The submissions of New Dietary Ingredient notifications seems as fraught as ever, and part of the issue is that regulators are not as communicative as they could be, according to Alex Schauss, senior director of AIBMR Life Sciences.
The rejection rate for NDI notifications stands at about 75%, based on the most recent data available from the American Herbal Products Association. Some submissions are rejected based on incomplete characterization of the ingredient in question, whereas others are turned down based on the strength (or lack thereof) of the data that the submitting company uses to prove that the ingredient can reasonably be expected to be safe under the conditions of use.
”If you went to visit FDA and asked them what do I need to do, you are not going to get clear guidance. That is a little unusual. They don’t take the liability of making those recommendations. You are going to have to find professionals who know what studies to do and understand what quality of studies are needed to prove safety,” Schauss told NutraIngredients-USA during a video interview at the recent Institute of Food Technologists show in New Orleans.
Procedure is necessary
While the submission of a notification is a costly and time-consuming undertaking, Schauss absolutely supported the need for the procedure.
“You want to make sure that anything that we ingest is safe. Because a dietary supplement ingredient could be ingested chronically, even though it comes from a plant or a fruit does not mean that it could not contain chemicals in it that could be potentially harmful. Remember, the only defense mechanism plants and marine organisms have is chemistry. At low dosages these chemicals are innocuous. But we can make mistakes in the processing and concentrating of those materials and raise the levels of those chemicals to where they can become harmful,” he said.
Schauss said that despite the clear need to vet the safety of new ingredients, some companies were skirting the issue. He said he found a number of ingredients for sale on the show floor in New Orleans that should have had NDI notifications on file and did not.
“When I see something that really concerns me I don’t hestiate to tell the company this is who I am, this is what I do and I am familiar with this ingredient and are you aware that you need to file a NDI notification in this market. Many of them are here because they got regulatory approval in another market, but that market might not have been rigorous in terms of safety,” Schauss said.
Companies that want to use a dietary ingredient not marketed in the U.S. before Oct. 15, 1994 are required to submit an NDI notification explaining why the ingredient is reasonably expected to be safe. This notification must be submitted at least 75 days before the dietary ingredient is introduced or delivered for introduction into interstate commerce.
FDA does not "approve" or "disapprove" NDI notifications. Instead, the agency generally provides one of several types of responses. According to FDA, examples of these responses include, but are not limited to: (1) letter of acknowledgement without objection; (2) letter listing deficiencies that make the notification incomplete; (3) objection letter raising safety concerns based on information in the notification or identifying gaps in the history of use or other evidence of safety; and (4) letter raising other regulatory issues with the NDI or dietary supplement (e.g., the NDI is not a dietary ingredient as defined by regulation or the product is excluded from the definition of "dietary supplement" under current regulations because it is not intended for ingestion.
Raising the bar
One of the things that characterized some early submissions was their low quality, which contributed to the high failure rate. Some companies had obviously not taken the time (or spent the money on legal counsel) to understand what the law was calling for in terms of properly idetifying the ingredient in question and citing scientific data backing an assertion of safety that aligned adequately with that particular ingredient.
But even as companies have become more sophisticated, the level of proof needed has gone up, too, in the opinion of some observers.