FDA should issue targeted guidances to facilitate the filing of New Dietary Ingredient Notifications, according to comments filed by the American Herbal Products Association.
There are several ingredient lists on FDA’s website that imply some sort of warning to the public. But what's the criteria that decides into which list an ingredient will fall?
Congress should act to create a new law to solve the CBD (cannabidiol) regulatory issue, while simultaneously “closing long-standing gaps” in the oversight of all dietary supplements, according to a new paper by Dr Pieter Cohen and Dr Joshua Sharfstein.
It was a who’s who of the dietary supplement world in College Park for the FDA public meeting on responsible innovation in dietary supplements. Here are some of the key comments:
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.
FDA has reiterated its enforcment stance on CBD and hemp products, has updated a Q&A document on the subject and has specified what kind of information it is seeking in the runup to a public meeting on the subject in May, all as part of documents...
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.
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.
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?
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.
“Just because we haven’t taken enforcement action people seem to think it [CBD] is OK,” said Steven Tave, director of the FDA’s Office of Dietary Supplement Programs, at a recent industry conference. “Anyone who thinks it is lawful is mistaken.”
Amarin Corporation, maker of EPA drug Vascepa, has sued two omega-3s finished good manufacturers for unfair trade practices for allegedly using the results of the company’s large scale drug trial to market their own fish-oil based dietary supplements.
