The ink on the US Supreme Court’s decision to overturn the Chevron deference was barely dry when dietary supplements stakeholders were asking about potential implications for their industry.
In a constantly evolving marketplace, dietary supplement companies are exposed to a constantly evolving risk profile determined by off-script influencers, generative AI, elongated supply chains and the proliferation of new ingredients and manufacturing...
At the DSHEA Summit last week in Salt Lake City, Dr. Cara Welch, director of the Office of Dietary Supplement Programs (ODSP), had an allotted 10 minutes to provide a report card on the state of the industry.
The letter also addresses concerns over FDA’s Human Foods Program reorganization and how it will impact the Office of Dietary Supplement Programs, new dietary ingredient notifications (NDIN) and more.
An institution since 2000, this year the Oxford International Conference on the Science of Botanicals (ICSB) gathered over 300 scientists, regulators and industry professionals from across the globe for an immersive program of expert educational sessions...
Top takeaways from regulatory session at SupplySide East
The U.S. Food & Drug Administration's good manufacturing practice (GMP) inspections of dietary supplement facilities is back up to 500 per year, a return to pre-COVID levels, but those levels are still inadequate, says Dr. Cara Welch, FDA’s director...
FDA’s director of the Office of Dietary Supplement Programs (ODSP), Cara Welch, PhD, stopped by SupplySide East to present an overview of the agency’s FY23 activities related to dietary supplements and FY24 plans as well as an update on the pending Human...
When it comes to starting a dietary supplement brand from scratch, there is a lot to consider: suppliers, contract manufacturers, regulations, supply chain and so much more. So where should entrepreneurs start?
SupplySide East just wrapped up, and attendees were buzzing about a number of issues ranging from restrictive laws to NDI guidance to DSHEA. NutraIngredients-USA caught up with CRN’s President and CEO Steve Mister Wednesday in Secaucus, NJ to discuss...
Registration is open for the DSHEA Summit, a landmark event bringing together the architects of the law and leading industry voices, including current and former FDA officials.
The Food and Drug Administration (FDA) has released draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.”
Loren Israelsen, president of the United Natural Products Alliance (UNPA) and one of the key architects of the Dietary Supplement Health and Education Act (DSHEA), is urging the Food and Drug Administration (FDA) to “move along as quickly as they can”...
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.
The Food and Drug Administration (FDA) has finalized guidance for industry titled “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry".
The 4th Annual Business Leaders Forum will take place on January 25. The FREE webinar gives attendees the opportunity to ask a burning question (or two) to our C-suite panel from some of the most iconic brands in the dietary supplements space.
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.
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.
