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.
FDA has reiterated its enforcment stance on CBD and hemp products, has updated a Q&A document on the subject and has specified what kind of information it is seeking in the runup to a public meeting on the subject in May, all as part of documents...
Synthesized analogs of botanical ingredients, and ingredients of wholly artificial origin, could have a place in the dietary supplement industry. But if they do, full transparency would argue that they be labeled as such.
The proposed 2020 budget for FDA includes a request for mandatory registration of dietary supplements as well as decreased funding for research into these products, according to an analysis supplied to NutraIngredients-USA.
Dr Ned Sharpless, MD, who is the current head of the National Cancer Institute, will be the interim head of the Food and Drug Administration when Dr Scott Gottlieb, MD, leaves next month.
On Monday FDA Commissioner Scott Gottlieb put forward some ideas about where the regulation of dietary supplements should go in the coming years. This is an opportunity that should not be missed. What should be tops on the industry’s wish list?
FDA will inaugurate a public dialogue process this spring to discuss possible changes to DSHEA, take a fresh look at botanical product safety and to reinvigorate the NDI process. The plan was laid out in a statement from FDA Commissioner Dr Scott Gottlieb,...
The federal government shutdown has thrown a wrench into the works of the Food and Drug Administration. While food safety might not have been compromised, many of the agency’s more routine assignments are on hold and it may take months to catch up.
“Just because we haven’t taken enforcement action people seem to think it [CBD] is OK,” said Steven Tave, director of the FDA’s Office of Dietary Supplement Programs, at a recent industry conference. “Anyone who thinks it is lawful is mistaken.”
Amarin Corporation, maker of EPA drug Vascepa, has sued two omega-3s finished good manufacturers for unfair trade practices for allegedly using the results of the company’s large scale drug trial to market their own fish-oil based dietary supplements.
The Nagoya Protocol, the big changes coming for Lactobacillus classification, and how to boost your chances of success with an NDI notification were just some of the topic covered during the third annual IPA Workshop in DC.
Does DHSEA contain within it the seeds of the industry’s downfall? The freewheeling marketplace this regulation created has placed the barriers to entry so low that less than reputable companies have room to maneuver, creating risk for the whole industry.
Are dietary supplements getting ‘better?’ Or are the new products that come onto the market merely a matter of churn, replacing tired packaging and marketing concepts with updated versions?
A new study has found that supplements marketed for weight loss and sports applications that contain the ingredient higenamine had widely varying and unpredictable dosages of this stimulant.
The confused picture on New Dietary Ingredients became a bit clearer this week when FDA updated the public docket on filings and said it does not expect there to be a significant change in how many companies are choosing to go through the process.
A statement by FDA Commissioner Dr. Scott Gottlieb on the approval of a CBD drug has left some industry stakeholders wondering what the exact implications are for the many CBD products being marketed as dietary supplements.
Algatechnologies has launched Fucovital, a fucoxanthin oleoresin produced and extracted from microalgae, available in the US and Japan with launches in other markets to follow.
Nootropics is an area of the dietary supplement industry burgeoning with new ingredients. But at the ragged fringe of the category are drug-like substances that just won’t go away.
A recent sharp drop in the number of NDI Notifications filed with FDA has industry stakeholders scratching their heads and serves to shine a spotlight on the continuing uncertainty surrounding the present system for bringing new ingredients to market.
The Natural Products Association said that members had more than 200 meetings with members of Congress and their staffs at the organization’s recent advocacy event.
Does CBD belong in dietary supplements? FDA says no, and many industry stakeholders who sounded off at a recent industry meeting were inclined to agree.
Since receiving an NDI for its BQQ Ingredient in 2008, Mitsubishi Gas Chemical America is uncovering further potential benefits beyond cognitive health functions such as increased energy and stamina.
A Florida court has dismissed a class action lawsuit predicated on the presence of an illegal ingredient—DMBA—in weight loss products. The court didn’t buy the argument that the plaintiffs had been harmed by not knowing the ingredient’s impaired regulatory...
Two stakeholder groups have collaborated to file an amicus brief in the Amarin fish oils appeal, in which the drug maker is seeking to force the International Trade Commission to hear a case whereby the company is pursuing a ban on the importation of...
An unsettled national political environment is one rife with opportunity. That’s one reason the Natural Products Association has cited for the strong turnout anticipated for its lobby day, which is set for mid-April.
In a comment submitted to FDA, The Council for Responsible Nutrition supports the rescheduling of pyridoxamine as a legal dietary ingredient. The ingredient, a form of vitamin B6, has been off limits for years because of its development as a potential...
Increasing collaboration within the herbal industry will drive the sector forward. That’s one of the goals Holly Johnson, PhD, has in her new role as chief science officer of the American Herbal Products Association.
