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.
Recent warning letters show the Food and Drug Administration continues to hone in on the provenance of ingredients, and demonstrate that the tempo of enforcement remains unchanged despite the moves by the Trump Administration to roll back regulations...
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.
Dietary supplement manufacturer Jarrow Formulas Inc. has filed a lengthy comment challenging FDA’s position on probiotics as set down in the most recent Revised Draft Guidance on New Dietary Ingredients.
Careful and consistent work on claims substantiation and a commitment to transparency has helped make Bergstrom a leader in the developing field of MSM, a company executive said recently.
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.
The presence and proliferation of phenylethylamines in sports nutrition products continues to be a thorn in the side of the dietary supplement industry. But trying to regulate these ingredients away is not nearly as straightforward as was the case with...
The US Food and Drug Administration has received over 800 comments about vinpocetine, as the agency continues to assess the regulatory status of the ingredient.
The updated New Dietary Ingredients draft guidance is an attempt to over regulate and weaken the dietary supplement industry with no increase in public safety, according to comments filed recently by finished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.
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on almost every new product will create a situation in which few companies will be able to comply with the new draft guidance, the United Natural Products Alliance said.
Senator Claire McCaskill (D-MO) is frustrated with bureaucratic delays to the New Dietary Ingredient (NDI) draft guidance, and is calling on the FDA to quickly finalize the document.
The International Probiotics Association has urged the FDA to expanded the ‘grandfathered list’ of dietary ingredients to include bacterial strains globally recognized as used historically in foods.
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.
