FDA addresses NOW Foods testing program, reorganization’s effect on ODSP

The Food and Drug Administration has written to a U.S. lawmaker over dietary supplement issues, including a years-long testing program by NOW Foods that has revealed quality problems with supplements sold on e-commerce, including Amazon. 

In a letter to Rep. Jeff Duncan (R-S.C.) that the Natural Products Association (NPA) shared for this story, FDA also discussed the effect of its pending reorganization on the Office of Dietary Supplement Programs and a 2022 FDA draft guidance related to enforcement discretion for certain new dietary ingredient notifications. 

Finally, the agency addressed concerns that dietary supplements were not included in an independent evaluation of the Human Foods Program by the Reagan-Udall Foundation. 

NOW testing program  

In communications shared with FDA, NOW “has reported dozens of branded supplements sold almost exclusively on e-commerce platforms that do not meet FDA requirements for potency claims on the label,” Duncan wrote to FDA Commissioner Robert Califf, M.D., in an April 12 letter. 

Despite NOW communicating its findings to FDA, “I am told that FDA has seemingly taken no action in response,” Duncan noted. He asked Califf to answer how FDA evaluates information from dietary supplement stakeholders such as the results shared by NOW and whether the agency has acted against fraudulent products. 

Related:Congressman asks FDA about supplements fraud on e-commerce exposed by NOW Foods

“As a matter of policy, FDA does not take enforcement action based on third-party reports,” and if the agency needs analytical testing to support an enforcement action, its “practice is to obtain a regulatory sample and perform [its] own analytical testing to support product violations,” Erin O’Quinn, FDA’s acting associate commissioner for legislative affairs, wrote to Duncan. 

She said her agency is aware of NOW’s reports regarding its testing results, and FDA has asked the company for additional “information about these results to evaluate the findings and determine how these reports might inform the agency’s future inspection or sampling plans.” She added FDA is reviewing some background information from NOW for some of the reports.  

“When a product is determined to be in violation of the FD&C Act, FDA considers many factors in deciding whether to initiate an enforcement action,” O’Quinn wrote to Duncan. “Those factors include, among other things, agency resources and the threat to the public health. FDA also may consult with its federal and state partners in making decisions about whether to initiate a federal enforcement action. However, FDA does not discuss open investigations or plans for future investigations with third parties.”  

Jim Emme is CEO of NOW and a member of NPA’s board of directors. He said his company is appreciative of FDA’s response to the congressman.  

FDA’s statements “in the letter regarding the NOW testing program are generally consistent with what has taken place during our meetings and discussion with the agency since last January, including the statement that they had requested more information from us and that we provided the information they have requested,” Emme said in an email to Natural Products Insider.  

It's NOW’s preference that FDA begins “to take enforcement actions against these sellers of fraudulent dietary supplement on Amazon,” he continued, adding his company is encouraged that FDA has indicated it is reviewing the additional information provided by NOW. “We are available to provide additional information on these matters and will respond promptly to any additional FDA requests about our testing program of these fraudulent products.” 

Having tested products for several years on e-commerce, NOW has built a track record, NPA President and CEO Dan Fabricant, Ph.D., said. Fabricant, who oversaw FDA’s Division of Dietary Supplement Programs during the Obama administration, argued the agency should be doing something concrete with the information from NOW.  

“We’re not saying that FDA’s just going to take it and go enforce,” he said in an interview. “But if you have the same companies that are showing up again and again and not meeting [specifications], FDA can’t find out (1) if they’re registered [as food facilities with FDA] and (2) if they aren’t registered, say ‘Hey, you may not be registered because you don’t make anything, but … we need to know who your contract manufacturer is’’’? 

“Why can’t FDA do something like that?” he asked. “That’s not enforcement action.” 

Such activities, he and others have argued, could lead to FDA enforcement actions, helping to clean up the sprawling marketplace of poor-quality, fraudulent and potentially harmful dietary supplements sold online. 

FDA reorg impact on ODSP  

FDA’s letter to Duncan also addressed the impact of its reorganization on the Office of Dietary Supplement Programs. 

FDA announced on May 30 that its reorganization involving the creation of the Human Foods Program, adoption of a new model for its field operations and other modernization efforts have been approved. As part of the reorg, FDA intends to create an Office of Food Chemical Safety, Dietary Supplements and Innovation (OFCSDSI). 

“The reorganization will enable the FDA to be more efficient, nimble and prepared for the ever-changing and complex industries we regulate, new food and medical product technologies, as well as the impacts of globalization, climate change and other factors that require the agency to quickly adapt,” FDA said in a news release. 

Duncan had expressed concerns in an April 12 letter addressed to the commissioner of FDA that the decision to combine the Office of Dietary Supplement Programs (ODSP) with the Office of Food Additive Safety would “dilute the agency’s focus on dietary supplements.” 

In her May 28 letter to the congressman, O’Quinn responded that the reorganization at FDA “does not diminish or otherwise decrease the importance of the dietary supplement program.”  

“ODSP will remain the lead office responsible for executing the agency’s dietary supplement responsibilities under the Federal Food, Drug and Cosmetic Act (FD&C Act), and resources or capabilities will not be reduced,” she wrote to Duncan. “In fact, FDA continues to prioritize additional resources and modernized authorities to strength our oversight of the dietary supplement marketplace.”  

She also noted the current dietary supplement program would be integrated within the broader foods program, and ODSP would retain "the distinct dietary supplement perspective to ensure the agency is applying the appropriate statutory authorities to supplement-specific matters."

Fabricant said FDA didn’t explain in the letter to the congressman how it would confirm supplements aren’t deprioritized in the reorganization, such as ensuring that money is adequately appropriated to dietary supplements.  

“There’s no real discussion,” he said. “There’s no content there. It’s just like, ‘Ya, ya, ya, we heard your concerns. Nothing to see here. We’re with the government. We’re here to help. Don’t worry about it.’”