FDA calls for new tools
Schiller, who is the principal associate commissioner for policy in FDA’s Office of Policy, made his observations as part of a speech at teh Council for Responsible Nutrition’s annual members meeting, which is taking place this week in Carlsbad, CA.
CBD explosion adds to burden
Schiller said the CBD issue has put into stark relief the mismatch between FDA’s capabilities and the responsibilities it faces. The dietary supplement marketplace continues to grow appreciably. If all of the supplement-like CBD products now on the market are thrown into the mix, it’s exploding. But FDA’s resources are not growing to match.
FDA is under significant pressure from lawmakers to come to a quick resolution on CBD. But Schiller warned that whatever happens on CBD, FDA can’t ignore its current responsibilities in favor of the new darling ingredient of the industry.
“By some estimates, the CBD market has already grown to roughly half the size of the entire dietary supplement market at the time DSHEA was passed. Think about that,” Schiller said.
“And think about this: If we were to create some kind of exception for CBD, how many new products would come on the market from manufacturers without a history of complying with basic requirements like good manufacturing practices, or truthful labeling?
“Do we at FDA have the tools and resources we would need to identify all the potential violations we might see, let alone address them? And what would that mean for our existing work?” Schiller added.
Mandatory product listing
Schiller noted that FDA is continuing to work through comments made as part of the meeting the agency convened in mid May on responsible innovation in the industry. The goal, he said, was to identify key points and get a dialogue started, not necessarily to come up with a finished plan on how DSHEA might altered or added on to.
Among the changes that FDA is advocating for in the structure set up by DSHEA is for a mandatory product listing. Under the plan, before bringing a new product to market manufacturers would need to submit certain basic information to FDA including what’s in the product and who’s making it. This is information that is already mostly available via other sources, Schiller acknowledged. But having such a central database, which he believed wouldn’t cost companies much to comply with and which he emphasized was not a step on the road to premarket approval, would provide a valuable tool for FDA in dealing with the new market realties.
In Schiller’s view, in absence of such a listing, FDA currently faces the following challenges:
- The agency doesn’t know how many dietary supplements are on the market, and has no systematic way of knowing when a new product is introduced.
- FDA doesn’t know how many products contain any given ingredient. And if it turns out that there’s a safety problem with a particular ingredient, or a particular ingredient supplier, the agency doesn’t have the basic information to quickly identify which products are affected.
- FDA doesn’t have a reliable way to capture trends in the market so it can anticipate and adapt to new areas of risk.
- And the agency doesn’t have the visibility it needs to be able to effectively prioritize its resources.
Better enforcement on tainted products
Schiller said another issue that could be addressed as part of the agency’s new tools would be a simpler enforcement decision tree for products adulterated with drug substances.
At the moment if a product being marketed as a dietary supplement is found to contain a drug ingredient and is making drug claims on the label or on the website, FDA has a clear enforcement path. But if it contains a drug ingredient, such as undeclared sibutramine which is found in many weight management products, but is not making explicit disease treatment claims, the situation is murkier. It’s not a supplement, because it no longer meets that definition. Is it a mislabeled drug, if it makes no claims? It’s a question that gums up the enforcement machinery and can gobble up scarce resources, Schiller said.
“One way to help address this issue would be to move the drug substance exclusion out of the definition of ‘dietary supplement,’ and make it clear that the presence of such substances in a dietary supplement renders the product an adulterated dietary supplement – which would be in addition to any other potential violations. The universe of what could be a lawful supplement wouldn’t change, but FDA would have a clear and direct way to use our authorities over adulterated dietary supplements to move against these unlawful and potentially dangerous products containing drug ingredients,” he said.
Schiller emphasized the goal in all of these suggestions is to give FDA additional tools without placing much in the way of new burdens on industry.
“As we continue to consider possible legislation in this space, we should be looking for more opportunities like these – updates that can preserve the essential balance of DSHEA while at the same time advancing FDA’s ability to detect and address violations that put the public health and safety at risk,” he said.