9/25/2011
One of the hottest issues that face the supplement industry, and can considerably alter the way business is done, is the proposed guidelines over any new ingredients used in dietary supplements.
The FDA, in July, has issued its draft guidance on new dietary ingredients, often referred to as NDI’s. Companies are apprehensive that rather than obtain a blanket clearance for any new ingredient, they would have to secure approval for each new product that contains it.
There is also rising concern that grandfathered ingredients in the past, or those used prior to 1994, might be re-classified as new, potentially requiring the company to file a notice with the FDA.
Siobhan DeLancey, the FDA spokeswoman, said that if the dietary ingredient was only available as raw botanical before 1994, and the manufacturer used a chemical solution to extract the botanical, it could be classified as NDI because the ingredient is already in a different form that what was then available before DSHEA.
According to Steve Mister, the CEO of the Council for Responsible Nutrition, the broadened definition of an NDI hugely increases the burden on the industry. Others are also saying that the FDA would not be able to handle the overwhelming paperwork.
Attorney Marc Ullman, the chairman of the legal advisory group for the Natural Products Foundation, for his part said, “Every time a company wanted to combine an ingredient with another one, it would need to spend millions of dollars proving it was safe and it would require a new FDA notification each time.”
Ullman also said, “The agency is literally inviting thousands of submissions into a process that it’s barely able to handle today.”
