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.
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.
The presence and proliferation of phenylethylamines in sports nutrition products continues to be a thorn in the side of the dietary supplement industry. But trying to regulate these ingredients away is not nearly as straightforward as was the case with...
The US Food and Drug Administration has received over 800 comments about vinpocetine, as the agency continues to assess the regulatory status of the ingredient.
The updated New Dietary Ingredients draft guidance is an attempt to over regulate and weaken the dietary supplement industry with no increase in public safety, according to comments filed recently by finished goods manufacturer Jarrow Formulas.
Requiring NDI notifications on almost every new product will create a situation in which few companies will be able to comply with the new draft guidance, the United Natural Products Alliance said.
Senator Claire McCaskill (D-MO) is frustrated with bureaucratic delays to the New Dietary Ingredient (NDI) draft guidance, and is calling on the FDA to quickly finalize the document.
The International Probiotics Association has urged the FDA to expanded the ‘grandfathered list’ of dietary ingredients to include bacterial strains globally recognized as used historically in foods.
The Natural Products Association has urged FDA to cease its attempt to apply food additive standards to dietary ingredients. To do so would create an undue burden on small business, many of which are represented by NPA.
Some proponents of botanicals such as kratom or CBDs have chafed under regulatory restrictions that have forestalled wider acceptance and availability. But the full market is potentially available for those companies willing to go through accepted channels,...
A recent presentation to FDA that was well received made the case that simple changes in fermentation media would not result in the creation of a New Dietary Ingredient.
Dietary supplement retailer bodybuilding.com has asked the FDA to reaffirm the exemption that self-affirmed GRAS ingredients have from the NDI notification provision. The company has also suggested changes to the NDI master file idea and has asked the...
The US Food and Drug Administration has accepted a New Dietary Ingredient (NDI) notification from Algae Health Sciences, Inc., a subsidiary of BGG, for high-dose but limited duration astaxanthin dosing.
Ingredient supplier Linnea has added its voice to the vinpocetine issue, submitting comments requesting the FDA to withdraw the tentative conclusion that vinpocetine cannot be used as a dietary ingredient.
Donald Trump’s historic victory leaves dietary supplement industry observers wrestling with the question of what will be the character of his administration, when the candidate himself has taken so many positions, some of which match standard conservative...
From market sizing to the positions from FDA and FTC on NDIs and claims substantiation, the International Probiotic Association’s DC workshop succeeded in providing a venue for sharing knowledge and expertise.
Dietary supplement champion Sen Orrin Hatch (R-UT) is calling for the withdrawal of a Federal Register Notice that questioned the regulatory status of vinpocetine as a new dietary ingredient.
A workshop hosted by the International Probiotics Association (IPA) in Washington, DC will tackle some of the key issues facing the probiotics sector, including positions from FDA and FTC on NDIs and claims substantiation.
According to UNPA president Loren Israelsen there has been plenty of recent innovation within the dietary supplement despite complaints to the contrary. But the NDI draft guidance could bring that to a screeching halt.
Under the combined pressure of industry and lawmakers, the federal Drug Enforcement Administration has backed off its emergency listing of kratom to the schedule 1 list of controlled substances.
The NDI draft guidance contains several points that are potentially issues for probiotics, and there appears to be a disconnect with the GRAS (generally recognized as safe) process, says a leading industry expert.
The NDI draft guidance offers a workable road map for companies willing to provide the safety information already called for by law, according to one ingredient supplier.
The Food and Drug Administration has extended the comment period on the updated draft version of the New Dietary Ingredients guidance. The new deadline for comments is Dec. 12.
