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The updated New Dietary Ingredients draft guidance is an attempt to over regulate and weaken the dietary supplement industry with no increase in public safety, according to comments filed recently by finished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on almost every new product will create a situation in which few companies will be able to comply with the new draft guidance, the United Natural Products Alliance said.
Senator Claire McCaskill (D-MO) is frustrated with bureaucratic delays to the New Dietary Ingredient (NDI) draft guidance, and is calling on the FDA to quickly finalize the document.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.
In response to the recently re-released NDI draft guidance, the Natural Products Association (NPA) has said it is in the later stages of developing a comprehensive safe harbor list of pre-DSHEA dietary ingredients.
More than half (56%) of dietary supplement professionals said they haven’t read the Aug. 11 NDI guidance—and 6% said they haven’t read it, but told their boss that they did.
The drive toward shorter, cleaner labels and the oft-mentioned dearth of innovation in the supplement sphere are both factors of the maturation of the dietary supplement and functional foods industries, according to one expert.
From ingredient combinations to supercritical CO2 extraction to nanotechnology, here are some things to note from the new NDI draft guidance FDA released Aug. 11.
Over the last few years, the FDA has zeroed in on the dietary supplement industry. It has taken numerous actions against dietary supplements where it believes the ingredients pose health risks to the public. This scrutiny continues with the release...
In what has been called an ‘unprecedented’ move, the Food and Drug Administration has initiated a proceeding to take vinpocetine off the market despite a number of successful NDI notifications filed on the ingredient.
In addition to the areas that require clarification, the dietary supplement industry should look carefully and cautiously at the revised draft guidance for new dietary ingredient notifications, specifically at the economic impact of the FDA's new...
The devil is in the detail, and one detail easily missed in the new draft guidance for new dietary ingredient notifications is that self-affirmed GRAS is no longer mentioned as an ‘alternative’ to an NDI notification.
The new NDI draft guidance is very similar to the previous version, and yet the howls of outrage heard in 2011 are silent. What’s changed? Well, a lot…
The new draft guidance for new dietary ingredient notifications is “more positive than negative”, says Steve Mister, CEO of the Council for Responsible Nutrition.
The updated New Dietary Ingredients draft guidance, issued yesterday by the Food and Drug Administration, modifies the agency’s stance on the contentious issue of synthetic, nature-identical compounds. But not by much.
Master Files and a grandfathered list are among the highlights in the FDA’s new Draft Guidance for New Dietary Ingredient Notifications, released this morning.
A new policy by the American Medical Association on nootropics once again highlights the blurred edges of what can legitimately be called a ‘dietary supplement.’
With the recent elevation of dietary supplement oversight from a division to its own office at FDA’s Center for Food Safety and Applied Nutrition, the agency should renew its focus on reducing tainted supplements, improving compliance with good manufacturing...
Chinese supplier BGG is taking a big step to expand the global footprint of its ingredients with recent establishment of an office in Mexico City to go along with a new European site.
BGG subsidiary AlgaeLife Sciences, Inc. has successfully petitioned the US FDA with a New Dietary Ingredients notification (NDI) for its flagship product AstaZine Natural Astaxanthin.
The recent spate of FDA warning letters on the use of CBD as an ingredient in dietary supplements seems to have done little to dampen formulators’ enthusiasm for its use in new products. The situation is unprecedented in the herbal products sphere, observers...
The Natural Products Association enters its 80th year as the premier organization dedicated solely to the natural products industry in 2016. For those 80- years, our top priority has been and always will be enhancing, expanding and protecting our members’...
Despite an import ban on the substance, kratom-containing products continue to find their way into the country. In the latest action, the Food and Drug Administration has seized 90,000 bottles at a facility in Illinois.
By Steve Mister, president & CEO, the Council for Responsible Nutrition (CRN)
What a difference a year makes! Last January at this time, who in the industry would have predicted the New York Attorney General (AG) debacle in February? Or Senator Dick Durbin’s dietary supplement amendments on the defense authorization bill in May?...
What’s the future for botanical ingredient discovery? Experts differ on whether there are wholly new, useful species yet to be discovered, but agree that there are still more ingredients to be derived from source materials already in use.
The actions of New York Attorney General Eric Schneiderman have put an unprecedented pressure on the dietary supplement business, especially those companies dealing in herbal products.
As we enter the twilight days of 2015 the editors of NutraIngredients-USA become a reflective bunch. A lot of things happened this year, and here is our top 10 of most important events of the year…
