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.
A victory for Natural Alternatives International in its beta alanine patent case is being heralded as a huge IP protection precedent in the natural products industry.
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.
Dr Ned Sharpless, MD, who is the current head of the National Cancer Institute, will be the interim head of the Food and Drug Administration when Dr Scott Gottlieb, MD, leaves next month.
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.
China will not implement a new set of cross-border e-commerce (CBEC) regulations in January next year and will instead continue with existing regulations.
A new study has found that supplements marketed for weight loss and sports applications that contain the ingredient higenamine had widely varying and unpredictable dosages of this stimulant.
The European Commission (EC) has given the go-ahead to rename the carotenoid zeaxanthin currently listed in the novel foods register after an application by DSM Europe.
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...
Algatechnologies has launched Fucovital, a fucoxanthin oleoresin produced and extracted from microalgae, available in the US and Japan with launches in other markets to follow.
Nootropics is an area of the dietary supplement industry burgeoning with new ingredients. But at the ragged fringe of the category are drug-like substances that just won’t go away.
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.
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...
The European Commission (EC) has given the go ahead for a blend of three herbal roots to be used as a novel food in a supplement intended for post-menopausal women.
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...
New regulations set to take effect in Brazil will significantly improve market access for dietary ingredients and finished dietary supplements, an expert says.
Product development featuring CBD continues despite the ingredient’s regulatory impediments, with the latest example being a protein powder offered by a Colorado startup.
Where does the tide of innovation stand in dietary supplements? An online forum set for 11:30 AM Eastern time tomorrow hosted by NutraIngredients-USA will seek to answer this question.
Lonza’s assertion that L-carnitine contributes to normal lipid metabolism was rejected by EU authorities, who could not find a link between the supplement and a ‘beneficial physiological effect.’
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.
Is the tide of innovation in the dietary supplement industry waxing or waning? An expert says that there is plenty of innovation happening if you are willing to look hard enough.
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.
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 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.
