US. But that figure might disguise a number of unregistered domestic facilities, according to a recent analysis.

JAMA: Cranberry for UTIs is the only herbal supported by some scientific evidence

09-Mar-2016 By Stephen Daniells

Herbal medications and supplements are lacking clear proof of any beneficial effects, except cranberry for UTIs, states a new Patient Page in the Journal of the American Medical Association (JAMA).

FDA issues warning to consumers about tainted products sold in ethnic markets

08-Mar-2016 By Hank Schultz

In a move widely applauded by industry groups, the Food and Drug Administration sent out a warning on a category of purported health products sold in ethnic communities that are subject to tainting with undeclared pharmaceutical ingredients.

FDA sends warning letters to 8 companies marketing CBD products

10-Feb-2016 By Hank Schultz

The Food and Drug Administration has sent eight warning letters out to companies marketing dietary supplements containing CBD. The warning letters cite illegal drug claims and also hinge upon the existence of CBD as the active ingredient in two drugs...

Onset of FSMA to drive continued demand for consulting services, expert says

21-Jan-2016 By Hank Schultz

The demand for consulting services will only continue to rise as new laws come into full implementation, said a consulting company executive.

Frontline TV segment bashing supplements called 'patently dishonest' by NPA chief

20-Jan-2016 By Hank Schultz

The national investigative TV program Frontline segment that aired last night was a rehash of familiar criticisms of the supplement industry, and was in part “patently dishonest,” according to NPA executive director Dan Fabricant, who was quoted at several...

Consulting firm rolls out monitoring tool to help with FSMA compliance

15-Jan-2016 By Hank Schultz

Record keeping can be the bane of the compliant manufacturer’s existence. The Food Safety Modernization Act will impose further burdens, which can be streamlined with a service being rolled out by Registrar Corp.

FDA's move to seize products from foreign firms failing GMPs seen as important first step

14-Jan-2016 By Hank Schultz

A recent move by the Food and Drug Administration to detain products without examination from  foreign firms that have failed GMP inspections is welcome step toward "draining the swamp," said United Natural Products Alliance president Loren...

FDA seizes $400,000 worth of kratom products in Illinois

08-Jan-2016 By Hank Schultz

Despite an import ban on the substance, kratom-containing products continue to find their way into the country. In the latest action, the Food and Drug Administration has seized 90,000 bottles at a facility in Illinois.

There's plenty of room for botanical discovery, especially in finding new ingredients from familiar sources, experts say

04-Jan-2016 By Hank Schultz

What’s the future for botanical ingredient discovery? Experts differ on whether there are wholly new, useful species yet to be discovered, but agree that there are still more ingredients to be derived from source materials already in use.

Legal dietary supplements vs illegal drug-spiked products: FDA clarifies its language

07-Dec-2015 By Stephen DANIELLS

The US Food and Drug Administration has updated terminology on its web pages to more accurately describe illegal, drug-spike products and to remove references to these as dietary supplements, following requests from the American Herbal Products Association...

The new DMAA: DMBA warnings spread to EU

12-Nov-2015 By Annie Harrison-Dunn

The Swedish Food Safety Authority (NFA) has urged consumers not to buy products containing DMBA – a novel substance used to replace the banned stimulant DMAA.

What is 'natural'? FDA finally weighs into the debate

FDA seeks comments on use of the term ‘natural’ on food labels

10-Nov-2015 By Elaine Watson

Having studiously avoided this food labeling minefield for years, the Food and Drug Administration (FDA) has surprised many in the trade by seeking comments on the definition of a word that has launched a thousand class action lawsuits (well almost):...

Special Edition: Regulatory Focus

Federal court rebuffs FTC effort to apply pharmaceutical standards to dietary supplement substantiation

03-Nov-2015 By Marc Ullman and Steven Shapiro

The decision in the Bayer Corp. contempt case has important implications for the dietary supplement industry, say attorneys Steven Shapiro and Marc Ullman in this guest article: 

FDA's action in picamilon case sets bad precedent, CRN's Mister says

28-Oct-2015 By Hank Schultz

The declaration from FDA on picamilon that formed part of the lawsuit filed by the Oregon Attorney General sets a troubling precedent, said Steve Mister of  the Council for Responsible Nutrition.

AHPA: NEJM ER visits study actually demonstrates the relative safety of supplements

21-Oct-2015 By Michael McGuffin, president of the American Herbal Products Association

The recent NEJM study on emergency room (ER) visits associated with dietary supplements demonstrates the relative safety of this product class, when placed into the context of the U.S. population of supplement users and compared to other product categories.

Wholesale hemp prices declining despite fractured US supply chains, investment advisor says

20-Oct-2015 By Hank Schultz

Investment opportunities in the CBD space continue to abound despite the regulatory uncertainties, the director of a Boulder-based fund says.

DMAA: Almost 40 products still commercially available with the controversial ingredient

16-Oct-2015 By Stephen DANIELLS

Thirty nine products containing controversial ingredient DMAA are commercially available in the US, according to the Human Performance Resource Center.

FDA’s Welch: ‘We are not seeing the drastic jumps in GMP compliance that we would like to see’

15-Oct-2015 By Stephen Daniells

With about 50% of the industry's facilities inspected, GMP compliance is largely not where the FDA would want it to be, said the Agency's Dr Cara Welch. 

Quality of vinpocetine, picamilon supplements questioned by Ole Miss-Harvard study

02-Oct-2015 By Stephen DANIELLS

A new analysis of over 50 dietary supplement products containing vinpocetine or picamilon has found that wide ranges in levels of the bioactives, with some products not containing anything at all.

DOJ: ‘We have put fighting illegal activity in the dietary supplement industry high on the priority list’

17-Sep-2015 By Stephen Daniells

Illegal activity in the dietary supplements industry has become "a massive, and wide-ranging, consumer-protection problem", says the Department of Justice, which has put the issue high on the priority list within its consumer protection agenda,...

The NY AG’s herbal probe so far: From GNC to devil’s claw

11-Sep-2015 By Stephen Daniells

It started with cease and desist letters to four major retailers and then grew and grew. A lot has happened since NY AG Eric Schneiderman launched his investigation into herbal supplement quality.

With no study showing how CoQ10 eases statin side effects, it's two steps forward, one step back for ingredient

01-Sep-2015 By Hank Schultz

A recent article in The New York Times that hinged on the side effects of statins had nothing to say about CoQ10, despite widely available information about the ingredient’s potential benefit in dealing with these side effects.

NDI draft guidance continues to inform FDA's enforcement thinking, latest DMBA warning letter shows

20-Aug-2015 By Hank Schultz

The Food and Drug Administration is continuing enforcement actions based on the precepts laid out in the draft guidance on New Dietary Ingredients with a warning letter sent to a company marketing a product that contains the stimulant-like ingredient...

Industry opening up to idea of pre-market notification process for supplements

03-Aug-2015 By Hank Schultz

Is it time to consider new legislation to alter the landscape that DSHEA created for the dietary supplements industry? The issue was raised in a recent public industry forum and met a generally positive reception.

FDA cites 47 separate disease claims in warning letter to Wyoming firm

29-Jun-2015 By Hank Schultz

In another example of what can happen when the FDA steps through the doors, dietary supplement manufacturer Country Doctor Herbals has received a warning letter from the Food and Drug Administration that is remarkable in its comprehensiveness.

Dr Taylor Wallace: ‘DSHEA needs to be updated to better protect consumers, but premarket approval isn't the answer’

17-Jun-2015 By Stephen DANIELLS

The laws governing dietary supplements must expand and evolve to protect consumers from potential harm and misleading communication, says Dr Taylor Wallace.

Industry opposes Durbin/Blumenthal amendments to limit military access to dietary supplements

09-Jun-2015 By Stephen Daniells

The Natural Products Association and the Council for Responsible Nutrition are rallying support against amendments to the Department of Defense 2016 spending bill to limit military access to dietary supplements. The spending bill is considered by some...

FDA's decision on CBD likely to be overturned after more info comes in, exec says

26-May-2015 By Hank Schultz

An executive with one of the companies promoting cannabidiol for dietary supplements believes that FDA’s recent determination that the compound is not a legal dietary ingredient is premature and will be overturned.

FDA says no to CBD in supplements

18-May-2015 By Hank Schultz

In a recently updated communication on marijuana, the Food and Drug Administration has flatly stated that products based on cannabidiol (CBD), a non-narcotic fraction of Cannabis sativa, cannot be marketed as dietary supplements.  The reason? A pre-existing...

Organic & Natural file citizen petition to apply GMPs to ingredient suppliers

15-May-2015 By Stephen Daniells

The Organic & Natural Health Association has filed a citizen petition with the US Food and Drug Administration to extend the FDA’s current cGMPs (code 21 CFR Part 111) to raw material manufacturers.

Hi-Tech Pharmaceuticals suing Harvard researchers for $200 million

04-May-2015 By Stephen DANIELLS

BMPEA proponent Hi-Tech Pharmaceuticals, Inc, has filed a suit against four researchers, including Dr Pieter Cohen, alleging a recent study published in Drug Testing and Analysis is defamatory. Hi-Tech is seeking $50 million in compensatory damages and...

‘A bold, aggressive move’: FDA sends warning letters to 14 companies over DMBA

28-Apr-2015 By Stephen Daniells

Fourteen companies have received warning letters from the FDA regarding products containing DMBA (1,3-Dimethylbutylamine), which the Agency states is not a legal dietary ingredient and products containing it are considered to be adulterated.

FDA says BMPEA not a legal ingredient, sends warning letters to 5 companies listing stimulant on labels

23-Apr-2015 By Hank Schultz

The Food and Drug Administration announced Wednesday that it has banned the use of the stimulant BMPEA in dietary supplements and foods. The agency also sent five warning letters to companies that have used the variant of amphetamine in weight loss supplements. ...

BMPEA proponent Hi-Tech Pharmaceuticals expands with acquisition of Mexican company

17-Apr-2015 By Hank Schultz

Hi-Tech Pharmaceuticals, a controversial Georgia-based dietary supplement finished products and contract manufacturer, has announced plans to acquire a major Mexican dietary supplement and OTC drug manufacturer, the company announced this week. Hi-Tech...

Durbin, Blumenthal urge FDA to take action against BMPEA

15-Apr-2015 By Hank Schultz

US Senators Dick Durbin and Richard Blumenthal sent a letter yesterday to the Food and Drug Administration asking the agency to take action against products containing the synthetic stimulant ingredient known as BMPEA, products which the pair called both “mislabeled...

Welch: FDA is OK with actions such as Schneiderman's if they result in stronger industry

13-Apr-2015 By Hank Schultz

If it results in a stronger, more compliant industry, the Food and Drug Administration is supportive of activities such as those undertaken by New York Attorney General Eric Schneiderman, according to a statement from agency official Cara Welch, PhD.

Jarrow: There is a NY State agenda for ‘supplement safety’ legislation

13-Mar-2015 By Stephen DANIELLS

There is a larger anti-supplement agenda in New York State, with key state politicians all seeking greater oversight of supplements, says Jarrow Formulas.

Updated: NBTY appreciates AG's efforts & will comply. "We are confident that our products meet our label claims"

NBTY, Pharmavite, Nature's Way and Nutraceutical Corp. pulled into NY AG’s probe

24-Feb-2015 By Stephen Daniells

NY AG Eric Schneiderman has extended his investigation into herbal supplements by sending letters to four leading manufacturers demanding detailed ingredient and quality control information on every herbal supplement they sell in his state.

NY AG shifts focus & subpoenas retailers on structure-function label claims

12-Feb-2015 By Stephen Daniells

A new twist has developed in the NY AG’s investigation into herbal products as subpoenas have been issued to GNC, Walgreens, Target and Walmart to demand evidence to support the structure-function claims on their labels.

High NDI failure rate putting more emphasis on GRAS status for new ingredients

09-Feb-2015 By Hank Schultz

The high rate of failure in New Dietary Ingredient notifications has led some companies to seek workarounds. Anecdotal evidence gathered by NutraIngredients-USA shows that companies are increasingly leaning on GRAS status as a way to avoid having to enter...

FDA Commissioner Margaret Hamburg to step down

05-Feb-2015 By Stephen DANIELLS

The US Food and Drug Administration (FDA) has confirmed media rumours that Dr Margaret Hamburg is stepping down from her role as Commissioner at the end of March, with Stephen Ostroff, MD, the FDA's chief scientist, serving as acting Commissioner.

FDA budget request outlines priorities in FSMA implementation, increased inspections

05-Feb-2015 By Hank Schultz

The budget request from the White House for the Food and Drug Administration is part of President Obama’s overall budget that will not see the light of day.  Nevertheless, the massive document does include priorities that are likely to be addressed in...

Guest article

UNPA: On a host of issues, it's back to the future in 2015

08-Jan-2015 By Loren Israelsen, president of the United Natural Products Alliance

On the cusp of its 30th anniversary, there’s been a lot of talk about the look forward provided by the 1985 movie, Back to the Future. A similar look back at the natural health products industry to see the future is not such a far-fetched idea. A number...

Seller of supplements diluted with fillers pleads guilty, agrees to pay more than $1 million

18-Dec-2014 By Hank Schultz

The owner of a dietary supplement company has pleaded guilty of conspiracy to commit wire fraud in connection with the sale of diluted and adulterated ingredients and supplements.  The plea deal comes with an agreement to pay a fine that exceeds $1 million.

ChromaDex bolsters IP protection around pTeroPure with memory, sun damage patents

26-Nov-2014 By Hank Schultz

ChromaDex has bolstered the IP protection around pTeroPure, one of its branded ingredients, with the announcement of two patents relating to pterostilbene, which are the second and third patents granted to the company on the ingredient.

Boston Therapeutics expands Asian markets for Sugardown ingredient as company scrambles to raise capital

26-Nov-2014 By Hank Schultz

Boston Therapeutics Inc. has announced a new marketing deal for its recently-launched Sugardown blood sugar management ingredient that will expand the potential distribution in Asia. The deal comes at an opportune time as the company is scrambling to...

New online option for NDI notifications could cut basic errors, expert says

17-Nov-2014 By Hank Schultz

The Food and Drug Administration has opened a public comment period on a proposed change that would allow the online submission of New Dietary Ingredient notifications.  The change could help clear up some confusion within the industry about what exactly...

20 Years of DSHEA: Focusing on the Future

13-Nov-2014 By Daniel Fabricant, PhD, CEO and Executive Director, Natural Products Association

While we should certainly take a second to pause and reflect in honor of the 20th anniversary of the passage of the Dietary Supplement Health and Education Act (DSHEA), it’s important to keep in mind that the industry as a beacon of growth must focus...