The Norwegian fishing and biotech company has successfully achieved New Dietary Ingredient (NDI) status from the US Food and Drug Administration for its Lysoveta. Under the NDI, Aker BioMarine can market Lysoveta at 1.5 grams/day for the general adult...
Fresh off a new Draft Guidance release, many are hopeful that Master Files would provide clarity on NDI filing requirements and provide protections for intellectual property.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...
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...
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.
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.
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.
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.
Delegate registration is now open for Probiota Americas in Chicago, with the event kicking off with a panel with CEOs from some of the most iconic brands in the US dietary supplements space.
The Sports & Active Nutrition Summit 2023 is just two months away! Bridging the science and business of the sports and active nutrition categories, SANS is a must-attend event, and let us tell you why…
An importer of coca leaf powder has been taken to task by the US Food and Drug Administration over disease claims associated with the ingredient. But the warning letter had nothing to say about the products’ legal status.
This year’s Dietary Supplement Regulatory Summit in Washington, DC, featured updates and insights from top FDA officials, including the Office of Dietary Supplement Programs along with top stakeholders and industry experts. Here are a few key takeaways...
FDA and FTC have issued four joint warning letters to kratom companies centered on opioid claims. It’s a move that comes on the heels of FDA rejecting an NDI filing on the ingredient for the sixth time.
NDIs, drug preclusions, the CBD stalemate, actions at the State level, and an impending supply chain nightmare around plastics were just some of the highlights from a recent conference in New York City.
This year’s International Society of Sports Nutrition Annual Conference & Expo marked its 19th year promoting the science and application of evidence-based sports nutrition and supplementation. NutraIngredients-USA was there to hear about the latest...
Ingredient-specific actions, as evidenced recently by warning letters to 10 firms in the sports nutrition space, are important to FDA’s regulation of dietary supplements but additional actions are hampered by having to deal with problematic ingredients...
The head of the FDA’s Office of Dietary Supplement Programs suspects that remote regulatory assessments (RRAs) will continue even as regular facility inspections resume post-COVID, as the agency seeks to get a good picture of the compliance status of...
Mandatory Product Listing can still be a good idea for industry, proponents maintain, even if the latest legislative iteration has failed to garner support from stakeholders.
The US Food & Drug Administration intends to release multiple draft guidance documents to the industry as smaller, discreet topics relating to New Dietary Ingredients (NDI), a senior figure said recently.
Authors of a bipartisan bill to reauthorize FDA user fees have included provisions bearing on dietary supplements, which has stirred up a hornets nest within the industry.
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.
Start 2021 with insights from CEOs of some of the industry’s leading companies in a wide-ranging, interactive, and FREE webinar on NutraIngredients-USA.
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.
