In a letter dated April 12, Rep. Duncan also asked questions of Dr. Califf relating to the New Dietary Ingredient Notification (NDIN) process and why the Office of Dietary Supplement Programs (ODSP) was not considered in a Reagan-Udall Foundation evaluation of FDA’s Human Foods Program (HFP) despite ODSP being relocated within a larger Office of Food Chemical Safety, Dietary Supplements and Innovation.
But it is NOW’s testing program that dominates the first page of Rep. Duncan’s three-page letter. The Illinois-based company has performed 16 rounds of testing of lesser-known brands on Amazon, putting a range of supplement segments under the proverbial microscope. NOW’s program was recognized by the Editors of NutraIngredients-USA with the 2021 Award for Industry Initiative of the Year.
“What troubles me most is that despite sharing each round of testing results with the FDA and e-commerce platforms in question, I’ve been told that the natural products manufacturer claims they have never received a response or observed changes in the marketplace, with the same concerning brands continuing to be widely sold,” stated Rep. Duncan, who is the Chair of the House Subcommittee on Energy, Climate and Grid Security.
“I believe FDA’s failure to act on information from credible sources in this matter has consequences.”
In his questions at the end of the letter, Rep. Duncan asks: “When dietary supplement stakeholders provide information of this type to the agency, how does FDA evaluate the findings? Has the agency concurred with NOW and others’ findings and taken action against fraudulent products?”
NOW CEO: “There is fraudulent behavior going on”
Speaking with NutraIngredients-USA, Jim Emme, CEO of NOW Health Group, confirmed that his company has shared test results with FDA.
“Clearly the FDA has a difficult job to manage these situations, but we’re trying to show them where the facts are. If nothing else, get your own labs to test,” Emme said. “For a fact, there is fraudulent behavior going on.
“We were asked to meet with the FDA, which we did on January 18th of this year, and we had a discussion about some of the latest testing […] They asked us how we determine which products were fraudulent [and therefore should be subject to additional testing]. We basically do it economically. We know what the cost of active ingredients are—we’re big enough that we get really good pricing on them—and very quickly you can extrapolate if that expensive ingredient is in there or not.”
When asked what he hopes the response to the letter will be. “The optimist in me says there’s going to be enforcement that comes of it. I don’t know that that’s the case.”
The NDI situation
Rep. Duncan’s letter also discussed the NDI issue, and noted that a six-page draft guidance released in 2022 proposed exercising enforcement discretion on missing New Dietary Ingredient Notifications, granting an amnesty period of sorts so that the missing notifications can be filed without fear of having products that are technically adulterated pulled from the market.
“What was the basis for the FDA’s change in policy on the requirement that manufacturers or distributors of an NDI that has not been present in the food supply as an article used for food or a dietary supplement that contains the NDI, must submit a premarket safety notification to FDA at least 75 days before introducing the product to interstate commerce?” asks Rep. Duncan.
“Why has the FDA not taken enforcement action against these violative products?”
