At 241 pages, reading—much less understanding—the deeming regulations proposed by the U.S. Food and Drug Administration (FDA) is no simple task.
Andrew Perraut has a unique perspective on just how complex that document is. As a policy analyst for the White House Office of Information and Regulatory Affairs (OIRA), Perraut was the lead for all regulatory issues for tobacco for six years (pre-dating the FDA’s Center for Tobacco Products) and participated in the redrafting of the deeming regulations before the proposed regs went public in April 2014.
“There’s a lot there,” Perraut says. “The FDA is going to be asserting its authority over this entire class of products for the very first time. That comes with a tremendous amount of change.”
After leaving OIRA last August, Perraut has gone from reviewing proposed regulations to advising clients on navigating the regulatory process. Clients of Perraut’s San Francisco-based consulting firm, Radiant Strategies, are advised on how regulatory policies get made and how they can best participate in the process.
In an exclusive interview with CSP, Perraut shares some of his wisdom on what retailers need to know about the proposed deeming regs, what’s not in the proposal, and the realities of the rulemaking process in the future.
Q: There’s been lots of chatter about flavors and open systems. Should we be worried about an FDA attempt to ban these options?
A: “I have heard some folks saying that perhaps the FDA might want to ban open systems or flavors in some way,” says Perraut. “I think that is exceedingly unlikely.”
The first hurdle for a flavor or open-system ban? The FDA did not propose a ban on flavors or open systems in the proposed rule. Typically, Perraut says, the agency can’t include wholly new provisions in a final rule that were not present in the proposal.
Another problem is the potential legal challenges of such a drastic action. Both the FDA and the White House must consider potential litigations and cost-benefit analysis when drafting and reviewing this kind of legislation.
“It would be incredibly difficult for the FDA to make the case that a ban on open-ended systems could pass any rational cost-benefit test,” Perrault says.
That isn’t to say flavors or open systems won’t be addressed in some way. If anything, Perraut expects a “lighter touch” regulatory approach—such as a requirement for childproof caps on e-liquids—in the revised deeming regulations. Alternately, he says the FDA could start a new rulemaking specifically to address open systems, flavors or even Internet sales. As to that likelihood, the FDA hasn’t given any indication that banning flavors, open systems or Internet sales are the priority.
“The FDA has a really aggressive schedule and has already listed out several wish lists for the near term on tobacco,” he says. “Internet sales, flavors or open systems weren’t on them. That doesn’t mean they couldn’t pursue it—but it’s not on the agency’s immediate list.” (See chart below for what is indeed on the FDA’s agenda.)
CONTINUED: Retailer-Friendly Deeming Rules?
Q: No flavor ban, no open-system ban—the deeming rules seem fairly retailer-friendly. Am I missing something here?
A: Perraut says the biggest red flag of the proposed deeming regs has more to do with manufacturers—and the pre-market approval requirement.
“The reality is, the process that the FDA has proposed is not very well fleshed-out,” he says. “They have not published the specific standards that they’re expecting applicants to meet, so a lot of this remains a little bit unknowable.”
Issues Perraut expects will arise from the pre-market requirement include:
Cost: Perraut would not be surprised if the cost to file a pre-market tobacco application (PMTA) is in the millions of dollars—a prohibitive figure that could put some manufacturers out of business.
Lack of Labs: Each PMTA will require substantial scientific testing and analysis. There are a finite number of facilities in North America qualified to handle this kind of analysis, which could create a steep backlog.
Lack of FDA Manpower: The FDA has ruled on less than 3% of the significantly less detailed substantial equivalence (SE) applications. With 4,000 SE applications still pending, how can the agency possibly handle what Perraut predicts will be tens of thousands of science-heavy applications?
Bye-Bye Innovation: This is where it hits home for retailers: If it’s going to cost millions and take years to complete and process a PMTA, e-vapor innovation will likely come to a screaming halt.
“Assuming these regulations are finalized in their current form, the pre-market approval process is going to be really cumbersome,” Perraut says. “Because of the 2007 grandfather date, unfortunately, the less burdensome SE pathway isn’t going to be available. It’s obviously a primary concern.”
Q: Could SE be an option? And if not SE, what else could be?
A: There are varying opinions on whether or not the grandfather date—which states only products on the market by 2007 can qualify for the SE pathway—can be moved.
Though not a lawyer himself, Perraut suspects this might be “a legal heavy lift” due to the clear language in the original statute. “It’s not yet clear that the FDA would want to move the SE date if they could,” he says. “But because of the statutory construction, it’s a difficult spot for vaping products.”
Fortunately, moving the grandfather date is not the only option. The FDA could delay the effective date of the PMTA requirement, giving companies (and the agency) more time to process applications; the agency could simplify or revise the pre-market application, making it more attainable. Alternatively, the FDA could propose a separate, less-complicated PMTA process based on a product’s place on the nicotine risk continuum.
“There are all sorts of strategies to make the process work better,” Perraut says. “So it’s certainly worth engaging in the process.”
Q: I thought the public commenting period ended in August. Isn’t it too late?
A: Yes, the period to submit comments to the FDA has passed. But the FDA isn’t the only way to engage in the rulemaking process. Interested parties can also share their perspective during the White House review.
“It’s as important, if not more important, to be engaged during the period of White House review than it is to give comments(to the FDA),” Perraut says.
While the FDA must first and foremost consider public health, the White House review takes a much broader approach. This process, led by the aforementioned OIRA, focuses on making sure the regulations align with the president’s agenda and balances the costs and benefits of the proposed regulations.
“That (OIRA) process is really a time to think about unintended consequences,” says Perraut. “This is a rule where we’re expecting to see a lot of those.”
Because of that approach, the proposed regulations often go through a lot of change during the White House review. Perraut says the FDA’s proposed deeming rule came out of the process “fundamentally different.”
Though multiple government agencies are involved in the White House/OIRA review, it is not widely known that the public at large has the opportunity to participate as well. “The OIRA process is very intentionally a little bit under the radar,” Perraut says. “Parties are generally fairly informed on how to submit their comments [to the FDA]; folks are much less informed about how to engage during the White House review.”
According to Perraut, retailers and manufacturers can request a meeting to present their case to OIRA during the review period—a meeting that typically includes OIRA, the FDA and other executive branch agencies directly involved with the rule’s review.
Q: How long before these regulations are actually fınalized?
A: The deeming of e-vapor, cigars and other tobacco products has dragged on, thanks in part to a changing of the guard at the FDA’s Center for Tobacco Products and a government shutdown. But Perraut expects the end is near, in part because we’re on step seven of the nine-step rulemaking process (see chart), and because President Obama’s time in the White House will soon end.
“With the looming election, there will be significant pressure to get the rule done,” Perraut says. “I would be very surprised if [deeming] is not finalized far before the 2016 election. We’re on a much swifter timeline.”
And the gridlock in Congress combined with an outgoing president could also result in a slew of executive actions on tobacco.
“As we get closer to the election, we will enter what’s known as ‘the midnight regulations period,’ ” says Perraut. “The deeming rule is certainly not going to be the end of tobacco regulations during this administration.”
CONTINUED: FDA's Agenda & Schedule
What’s on the FDA’s Agenda
The FDA’s unifıed agenda—or “wish list” of potential tobacco regulations—is a matter of public record (www.reginfo.org). While limiting or banning open systems, flavors or Internet sales of e-vapor products is not on that list, there are issues that might affect tobacco retailers and manufacturers. These issues include:
- Clarifıcation of When Products Made or Derived From Tobacco Are Regulated as Drugs or Devices: “The rule will describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device or a combination product.”
- Investigational Tobacco Product Applications, and Establishment Registration and Product Listing for Tobacco Products: “This regulation would prescribe the form and content of domestic establishment registration and product listing for manufacturers of tobacco products. The regulation would also establish a requirement for foreign establishment registration and listing for manufacturers of tobacco products, and prescribe the form and manner of such registration and listing.”
- Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients and Additives: “The Federal Food, Drug and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act, requires the Food and Drug Administration to promulgate regulations that require the testing and reporting of tobacco product constituents, ingredients and additives, including smoke constituents, that the agency determines should be tested to protect the public health.”
Down the Rulemaking Pipeline
2009 | The “initiating event.” Congress granted the FDA the authority under the Tobacco Control Act to extend federal regulations to other kinds of tobacco products, potentially cigars, pipe tobacco, electronic cigarettes. |
2011 | FDA determines the necessity to adopt new regulations. The agency issues an Advance Notice of Proposed Rulemaking for deeming other tobacco products. |
2011-2013 | Drafting of the proposed rule. |
2013 | White House review of proposed rule. |
April 25, 2014 | Publication of proposed rule. |
April-August 2014 | Public commenting period. |
Today | FDA reviews and responds to comments. This is where the FDA makes any changes to the fınal rule based on comments (timing TBD). If the FDA adds new regulations not included in the original proposal, the agency will have to begin a new rulemaking process for any additional regulations. |
TBD | White House review of fınal rule (typically 90 days maximum). |
TBD | Publication of the fınal rule in the federal register. This will include an effective date for the new regulations. |
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