Fda

Poll finds many parents don't understand CBD

15-Mar-2022 By Danielle Masterson

Despite the wide availability of CBD in its various forms—oil, topical ointments, tinctures, vaping and edibles— a recent poll shows parents are misinformed on CBD.

CRN’s Mister on NAC: ‘This isn’t a one ingredient issue’

14-Mar-2022 By Stephen Daniells

As the uncertainty around the regulatory status of NAC (N-acetyl cysteine) continues, it is important the industry doesn’t lose this for the precedent it sets for other potential ingredients, said CRN’s Steve Mister.

Cara Welch named permanent director of ODSP at FDA

11-Mar-2022 By Stephen Daniells

The US Food and Drug Administration has announced that Dr Cara Welch will be the new permanent director of its Office of Dietary Supplement Programs. The announcement was welcomed by industry trade groups.

In memory of Ben Zaricor, 1947-2022

Fmali v Heckler: The landmark herb case that changed the industry

02-Mar-2022 By Stephen Daniells

It started with ten-speed bicycles and ended with an Appeals Court decision in 1983 that changed the herb industry and knocked FDA down a peg. Four decades later, it’s time to shine the spotlight on this game-changing court case.

Rats overwhelm Family Dollar warehouse; 404 stores closed as part of recall

24-Feb-2022 By Hank Schultz

Dietary supplements and other products purchased from Family Dollar stores in six states may be contaminated because of massive rodent infestation, FDA warned the public recently.

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.

Navigating the legal landscape of weight loss supplements

08-Feb-2022 By Danielle Masterson

Over 42% of adults in the US are considered obese—giving weight loss brands easy marketing fodder amid the obesity epidemic. Unfortunately, this category of supplements has a checkered history, and has become labeled as one of FDA's problem children.

Sixth time still not a charm: FDA again rejects NDIN for kratom

02-Feb-2022 By Stephen Daniells

The FDA has again rejected a new dietary ingredient (NDI) notification for kratom, with one industry lawyer telling us he is not optimistic that anyone will achieve a successful NDI notification for the botanical.

FDA approves IND application for CBD product

24-Jan-2022 By Danielle Masterson

Researchers hope CBD could help combat opioid use disorder, but what does this IND mean for the supplement industry?

Warning letter signals return of on the ground inspection observations for 2022

04-Jan-2022 By Hank Schultz

A warning letter sent to a dietary supplement manufacturer signals a return of enforcement actions based on on-site inspections, which had been suspended for a time during the global pandemic.

11th defendant in Blackstone case convicted of fraud and distributing controlled substances

13-Dec-2021 By Stephen Daniells

Another defendant in the Blackstone Labs steroids enforcement action was convicted in a Florida court last week.

NPA sues FDA over NAC: ‘We’ve been left with no choice,’ says Fabricant

07-Dec-2021 By Stephen Daniells

The Natural Products Association (NPA) has filed a lawsuit in the US District Court for the District of Maryland requesting the Food and Drug Administration cease its “unlawful retroactive application of the Food, Drug, and Cosmetic Act” against N-acetyl-L-cysteine...

‘FDA kicked the can’: NPA & CRN slam Agency’s ‘tentative’ responses to NAC Citizen Petitions

24-Nov-2021 By Stephen Daniells

The Council for Responsible Nutrition and the Natural Products Association have slammed the Food and Drug Administration (FDA) for delaying a decision on the regulatory status of NAC (N-acetyl-L-cysteine) in dietary supplements, as the Agency issues ‘tentative...

Trade organizations welcome Califf’s formal nomination to lead FDA

12-Nov-2021 By Hank Schultz

As expected, the Biden Administration has nominated Dr Robert Califf, MD, as the new FDA Commissioner. Dr Califf previously served in the role during the Obama Administration.

Grandma’s Herbs & owners ordered to stop distribution of adulterated products

25-Oct-2021 By Stephen Daniells

Utah-based Grandma’s Herbs, Inc. and its owners, Kevin Parr and Tracey Parr have agreed to a consent decree of permanent injunction to stop distributing unapproved and misbranded drugs and adulterated products.

Likely new FDA Commissioner's experience seen as plus by industry

15-Oct-2021 By Hank Schultz

Industry stakeholders have welcomed the news that the Biden Adminstration is reportedly ready to name Dr. Robert Califf, MD as the new FDA Commissioner, given that he has prior experience at the Agency during the Obama years.

Legality of the Self-GRAS process upheld in federal court

05-Oct-2021 By Danielle Masterson

The ruling affirms that substances that are self-determined to be GRAS can continue to be exempt from premarket review by FDA.

FDA sends Amazon letter over sexual enhancement & weight loss products

05-Aug-2021 By Stephen Daniells

The US Food & Drug Administration has sent a letter to Amazon about the availability of drug-tainted sexual enhancement and weight loss products for sale on its platform, the majority of which were marketed as dietary supplements.

Democratic Senators request $3.75 million increase in ODSP budget

13-Jul-2021 By Stephen Daniells

Five Democratic Senators have cosigned a letter the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies asking for a significant increase for the budget for the Office of Dietary Supplement...

COVID-19 and legal chaos dent CBD market – but Congress and a stronger economy offer hope

16-Jun-2021 By Shane Starling

The COVID-19 pandemic and ongoing legal quagmire surrounding CBD supplements and foods in the US have knocked what was a booming category – along with scarce science and raw material pricing and QC concerns – but the sector is looking to economic and...

FDA’s Welch on DSHEA 2.0: ‘We have an opportunity for real, common sense reform that I don’t believe we can let pass by’

25-May-2021 By Stephen Daniells

“FDA is not looking to throw out DSHEA and start fresh – rather we are talking about building on the current framework,” said FDA’s Dr Cara Welch. Done correctly, initiatives like a mandatory product listing would not impose significant burdens on the...

FDA seizes ‘adulterated dietary supplements’ containing kratom worth $1.3 million

24-May-2021 By Stephen Daniells

US Marshals, at the request of the U.S. Food and Drug Administration, seized over 207,000 units of dietary supplements and bulk dietary ingredients containing kratom worth approximately $1.3 million.

‘A straight shooter and person who cared about doing things the right way’: Industry pays tribute to passing of veteran FDA public servant

03-May-2021 By Stephen Daniells

The dietary supplements community has paid tribute to William "Bill" Correll Jr., who was the Director of the Office of Compliance at the Center for Food Safety and Applied Nutrition (CFSAN) until his death due to complications from COVID-19.

CRN’s Mister on the best solution for CBD, DSHEA 2.0, and more

14-Apr-2021 By Stephen Daniells

The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act represents ‘the best way’ to deal with the hemp-CBD issue for dietary supplements, says CRN’s Steve Mister, and once that’s clarified then the FDA and industry can address...

Steven Tave to leave FDA's ODSP, Dr Cara Welch to be acting director

18-Feb-2021 By Stephen Daniells

Dr Cara Welch will step in as the acting director of the Office of Dietary Supplement Programs (ODSP) at the FDA from March 15, as Steven Tave accepts a new role as director of the Office of Strategic Planning and Operational Policy.

FDA yanks pending CBD enforcement proposal

27-Jan-2021 By Danielle Masterson

The White House Office of Management and Budget pulled six FDA guidances and rules from its review, including the proposal "Cannabidiol Enforcement Policy; Draft Guidance for Industry" — handing the CBD industry yet another setback.

FDA warns consumers about weight loss & male enhancement products sold through Amazon, eBay

04-Jan-2021 By Stephen Daniells

The US Food and Drug Administration issued a consumer warning on December 17 about potentially dangerous drug ingredients in certain male enhancement or weight loss products sold through Amazon, eBay and other retailers.

FDA’s Tave: Mandatory product listing would be ‘a dramatic step forward in narrowing the regulatory gap’

15-Oct-2020 By Stephen Daniells

“We cannot enforce against what we cannot see or cannot know is there”, said FDA’s Steven Tave, and that’s why mandatory listing requirement for dietary supplement products would be a step forward for enforcement.

FDA announces public meeting to discuss gender differences in use and responses to CBD

24-Sep-2020 By Stephen Daniells

The US Food and Drug Administration has announced a virtual public meeting to explore the potential sex (biological) and gender (psychosocial) differences in use and responses to cannabidiol (CBD) and other cannabinoids.

FDA’s Tave highlights ‘Regulatory Gap’ for dietary supplements

17-Sep-2020 By Stephen Daniells

A ‘Regulatory Gap’ exists within the US dietary supplements industry, and recent talk of modernizing the regulations are ways to close that gap, FDA’s Steven Tave said yesterday

NutraVideo: Caliper on finding the right CBD dose

14-Sep-2020 By Danielle Masterson

Representatives Kurt Schrader and Morgan Griffith recently introduced the Hemp and Hemp-Derived CBD Consumer Protection & Market Stabilization Act of 2020.

Trade groups unite to support new Hemp-CBD bill

09-Sep-2020 By Stephen Daniells

Multiple hemp and dietary supplement industry trade groups have written to Reps. Kurt Schrader (D-OR) and Morgan Griffith (R-VA) to thank them for their leadership on the hemp-CBD issue.

FDA rejected oleander constituent as a new dietary supplement ingredient a month ago

09-Sep-2020 By Stephen Daniells

The US Food and Drug Administration rejected mid-August a New Dietary Ingredient notification from Phoenix Biotechnology Inc for oleandrin, a constituent of oleander touted as a COVID-19 cure.

Hemp-CBD dietary supplement bill introduced in the House

04-Sep-2020 By Stephen Daniells

Rep. Kurt Schrader (D-OR) and Rep. Morgan Griffith (R-VA) have introduced the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2020 to allow hemp and hemp derived CBD to be legally marketed in dietary supplements.

NutraCast Podcast: Are brands responsible for consumer reviews? Atty Marc Ullman weighs in

04-Sep-2020 By Danielle Masterson

When it comes to discussing immunity and other health claims, marketers have to be cautious, especially in the current climate. A recent National Advertising Division (NAD) decision stated this is an “unprecedented time” and declared it would fulfill...

AHPA event aims to guide CBD industry

25-Aug-2020 By Danielle Masterson

Products containing cannabidiol (CBD) represent a rapidly growing yet uncertain market segment, with those in the industry often finding themselves with more questions than answers.

Guest article

New Dietary Ingredients: Will FDA protect consumers from pirates and piggybackers?

05-Aug-2020 By Steve Mister, President & CEO, Council for Responsible Nutrition

Why is it so hard to get FDA to enforce the law when it comes to NDIs?

FTC hits marketer with lawsuit over pricey ‘FDA accepted’ COVID-19 ‘treatment’ plan

04-Aug-2020 By Danielle Masterson

The Federal Trade Commission charged Golden Sunrise Nutraceutical, Inc. with deceptively advertising an ‘Emergency D-Virus’ treatment as a scientifically proven way to treat COVID-19. The company even went as far as claiming their treatment was ‘FDA accepted.’

NutraCast Podcast: CSPI’s Laura MacCleery on ‘antiviral' supplements in the marketplace

04-Aug-2020 By Danielle Masterson

Over 70% of Americans take dietary supplements, and by now, most consumers have probably noticed the disclaimer that says "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Is FDA open to entertaining an NDI for CBD products?

30-Jul-2020 By Stephen Daniells

The US Food and Drug Administration may be willing to sit down with a company about a possible NDI submission for full-spectrum hemp extracts, says Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN).

NPA Fabricant on CBD, NDIs, FDA resuming inspections

24-Jul-2020 By Stephen Daniells

FDA has stated it is making ‘substantial progress’ with CBD, and a new enforcement guidance could be very significant for the industry, said NPA’s Dr Daniel Fabricant, but he said the Agency needs to ‘get in the game’ for NDIs.

Uphill battle for CBD companies registering trademarks

15-Jul-2020 By Danielle Masterson

The United States Trademark Trial and Appeal Board (TTAB) recently issued a precedential decision that would control future rulings on whether a company could register a trademark for a dietary supplement or food containing cannabidiol (CBD).

FDA to resume on-site domestic inspections

13-Jul-2020 By Danielle Masterson

After pausing on-site surveillance inspections in March, the Food and Drug Administration plan to resume domestic inspections starting the week of July 20.

NutraCast Podcast: Hemp pioneer Richard Rose on CBD, FDA

10-Jul-2020 By Danielle Masterson

On this episode of the NutraCast, we were joined by Richard Rose, who has worked with hemp for decades and is a self-described ‘Hemp OG.” He created the first “open-source” hemp brands Nobacco and Notpot. He has also created CannaSearch, which has opened...

CBD lawsuits highlight labeling, advertising risks

02-Jul-2020 By Danielle Masterson

As more and more cannabidiol (CBD) products continue to hit the shelves, an increasing number of lawsuits are showing up on dockets.

Study rings alarm on avocado oil, finds 82% expired or adulterated

18-Jun-2020 By Danielle Masterson

Researchers issue a call to action to establish standards and cautions there is “an urgent need to develop standards for avocado oil.”

NPA calls for FDA to issue import alerts on imported adulterated dietary supplement ingredients

03-Jun-2020 By Stephen Daniells

The Natural Products Association (NPA) is calling for the US Food and Drug Administration to use import alerts to stop nutritional supplements that fail to comply with New Dietary Ingredient (NDI) regulations.

Despite coronavirus dislocations, FDA, FTC not taking foot off compliance pedal

18-May-2020 By Danielle Masterson

The Food and Drug Administration (FDA) may have suspended all routine plant inspections, but dietary supplement producers are still expected to remain in compliance. In the meantime, the Federal Trade Commission has sent another 37 warning letters over...

Alkemist Labs rings alarm on doctored C of A certificates

14-May-2020 By Danielle Masterson

Alkemist Labs' CEO Elan Sudberg says he's seen evidence that some ingredient suppliers and marketing companies have been altering valid lab reports and using those falsified reports to promote their products.