Fda - Food

Researchers highlight need for more responsible CBD labeling

26-Mar-2020 By Danielle Masterson

The increasing popularity of cannabidiol (CBD) only underscores the need for accurate and informative labeling of hemp and hemp-derived CBD products, according to researchers.

Industry stakeholders lay out safety, regulatory challenges

23-Mar-2020 By Danielle Masterson

The Natural Products Association (NPA) recently held a webinar on political and legislative insights. At the forefront — the expansion of health savings accounts, new dietary new dietary ingredient enforcement, DSHEA, accurate labels, and Cannabidiol...

CBD firm CV Sciences reports 11% rise in sales

17-Mar-2020 By Danielle Masterson

One of the pioneers of the space topped $53 million in annual revenue, but also recorded a loss as the founders cashed out. The firm also said regulatory uncertainty has increased competition as numerous small brands crowd into the field.

FDA issues public health alert about cesium salt-containing supplements

05-Feb-2020 By Stephen Daniells

The US Food and Drug Administration has issued a consumer warning about dietary supplements containing cesium salts, primarily cesium chloride.

Stakeholders: FDA vacancies will hurt, but agency will weather storm

15-Jan-2020 By Hank Schultz

Industry stakeholders say that while critical vacancies at the US Food and Drug Administration come at an awkward time they believe the agency will fulfill its responsibilities.

2020 predictions: Staff changes at FDA, CBD, personalization, and the microbiome

15-Jan-2020 By Stephen Daniells

The year is new and a lot of people are getting out their crystal balls. NutraIngredients-USA is no exception, and here are our top big issues that will impact the dietary supplements industry in this new decade.

Dr Sibyl Swift exits FDA to join NPA as SVP for Scientific & Regulatory Affairs

06-Jan-2020 By Stephen Daniells

Former Food and Drug Administration (FDA) official Sibyl Swift, PhD, has joined the Natural Products Association as its new Senior Vice President for Scientific and Regulatory Affairs.

Senate confirms Dr. Stephen Hahn as new FDA commissioner

13-Dec-2019 By Danielle Masterson

The cancer specialist from Houston takes the helm amidst a full-blown vaping crisis.

“Recreational Marijuana and CBD: Public Attitudes, Science, and the Law” overview

04-Dec-2019 By Danielle Masterson

The Harvard School of Public Health and Politico jointly presented a live webcast that focused on the evolving landscape of cannabinoids.

FDA revises consumer info on CBD, says ingredient is not GRAS, sends 15 CBD warning letters

26-Nov-2019 By Stephen Daniells

The US Food and Drug Administration has stated that it cannot conclude that CBD (cannabidiol) is generally recognized as safe (GRAS) for its use in human food, based on a “lack of scientific information supporting the safety of CBD in food”.

Lawmakers ask IRS to expand health savings accounts to include nutritional supplements

25-Nov-2019 By Danielle Masterson

The bipartisan effort is picking up steam as more senators join the cost-reducing effort.

Editor's Spotlight

FDA needs new tools in face of CBD explosion, official says

08-Nov-2019 By Hank Schultz

FDA needs new tools to effectively deal with an expanding supplement marketplace, according to agency official Lowell Schiller. This is especially true when contemplating the flood of CBD products, with many more yet to come.

Comet Bio achieves milestone with self-affirmed GRAS status for prebiotic fiber

07-Nov-2019 By Danielle Masterson

The prebiotic Arabinoxylan Plant Fiber Extract trademarked as Arrabina, is officially considered safe.

FDA warns pregnant and breast-feeding women to avoid CBD and cannabis products for fear of ‘serious risk’

17-Oct-2019 By Elizabeth Crawford

FDA warned pregnant and breast-feeding women yesterday to avoid CBD, THC and marijuana in any form, including the proliferation of food, supplements and cosmetics containing CBD and other cannabis-derived ingredients that currently are flooding the market...

Trump exec orders will affect guidances from FDA and FTC, expert says

11-Oct-2019 By Hank Schultz

New Trump Administration executive orders on guidance documents from regulatory agencies likely will affect the dietary supplement industry, an attorney says.

Senator demands FDA safety regulations on CBD

09-Oct-2019 By Danielle Masterson

Senator Richard Blumenthal is calling on the Food and Drug Administration to regulate CBD.

Warning letter shows FDA still enforcing status quo on CBD

07-Oct-2019 By Hank Schultz

FDA is continuing to crack down on the legality of CBD when a case comes across its desk, despite a call for an official enforcement discretion policy.

Oncologist Stephen Hahn reportedly poised to be next FDA chief

04-Oct-2019 By Danielle Masterson

President Trump is poised to nominate Oncologist Dr. Stephen Hahn to head the Food and Drug Administration, pending completion of the vetting process, several news outlets are reporting.

Industry pushes for 100% adoption of standard food date labeling by January 2020

25-Jun-2019 By Mary Ellen Shoup

By the end of 2019, 98% of food and beverage products will have adopted a standardized version of date labeling – ‘Best If Used By' – with complete adoption anticipated by January 2020, predict the Grocery Manufacturers Association (GMA) and the...

Notes from CRN/ACI Annual Legal, Regulatory and Compliance Forum on Dietary Supplements

The case for mandatory product listing, and the arguments against it

19-Jun-2019 By Adi Menayang

Controversy swirls around whether dietary supplement brands should be required to register the products they have on the market with FDA. Two attorneys debated the risks and benefits of a mandatory product registry yesterday at the CRN/ACI Annual Legal,...

Insufficient scientific research & labeling constraints could limit use of CBD in food, supplements

03-Jun-2019 By Elizabeth Crawford

When it comes to legally marketing conventional food and dietary supplements with CBD and other cannabis-derived compounds, FDA and industry appear stuck in a catch-22.

No progress made in push for FDA to drop requirement of labeling probiotics by weight in metric units

31-May-2019 By Adi Menayang

Frustration filled the air at the Dietary Supplements Regulatory Summit earlier this month when it became apparent that no progress has been made in the industry’s push for FDA to drop weight requirements on probiotic product labels.

Notes from the Dietary Supplements Regulatory Summit

FDA’s Yiannas: ‘At the end of the day you’re not selling products, you’re selling trust’

15-May-2019 By Adi Menayang

What do housing crises and dietary supplement recalls have in common? They cause a big bust to consumer trust, said Frank Yiannas, deputy commissioner for food policy and response at the Food and Drug Administration.

FDA Acting Commissioner Sharpless promises ‘there will be no pause at FDA’ following Gottlieb’s departure

07-May-2019 By Elizabeth Crawford

FDA’s new Acting Commissioner of Food and Drugs, Norman Sharpless, promised last week that he will pick up where outgoing Commissioner Scott Gottlieb left off in strengthening nutrition policy and regulation to improve the public’s health and implementing...

Consumer advocacy group presses FDA to take enforcement against smoking-cessation drugs sold as supplements

25-Apr-2019 By Adi Menayang

The Center for Science in the Public Interest (CSPI) sent a letter to the FDA yesterday, asking the agency to take enforcement action against 15 companies selling products as dietary supplements to help smokers quit.

FDA’s new advisory list receives mixed reactions from industry

17-Apr-2019 By Adi Menayang

The Food and Drug Administration announced a new ‘rapid communication tool,’ called the Dietary Ingredient Advisory List. Trade groups and industry experts applauded the effort, but many opined that this step still has much left to be desired in terms...

To prep for upcoming Supplement Facts changes, CRN launches Be Label Wise campaign

02-Apr-2019 By Adi Menayang

The Council for Responsible Nutrition, a dietary supplements industry trade group, launched its Be Label Wise campaign targeting consumers to help them anticipate for upcoming changes in Supplement Facts labels.

Editor's Spotlight

Nature's Way strategy and innovation chief shares how a legacy company is keeping up with the times

27-Mar-2019 By Adi Menayang

At the Natural Products Expo West show this year, we caught up with the chief strategy and innovation officer at legacy supplement brand Nature’s Way to talk about consumer trends, CBD, and the body of laws that regulate supplements.

What's in store for CBD? The hype and attention will die down, says attorney

03-Jan-2019 By Mary Ellen Shoup

While the Farm Bill has removed industrial hemp from Schedule I of the Controlled Substances Act, the use of CBD as an ingredient has many more hurdles to overcome especially with the FDA, according to attorney Todd A. Harrison.

FDA's Gottlieb announces plan to look at new regulations; stakeholders say they're willing to listen

13-Dec-2018 By Hank Schultz

An initiative unveiled by FDA Commissioner Dr Scott Gottlieb that could result in new legislation governing the dietary supplement industry was met with a spirit of cautious cooperation by stakeholders.

AKA says it can see signs that government position on kratom is evolving

03-Aug-2018 By Hank Schultz

Kratom advocates say they can see cracks developing in the wall the federal government has tried to build around access to this botanical.

Trade group advocates to keep skip lot testing option in dietary supplements GMPs

19-Jul-2018 By Adi Menayang

The Food and Drug Administration (FDA) is soliciting comments for a GMP code in which ingredient companies can petition for skip lot testing, but one trade group found discrepancies in the Federal Registrar notice.

Use of aromatase inhibitor forms basis of warning letter

30-May-2018 By Hank Schultz

A recently posted warning letter cites a New York company for the presence of an aromatase inhibitor in one of its dietary supplements. This class of chemicals is popular with strength trainers for its purported ability to suppress estrogen levels.

Are chemical names of vitamins on packaging scaring away consumers? DSM thinks so

09-Apr-2018 By Adi Menayang

Ingredient supplier DSM Nutritional Products filed a citizen petition to the FDA, suggesting an amendment to allow brands to use simpler vitamin names on pack instead of chemical nomenclature, in an effort to appease consumers looking for ‘recognizable...

FTC, FDA jointly crack down on firms making illegal opioid withdrawal treatment claims

25-Jan-2018 By Hank Schultz

Two federal agencies announced a crackdown yesterday on companies marketing dietary supplements to consumers trying to overcome opioid addictions.

FDA calls for safety recall, disallows medical food positioning on osteoarthritis product

04-Jan-2018 By Hank Schultz

FDA has branded one of medical food specialist Primus Pharmaceuticals’ products as an unapproved drug and has stipulated a recall based on what it called ‘life threatening’ safety concerns.

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...

Biotin interferes with some lab test results, according to FDA alert

01-Dec-2017 By Adi Menayang

The US Food and Drug Administration (FDA) issued an alert to laboratories, health care providers, and the public, saying that consumption of biotin can “significantly interfere with certain lab tests.”

‘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).

Supplement trade associations and USADA warn consumers about SARMs

09-Nov-2017 By Stephen Daniells

The dietary supplement industry’s leading trade associations and the US Anti-Doping Agency have voiced their support of the recent FDA actions to protect consumers from body-building products containing Selective Androgen Receptor Modulators (SARMs) illegally...

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.

FDA issues consumer warning on sports products that contain SARMs

01-Nov-2017 By Hank Schultz

The Food and Drug Administration has issued a consumer warning against supplement-like body building products that contain SARMs, or selective androgen receptor modulators.

FDA proposes to revoke health claim for soy protein and reduced risk of heart disease; Soyfoods association 'concerned' by move

30-Oct-2017 By Elaine Watson

The FDA is proposing to revoke a health claim on the relationship between soy protein and reduced risk of heart disease, citing “inconsistent findings” from research published since the claim was authorized in 1999.

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.

Hi Tech founder Wheat indicted on 18 counts including mail fraud, money laundering

09-Oct-2017 By Hank Schultz

Hi Tech Pharmaceuticals founder Jared Wheat has been charged with money laundering and wire fraud by federal authorities in an indictment unsealed last week.

Police officer's death linked to kratom use

05-Oct-2017 By Hank Schultz

A law enforcement officer has died after reportedly overdosing on kratom, according to the Associated Press.

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,...