Mandatory dietary supplement product registration is coming, DSHEA author says

July 31, 2018

In July, attorney Scott Bass, who helped draft DSHEA, told Nutritional Outlook that mandatory product listing not only makes sense for industry but is also likely to happen in the near future.

Mandatory product registration could soon become a reality for dietary supplement companies, according to an industry expert. In July, Attorney Scott Bass, who helped draft the Dietary Supplement Health and Education Act of 1994 (DSHEA), told Nutritional Outlook that mandatory product listing not only makes sense for industry but is also likely to happen in the near future.

In June, Bass, a partner at law firm Sidley Austin LLP, along with Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN; Washington, DC), co-chaired the American Conference Institute’s 6th Annual Legal, Regulatory, and Compliance Forum on Dietary Supplements. During his presentation, “Industry at a Crossroads: Five Challenges We Need to Confront,” Bass told attendees that a mandatory federal dietary supplements product registry, not a voluntary product registry, is needed in order for industry to self-regulate.

“Without mandatory listing of dietary supplements, none of it is going to work,” he told Nutritional Outlook. “I think people have to just come to that recognition, and whether it’s through regulation or legislation, it’s in the industry’s best interest to have a listing of products.”

The registry Bass has in mind would require companies to submit a list to FDA of all the products they are selling in the market. “The listing would just be the name of the product, what ingredients are in it, and the name of the company marketing it,” he says.

What would FDA do with this information? At the very least, Bass says, the agency would know which products are on the market, which should then enable it to better enforce against bad actors and illegal products. As he told forum attendees: “[There is] no hope for effective fraud prevention unless government knows what is on the market.”

“When FDA says, ‘We want to stop lousy products from China coming in that are spiked with illegal drugs, how do they know what’s on the market? How do they know what to stop? They don’t,” he told Nutritional Outlook.

Without a comprehensive view of all products on the market, Bass said other dietary supplement regulatory initiatives won’t be successful. For instance, he says, DSHEA’s provision that companies submit new dietary ingredient (NDI) notifications to FDA for ingredients not on the market prior to October 15, 1994, will never be fully realized if the agency doesn’t know for sure which products are on the market. “NDIs are semi-meaningless without” mandatory registration, he told forum attendees.

A mandatory listing could also help FDA get a better sense of which products on the market came from inspected facilities and which didn’t, he points out. Not only that, but industry companies themselves would also benefit from knowing what’s on the market in order to then know whether or not they need to file an NDI notification.

This kind of knowledge, Bass says, “is not threatening; in fact, it would be empowering to legitimate industry.”

 

Getting Industry on Board with Mandatory Listing

There are some in the dietary supplements industry opposed to the idea of mandatory product registration. Bass says they shouldn’t be. Companies should not be uncomfortable submitting information such as product name, ingredients list, and company info, he says, because if a product is already on the market for retail, this information is already in the public sphere. “There is nothing secret if you’re offering it for sale to consumers,” he says.

Moreover, he says, the government deserves to have access to this information. “If you’re selling a product on the Internet or in a store, you bet the government has a right to know about it,” he says.

He points to other markets in which product registration with FDA is mandatory, such as over-the-counter drugs and medical devices-markets that he says have flourished even in the face of mandatory registration.

Also, he says, enhancing the industry’s legitimacy through mandatory registration might also help industry finally achieve its longtime efforts to, for instance, get dietary supplement purchases more broadly covered under the federal Supplemental Nutrition Assistance Program (SNAP), or even Medicare or Medicaid, similar to the way that insurance companies cover prenatal vitamins.

Those likely to resist mandatory registration fall into two camps, Bass says. The naysayers are likely to be those who don’t trust the government or those who have something to hide.

“Some industry people have resisted because they think it’s Big Brother trying to hold its hand,” he says. In part, he says, “That’s fine. I expect that. It’s not a current [point of view], but there was distrust for decades before that.”

In his opinion, FDA’s trustworthiness has improved. “What led to DSHEA was the underlying premise that FDA abused its authority, which it did, and that they couldn’t be trusted because they were constantly out to kill the industry. But that’s history,” he says, pointing to his own current interactions with the agency as evidence. “The current Office of Dietary Supplements and the FDA Commissioner are not against the dietary supplement industry. They are not. As I pointed out, FDA isn’t the problem anymore. It’s us.”

The other group of people who would resist the idea of mandatory registration are the bad actors, those “selling products they don’t want to be discovered [because they] have stuff in there they don’t want people to know about.”

The bottom line is that the dietary supplements industry needs to learn to better self-regulate and to be more transparent, Bass says. At the forum, he told attendees that the U.S. supplements industry, $40 billion strong, needs to “take charge of itself and grow up.”

“[Some people] want to keep trying to fly under the radar, allow themselves to use cheap suppliers, and not spend the money on GMPs. It’s just too late for that,” he says. “It’s a $40 billion industry. They have to grow up and consider not just the public health but the advantage in having legitimate products. Big retail outlets want to know there’s legitimacy, and they’re not providing that.”

Bass also doesn’t feel that a voluntary registry goes far enough. “A voluntary listing program is the right idea but by definition will only include the good players who want a clean market. The whole purpose of the listing is to identify those who are on the market and those who shouldn’t be on the market, and a voluntary listing doesn’t do that.”

 

Changes Are Coming?

Does FDA currently have the power to require mandatory registration? Bass says yes. “I’ve been talking to a number of parties about that. I believe FDA has the power under its current statutory mandate,” he says.

 

When asked which parts of the Federal Food Drug and Cosmetic Act today would allow FDA to mandate listing, Bass points to two. First, he points to 21 CFR 402(f)(1)(A), which makes it illegal to market an adulterated dietary supplement. This provision, he says, could be interpreted as requiring FDA to know the full scope of products on the market. Again, he says, “I think the only way FDA can legitimately enforce the adulteration provisions is to have knowledge of what products are on the market, and without a listing, I don’t think that it can.”

The second existing statute Bass points to is the FD&C Act’s new dietary ingredient regulation (Section 413(a)(2)). This regulation could be interpreted to mean that in order to establish and maintain an NDI process, FDA would need to know which companies need to file an NDI notification. “And to be able to know who has to file, you need to have a listing,” Bass says.

Despite the current authorities outlined above, Bass says he expects most to prefer enacting registry requirements through legislation. He adds that it’s uncertain, in the current political climate, whether the agency would exercise its current statutory authority to mandate registration.

The prevailing question is how soon could a mandatory product registration happen? Sooner than you’d think, Bass says. “I don’t think it’s a dream far away. Let’s just say there’s a lot in motion now,” he tells Nutritional Outlook. “This is not just some idea for five years from now.”

“I think mandatory listing is coming, but I don’t know in what form or when-but it will not be far away,” Bass states.

Ideally, the industry should be leading efforts to establish a mandatory registry, Bass says. “It should be industry who pushes it because it’s in their best interest. The people who want to make legitimate products and sell to large players and who want to have the industry cleaned up should be the ones clamoring for it.”

“It’s not a big ask,” Bass says, of the requirement that companies register their products. “It really isn’t.”