In a coordinated enforcement action, FDA has sent warning letters to 10 dietary supplement companies using ingredients that have been added to its Ingredients Advisory List.
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.
By Steve Mister, President and CEO, Council for Responsible Nutrition
As the dietary supplement industry turns the corner to 2022, a range of challenges confronts us— supply chain disruptions, staffing shortages, and inflationary pressures, to name a few. Some difficulties must be addressed individually, but I suggest the...
Start 2022 with insights from CEOs from some of the industry’s leading companies in a wide-ranging, interactive, and FREE webinar on NutraIngredients-USA.
The Sports & Active Nutrition Summit 2022 returns in February as an in-person event. Located in sunny San Diego, the meeting will feature cutting-edge content from subject matter experts that will help companies succeed in this market sector that...
CRN president and CEO Steve Mister laid out four priorities for the supplement industry at a meeting yesterday. Among the highlights were to prepare for state based regulations and strengthening self regulation.
By By Steve Mister, President & CEO, Council for Responsible Nutrition
We all want an expedient solution to the stalemate with FDA over the legal status of cannabidiol (CBD), but the call to allow FDA to set a maximum safe level for CBD is antithetical to the law governing dietary supplements, DSHEA.
Nuseed Nutritional US has announced its omega-3 ingredient derived from a genetically modified canola strain has successfully completed a New Dietary Ingredient Notification with FDA.
FDA has issued an import alert on a Southeast Asian herb that reportedly has been used in a similar way to kratom, about which the Agency has also raised a red flag.
The publication of a recent FDA priorities list that omitted the hemp/CBD question is a reminder that a legislative solution is the only practical way forward for a regulatory resolution for these ingredients, advocates say.
Publishing a revised version of the NDI Draft Guidance has made a list of FDA priorities for the coming year. Industry observers welcomed the news, but questioned how much impact it might have if enforcement priorities remain as they are.
The Council for Responsible Nutrition has filed a citizen’s petition with FDA requesting that the Agency reverse its decision that the ingredient NAC is not legal for use in dietary supplements. CRN states that FDA’s ruling on the matter, voiced in warning...
Proposed modernizations to the Dietary Supplement Health and Education Act (DSHEA) and solutions to the CBD issue require “an outstanding effort by industry to speak with a united voice”, says Loren Israelsen, President of the United Natural Products...
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...
A recent paper claims FDA is in the dark as to how many new ingredients have come onto the market via the GRAS process. Only limited progress has been made in the decade since a Congressional report first raised the issue and directed the Agency to make...
Efforts to move the needle on hemp-CBD at the Federal level are slow, and upcoming exits of key personnel at FDA are unlikely to affect progress much, says NPA’s Dr Daniel Fabricant. “In some ways I think FDA likes the status quo,” he tells NutraIngredients-USA.
The US Food and Drug Administration has issued an import alert and seized products from two firms that were deemed to be offering New Dietary Ingredients that have not gone through the notification process.
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.
New users of dietary supplements – and increased usage among established consumers – are predicted to stay with the category after the pandemic subsides, according to industry CEOs.
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Federal regulators could do more to protect consumers by using existing import authorities as well as moving forward on hemp/CBD regulation, the National Products Association has said.
Attorney Bob Durkin said that he regularly comes across clients who are curious about the prospects of studying an ingredient for use in both food and drugs.
How has Covid-19 affected business? Beyond immunity which categories were big winners in 2020? And did we learn anything about delivery formats this year?
Aker BioMarine has debuted a new ingredient developed from krill oil. The new product, which features EPA and DHA bound to a lysophosphatidylcholine (LPC) backbone, is based on cutting edge research and breaks ground in the area of brain and eye health,...
The American Medical Association has issued a new policy on dietary supplements that calls for more enforcement from FDA, labeling changes and other measures. Industry stakeholders found points of agreement with the group’s position, but also highlighted...
Industry stakeholders anticipated a smooth working relationship with a new Biden Administration, but said this year’s highly unusual circumstances makes this transition more uncertain than most.
A renewed emphasis by FDA on the precise regulatory status of legacy ingredients as seen in the case of NAC is a cause for concern, an industry observer says.
“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.
Nutraveris, a software firm that consults on regulatory affairs for nutrition and dietary supplement markets in Europe, has announced that they have launched an online platform for supplement compliance in the United States.
A new paper from a prominent industry critic has found a number of unapproved drugs in a suite of cognitive and memory support products purchased online.
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
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).
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.
A US Food and Drug Administration study reveals that a number of the products it tested labeled as ‘bitter orange’ did not meet label claim for synephrine content and more than 10% contained undeclared synthetic ingredients.
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.
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.
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.
A paper published today in a prominent medical journal asserts that the law governing dietary supplements is no longer adequate to protect consumers and sweeping changes are needed to keep potentially dangerous new ingredients off the market.
The Court of Appeals for the Eleventh Circuit has paved the way for a potential class action against a supplement brand because of the alleged presence of an illegal ingredient, which rendered the product worthless and gave the plaintiffs standing to...
Legislative challenges to dietary supplements and opportunities for regulatory fine tuning continue even as the industry is distracted, said Steve Mister of CRN.
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.
FDA should issue targeted guidances to facilitate the filing of New Dietary Ingredient Notifications, according to comments filed by the American Herbal Products Association.
There are several ingredient lists on FDA’s website that imply some sort of warning to the public. But what's the criteria that decides into which list an ingredient will fall?
Congress should act to create a new law to solve the CBD (cannabidiol) regulatory issue, while simultaneously “closing long-standing gaps” in the oversight of all dietary supplements, according to a new paper by Dr Pieter Cohen and Dr Joshua Sharfstein.
It was a who’s who of the dietary supplement world in College Park for the FDA public meeting on responsible innovation in dietary supplements. Here are some of the key comments:
The recent slew of warning letters on DMHA and phenibut signals a new scrutiny on the part of FDA of ingredient status without reference to other issues, says an attorney with a long history in the field.
The US Food and Drug Administration issued 11 warning letters yesterday to companies that have non NDI ingredients in their products. Eight of the warning letters concerned DMHA, with the other three concerned phenibut.
