The old Boy Scout motto — be prepared — applies now more than ever.
It is expected — though it's not certain — that FDA will issue a guidance document covering the issue of New Dietary Ingredients (NDIs) sometime in 2011. No one can know for sure what this document will say, but experts familiar with the issue are unanimous in saying companies had better start getting ready for the worst.
The cloud that hangs over the industry is this: If FDA takes a broad view of what constitutes an NDI and therefore creates a large number of ingredients that might be subject to an NDI filing, it could create a huge backlog of such filings at the agency. It's possible that for a significant number of ingredients and finished products, companies might have to choose between being in technical violation of the law by continuing to sell an ingredient, or pulling a product from the shelves while awaiting the very uncertain outcome of an NDI filing.
When DSHEA was passed in 1993 the bill's language was somewhat vague as to the definition of what constitutes an NDI. The statue includes a "grandfather" date of Oct. 15, 1994. Any ingredient that came on the market after that date was supposed to have gone through the NDI filing process.
"We know form the 'podium policy' over the last couple of years that there are people who would cast it very broadly, as to what's an NDI," said Steve Mister, president and CEO of the Council for Responsible Nutrition. "There are a few things that are clearly grandfathered. Then there are some things that are clearly new. Then there's this huge gray area."
"There are a lot of things they have done that clearly telegraph that. When you get bits and pieces of what FDA is thinking they are going to define it as broadly as possible in their favor and as narrowly as possible in the industry's favor," said Todd Harrison, an attorney with law firm Venable LLP.
Some companies whose ingredients seem to meet the grandfather clause might be inclined to breathe a sigh a relief at this point. You're good to go, right?
Not so fast. What if, for instance, your botanical is now extracted with water, whereas alcohol was being used in the early 90s for the same extract? Or what if you found a way to boost the extract concentration into the 90% range, whereas the grandfathered material came it at 60%? Or what if you have changed your process or formulation to somehow boost the ingredient's bioavailability? All of these cases could end up being defined as NDIs under the new guidance.
Another issue centers on how you determine what was on the market in 1994. "There is no single official list of what was on the market in 1994, " Mister said.
FDA never generated its own list of these ingredients at the time, nor did it accept any list submitted by the industry.
And, while FDA sat on its hands the world changed. Records went from paper and microfiche to floppy disks and then online, with an inevitable amount of data loss in the process. So proving what was being sold in early October 1994 becomes harder and harder.
So what can companies do to prepare for this very uncertain future?
"I think I would want to be really thinking about what am I doing that was really different than 1994," Mister said. "What's my evidence of safety?"
"Make sure that you have good data on the safety side on your product," Harrison said. He recommends companies invest in safety studies even for ingredients that would seem to fall clearly on the grandfathered side of the equation.
"There are reasonable ways of interpreting the statue and there are unreasonable ways," Harrison said.
Preparing now could help a company weather the storm if FDA chooses the latter.