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There may be no better time than now to work with FDA and those at the agency who seem to want to work with industry to solve problems.
“Time brings change” is an apt description of the relationship between FDA and the dietary supplements industry. Today, the agency and responsible members of industry seem more willing than ever before to work together on initiatives that promote the safety and integrity of dietary supplements on the market. But don’t take my word for it. Take FDA’s.
At the Council for Responsible Nutrition’s The Conference in California in October, guest speaker Steven Tave, FDA’s Director of the Office of Dietary Supplement Programs, spoke about “the common ground that we all”-agency and industry-“share towards the goal of a well-working dietary supplement market.” During his presentation, Tave highlighted several recent actions FDA and the dietary supplement industry each took to help protect consumer safety. One example he provided related to pure and highly concentrated caffeine products. In April of this year, FDA issued a final guidance warning the public about the dangers of products marketed as dietary supplements that contain highly concentrated, unsafe amounts of caffeine. Industry associations have also issued their own guidelines banning their memberships from selling concentrated caffeine products.
In his speech, Tave made sure to discriminate between responsible and irresponsible/illegal companies. When discussing the industry’s compliance with Good Manufacturing Practices, Tave said that while there is still a gap in overall compliance, “many firms are getting it right, and many firms are committed to ensuring that they deliver a quality product to their consumers-and that’s attributable in many ways to industry-led efforts to promote compliance.”
Comments like these give hope to industry that FDA is not out to act against all dietary supplements, but rather just those that are illegal and dangerous. Case in point, when Tave spoke about the agency’s enforcement actions against companies selling concentrated caffeine products, he made sure to point out that the agency “didn’t sweep too broadly and declare that all caffeine is hazardous.” He said the agency recognizes that caffeine, “when formulated and marketed appropriately, can be an ingredient in a safe dietary supplement product.” As such, he said, the agency was “conscious to leave a path for responsible firms…”
There’s been growing evidence in recent years that the agency and the industry are dialoguing more effectively. Take the agency’s draft guidance for new dietary ingredients (NDIs). While Tave did not have any updates on when FDA will release another revised or a final guidance, he did say that even as FDA grapples with how to handle some of the more complicated parts of the draft guidance, the agency also hopes to “make progress” on parts of the NDI draft guidance that are less contentious. He highlighted how the agency and the industry began discussions last October, at a public meeting held by FDA and attended by industry, on how best to handle the matter of determining which ingredients might not require an NDI notification (namely, those old dietary ingredients launched in the market prior to the passage of the Dietary Supplement Health and Education Act of 1994).
“The approach has been to try to make progress where we can on discreet topics, especially where there seems to be some consensus among stakeholders, and equally importantly, to do so in a transparent way while we continue to grapple with some of the difficult issues,” Tave said. He underlined: “We’ve committed to being transparent as we decide how to move forward on this issue.”
Another NDI issue the agency has been working to address is that of NDI master files that would allow an ingredient or manufacturing firm to submit a single NDI notification for an ingredient that other companies using that ingredient can thereafter operate under without needing to submit an NDI notification of their own. Tave said FDA “has been holding discussions with our stakeholders, including CRN,” to continue discussions of what kind of master file process would best serve the market. “If we’re going to invest in developing a master file process, we want to make sure that it’s consistent with stakeholder needs,” he said. “We don’t want to spend our time developing a process if it won’t be used.”
Tave said FDA is cognizant of the need to reduce the burden of the notification process-a sentiment industry wholeheartedly agrees with. “We don’t need to review notifications for products that aren’t required to submit them,” he said. “That’s not a valuable use of anyone’s resources.” And, he repeated what the agency has said in the past: that companies are welcome to meet with FDA staff before submitting a notification to ask any questions they may have-an option he said usually results in a higher likelihood of a successful notification.
FDA’s willingness to communicate openly with the dietary supplements industry in a transparent fashion could be very important as industry looks toward upcoming industry initiatives. One developing industry topic under discussion, not only at the CRN conference but also among the industry behind doors, has been the topic of whether or not FDA should create a mandatory, federal product listing where companies must list their dietary supplement products, the idea being that FDA will have a better idea of which products are on the market so it can do a better job of regulating the industry.
One industry expert I’ve interviewed previously about the notion of a mandatory listing is attorney Scott Bass, a partner at law firm Sidley Austin LLP. Bass sat on a panel at the CRN conference that debated the pros and cons of a federal listing. Bass, who believes FDA should create a mandatory listing, acknowledged those industry members who don’t want an FDA listing because they are concerned FDA might use that information in ways industry won’t like. Bass helped to draft the DSHEA statute, which was created at a time when the relationship between FDA and industry was much more contentious than it is today. Bass said at the panel debate, “I understand the well-based view that people don’t or did not trust FDA, but I can tell you firsthand, there is nobody in power at FDA now who is trying to go after industry.”
Should industry take the optimistic road and accept FDA’s sentiments that the agency would like to work with, not against, the industry? And if so, will the industry be able to find new opportunities to work with FDA that could serve to better the regulatory framework for both industry and consumers? Only time will tell.
“I would say that I have never seen more possibility for cooperation-and in some cases, collaboration-with FDA since the passage of DSHEA as to what we have now,” Steve Mister, CRN’s president and CEO, told me. “I’ve never seen a time when the agency is so eager to work with the industry to solve problems. That’s not to suggest that we agree with them, or that they’re going to roll over on us, but there is a genuine effort to solve issues and make it a better marketplace for consumers. And, I mean, we can’t argue with that. That’s what we’re all looking to do.”
Of course, Mister points out, on something like the topic of a mandatory listing-which, for the record, CRN has not taken a position on, pro or con, and that FDA has not mentioned publicly itself-“I think we have to go in with eyes wide open.”
But, the fact is there may be no better time than now to work with FDA and those at the agency who seem to want to work with industry to solve problems. For, there’s no telling how long the spirit of cooperation at FDA will last. “You always have to think about the fact that the relationship you have now [with the agency] might be different in five years, particularly if the leadership changes,” Mister says. “So, you want to be sure that you’re protecting yourself against potential changes in that relationship, but this is a very good time to be working with the agency and to try to do some things that maybe we couldn’t have done in the past.”