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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UNANSWERED QUESTIONS

For the FDA’s CTP, the rubber has already met the road, and what have surfaced are numerous gray areas within the regulations. The origin of these is not only the fact that the agency has an aggressive timetable set by Congress to meet in rolling out regulations, but that it is also still get-ting up to speed on the business of tobacco retail.

One major gray area for the CTP, says Kantor of Steptoe & Johnson, is the sometimes complex framework of retailers’ tobacco discount pro-grams. “I don’t think FDA has any expertise on the diversity of discount programs,” he says.

Questions also loom over loyalty programs—for example, whether, as part of a points-based loyalty pro-gram, a tobacco purchase can count toward earning a nontobacco reward. “No question,” says Kantor, “that’s a complicated area, and more guidance there would be helpful.” To address many of these gray areas directly, and ensure that retail-ers are comfortable with regulations passed thus far, the CTP has held a series of educational sessions in major cities, as well as one at the 2010 NACS Show. Ann Simoneau, director of the CTP’s Office of Compliance and Enforcement, says the agency has not come to a final determination on loyalty programs, and realizes that a lack of concrete answers can make retailers anxious.

 “With a new law, it’s always sub-ject to interpretation in some areas,” Simoneau acknowledges. The FDA’s Office of Chief Counsel reviews and evaluates many of the legal questions that pop up as the regulations are refined, and works with the CTP on reaching a final interpretation.

On the foodservice side, money and manpower stand in the way of regula-tions trickling down, an indication of how the country got to such a patch-work of regulations in the first place.

Big questions also surround menu labeling as the industry awaits final pro-visions from the FDA. Congress gave the agency one year, until March 23, to publish the final proposals for the provisions. As CSP went to press, no final proposals had been released, leav-ing retailers in a tricky holding pattern.

“They make federal regulations, but they don’t give the money or wherewithal for people to enforce it,” says Ludwig. “It’s those unfunded mandates that make us all pull our hair out.”

While the FDA received specific direction from Congress on the enforcement of tobacco legislation, little direction was offered on menu labeling. And while NACS has sub-mitted official comments a number of times in an effort to educate the agency on the c-store industry, menu- labeling legalese is still written largely through the lens of quick-service and sit-down restaurants.

“It makes compliance for out industry very questionable at this point because we offer in such a different manner,” says Julie Field, director of government relations for NACS.

Beyond how it will be enforced, big calories

Likewise, initial excitement from Modernization wasn’t determined before the bill was signed into law.

Enforcement on the tobacco side is in various stages of rollout in 15 states with which the FDA has so far contracted with state regulatory agencies. This may partly explain why there has not been a tidal wave of enforcement activity immediately following June 22, 2010, the date when several of the Family Smoking Prevention and Tobacco Control Act’s provisions went into effect. “I think FDA has exercised some discretion early on, knowing that some things are not 100% clear, and it takes a little time to get familiar with regulations and implement them,” says Kantor. His office, which typically catches wind of any unfairness in enforcement, had heard no complaints as of press time.

The hope is to have enforcement contracts signed with all 50 states by 2012. Throughout the fall of 2010, regulators in the state of Mississippi, one of the first under contract with the FDA, had made several initial retailer visits and issued warning letters, mainly on selling cigarettes or smokeless products to minors. A list of these retailers and the warn-ing letters detailing the violations were posted on CTP’s website, in addition to the many retailers who passed compliance checks. Simoneau says the FDA will post these lists on a monthly basis. Having state regulators carry out tobacco enforcement seems, at first glance, to be a win for the industry, because retailers already have an established relationship with their local regulators. However, as with food-safety regulations, some are concerned about the potential for inconsistent enforcement state by state. For one, these FDA inspectors, who will primarily be focused on fed-eral violations, will also be empow-ered to monitor state regulations.

“If the information they gather at inspection also determines there can be a state law violation,” Simoneau says, “then they can pursue a separate violation, and enforcement under state law.” Possibly the biggest area of retailer consternation is age verification, specifically the requirement for store clerks to ask for ID from anyone who appears younger than 27; this is in addition to the requirement that a retailer not sell tobacco to anyone younger than 18. A store could poten-tially be hit with two violations. “It is a tough rule and people ought to play it safe. And if it means checking IDs of people older than 27, well, that’s probably the price you need to pay to protect yourself under the current rules,” says Kantor.

THE MORE YOU KNOW

Opening the lines of communication begins at the federal level and trickles down to state and city officials and inspectors.

“One of the best ways for retailers to protect their business is to keep up to date on the FDA regulations and how the regulations will be administered,” says NATO’s Briant, who recommends regularly checking the FDA website for developments. He also recommends submitting comments on proposed guidance documents or new rules.

 “When we met with FDA officials, they stressed the importance of submitting comments because all of the comments are reviewed by FDA staff and used to shape how the agency will administer a regulation,” he says, citing that NATO routinely submits comments to the FDA on behalf of its retail members.

Lou Maiellano, of tobacco retail consultancy TAZ Marketing & Consulting Group, Sevierville, Tenn., is concerned that some retailers may be following directives by their corporate offices not to participate in commenting periods or advisory committees, due to vague liability concerns or general privacy policies. “The reality is that you’re in a situation where retailers need to become incredibly involved in this,” he says. “But, from my own experience, some small and large retailers have restraints from within on this.”

This, he says, would be a grave mistake: “If we don’t say and do the things we need to do, there won’t be reasonable rules or regulations.”

The food-safety side offers helpful insights for how to communicate with state and local FDA inspectors. “It’s all about relationships,” says Kwik Trip’s Ellingson. “The time is now to start engaging and opening the lines of communication with your local, state and federal officials in your jurisdiction.”

Because the three states Kwik Trip does business in (Wisconsin, Minnesota and Iowa) all have different food-safety laws, the 410-store chain adheres to the strictest regulations among the three. Ellingson recommends getting face time with state officials to show them your food-safety plan and ask, “Where you do you see risk?”

Kwik Trip also brings in a third party to audit its facilities, and it invites the state inspectors to come in and observe the process.

Tara Paster, president of food-safety training firm Paster Training, Pottsville, Pa., turns to state and local chapters of FDA officials, such as the Association of Food and Drug Officials, to help her understand new regulations. “Talk to them and build the relationships prior to any law changes: ‘What’s your interpretation of it? How is your jurisdiction going to interpret this information?’ ” she says. “Having the relationships built ahead of time with the regulatory community definitely helps when trying to maneuver through the regulations.”

If there is a critical violation, the Maricopa County Environmental Services Department will offer to conduct a risk-control plan, in which they discuss not only how the problem can be corrected, but also how to ensure it won’t happen again.

“If you have a good [inspector], you’re going to know it from the get-go,” Ludwig says. “They’re going to ask questions, they’re going to communicate well with you and they’re going to ask for your reasoning behind things.

“The bottom line,” he says, “is I hope inspectors can be approachable. It’s not about getting into a fight and arguing with them about a violation; it’s asking them to explain so you can do a better job. If you’re open with an inspector that way, it will help.”

Paster stresses the importance of training hourly employees on regulations—not only for general safety, but also to pass inspection. “They are asking employees questions, so operators need to make sure they talk to employees about some of the questions that inspectors may ask,” she says.

Paster’s sentiments on the Food Safety Modernization Act reflect the overall climate of the growing relationship between the FDA and the industry: Overall, it’s for the good.

“But the devil’s in the details,” she says. “How is this going to happen, how are we going to execute it, what’s the follow-up, what’s the monitoring, what’s the verification, how are we going to make this happen?”


How to Build a Strong Food-Safety Program

  1. Engage and open lines of communication with local, state and federal official in your jurisdiction.
  2. Get face time with state officials to show them your food-safety plan and ask, “Where do you  see risk?”
  3. If you have a commissary, have a third part audit your foodservice facilities, and invite state inspectors to observe the process.
  4. Ask state and local chapters of FDA officials, such as the Association of Food and Drug officials, to help understand new reguations. 
  5. When a violation has occurred conduct a risk -control plan to determine how the problem can be corrected and how ot prevent it from happening again.

FDA Defined

Center for Tobacco Products: Oversees the implementation of the Family Smoking Prevention and Tobacco Control Act. The CTP currently has a staff of around 200, which is anticipated to grow to 400 to 500 employees once it is fully established, and a 2011 bud-get of $421 million. Some of the Agency’s responsibilities under the law include setting performance standards, reviewing premar-ket applications for new and modified-risk tobacco products, requiring new warning labels, and establishing and enforcing adver-tising and promotion restrictions.

Center for Food Safety and Applied Nutrition: Responsible for promoting and protecting the public’s health by ensuring that the nation’s food supply is safe, sanitary, wholesome and honestly labeled, and that cosmetic products are safe and properly labeled. Eight hundred people work for the CFSAN, including chemists, microbiologists, toxicologists, food technologists, patholo-gists, molecular biologists, pharmacologists, nutritionists, epidemiologists, mathemati-cians, sanitarians, physicians and veterinar-ians, as well as support staff.

Food Safety Modernization Act: Signed into law in January, it gives the FDA a more proactive and less reactionary role in ensuring safety and sanitation in food pro-cessing plants. It empowers FDA to demand food recalls; requires larger food processors and manufacturers to register with FDA and create detailed food-safety plans; and greatly increases the number of inspections the FDA must conduct of processing plants.

 Basics for the Industry: In January, the FDA launched a new website for regulated industries in a larger push toward more transparency. The website, www.fda.gov/ FDABasicsforIndustry, includes basic informa-tion about the regulatory process, including information that is frequently requested.

 Nutrition-Disclosure Provision: As part of the 2010 Patient Protection and Affordable Care Act, foodservice operations with more than 20 locations must post calorie counts on menus and menu boards, a succinct statement concerning suggested daily caloric intake, and referral statement regarding the availability of additional nutrition informa-tion. The FDA must propose regulations within one year (ending March 23, 2011); mandatory requirements are not expected to take effect until after FDA finalizes the regulations.


Age Verification & You

  • Have a company policy on age verification for the sale of tobacco products—and follow it without exception. “The important thing is to have a policy, and follow the policy,” says Dave Gaudet, presi-dent of the BARS Program, which provides compliance training pro-grams to retailers.
  • With FDA regulations requiring retailers to ask for age verification from anyone who appears 27 years old or younger with each tobacco purchase, it’s best to play it safe, says Gaudet. He suggests clients consider a policy to card anyone who appears younger than 35 for tobacco and alcohol purchases.
  • Some retailers may worry that they will anger repeat customers if they ask them for age verification with each tobacco purchase. As Gaudet warns, even your competi-tion must follow this regulation. With FDA threatening a $250 fine whenever a retailer does not card anyone who appears 27 years old or younger—regardless of whether they actually are of legal age to purchase tobacco—do not let employees get complacent.
  • At the same time, do not card all customers, regardless of age— that’s not only a waste of resources but also a reason to give business to your competitors, Gaudet says. “A 55-year-old man will not be doing a sting for the government, but people with tattoos and a ring out of the nose very well could be.”

Key Issues for 2011

Compliance checks to ensure retailers are following FDA regulation on tobacco sales will step up as the agency continues to sign contracts with the rest of the 35 states.

The future of menthol flavoring in cigarettes and whether tobacco can be included in a loyalty program will likely be decided. The regulatory future of cigars will also be under scrutiny.

Final mandates on the nutrition-disclosure provi-sion (e.g., calorie counts) is due from the FDA March 23, though a due date on compli-ance has not been issued.

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