Fda

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Fresh off a new Draft Guidance release, many are hopeful that Master Files would provide clarity on NDI filing requirements and provide protections for intellectual property.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The US Food and Drug Administration recently released a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials.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.

CBD stakeholder’s call: “It’s really in Congress’ hands”

01-Jun-2023 By Danielle Masterson

With the ongoing theme of safety, FDA recently addressed CBD. While offering up several potential scenarios, the Agency said the CBD marketplace ultimately rests in the hands of Congress.

CRN’s citizen petition makes case for dietary supplements, drugs to coexist

11-May-2023 By Danielle Masterson

“This is about certainty for supplement companies and access and certainty for consumers.”

FDA: SARMs not worth the health risk ‘for a few extra likes’

28-Apr-2023 By Asia Sherman

The U.S. Food and Drug Administration (FDA) issued an advisory this week warning of adverse event reports related to selective androgen receptor modulators (SARMs). In the letter, the agency also takes issue with online vendors and social media influencers...

ODSP’s director on NDIs, MPL, and NMN

27-Apr-2023 By Danielle Masterson

NutraIngredients-USA caught up with Cara Welch, PhD, Director of FDA's Office of Dietary Supplement Programs. Welch talked inspections, made the case for MPL and hinted NDI guidance is on the way.

CRN: NDI guidance is 'doable'

24-Apr-2023 By Danielle Masterson

NutraIngredients-USA caught up with CRN’s Steve Mister at SupplySide East to discuss new research, top priorities for the year and what they hope to see from FDA this year.

AHPA: ‘Amazon reportedly enforces erroneous FDA adulteration allegation’

24-Apr-2023 By Asia Sherman

The American Herbal Products Association (AHPA) has called out Amazon for allegedly prohibiting the sale of products containing Pinellia ternata based on an inaccurate adulteration allegation issued by the U.S. Food & Drug Administration (FDA).

Women’s health claims: What you can and cannot say

20-Apr-2023 By Stephen Daniells

As supplements to support women’s health increase in the marketplace, marketers need to understand what they can and cannot say regarding claims relating to PMS relief, menopause symptoms, reproductive health, and more.

CHPA’s MacKay: ‘It’s really important for industry to take a position on proprietary blends’

20-Apr-2023 By Stephen Daniells

A new paper explores the topic of proprietary blends in dietary supplements, with one of the authors noting that industry needs to take a position on an issue that pits transparency on one side against intellectual property protection on the other.

Broad Institute of MIT, NOW, FDA among first raft of speakers for Probiota Americas

12-Apr-2023 By Stephen Daniells

Today we can reveal the first wave of speakers confirmed for Probiota Americas, the must-attend conference bridging the business and science of microbiome modulation for human health.

Floyd Landis on the industry issue that keeps him on at night

11-Apr-2023 By Danielle Masterson

CBD sellers were holding onto hope that the FDA would regulate CBD in order to stabilize the industry and give customers confidence, but the lack of guidance has left business owners like Landis feeling trapped.

NutraCast: Payment processing challenges that nutraceutical merchants face

07-Apr-2023 By Danielle Masterson

Regulatory issues, high chargeback rates, reputation and fraud all make dietary supplements 'high-risk.' So when it comes to accepting online credit card payments, traditional financial institution don't want to go through the hassle.

Industry win: Colo. bill restricting dietary supplements for minors amended

24-Mar-2023 By Danielle Masterson

Stakeholders worked with the sponsor and supporters of the bill to remove supplements from the equation.

Bipartisan house bills reintroduced to regulate CBD in food, dietary supplements

20-Mar-2023 By Danielle Masterson

Does the legislation have legs or is it just for optics? Stakeholders agree the bills are a step in a positive direction, but what impact they will have, if any, is yet to be seen.

Lawsuit against FDA on NMN ‘certainly being considered’, says NPA CEO

14-Mar-2023 By Stephen Daniells

The Natural Products Association is hoping the US Food & Drug Administration is responsive to its recent Citizen’s Petition on the status of NMN, but if it’s not then other options are being considered, Dr Daniel Fabricant, NPA’s CEO tells NutraIngredients-USA.

‘Here we go again’: NPA and ANH file Citizen’s Petition with FDA for NMN relief

07-Mar-2023 By Stephen Daniells

A new Citizen’s Petition is requesting the FDA reevaluate the status of NMN or exercise Enforcement Discretion on the Drug Exclusion Clause for the ingredient.

FDA launches directory of ingredients used in products marketed as supplements

07-Mar-2023 By Stephen Daniells

The US Food and Drug Administration (FDA) has unveiled a new Dietary Supplement Ingredient Directory, providing detailed information on 27 ingredients that the Agency states are used in products marketed as dietary supplements.

Oxford ICSB: ‘You always learn something from this meeting’

06-Mar-2023 By Stephen Daniells

From authentication and identification of botanicals to approached to establishing safety and efficacy, the 21st International Conference on the Science of Botanicals (ICSB) provides stakeholders in the botanicals space a unique opportunity to learn and...

DEA: Delta-8 and -9 THCO are controlled substances

02-Mar-2023 By Danielle Masterson

Once seen as a legal alternative to marijuana, the Agency is making it clear that synthetic cannabinoids are illegal under the Controlled Substances Act.

FDA commissioners calls for supplements listing, wider regulatory changes

01-Mar-2023 By Stephen Daniells

Robert Califf, MD, Commissioner of Food and Drugs, has stated his hope for an “an improved framework to appropriately regulate dietary supplements”, including product listing.

FDA’s update for new Human Foods Program falls short of industry expectations

01-Mar-2023 By Elizabeth Crawford

Even as FDA kicks off a search for a deputy commissioner for its proposed Human Foods Program who it says will have a “clear line of authority over” all human food safety and nutrition programs, industry stakeholders worry agency is choosing a “business...

Amazon removing NMN dietary supplements, citing FDA actions

16-Feb-2023 By Stephen Daniells

The online retail giant has moved to remove supplements containing NMN, an anti-aging ingredient, from its platform following an FDA announcement that NMN is not a legal dietary ingredient.

Q&A: Bill Bookout on the animal supplement market, trends and regulations

16-Feb-2023 By Asia Sherman

The animal supplement market has come a long way, says Bill Bookout, president and cofounder of the National Animal Supplement Council (NASC), which has made it its mission to ensure the survival and quality of animal supplements on the market.

Proposed suit alleges Amazon selling “illegal drugs masquerading as therapeutic dietary supplements”

07-Feb-2023 By Danielle Masterson

Big name brands, “illegal drugs” and a formidable opponent to the supplement industry: it has all the underpinnings of a dramatic suit— but does it hold water?

Brands gear up to work with Congress on CBD pathway

06-Feb-2023 By Danielle Masterson

As CBD rulemaking languishes, businesses experience frustration and uncertainty.

FDA will not object to limited health claims regarding cocoa flavanols and cardiovascular disease

06-Feb-2023 By Lauren Nardella

FDA will allow a very narrow set of claims linking cocoa flavanols in high flavanol cocoa powder and reduced risk of cardiovascular disease following a petition from Switzerland-based chocolate and cocoa product manufacturer Barry Callebaut AG.

Steve Mister on proposed FDA reorg, MPL, CBD, and CRN at 50

02-Feb-2023 By Stephen Daniells

The first month of 2023 is over, and already there’s some big developments (or non-developments in the case of CBD) for the US dietary supplements industry. We caught up with Steve Mister, president and CEO of the Council for Responsible Nutrition, to...

NPA's Fabricant on CBD, State-led regulations, and NMN's dangerous precedent

31-Jan-2023 By Stephen Daniells

2023 may be a New Year, but many of the old issues for the dietary supplements industry remain. In this wide-ranging interview with Daniel Fabricant, PhD, CEO of the Natural Products Association, we dug into some of the most front-of-mind issues for this...

FDA heeds call for unified Human Foods Program under one leader as part of ‘transformative vision’ for food safety, nutrition oversight

31-Jan-2023 By Elizabeth Crawford

FDA this morning unveiled a “transformative vision” for a unified Human Foods Program that will bring together under one empowered deputy commissioner nearly all of its major food components that currently are scattered across multiple divisions to better...

More trades react to sleepy FDA

30-Jan-2023 By Danielle Masterson

“FDA’s indecision has been the decision on CBD for far too long”

Drumroll, please… waiting game continues to plague CBD industry

26-Jan-2023 By Danielle Masterson

Rumors about a big FDA announcement began swirling earlier this week, with the industry bracing for a potential end to a five-year wait on the regulatory future of CBD. But, much like the last few years, CBD professionals were left waiting without answers,...

House Oversight chair to FDA: Enough is enough

17-Jan-2023 By Danielle Masterson

FDA’s failure to act on CBD created a space for bad actors and poor products to thrive, now the chairman—and the industry—want answers.

FDA to reveal CBD oversight plans soon

06-Jan-2023 By Danielle Masterson

After dragging its feet for nearly five years, the agency is gearing up to make big moves.

Mandatory Product Listing not included in omnibus spending bill

22-Dec-2022 By Stephen Daniells

Attempts to include provisions establishing mandatory product listing (MPL) for dietary supplements in the FY 2023 omnibus spending bill have failed.

Guest Article: ‘Responsible’ has been our middle name for 50 years

21-Dec-2022 By Steve Mister, President & CEO, Council for Responsible Nutrition (CRN)

As the year’s end approaches, I find even more reason than usual to contemplate the state of things. December is always a time for reflection--the end of one year, the end of the 117th Congress, and most state legislative sessions. It’s also a time for...

SPECIAL REPORT: FDA doubles down on titanium dioxide safety as CSPI raises concerns; Skittles lawsuits dismissed

12-Dec-2022 By Elaine Watson

While the European Commission recently banned the use of titanium dioxide (TiO2) in foods in the EU, and the Center for Science in the Public Interest (CSPI) has just warned consumers to avoid it, the FDA tells us it has reviewed the scientific opinion...

Reagan-Udall report calls for sweeping changes in FDA’s food program, leadership structure

07-Dec-2022 By Elizabeth Crawford

Industry leaders are lauding proposed changes to FDA’s food program outlined in a highly-anticipated external review by the Reagan-Udall Foundation published yesterday that includes calls for a “single clearly identified” leader with direct lines of authority...

‘A continuing pattern of antagonism by FDA toward CBD in food and beverages’: Experts weigh in on recent warning letters

05-Dec-2022 By Stephen Daniells

The recent raft of warning letters to brands selling CBD-infused foods and beverages marked a shift in FDA approaches to the ingredient, with the Agency seeming to opine that food and beverages are “somehow a greater risk than supplements”.

Colorado firm cited for plethora of disease claims

30-Nov-2022 By Hank Schultz

A warning letter issued to a Colorado-based supplement distributor points out the dangers of unguarded language used on supplemental websites.

NPA: Change in House could help make FDA more accountable

22-Nov-2022 By Hank Schultz

The change in House leadership could be an opportunity to hold federal agencies more accountable, says Daniel Fabricant, PhD, head of the Natural Products Association.

'Quite frankly, I'm concerned for our entire industry...' FDA cracks down on firms selling CBD-infused foods & beverages in ‘aggressive’ new stance

22-Nov-2022 By Elaine Watson

The FDA has sent out a raft of warning letters to brands selling CBD-infused foods and beverages, adopting an “aggressive position” that one industry source told us made him “concerned for our entire industry.”

FDA warns seven companies over cardiovascular disease claims

18-Nov-2022 By Hank Schultz

Seven companies have been warned by the US Food and Drug Administration over claims of treating cardiovascular disease, the Agency announced yesterday.