Fda

FDA’s 2025 legislative wish list calls for mandatory supplement product listing

12-Mar-2024 By Stephen Daniells

The U.S. Food and Drug Administration has outlined its budget and legislative proposals for 2025, with the only dedicated section concerning dietary supplements renewing calls for mandatory product listing and seeking clarifications on the Agency's...

Progress or a giant nothingburger? Trade associations react to FDA NDI guidance announcement

06-Mar-2024 By Stephen Daniells

FDA's final guidance on New Dietary Ingredient (NDI) notification procedures and timeframes has prompted a range of responses from the dietary supplement industry trade associations, with some more welcoming than others.

FDA issues final guidance on NDIN procedures, timeframes

05-Mar-2024 By Stephen Daniells

The Food and Drug Administration (FDA) has finalized guidance for industry titled “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry".

FDA Human Foods Program launch may not come until next fall, but ‘going quite well’

04-Mar-2024 By Elizabeth Crawford

FDA's massive reorganization to create a unified Human Foods Program under one leader who reports directly to the agency’s commissioner may take longer than originally anticipated, but is “going quite well,” the program’s first Deputy Commissioner...

‘Illegally marketed’: CRN calls for FDA response to study on galantamine products

23-Feb-2024 By Stephen Daniells

The Council for Responsible Nutrition is calling on the U.S. Food and Drug Administration (FDA) to act against products formulated with the Alzheimer drug galantamine and marketed as dietary supplements .

FDA updates supplements ingredient directory to reflect stakeholder feedback

21-Feb-2024 By Stephen Daniells

The U.S. Food and Drug Administration (FDA) has renamed its Dietary Supplement Ingredient Directory and added classification categories following “some constructive stakeholder feedback”.

FDA tackles safety challenges related to ‘misinformation’ about CBD, food additives and how it makes science-based decisions

19-Feb-2024 By Elizabeth Crawford

Even as FDA stands by its decision that CBD is not safe for use in foods, beverages and dietary supplements, the agency is considering how best to ensure it is clearly labeled, safely manufactured and consumers understand what it is, according to a senior...

Experts advocate for new quality control position within C-suite

24-Jan-2024 By Claudia Adrien

Industry experts propose the creation of a new executive position within organizations to help combat a rise in Food and Drug Administration citations against supplement companies who don’t meet quality control standards.

NOW offers roadmap to help consumers confidently navigate supplements

09-Jan-2024 By Claudia Adrien

Seventy-four percent of U.S. adults take dietary supplements, according to the 2023 CRN Consumer Survey on Dietary Supplements. That does not mean that they are always equipped with the tools to navigate the myriad of products available or are confident...

‘The cost is credibility’: FDA sends warning letter to Amazon on tainted male sexual products

03-Jan-2024 By Stephen Daniells

The U.S. Food & Drug Administration has warned Amazon about “energy enhancing supplements or foods” alleged to contain undeclared sildenafil and tadalafil for male sexual performance.

Why the FDA reorg is the biggest story of the year

21-Dec-2023 By Danielle Masterson

UNPA’s Israelsen breaks down the FDA’s restructuring and issues a call to action for the future of the industry.

UNPA's reflections on 2023: The year of opposite choices

21-Dec-2023 By Loren Israelsen, Founder & President, United Natural Products Alliance (UNPA)

My reflection on 2023 has little to do with specifics. In my view, this was a year of opposite choices and opposing directions – the big stuff. Yet, daily demands to address the urgent (but often not so important) dulled our senses and intuition. Hence,...

FDA & Pharmavite join speaker roster for the DSHEA Summit

13-Dec-2023 By Stephen Daniells

Dr Cara Welch, Director of FDA’s Office of Dietary Supplements Programs, and Christine Burdick-Bell, EVP & General Counsel at Pharmavite, have confirmed their participation in the NutraIngredients-USA’s landmark DSHEA Summit.

FDA delays response to Nammex’s Mushroom product labeling petition

08-Dec-2023 By Stephen Daniells

The US Food and Drug Administration has declined to respond to a Citizen Petition by North American Reishi Ltd (“Nammex”) on the labeling and sale of food and supplements containing fungal ingredients, citing “competing agency priorities”.

Announcing the DSHEA Summit: A landmark event bringing together the architects of the law & leading industry voices

04-Dec-2023 By Stephen Daniells

Join Scott Bass, Loren Israelsen, Bob Durkin, Jim Emme, and more industry luminaries for NutraIngredients-USA’s landmark DSHEA Summit.

Court orders Balance of Nature to stop production & sale of non-compliant supplements

21-Nov-2023 By Stephen Daniells

A federal court has ordered the manufacturer and distributor of the Balance of Nature brand to cease the production and sale of the dietary supplements after the FDA accused the two Utah-based companies behind it of multiple violations spanning years.

FDA Deputy Commissioner of proposed Human Foods Program moves forward with aggressive agenda while waiting for reorg finalization targeted for June

14-Nov-2023 By Elizabeth Crawford

FDA’s massive reorganization to create a proposed unified Human Foods Program under one leader who will report directly to the agency’s commissioner may not be finalized until next June, but the program’s first Deputy Commissioner James ‘Jim’ Jones isn’t...

Guest Article

Apple Picking and Drug Preclusion: Let’s Make it a Fair Contest

08-Nov-2023 By Steve Mister, President & CEO, Council for Responsible Nutrition

In this guest article, Steve Mister, President & CEO, Council for Responsible Nutrition, discusses how “surgical amendments to the existing drug preclusion provision” can balance the interests of drugs and supplements and allow innovation in both...

FDA delays response to CRN petition on the drug preclusion clause

03-Nov-2023 By Stephen Daniells

For the second time in two months, the US Food and Drug Administration has declined to respond to a Citizen Petition, citing “competing agency priorities”.

CRN’s Mister on FDA reorg, FTC petition, and state of the market

02-Nov-2023 By Stephen Daniells

Recent statements and conversations with senior officials at the FDA have revealed “an apparent knowledge gap within the upper echelons of the Agency” regarding the regulation of dietary supplements, says Steve Mister, President and CEO of the Council...

NPA’s Fabricant on NMN, 25-(OH)D, NDIs, and more

31-Oct-2023 By Stephen Daniells

While uncertainty continues around NMN, FDA should make it clear to commercial platforms that they haven’t made a final decision on the ingredient and that it should be still available to consumers, says Daniel Fabricant, President & CEO of the Natural...

California Food Safety Act “sets a dangerous precedent,” food policy experts say

24-Oct-2023 By Deniz Ataman

California’s Food Safety Act (AB 418) bans the inclusion of four food additives—propyl paraben, brominated vegetable oil, Red Dye No. 3 and potassium bromate—in food and beverages, a landmark state-wide law highlighting the potentially widening gap between...

Califf and Mister talk: Top 6 takeaways

10-Oct-2023 By Danielle Masterson

Making several references to sports, Califf talked transparency, innovation, MPLs, CBD and more. But did he drop the ball or knock it out of the park?

California Food Safety Act signed into law, bans four food additives by Jan. 2027

10-Oct-2023 By Deniz Ataman

California Governor Gavin Newsom signed the California Food Safety Act on Oct. 7, 2023. The statewide legislation, the first of its kind in the US, “will prohibit any food product manufactured, sold, delivered, distributed, held or offered for sale in...

Attorney breaks down Dr Robert Califf’s comments at CRN conference

05-Oct-2023 By Danielle Masterson

On Wednesday Steve Mister, President & CEO of the Council for Responsible Nutrition (CRN), had a fireside chat with FDA Commissioner Dr. Robert Califf at CRN’s annual conference.

Hemp Beverage Alliance sets out to help the category reach its potential

27-Sep-2023 By Rachel Arthur

Regulatory confusion and poor availability is hampering the success of hemp beverages in the US. But the consumer demand is clearly there, says the newly formed Hemp Beverage Alliance - which believes that, if these challenges are addressed, the category...

Bipartisan support for cannabidiol puts FDA, CBD coalitions in spotlight

26-Sep-2023 By Claudia Adrien

Advocates say there’s momentum in Congress to offer regulatory guidance for CBD supplement use.

Citizen Petition demands FTC withdraw Notice of Penalty Offense sent to 700 companies

18-Sep-2023 By Danielle Masterson

Earlier this year, the FTC sought to flex its penalty offense authority by issuing compliance reminders to advertisers–but trades say that ‘friendly reminder’ was unlawful.

Charlotte’s Web-Canopy Growth analysis identifies safe CBD intake levels for supplements

18-Sep-2023 By Claudia Adrien

Upper CBD intake levels ranging from 70 mg to 160 mg per day for dietary supplements are acceptable and do not harm the liver, says a new scientific review commissioned by Canopy Growth Corporation and Charlotte’s Web.

‘The risk we have here is enough to manage’: Athlete turned entrepreneur Floyd Landis discusses how regulatory uncertainty threatens the global CBD industry

15-Sep-2023 By Oliver Morrison

Regulatory bottlenecks are threatening to hinder CBD innovation on both sides of the Atlantic, the former professional road racing cyclist Floyd Landis tells FoodNavigator.

ODSP’s Cara Welch talks FDA priorities and resources in evolved market

15-Sep-2023 By Asia Sherman

The National Institutes of Health kicked off its annual Office of Dietary Supplements Seminar Series this week with a presentation by Dr. Cara Welch on how the Food and Drug Administration (FDA) regulates the dietary supplement marketplace.

Stakeholders go to bat over controversial ingredient titanium dioxide

13-Sep-2023 By Danielle Masterson

Less than a year ago, FDA told FoodNavigator-USA that it considers TiO2 to be safe, citing available studies that do not demonstrate safety concerns connected to the use of TiO2 as a color additive.

NPA’s Fabricant on NMN: ‘Taking FDA to Federal Court is expensive, but I don’t see another option’

12-Sep-2023 By Stephen Daniells

The US Food and Drug Administration (FDA) has been unable to reach a decision on the requests made in a Citizen Petition about NMN due to “competing agency priorities”, a response that threatens the NMN sector, says Daniel Fabricant, PhD.

Gaia Herbs invites FDA to come visit ‘any time at all’

30-Aug-2023 By Asia Sherman

As part of a new campaign to showcase responsible and rigorous practices in the dietary supplement industry, Gaia Herbs has extended an open invitation to the Food and Drug Administration (FDA) to inspect its operations.

Sens. Durbin & Blumenthal express concerns over proposed changes to FDA's Supplement Office

26-Aug-2023 By Stephen Daniells

Two of the dietary supplement industry’s most vocal critics in Congress – Senators Dick Durbin (D-IL) and Richard Blumenthal (D-CT) – have written to the FDA to express concerns about proposed changes to the Office of Dietary Supplement Programs (ODSP).

Jim Jones named as 1st FDA Deputy Commissioner of Human Foods

23-Aug-2023 By Stephen Daniells

The US Food and Drug Administration has selected James “Jim” Jones as the first Deputy Commissioner for Human Foods to lead the Agency’s proposed unified Human Foods Program (HFP).

cbdMD CSO: ‘It appears that we’re finally making headway in Congress’

22-Aug-2023 By Stephen Daniells

The recent congressional hearing about CBD and subsequent ‘historic’ bicameral Request for Information (RFI) shows that hemp-derived CBD for use in dietary supplements has finally got the attention of Congress, said cbdMD’s CSO.

CRN urges FDA to put resources behind enforcing supplement master file framework

14-Aug-2023 By Stephen Daniells

The Council for Responsible Nutrition (CRN) has written to the US Food & Drug Administration urging the agency to put resources behind any dietary supplement master file framework, or rethink prioritizing a master files guidance.

NPA submits Citizen Petition on labeling of mushrooms & mycelia

11-Aug-2023 By Stephen Daniells

The Natural Products Association (NPA) is seeking clarity on the labeling of fungi ingredients in dietary supplements, with a Citizen Petition requesting FDA to incorporate aspects of guidance from the American Herbal Products Association (AHPA).

Pressure mounts on FDA to regulate CBD

31-Jul-2023 By Danielle Masterson

Lawmakers and stakeholders assembled for a congressional hearing on July 27 to highlight how FDA’s refusal to regulate CBD is threatening consumer access to safe products.

FDA rejects Congressional calls for public hearing on NMN

20-Jul-2023 By Stephen Daniells

The FDA has declined a request from South Carolina Congressman Jeff Duncan for a public hearing on NMN – nicotinamide mononucleotide – in dietary supplements.

AHPA’s McGuffin: We oppose the reorganization of FDA’s food and supplements program

17-Jul-2023 By Stephen Daniells

The Board of the American Herbal Products Association will oppose FDA proposals to reorganize its dietary supplements program into a new Office of Food Chemical Safety, Dietary Supplements, and Innovation.

All eyes on Dietary Supplement Master Files

11-Jul-2023 By Danielle Masterson

Fresh off a new Draft Guidance release, many are hopeful that Master Files would provide clarity on NDI filing requirements and provide protections for intellectual property. However, some point to issues with the NDI framework and say that must be solved...

UNPA’s Israelsen: ‘Dietary supplements are not food additives - full stop’

10-Jul-2023 By Stephen Daniells

FDA’s recent proposal to relocate the Office of Dietary Supplement Programs (ODSP) to a new Office of Food Chemical Safety, Dietary Supplements, and Innovation, is disturbing, says UNPA’s Loren Israelsen.

NPA’s Fabricant on FDA reorg, HSAs/FSAs, Master Files, NMN and more

07-Jul-2023 By Stephen Daniells

From a proposed reorganization of the Food & Drug Administration to progress (or not) on the NMN situation, there’s a lot going on in the dietary supplements industry. We caught up with Daniel Fabricant, PhD, president and CEO of the Natural Products...

HSA, FSA for supplements: ‘We are about to get the legislation introduced,’ says CRN’s Mister

05-Jul-2023 By Stephen Daniells

The ability for consumers to use pre-tax dollars for healthcare related expenses to purchase dietary supplements may be edging closer as legislation is about to be introduced in Congress to expand eligibility of dietary supplements in HSA and FSA accounts.

Fungi Perfecti responds to ‘puzzling opinion’ in Nammex petition

22-Jun-2023 By Asia Sherman

Fungi Perfecti, a supplier of mycelium-based supplements, has written an open letter to address the citizen petition filed by mushroom extract company Nammex, which requested that the Food and Drug Administration act to ensure proper labeling of fungi...

FDA updates clinical trials guidance to align with ICH: What’s the impact for supplements?

14-Jun-2023 By Stephen Daniells

The US Food and Drug Administration recently released a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials.

Mushroom product labeling: Nammex files Citizen Petition requesting FDA actions

13-Jun-2023 By Stephen Daniells

North American Reishi Ltd (“Nammex”) has filed a Citizen Petition with the FDA on the labeling and sale of food and supplements containing fungal ingredients.

Guest Article

Ex-Health Canada NHP DG: ‘Cannabis is Canada’s New Wild West’

06-Jun-2023 By Adam Gibson, President, True Moderation

When it comes to regulating CBD and cannabis, Canada is an extreme cautionary tale for the US, says Adam Gibson, the former Director General of Health Canada’s Non-prescription and Natural Health Products Directorate.