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.
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.
The advocates for the reformation of the regulation of hemp derivatives in nutritional products were clinging to the hope that the abrupt resignation of FDA Commissioner Dr Scott Gottlieb will not mean the initiative will be stillborn.
By Will Chu, Niamh Michail, Hank Schultz, and Cheryl Tay
The interest in cannabidiol (CBD) use in food supplements, foods, and even as an ingredient in cosmetics has gained much momentum in the past five years, but what is the regulatory situation around the world?
Andrew Shao, PhD, will replace Duffy MacKay, ND, as head of scientific and regulatory affairs at the Council for Responsible Nutrition in an interim role. MacKay is leaving the organization for a similar role at cannabis specialist CV Sciences.
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?
The comments made by FDA Commissioner Scott Gottlieb, MD, on the NDIs issue have made dietary supplement industry stakeholders sit up and take notice. The comments were met with an air of cautious optimism.
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,...