Fresh off a new Draft Guidance release, many are hopeful that Master Files would provide clarity on NDI filing requirements and provide protections for intellectual property.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...
The Brazilian Health Regulatory Agency (ANVISA) has approved Kyowa Hakko’s Setria ingredient, making it the first glutathione authorized for use in dietary supplements and functional foods in the country.
Preliminary indications are that the mandatory product listing language won’t be included in the final FDA fees reauthorization bill now making its way through Congress.
The European Commission (EC) has agreed to amend the conditions of use for novel vitamin B3 ingredient nicotinamide riboside chloride (NR) in foods for special medical purposes and total diet replacement for weight control.
A new federal agency aimed solely at food safety would be created by a bill introduced recently by US Rep Rosa DeLauro (D-CT) and Sen Dick Durbin (D-IL).
The Council for Responsible Nutrition said that persistent problems with FDA’s NDI Draft Guidance means that few firms likely will file new notifications during the recently announced amnesty window.
A new study that sampled dozens of commercially available CBD products found detectable THC levels in 64% of them. Some levels were high enough to approach therapeutic thresholds or to potentially trigger drug test failures.
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.
Branded ingredient supplier Taiyo has announced new certifications on its products that will better align them both with new Amazon and Canadian governmental requirements.
Amendments offered by Sen. Mitt Romney, R-UT, could soften some of the hardest edges in an FDA fee reauthorization bill that includes language meant to tighten the regulation of dietary supplements. But the bill still sets a very troubling precedent,...
FDA announced today that intends to exercise enforcement discretion on missing New Dietary Ingredient Notifications. The Agency also set up a new portal to allow companies to more easily come into compliance by filing the notifications that they should...
The hemp/CBD market is going through a reckoning but ultimately will emerge in a stronger position, said the head of one of few publicly traded companies in the sector.
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.
Nestlé Health Science has agreed to acquire weight management service, PronoKal (PnK) from investment company, Abac Capital, to “add a new dimension” to its weight management portfolio.
A perplexing attitude towards enforcement on the part of federal regulators leaves the dietary supplement industry with little incentive to file New Dietary Ingredient Notifications, participants in a legal panel asserted recently.
Trade organizations have filed documentation with the US Food and Drug Administration bolstering their assertion that the Agency acted arbitrarily and illegally when it ruled that NAC is not a legal dietary ingredient.
A new study on TamaFlex, an ingredient arising out of the Ayurvedic tradition, has shown benefits in a population with knee osteoarthritis, bolstering the scientific backing for the ingredient.
The sports nutrition market continues to be a hotbed of new ingredient development, as attendees of the upcoming Sports & Active Nutrition Summit 2022 will learn.
The Council for Responsible Nutrition has turned up the heat on FDA over its position that NAC is not a legal dietary ingredient. CRN asserts that the Agency has ignored a central legal question.
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...
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.
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.
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.
Today (Aug 24) marks a deadline for public comment on a FDA request for input on the abuse potential of a number of drug substances, including kratom. Even as the regulatory winds shift around the ingredient, analytical labs are lining up to service...
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.
The US Food and Drug Administration has rejected two New Dietary Ingredient Notifications for CBD ingredients. Industry stakeholders said the fact of the rejections and some of wording used in the letters makes it clear that new legislation is likely...
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.
A bill put forward by Senate Majority leader Chuck Schumer, D-NY, to decriminalize marijuana includes language on CBD that has been welcomed by supplement industry stakeholders.
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...
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...
The FSA (Food Standards Agency) has backtracked on its initial expectation for companies to make their novel foods applications at least five weeks in advance of the deadline and confirmed that it will accept applications up until March 31st, after receiving...
Many UK CBD brands have been misled on how to prepare for the looming novel foods deadline meaning there is less than one month for some to pull together potentially impossible amounts of data, an industry expert has warned.
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.
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...
About 70% of the immune system is housed in the gut, so it’s no wonder probiotic bacteria have been shown to have a number of beneficial immune and health effects. With a pandemic playing out before us and immune-supporting ingredients at the forefront,...
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.
Earthlight Whole Food's Vitamin D, distributed by PLT Health Solutions in the US, has received novel foods approval in the EU, allowing it to be used in 'clean label' food and beverages in Europe.
Natural Products Expo West was supposed to be a launching pad for many new products. With the cancellation of the show and the many other coronavirus-related dislocations, natural products companies are scrambling to adapt.
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.
CBDepot has applied for Novel Food (NF) application for a synthetic form of cannabidiol (CBD) for food supplement use in a move the firm says has a better chance of regulatory approval.
New Trump Administration executive orders on guidance documents from regulatory agencies likely will affect the dietary supplement industry, an attorney says.
