CRN Sees Voluntary Supplement Registry Bringing Regulatory Plus Retail Benefits

While an industry-run registry would not conduct pre-market evaluations nor state that a product’s health claims and ingredients are compliant, retailers and other businesses selling supplements could see it as a seal of approval.

The Council for Responsible Nutrition suggests voluntary registration of dietary supplements in a database that could not only strengthen FDA’s oversight, but also help retailers determine which products reach their shelves.

While an industry-run registry would not conduct pre-market evaluations of products nor state that health claims and ingredients are compliant, it could be seen by retailers and other businesses selling supplements as a seal of approval for the quality of the registered items.

Retailers, including online businesses, “down the road, might say, ‘You know what, there’s a certain amount of credibility that comes with being on this registry. So if you want to be on the shelf in my store, you need to be in the registry,’” said President and CEO Steve Mister

“It could become one of the things that retailers look for when they’re deciding what they’re going to put on their shelves,” he said in an interview.

CRN’s board at the trade group’s conference in October considered suggestions from a task force of members studying options for a potential database of supplement products marketed in the US. The ideas included asking FDA to operate a mandatory registry with costs potentially paid by user fees from the industry, a program which would require authorization by Congress.

Mister said an industry consensus appears to support starting a registry of supplement products but does not extend to establishing user fees to pay for it.

“That was one of the reasons why we decided it is not the right time to go to Congress with this. We think there’s a pretty broad consensus that there needs to be a database, that there needs to be a single product registry,” he said.

However, once a user fee is suggested to pay for the registry, “then you start to lose your consensus. People are not aligned around whether we want to have user fees at FDA,” he said.

Instead, CRN is developing a plan for a registry and will present information at its board’s meeting in December on potential opportunities, including modeling it on or incorporating it into the National Institute of Health Office of Dietary Supplements supplement label database or other product registries already available online.

Some Information Open, Some Secure

In addition to labels, the registry would include a unique identifying code or number for each supplement, product marketers’ contact information available to all users and manufacturers’ information available only to FDA or other regulatory agencies.

Consumers should contact the company behind a brand – retailers or other businesses that sell private label supplements as well as firms that make and market their own brands – for questions or complaints about a product, Mister said.

“If the contract manufacturer’s name was easily available on the [registry] website, that would deter consumers from going back to their retailer and might send them directly to a contract manufacturer, who really isn’t set up for that kind of person-to-person interaction with the consumer.”

FDA, however, needs to know which firms are making each supplement, and CRN’s task force suggested making some information accessible only to regulatory agencies.

Similarly, the registry would need to keep proprietary ingredient blends confidential.

“We’re calling for whatever’s on the label would be in the database. There would have to be some assurance that that kind of information would be protected. If it were put into a central repository, it would have to be protected so that competitors could not have access to it,” Mister said.

On the other hand, FDA already can access supplement firms’ proprietary blends by reviewing master manufacturing records during good manufacturing practices inspections. “I think the question for us is whether we would want to put that into a central database and how we could protect so that competitors don’t have access to it,” Mister said.

Augment, Not Add To FDA Authority

The announcement of CRN’s registry project comes at the same time former FDA deputy commissioner Joshua Sharfstein suggests Congress authorize FDA to require pre-market registration of dietary supplements and to fund the program with user fees (Also see "Sharfstein Suggests Requiring Supplements Registration, Testing Standards" - Pink Sheet, 9 Nov, 2015.).

In a recent Drug Testing and Analysis journal article, Sharfstein also argued to move the focus of FDA oversight of supplements from evaluating efficacy to ensuring consumer access to safe products.

The Dietary Supplement Health and Education Act permits nutrient, health and structure/function claims for supplements while prohibiting claims on the prevention and treatment of disease, but did not provide FDA with authority for pre-market approval nor to require data justifying structure/function claims, Sharfstein, currently a dean at Johns Hopkins University Bloomberg School of Public Health, and a research colleague wrote in their article.

They suggest Congress “embrace the goal of promoting access to safe dietary supplements” through legislation that “would prioritize stronger [FDA] oversight of identity of supplements and risk to consumers.”

CRN agrees with the suggestion that FDA “is not the best-equipped to evaluate the efficacy” of supplements, but disagrees that the agency needs additional authority for effective oversight of the industry, Mister said.

“FDA already has some of the authority [Sharfstein and Kapoor are] talking about,” but the agency “just is reluctant to use it,” he said.

As an example he noted warning letters that identify supplement manufacturers with numerous, serious GMP violations or FDA announcements about products marketed as supplements but containing drug ingredients.

“There is no question that FDA has authority to go into those companies and stop production and seize product if they don’t meet GMPs.”

And while FDA must coordinate with the Department of Justice to gain court orders shutting down noncompliant supplement firms or to litigate civil or criminal charges against businesses operating in the supplement space, the agency also works with DoJ on enforcement in other areas of its oversight.

“Whether it’s cosmetics, prescription drugs or devices, if they’re going to seize product they’ve got to get outside help and they seem to do just fine if they want to seize a pharmaceutical. So that’s not a fair argument to say they need outside help. It’s all in where you put your priorities,” Mister said.

CRN advised other trade groups about its project and encourages firms from across the industry to register their products when a registry is available. It did not ask other groups to work on the project.

“We’re going to pursue this. We think CRN’s role in the industry, as being sort of the credible voice of the industry and being a thought leader for the industry, this is something that CRN can do and will show leadership by doing. We hope that the others will join us,” Mister said.

CRN’s board could decide in December on the supplement registry approach or wait until March for its first meeting of 2016.

“If we pursue a database that’s already up and running and just needs some tinkering, it could happen very quickly. If we decide that we’re going to create our own that could take longer,” Mister said.