Food And Drug Administration

Bioiberica to launch brand new ingredients and products at Vitafoods

14-Apr-2022 By Liza Laws

Life science company Bioberica will be bringing new ingredients to this year's Vitafoods Europe held in Geneva next month (May).

Warning letter cites ephedra inclusion, 18 years after ban

16-Mar-2022 By Hank Schultz

A recent FDA warning letter includes a citation concerning the inclusion of ephedrine aklaloids, an ingredient that has been theoretically off the market for almost 20 years.

FDA’s final voluntary recall guidance provides easy to follow road map, experts say

04-Mar-2022 By Hank Schultz

The US Food and Drug Administration has finalized a guidance on issuing recalls that first issued in draft form in 2019. The document’s plain language should help ensure compliance, experts contacted by NutraIngredients-USA agree.

NPA submits citizen’s petition demanding resolution on CBD issue

22-Feb-2022 By Hank Schultz

The Natural Products Association has filed a citizen’s petition calling for FDA to either rule that CBD is a legal dietary ingredient or to make a rule allowing enforcement discretion on the substance.

Trade organizations welcome Califf appointment as FDA commissioner

15-Feb-2022 By Stephen Daniells

Dr Robert Califf has been confirmed as the new commissioner of the Food & Drug Administration in a tight 50-46 vote in the US Senate.

As many as 18% of troops reported supplement adverse events in survey questioned by expert

04-Feb-2022 By Hank Schultz

A large survey of supplement use among US military personnel reported as many as 18% of respondents experienced an adverse event. But methodology questions makes it difficult to take those numbers at face value, an expert says.

Florida start-up CareMundi brings US supplements to Brazilian buyers

22-Feb-2018 By Adi Menayang

In the dietary supplement world, Brazil is notorious as being a tough market to get into. But there is demand for US-made products in the country, and one-year old start-up CareMundi, an online sales platform, is providing a bridge for US supplement makers...

Kratom linked to multistate Salmonella outbreak

21-Feb-2018 By Joseph James Whitworth

The US FDA and CDC are advising consumers to avoid kratom and kratom-containing products due to a link with a Salmonella outbreak that has sickened 28 people in 20 states.

Cancer claims, CBDs and SARMs highlights of 2017 enforcement picture

21-Dec-2017 By Hank Schultz

The picture painted by warning letters issued by FDA in 2017 is a chiaroscuro of old and new. Familiar enforcement action on claims language contrasted with warnings on the use of new, unapproved ingredients.

FDA now wants responses to foreign facility inspection requests within 24 hours

20-Dec-2017 By Hank Schultz

Foreign food facilities run the risk of ending up on import alert if they don’t take note of a change in policy in a recent guidance from the US Food and Drug Administration.

Letter to FDA seeks clarity on agency’s resources, enforcement aims

18-Dec-2017 By Hank Schultz

Three members of Congress have sent a letter to the US Food and Drug Administration requesting specifics on how enforcement funds are allocated. The three lawmakers are among those the Council for Responsible Nutrition has worked closely with on regulatory...

Firms making opiod treatment claims don't represent responsible industry, experts say

13-Dec-2017 By Hank Schultz

Dietary supplements took another hit in the mainstream press with an article in The New York Times that highlights supplements that claim to help treat opiod addiction. Trade organizations concurred the practice is illegal, while rueing the article’s...

Under the radar ingredient raises warning flags in Canada

07-Dec-2017 By Hank Schultz

Products containing lithium orotate—a salt of a mineral that has been used to treat psychiatric disorders—have been the subject of two Health Canada warnings this year. Yet similar products are freely for sale south of the border, and don’t seem to be...

ODI docket comments: Make the list big, or don’t make it at all

06-Dec-2017 By Hank Schultz

Will compiling an official list of Old Dietary Ingredients ultimately be worth the effort? Maybe, but the resulting list must be expansive rather than restrictive to be of much use, most stakeholders agree.

Repeat offender gets $3.7 million FTC fine over disease claims

04-Dec-2017 By Hank Schultz

A dietary supplement company that has received a previous warning letter from the Food and Drug Administration has agreed to a $3.7 million fine to settle a case brought by the Federal Trade Commission and the State of Maine for making over the top disease...

NAXA attacks Cardax’s synthetic astaxanthin via citizen’s petition

29-Nov-2017 By Hank Schultz

The Natural Algae Astaxanthin Association has filed a citizen’s petition that seeks regulatory action by FDA against a synthetic form of astaxanthin marketed by Cardax.

FDA bias against FTIR testing borne of industry's ignorance, expert says

27-Nov-2017 By Hank Schultz

A recent warning letter to a dietary supplement company shows that FDA is starting to drill down to the next level of GMP compliance in looking at the scientific validity of tests used to verify ingredients.

‘Needed’: FDA issues draft guidance for best practices for GRAS panels

20-Nov-2017 By Stephen Daniells

Hailed by experts as ‘needed’ and ‘significant’, the US Food and Drug Administration has issued draft guidance on best practices to follow when convening a panel of experts to evaluate whether a substance is “generally recognized as safe” (GRAS).

‘A useful regulatory guidepost’: NPA publishes book listing pre-DSHEA ingredients

08-Nov-2017 By Stephen Daniells

The Natural Products Association has released a book compiling a list of pre-DSHEA (old) dietary ingredients to provide a “useful regulatory guidepost” for industry and regulators.

FDA hardens stance against use of CBD in supplements

03-Nov-2017 By Hank Schultz

The Food and Drug Administration’s attitude that CBD does not belong in dietary supplements seems to have hardened, judging by the wording of four warning letters issued this week.

ITC declines to hear Amarin's fish oils complaint

30-Oct-2017 By Hank Schultz

The US International Trade Commission has decided not to hear a case in which the fish oil drug maker Amarin sought to prevent the import of some omega-3 dietary supplements.

ITC to take extra week to decide if Amarin’s fish oil complaint will proceed

18-Oct-2017 By Hank Schultz

The International Trade Commission has requested an additional week to decide whether it will commence an investigation requested by pharmaceutical company Amarin concerning certain high concentrate omega-3 fish oil ingredients.

Federal court issues permanent injunction against customized supplement maker Custompax

17-Oct-2017 By Adi Menayang

California-based supplement maker Custompax must stop selling products until it comes to compliance with the Food and Drug Administration (FDA)’s dietary supplement manufacturing regulations, according to a press release by the federal agency.

Trade groups pleasantly surprised by FDA's request to ITC to not hear Amarin's fish oils complaint

12-Oct-2017 By Hank Schultz

The US Food and Drug Administration has sent a letter to the International Trade Commission asking that agency not to hear a complaint in which the fish oil drug maker Amarin is seeking to prevent the import of some omega-3 dietary supplements.

Significant change in FDA's approach to ODI list needed, AHPA chief says

09-Oct-2017 By Hank Schultz

The American Herbal Products Association has put forward recommendations on how a list of Old Dietary Ingredients can best be assembled.

AHPA's botanical GMP document will help industry adapt to new requirements such as FSMA

06-Oct-2017 By Hank Schultz

Increasing scrutiny on the supply end of the dietary supplement business put the American Herbal Products Association in a position to contribute to the further legitimization of the dietary supplement industry, said the organization’s founder.

An FDA-approved list of ‘old dietary ingredients’ may not be possible or responsible, warn stakeholders

04-Oct-2017 By Elizabeth Crawford

FDA’s undertaking to create a master list of ‘old dietary ingredients’ that could be sold legally in dietary supplements without first going through the new dietary ingredient notification process likely will fall flat, despite the agency’s best intentions,...

Lack of adequate counsel when setting up operations can lead to big regulatory headache later

25-Sep-2017 By Hank Schultz

A recent warning letter to a Colorado dietary supplement company illustrates the hot water companies can get themselves into when starting business operations without adequate counsel.

FDA delays some safety requirements for produce under FSMA to make them less complicated, costly

15-Sep-2017 By Elizabeth Crawford

FDA is pushing back the compliance dates for most agricultural water testing standards outlined in the Food Safety Modernization Act’s Produce Safety Rule to “simplify our approach to make compliance less burdensome and less costly, while still being...

ChromaDex-Elysium fight highlights glitches in NDI and GRAS processes

01-Sep-2017 By Hank Schultz

The tussle between ChromaDex and Elysium Health highlights again the curious dance between a New Dietary Ingredient Notification and a GRAS affirmation as a way to bring ingredients to market.

ChromaDex alleges in petition that Elysium Health product is adulterated

31-Aug-2017 By Hank Schultz

ChromaDex has taken the somewhat unusual step of filing a citizen’s petition with FDA alleging that Basis, the dietary supplement manufactured by Elysium Health, a one time customer, is adulterated and should be removed from the market.

FTC, FDA ask consumers directly for help on policing claims, reporting adverse events

27-Jul-2017 By Hank Schultz

In a communication earlier this week two regulatory agencies sought input directly from consumers about outlandish claims and adverse events relating to dietary supplements. 

One week to go: UNPA hosts PCQI training for dietary supplement companies

10-Jul-2017

The United Natural Products Alliance (UNPA) is launching a new training course, “Preventive Controls Workshop for Dietary Supplements: PCQI Training for Dietary Supplement Companies”, but spaces are limited.

FDA continuing to drill down to provenance of ingredients

07-Jul-2017 By Hank Schultz

Recent warning letters show the Food and Drug Administration continues to hone in on the provenance of ingredients, and demonstrate that the tempo of enforcement remains unchanged despite the moves by the Trump Administration to roll back regulations...

The NutraIngredients-USA Botanicals Online Conference

Botanicals: The risks and benefits, opportunities and challenges

15-Jun-2017

Botanical experts will discuss the challenges and opportunities in the botanicals category in 2017 and beyond in a FREE online conference hosted by NutraIngredients-USA.

SIDI Work Group releases updated protocol, calls for stakeholder comments

01-Jun-2017

The SIDI Work Group, the dietary supplement industry’s self-regulatory coalition, has released an updated draft of its “Standardized Information on Dietary Ingredients (SIDI) Protocol”, and is calling for feedback from industry stakeholders and regulators.

FDA inspectors realignment will boost enforcement, CRN says

18-May-2017 By Hank Schultz

The Council for Responsible Nutrition has joined in applauding FDA’s move to organize inspectors according to areas of expertise.

FDA moves to organize inspectors along lines of expertise

17-May-2017 By Hank Schultz

A move by newly confirmed FDA commissioner Scott Gottlieb to reapportion FDA inspectors along lines of expertise has been welcomed as potentially improving the effectiveness of the inspection process.

LifeVantage's sales plummet amid accounting reforms

11-May-2017 By Hank Schultz

Network marketing company LifeVantage has been staggered by consecutive quarters of sequential and year-over-year sales declines as it struggles to reform its sales and accounting practices. In its most recent earnings statement sales slid by almost 20%.

CRN’s support of Gottlieb rises above standard level

09-May-2017 By Hank Schultz

The Council for Responsible Nutrition has enthusiastically supported the nomination of Dr. Scott Gottlieb as FDA commissioner in a letter to Senators.

FDA uses warning letter to check up on DMAA recall

04-May-2017 By Hank Schultz

In an unusual move, in a warning letter to a dietary supplement company the Food and Drug Administration has sought information about a recall, in this case one involving DMAA products.

FDA sends out 14 warning letters in sweep on cancer claims

26-Apr-2017 By Hank Schultz

The U.S. Food and Drug Administration has sent warning letters to 14 companies this week about marketing products for illegal cancer claims.

FDA nominee strongly affirms DSHEA during hearing

25-Apr-2017 By Hank Schultz

A staunch affirmation of DSHEA by Dr. Scott Gottlieb, MD the nominee for FDA commissioner, is a highly promising sign for the immediate prospects of industry cooperation with the agency, said the head of a trade organization.

FDA culls huge number of foreign food facility registrations

25-Apr-2017 By Hank Schultz

In its latest cleanup of its food facility registration database, the U.S. Food and Drug Administration has culled an eye-opening 28% of existing registrations. The biggest drops happened in overseas sites.

Does FDA underestimate the time, resources spent on regulatory compliance?

21-Apr-2017 By Stephen Daniells

The Food and Drug Administration is underestimating the amount of time and resources the supplement industry spends annually complying with government regulations, including current good manufacturing practices (cGMPs). 

Acacia rigidula still popping up on market

31-Mar-2017 By Hank Schultz

Acacia rigidula-containing products continue to find a place in the market, as a recent warning letter shows. 

Industry lauds accomplishments of late stevia pioneer James May

08-Mar-2017 By Hank Schultz

Herbal industry experts were quick to laud the accomplishments of stevia pioneer Jim May, founder of Wisdom Natural Brands, who died this week at the age of 80.

FDA continues to ‘carefully review’ vinpocetine comments

27-Feb-2017 By Stephen Daniells

The US Food and Drug Administration has received over 800 comments about vinpocetine, as the agency continues to assess the regulatory status of the ingredient. 

Medical foods for blood sugar still blocked by FDA guidance

23-Feb-2017 By Hank Schultz

The application of a medical foods positioning to the formulation of blood sugar management products continues to be blocked by a final guidance from FDA on the subject.

Hiring freeze at FDA dims view of industry as adequately regulated, experts say

02-Feb-2017 By Hank Schultz

A hiring freeze put into place by Pres. Trump could damage efforts to make the case that the dietary supplement industry is effectively regulated, experts say.