Several lawyers at a recent event hosted by the Council for Responsible Nutrition (CRN) praised FDA’s team overseeing dietary supplements for its open communications with industry, but they also shared certain criticisms of the office, including that it has engaged in “erratic enforcement.”
Steve Mister, president and CEO of CRN, asked a panel of attorneys about areas in which the Office of Dietary Supplement Programs (ODSP) is faring well since its creation in December 2015.
“[I]mproved communication with industry ranks right up there at the top in terms of [ODSP] being very clear about communicating the expectations to industry,” responded attorney Ricardo Carvajal.
Carvajal, a director with Hyman, Phelps & McNamara P.C., said the industry may be “headed toward an era where we have more consistency in terms of leadership, personnel, funding [and] programmatic objectives for that office.
“And I think that will make a world of difference both to the FDA’s program and to industry as well,” he added.
Carvajal specifically complimented Steven Tave, ODSP’s leader.
“Whether you agree or disagree with his take on a lot of these things, he’s shown he’s very thoughtful,” Carvajal said. “He … has a genuine interest in the program, a genuine interest in improving the situation with industry.”
Miriam Guggenheim, a partner with Covington & Burling LLP, suggested the relationship has improved between ODSP leadership and the industry.
“There’s more of a respect for industry and starting position that industry really is out to do the right thing,” Guggenheim said. “They are not looking to cut corners, and that with appropriate guidance and clear and consistent guidance from FDA, industry players really are desirous of doing the right thing.”
During the Oct. 14 virtual conference hosted by CRN, the lawyers—all of whom advise firms on FDA regulations—also offered critiques of ODSP.
Guggenheim said there are ways in which ODSP is providing incentives for “bad players” and disincentives for “good players” through “erratic enforcement and lack of clear guidance, so you don’t have the folks who would do things right even getting into the fray.
“They’re sitting on the sidelines while the less scrupulous players are jumping in and not necessarily crossing every ‘T’ and dotting every ‘I,’” she added.
During the lawyer panel, Guggenheim cited as an example the CBD market.
“The CBD context is exactly where you see the folks who would be the responsible players, who would apply the most rigorous GMPs [good manufacturing practices] and identity evaluations for the material … sitting back and waiting for clarity,” she said.
FDA’s inaction, Guggenheim added, means “only those who are willing to take a risk are entering the space, and that shouldn’t be the way the agency incentivizes the industry.”
Stuart Pape, a shareholder with Polsinelli, agreed “the communication is markedly better,” but in his view, ODSP has achieved less success “moving the agenda along, solving problems, checking things off on a list of things to do.
“The communication is great, but I think the list of things to do is as long as it’s ever been,” he concluded.
Pape identified a problem with FDA’s ability to deter unlawful behavior in the dietary supplement space through adequate enforcement. While most people are inclined to comply with a regulatory program, “the level of compliance requires the perception, if not the reality, that the risks of enforcement is there, and the consequences of getting caught up in an enforcement action are serious enough to reinforce your natural inclination to behave,” Pape observed.
“I don’t see very much in what FDA does in enforcement in the supplement space as supporting the inclination of people to comply,” added the lawyer, who previously served in various positions in FDA’s Office of Chief Counsel. “The enforcement is too infrequent.”
During recent industry events, Tave has identified a “regulatory gap”—what he has described as the gulf between requirements in the law and what can be “realistically” achieved through enforcement.
“I’ve been extremely encouraged by the positive reception … from so many firms and industry organizations on this topic,” he said in an interview. “And almost without exception, many stakeholders have shown sincere interest in wanting to better understand the challenges and work together to identify solutions here.”
In helping to close the regulatory gap, Tave is in favor of a requirement in the law that dietary supplement products be listed with FDA so the agency knows what supplements and dietary ingredients are in the market.
Industry stakeholders should view “modernization not from a threat mindset, which can tend to be sort of the default, but more as an opportunity because anytime you’re talking about a legislative update there’s also an opportunity to clarify or fix controversial areas and problem spots for them,” Tave said.