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 But the NDI draft guidance could bring that to a screeching halt.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The NDI draft guidance contains several points that are potentially issues for probiotics, and there appears to be a disconnect with the GRAS (generally recognized as safe) process,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The NDI draft guidance offers a workable road map for companies willing to provide the safety information already called for by law, according to one ingredient supplier.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.
