Meet Your Regulators

As ambiguities persist regarding tobacco and foodservice regulations, FDA and industry get to know each other.

By
Samantha Oller, Senior Editor/Special Projects Coordinator

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As c-store retailers grapple with a new relationship with the U.S. Food and Drug Administration (FDA)—a reality nearly two decades in the making—one can almost decipher the five stages of grief. First came denial: FDA oversight of tobacco had been struck down before, and it would be again. Then came anger as industry associations, retailers, manufacturers and their lobbyists fought relentlessly against federal oversight, which was picking up support in Congress. Bargaining began as NACS sat down with legisla-tive representatives to make the Fam-ily Smoking Prevention and Tobacco Control Act more palatable to retail-ers. And then there was depression, as the rest of the industry realized the inevitability of the act’s passage.

Now, as FDA tobacco regulation rolls out at a breakneck pace and over-sight of foodservice looms, it seems the industry has reached a begrudging acceptance—a sentiment that every-one’s just trying to do their jobs, so we might as well try to do it together.

This is true progress, as therapists might say. Consider that not only does the retail channel loathe regula-tion, but that the FDA, by overseeing tobacco and fresh food, now has veto power over two categories that gener-ate more than 56% of c-store retail-ers’ inside sales and more than 47% of their take-home profit, according to the NACS State of the Industry Report of 2009 data.

With this reality, it may be time to drop the “Us vs. Them” mentality, both retail representatives and gov-ernment officials say.

Learning how to work with the FDA, rather than merely castigate its existence, is crucial for the c-store channel to prosper and maximize its two most robust offerings. Lobby and litigate against specific measures? Absolutely. But in the meantime, open up communication. And that is precisely what is happening. Both sides are showing an early desire to open the lines of communication, from the drafting of regulations to enforcement and inspections. Despite the goodwill, many unknowns remain as the FDA continues to finalize and update its regulatory policy. They include:

  • How will regulations affect tobacco discount programs, or loyalty programs?
  • When will menu-labeling man-dates be finalized?
  • With state regulators likely to act as enforcers for the FDA, how will fair-ness and consistency be guaranteed?

With heightened foodservice regulatory authority only recently signed—without appropriations for enforcement—where will the money come from? The pressure to answer these and other questions are compacted by aggressive timetables from Congress. And these looming unknowns make communicating with federal, state, local and tribal regulators and inspec-tors all the more crucial for successful compliance.

If you haven’t already, it’s time to meet your regulators.

‘UNDERSTANDING COMPLEXITIES’

In exclusive interviews with CSP magazine, FDA officials from both the Center for Tobacco Products (CTP) and the Center for Food Safety and Applied Nutrition (CFSAN) stressed their wishes to better understand and work with the c-store industry. This is especially true for the tobacco side— an altogether new focus for the agency.

“I want us, FDA, to be seen as a good partner, and supporting what [retailers’] needs are, supporting their ability to implement and enforce the laws that they are now required to do, and I want them to see us as their partners—not as their big brother,” says Dr. Lawrence Deyton, director of the CTP.

Deyton is a fervent believer in the CTP’s mission and speaks with an enthusiasm for its goal—preventing the sale of tobacco to minors—that reflects his medical background. He formerly oversaw public health programs, including tobacco con-sumption, at the U.S. Department of Veterans Affairs, and still sees patients one day each week.

“I think it’s a phenomenal set of responsibilities we have,” he says, and cites the CTP’s first regulatory muscle flex—a ban on fruit- and candy-flavored cigarettes—as an especially powerful example of its potential impact.

“As soon as we put that in place, we started getting calls and letters from retailers who said, ‘Thank you—we don’t want to sell these products to kids,’ ” he says. “That’s where I understood very early the incredible power, the role the nation’s retailers have in being success-ful in implementing this law, and that they want to do the right thing.”

Despite agreeing with Deyton on the goal of barring youth access to tobacco, retail groups continue to voice concern about what future measures the FDA will adopt—from potentially barring menthol from cigarettes to imposing additional marketing restrictions—which can have a dramatic effect on this largest of in-store categories. At the same time, they are quick to praise the CTP for fostering a culture of two-way communication.

Thomas Briant, executive direc-tor of the National Association of Tobacco Outlets (NATO), Minne-apolis, has met with Deyton and staff from the CTP on two separate occa-sions with a group including sup-plier and retailer representatives, and found them “very open to working with tobacco retailers and the tobacco industry on these new tobacco regu-lations,” he says via e-mail.

Besides considering their com-ments on proposed regulations and guidance documents, the CTP has also met with the group to discuss how regulations will be administered and enforced. “I believe we have opened a real dialogue that will lead to a greater understanding of how the tobacco industry works and how to reach a shared goal of ensuring compliance with the new tobacco regulations,” Briant says.

Dave Riser, vice president of exter-nal relations, trade marketing, for R.J. Reynolds Tobacco Co., Winston- Salem, N.C., was a participant in those meetings, and he seconds Briant’s take. “In our meeting, and in training ses-sions I’ve listened in on and been a part of, they want to ensure success of guidance and provisions that are implemented,” he says. “They were very sincere, in my opinion, on listen-ing to retailers and wholesalers, and us as manufacturers.” While R.J. Reynolds and other manufacturers have disagreed with the FDA on some tobacco regulatory efforts, such as the requirement that all advertising be in black and white, Riser adds, “They have a job to do, just like we do.”

And while differences of opinion will likely characterize future talks, so will items of common interest. “We have common goals with FDA on youth tobacco prevention, on informing the public,” he says.

“We as a company want to work with FDA to provide information where we can— science-based information—to work together.

“They’re very open,” Riser contin-ues. “When it comes to the retail and wholesale community, they’re trying to be as visible as possible and learn about this industry, to work together and to ensure success of implementa-tion of the provisions.” This period of education will require patience from both retailers and the CTP.

“They’ve started regulating, but it takes an even longer period of time to get to know both the subject matter and industry in a fulsome way,” says Douglas Kantor, partner with Steptoe & Johnson LLP, a Washington, D.C.- based law firm that advises NACS on FDA regulatory law. “They have a lot of folks within the [CTP] with different levels of experience with either this industry or the product, and it takes some time, and will continue to take time for them to understand all of the complexities out there.”

And here is where retailers can play a role, in a situation where they might otherwise feel powerless.

“I want a vigorous response from the nation’s retailers and conve-nience-store owners, because that’s their voice in this process,” Deyton says. “We are going to be successful when we develop and implement regulations and rules that they under-stand and feel they’ve had a part in.”

STREAMLINED AND CALIBRATED

Meanwhile, on the foodservice side—a part of the industry the FDA already has an established relationship with, since the 1906 Pure Food and Drugs Act—the agency is trying to streamline enforcement. It’s pushing for a uni-form adoption of the Food Code and increased interaction with industry.

“There’s a desire on our part, and I think the industry’s part as well, to get more uniform adoption of the code itself. And there has been a lot of progress with that. … But there’s still some cherry picking that goes on,” says Donald Kraemer, acting deputy director for operations for CFSAN.

“We’re very committed to that pro-cess of making state and locals feel like they own the Food Code as well, not just FDA saying, ‘Here it is, this is your code,’ ” says Kevin Smith, director of the Retail Foods and Cooperative Pro-grams Coordination Staff for CFSAN.

The Food Code is a thick tome (just under 700 pages, if you count the annexes) that gives state, local and tribal jurisdictions a “scientifi-cally sound technical and legal basis for regulating the retail and food-service segment of the industry,” as it’s defined by the FDA. A new Food Code is released every four years, with a Food Code Supplement of amend-ments published in the interim.

But here’s the rub: When a new Food Code is released, it’s up to the state to automatically adopt the new code, accept parts of it, or continue to follow an older version. Such a patch-work of regulations causes a logistical nightmare for even the best of mul-tistate chains. Most retailers in this situation will adopt the strictest ver-sion of the interpretation and make it uniform throughout the company.

“It’s patchy, but at least it’s get-ting a science-based code adopted in some shape or form,” says David Ludwig, manager of the Environ-mental Health Division of Maricopa County’s Environmental Services Department, Ariz. He oversees the county’s 115 inspectors. “A lot of the time it’s very hard for regulatory authorities to, every two years, go and get a new code adopted,” he says. He points to the state of Ari-zona: “They really aren’t thinking about legislative issues with the Food Code right now; they’re thinking money matters with how to correct the budget.” The last Food Code was released in 2009, and Ludwig says it has gotten increasingly more industry-sensitive.

“A lot of the changes that I’ve seen in the last 20 years in the Food Code is that it’s not up to the inspector to make a judgment call,” he says. “It’s more black and white and not just common sense.” Such changes include more complete requirements for sanitizing equipment and sur-faces, and, for the first time, time and temperature-control requirements for cut leafy greens. The FDA, retailers and manufac-turers alike want regulations based more on science, not on subjective interpretation of individual inspec-tors. Thus, on the foodservice side, the agency is in the process of stan-dardizing how it trains inspectors to reduce such variances, including a set of “voluntary retail food regulatory program standards” for state, local and tribal regulating departments.

“This is the gold standard for the enforcement people,” says Kraemer. “It’s voluntary, but we are working to encourage state and local authorities to adopt or try to meet those standards.”

Further, while the FDA Food Safety Modernization Act, signed into law Jan. 4, will directly affect manufactur-ers and processors more than retail-ers, the structure clearly advances the mission of science-based food-safety enforcement.

 “The new Modernization Act, as it’s written in its current format, looks like they’re going to use a science- based approach to figure out risk, literally,” says Jay Ellingson, director of food safety and quality assurance for Kwik Trip Inc., La Crosse, Wis.

“That is a part of the act that I think is a positive thing,” he says. “But where the rubber meets the road is if the government, whether local, state or federal officials, come out and actually see how it runs at the ground level.”

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