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,...
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.
By Stephen Daniells, Hank Schultz and Adi Menayang
The year is new and many people are getting out their crystal balls. NutraIngredients-USA is no different, and here are five of our Top 10 big issues that will impact the dietary supplements industry in 2019.
While the Farm Bill has removed industrial hemp from Schedule I of the Controlled Substances Act, the use of CBD as an ingredient has many more hurdles to overcome especially with the FDA, according to attorney Todd A. Harrison.
Much has been made of potential benefits of artificial intelligence (AI) for the discovery and development of new products and ever-growing interest in personalisation. However, AI has other benefits, says Cédric Bourges, founder and CEO of Nutraveris...
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 new research partnership between Canadian CRO Nutrasource and a Florida medical clinic will aid the formulators of CBD products by providing baseline data that at the moment is lacking, an executive said.
Long-awaited guidance from the FDA spelling out which isolated or synthetic non-digestible carbohydrates it believes should be classified as ‘dietary fiber’ on the Nutrition Facts panel brings to an end a period of extended uncertainty for companies supplying...
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.
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...
A new study on ChromaDex Corp.’s Niagen ingredient confirms that supplementation with the vitamin B3 form boosts NAD+ levels in human tissue and suggests future avenues of research in blood pressure and arterial stiffness endpoints.
The US Department of Justice has filed an amicus brief in the Amarin case, asking a federal appeals court not to rule in favor of the drug maker’s attempt to force the International Trade Commission to hear its plea that certain concentrated omega-3 ingredients...
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...
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...
Startup Triton Algae Innovations is betting on a whole-cell protein positioning for an algae species that has been researched for years for its nutraceutical and pharmaceutical ingredient production potential.
Australian biotechnology firm Marinova has achieved novel foods status in the EU for its Maritech® fucoidan extracts, and the firm is now targeting growth in the region's functional beverage and supplement sectors.
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.