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...
Following on from the success of last year's survey, NutraIngredients-USA is running another 'state of the industry' survey to gauge views about the current state of the dietary supplements and the business landscape in 2018.
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.
Dr Dan Fabricant, PhD, executive director of the Natural Products Association, has continued his forceful advocacy of existing compliant paths to market for CBDs in an appearance on The Doctors TV show.
Will compiling an official list of Old Dietary Ingredients ultimately be worth the effort? Maybe, but the resulting list must be expansive rather than restrictive to be of much use, most stakeholders agree.
The Natural Algae Astaxanthin Association has filed a citizen’s petition that seeks regulatory action by FDA against a synthetic form of astaxanthin marketed by Cardax.
The Natural Products Association has released a book compiling a list of pre-DSHEA (old) dietary ingredients to provide a “useful regulatory guidepost” for industry and regulators.
From market sizing to the need for global probiotics standards at Codex, the International Probiotic Association’s second DC workshop in collaboration with the US Pharmacopeia succeeded in providing a venue for sharing knowledge and expertise.
Members of the Council for Responsible Nutrition must demonstrate a “unified commitment” to the Supplement OWL, with the organization’s Board of Directors indicating that all members must be substantially compliant by the beginning of the year.
NPA's Dr Daniel Fabricant recaps state of industry at SupplySide West 2017
From finalizing an NDI list to making dietary supplements eligible in welfare programs, Dr Daniel Fabricant of the National Products Association shared his take on the state of the dietary supplements industry.
The tussle between ChromaDex and Elysium Health highlights again the curious dance between a New Dietary Ingredient Notification and a GRAS affirmation as a way to bring ingredients to market.
Recent warning letters show the Food and Drug Administration continues to hone in on the provenance of ingredients, and demonstrate that the tempo of enforcement remains unchanged despite the moves by the Trump Administration to roll back regulations...
Experts expect the existing standoff on synthetic botanicals as voiced by FDA in the most recent draft NDI guidance will continue, despite the consensus from industry being the agency’s position is not rooted in science.
Dietary supplement manufacturer Jarrow Formulas Inc. has filed a lengthy comment challenging FDA’s position on probiotics as set down in the most recent Revised Draft Guidance on New Dietary Ingredients.
Careful and consistent work on claims substantiation and a commitment to transparency has helped make Bergstrom a leader in the developing field of MSM, a company executive said recently.
A federal district court judge in Atlanta has ruled in favor of FDA in its case against Hi-Tech Pharmaceuticals over its use of DMAA. But the ruling potentially weakens agency’s stance on the question of synthetic versions of constituents of botanicals.
A call from the U.S. Commerce Department for suggestions on streamlining manufacturing regulations has generated responses from industry trade organizations, with the different tacks the suggestions take reflecting those organizations’ membership.
