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.
The good news in the botanicals sector is that increasing numbers of systematic reviews and meta-analyses show that there is strong support for the health benefits of these ingredients, said Mark Blumenthal, founder of the American Botanical Council.
Experts expect the existing standoff on synthetic botanicals as voiced by FDA in the most recent draft NDI guidance will continue, despite the consensus from industry being the agency’s position is not rooted in science.
A federal district court judge in Atlanta has ruled in favor of FDA in its case against Hi-Tech Pharmaceuticals over its use of DMAA. But the ruling potentially weakens agency’s stance on the question of synthetic versions of constituents of botanicals.
A call from the U.S. Commerce Department for suggestions on streamlining manufacturing regulations has generated responses from industry trade organizations, with the different tacks the suggestions take reflecting those organizations’ membership.
Openness and transparency is the only way for genetic engineering technology to thrive in the supply of dietary ingredients, said an official with a company engaged in the practice.
The updated New Dietary Ingredients draft guidance is an attempt to over regulate and weaken the dietary supplement industry with no increase in public safety, according to comments filed recently by finished goods manufacturer Jarrow Formulas.
Oxford researchers behind a novel performance-enhancing ketone drink get around an email a day from sports teams hoping to buy the product – and another 20-30 unnamed professional teams have already been involved in research trials with the product.
Requiring NDI notifications on almost every new product will create a situation in which few companies will be able to comply with the new draft guidance, the United Natural Products Alliance said.
The Natural Products Association has urged FDA to cease its attempt to apply food additive standards to dietary ingredients. To do so would create an undue burden on small business, many of which are represented by NPA.
Zivo Bioscience, an algae company long focused on deriving unique bioactives from its proprietary strains, has pivoted to protein as developers realized the potential inherent in the straight, unrefined biomass.
The Council for Responsible Nutrition has submitted comments to a Health Canada that urges the agency not to scrap the existing product registration system but rather to further refine it if that is deemed necessary and to better educate the public about...
