“Since we first raised this a year ago at the ACI conference, there has been a lot of discussion throughout the industry,” said Scott Bass, partner and head of global life sciences at the law practice Sidley Austin LLP and co-chair of the forum.
Bass was one of the key architects of the Dietary Supplement Health and Education Act, or DSHEA, back in the early 1990s, which was signed into law in 1994 and is the current regulatory structure governing the dietary supplement industry.
When Bass spoke about mandatory product registration last year, he didn’t know it would become “such an integral part of the ‘DSHEA 2.0’ conversation,” he said, using the nickname given to plans to revamp and modernize the law.
“This is an issue that has split the industry a little bit, and therefore having a debate here is helpful to move forward.”
Joining him on the stage was Will Woodlee, a partner in the firm Kleinfeld, Kaplan & Becker, LLP.
“I was assigned the role of providing the counter arguments to Scott,” Woodlee told the audience.
Here are some of the pro and con arguments on the issue:
Catching ‘bad players’… but will it work?
One argument for mandatory product listing was that it makes it easier to weed out the bad industry players that formulate drug-spiked products masquerading as dietary supplements. However, Woodlee said, the people that make drug-spiked products probably aren’t rule-followers to begin with, and they’re not likely to participate in the list nor declare the ingredients of their product truthfully.
“It’s hard to see that [a mandatory registry] will address the drug-spike issue,” Woodlee said. “Creating a new requirement that these folks will violate, creating a chance for FDA or DoJ to take enforcement action probably isn’t going to help much here either.”
The agencies usually don’t seek injunctions to product listing violations, he argued. “They don’t seize products, they don’t prosecute people criminally because they didn’t list products properly. You don’t see that in the drug world, you don’t see that in the device world, you don’t see that in the tobacco world either,” he added.
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Bass offered a different perspective in his speech on the issue of seizing products, though he didn’t touch on drug-spiking specifically. His take was more about making bad players more obvious and easier to catch.
“If you have a mandatory listing system with a misdemeanor violation, which merely means that FDA could just send a letter, all they have to do is cite the company saying they violated [a specific section of the law],” he argued.
It would be a much easier process than what exists currently. The FDA wouldn’t have get the Department of Justice involved, Bass explained.
“Right now the government has to make the case for going after a product. It’s not easy. And then it has to go through layers of review, and then if they really want to go to court they have to go through the Department of Justice—if it’s worth it,” he said.
If a law requiring product registration were to pass with a misdemeanor violation section written into it, “All they have to do is go to the border, see a product and say ‘oh it’s not on the list,’ that’s in violation, and we could detain. It provides a screen that doesn’t exist.”
We have the laws already, they just need to be enforced
Another popular argument against mandated product registration is that there are already laws in place that would make such a list redundant.
“Firms already have to register their establishments to comply with the Bioterrorism Act…they also already have to maintain the records of who they bought products from, and who they sold them to, which will allow FDA to trace back products in their distribution systems,” Woodlee argued.
To this, Bass asked: But aren’t a lot of the products that are sold here, what’s on the market, come from oversees without being part of FDAs database?
“The Bioterrorism Act requires foreign food and supplement facilities to register, and they’re subject to FDA inspection. You need the BA number to get into the country, technically,” Woodlee answered.
In Bass’ arguments, he highlighted how under the existing regulatory framework, it is difficult for the FDA to enforce its authorities to ensure consumer safety. The example he used was the New Dietary Ingredient, or NDI, notification process (which, after CBD, was an overall hot topic at the event).
“The NDI is supposed to cover everything, except for grandfathered products and conventional foods. But the NDI process isn’t going to work if FDA doesn’t know what’s out there,” he said.
“It’s really tough in this administration particularly, to get enforcement done,” he added. “For one thing, you know that prosecutors like to take the easiest case not because they’re lazy, but because if they have to convince a jury, they want something hard and juicy that would appeal to a jury or a senior government official.”
“So even though of course some sleazy players aren’t going to list initially, it makes it very easy to have reports from the industry about who’s not on the list,” and this may make enforcement easier.
Big or small burden?
How much of a burden a mandatory product registry would be to the industry is subjective. Bass argued that it’s not that big of a burden.
“In a $40 billion industry supposedly selling healthful products, it doesn’t hurt to have a little bit of a burden. It’s not a big burden,” he said.
One number that has been thrown around, which Bass used as a placeholder, was $50 per SKU to help fund the operations of the registry.
“If you’re in a business, and you can’t afford the $50 for a SKU, I would rethink your business,” he said.
Woodlee argued that the proposal burdens small businesses. “Don’t discount the burdens,” he said. “They can be significant, particularly for small companies with very large numbers of products with limited resources.”