FDA responds to congressman's letter that calls out ‘FDA’s failure to act’ on NOW’s test results

Last April, South Carolina Congressman Jeff Duncan wrote to FDA Commissioner Dr. Robert Califf​, asking for clarification on several dietary supplements issues, with much of the April 12 letter focused on a perceived lack of a response from FDA to test NOW Health Group’s results from supplements purchased online.

“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, 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?”

This week FDA responded to Rep. Duncan’s email

In a letter dated May 28, FDA’s Erin O’Quinn, acting associate commissioner for legislative affairs, responded to those concerns. 

When it comes to how FDA evaluates findings such as test results by NOW, the FDA explained that it does not take enforcement actions that are solely based on third-party reports. If enforcement action is required, the FDA said it will obtain regulatory samples and perform its own testing. The FDA acknowledged the reports from NOW Foods and requested more information to evaluate the findings and consider them for future inspection or sampling plans.

"We are aware of the NOW Foods reports about their testing results; however, FDA asked the firm for more information about these results to evaluate the findings and determine how these reports might inform the Agency’s future inspection or sampling plans," the letter stated. "We recently received background information for some of the reports, and it is under review. However, FDA does not discuss open investigations or plans for future investigations with third parties."

Jim Emme, CEO at NOW Health Group, said NOW appreciates the FDA response to Rep. Duncan.  

"The information in the response regarding our testing of fraudulent Dietary Supplement product brands on Amazon generally reflects some of our discussions with the FDA," he said. "They acknowledge that we shared information with them during this process and also that we provided the FDA with the additional information they recently requested.

"We would prefer that the agency take immediate action against these sellers of fraudulent products. We do continue to be hopeful that the agency is still looking into the additional information we have shared with them and that this will lead to future enforcement action."

Natural Products Association President and CEO Daniel Fabricant, PhD, said he is happy to see the Congressman continue to push FDA on these issues, however he was disappointed that the Agency’s response was "pretty evasive."

"They basically just wrote off NOW Foods, versus saying ‘you know, look, we can't say we're going to use it," he said. "Obviously, we can't use it necessarily for anything specific enforcement-wise, but it's informative and we'll see. Hey, maybe we'll check the DSLD [Dietary Supplement Label Database] to see if these products are in there. Maybe we’ll check these firms to see if they’re registering. Maybe we'll find out who their contract manufacturer is.' There was really none of that, which kind of goes into the MPL discussion because it's like, this information is even better than MPL, and FDA made it pretty clear they're not even going to use this. So what's the value of an MPL?"

"NOW Foods does thousands of scientific tests a month," Fabricant added." It's not coming from a guy in the back alley. I'm not saying  they're going to use it in court, but I don't see how it's not informative—especially if there are companies that NOW tested that have repeatedly shown that they don't have anything in them. I mean, that's just allowing people to commit fraud, which FDA seems ok with."

Human Foods Program and other concerns 

The FDA reassured Rep. Duncan that the dietary supplement program remains a priority and that resources and authorities are being allocated to enhance oversight. The Agency said it continues to evaluate testing reports, address non-compliance with NDIN requirements and make improvements based on comprehensive evaluations.

FDA’s letter also responded to concerns over the reorganization of FDA's Human Foods Program (HFP), its impact on the Office of Dietary Supplement Programs (ODSP) and the NDIN program.

The FDA explained that the proposed HFP structure aims to prioritize the dietary supplement program within the Agency, with the dietary supplement program being part of the Office of Food Chemical Safety, Dietary Supplements and Innovation (OFCSDSI).

The Office of Dietary Supplement Programs (ODSP) will still exist within the new structure, integrating the dietary supplement program into the broader foods program while maintaining a distinct perspective on dietary supplements to ensure appropriate regulation.

The FDA emphasized that the proposed structure does not diminish the importance of the dietary supplement program and that ODSP will remain the lead office responsible for executing the Agency's dietary supplement responsibilities under the Federal Food, Drug, and Cosmetic Act (FDCA). The FDA also expressed its commitment to allocating additional resources and modernizing authorities to strengthen oversight of the dietary supplement marketplace.

Regarding the NDIN program, the FDA acknowledged that some products are marketed and sold without submitting the required premarket safety notification. The FDA reiterated that it issued draft guidance ​to exercise enforcement discretion for a limited time for overdue NDINs. The goal, it said, is to encourage firms to correct past failures, increase safety information and promote risk-based regulation. The guidance document is still in draft form, and the FDA said it is evaluating comments before finalizing it. The enforcement discretion policy only applies to past failures to submit NDINs and does not change the existing requirement for notifications.

Lastly, when responding to the question of why ODSP was not included in the  Reagan-Udall Foundation’s (RUF) evaluation of the Human Foods Program, FDA said that while the evaluation may not have included dietary supplements, the Agency did conduct an evaluation of the dietary supplement program​ as part of FDA’s announcement about new efforts to strengthen regulation of dietary supplements five years ago in February 2019.