Venable partner Todd Harrison was quoted in Functional Ingredients concerning the increasing likelihood of FDA regulation of so-called New Dietary Ingredients (NDIs).
If the FDA takes a broad view of what constitutes an NDI, the effect on the dietary supplements and functional foods industry could be substantial. Classifying a significant number of ingredients as NDIs could create a backlog of NDI filings, as companies race to avoid being in violation of the law or having to pull products off of store shelves.
"There are a lot of things they have done that clearly telegraph that," said Harrison. "When you get bits and pieces of what the 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."
Responding to a question about what companies can do to prepare for an uncertain future, Harrison responded "make sure that you have good data on the safety side on your product." Noting that existing regulations "grandfather" ingredients on the market prior to October 15, 1994, Harrison nonetheless recommended that companies pursue safety studies for those ingredients as well.
"There are reasonable ways of interpreting the statue and there are unreasonable ways," Harrison said.
If the FDA takes a broad view of what constitutes an NDI, the effect on the dietary supplements and functional foods industry could be substantial. Classifying a significant number of ingredients as NDIs could create a backlog of NDI filings, as companies race to avoid being in violation of the law or having to pull products off of store shelves.
"There are a lot of things they have done that clearly telegraph that," said Harrison. "When you get bits and pieces of what the 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."
Responding to a question about what companies can do to prepare for an uncertain future, Harrison responded "make sure that you have good data on the safety side on your product." Noting that existing regulations "grandfather" ingredients on the market prior to October 15, 1994, Harrison nonetheless recommended that companies pursue safety studies for those ingredients as well.
"There are reasonable ways of interpreting the statue and there are unreasonable ways," Harrison said.