FDA Looks at Future of Tobacco Products

Confusion Reigns Supreme


C-store operators aren’t the only ones left scratching their heads by the Food and Drug Administration’s (FDA) first foray into tobacco regulation.During the FDA’s teleconference, Catherine Lorraine, a lawyer for the administration, said, “I just want to draw your attention to the portion of the definition of a cigarette, which specifically refers to the appearance of the product and how it is perceived and offered for sale to consumers. And so we will be looking at products on an individual basis to determine if it meets that aspect of the definition of a cigarette.”

CNN reporter Miriam Falco responded by expressing confusion. “I’ve got to say I’m a little confused. Your answers are all very government-speak, if I may say so.”

Daniel DeNoon, an editor from WebMD also admitted to being “a little confused about exactly what is banned. It’s my understanding that we’re talking about any product that’s wrapped in paper and contains tobacco. Does this mean that cigars—small cigars that may be wrapped in a tobacco leaf and contain flavored tobacco are not included in the ban?”

Said Deyton, “the definition of a cigarette is that it has these characterizing flavors is what is banned. So it’s not what is labeled, it’s what is the actual product and its intended use.”

When a New York Times reporter asked, “have you made any decisions about what to do about flavorings in other forms of tobacco—small cigars, smokeless tobacco, snuff, other things like that?” Deyton responded that the act provides the FDA with the authority today to ban cigarettes with certain characterizing flavors. “Other flavored tobacco products are issues which we will be studying and certainly be discussing with the Scientific Advisory Committee, which is being set up.”

In other words, the waiting game continues.

The future could be clouded with uncertainty regarding tobacco products as the Food and Drug Administration (FDA) begins flexing its newfound regulatory muscle and keeps c-store operators guessing as to what it’s doing, what it’s asking for and what could be coming next.

What many fear is only the beginning of a series of disorienting stops and starts, second guesses and calls for clarification, which began on Sept. 22 with the FDA’s ban on manufacturing, importing, marketing and distributing flavored cigarettes, with the exception of menthol products.

At issue is which flavored tobacco products retailers will be permitted to sell going forward, and which are already banned. At the moment, no one seems completely certain.

Banned
It was back in June that President Barack Obama signed legislation giving the FDA the authority to regulate the tobacco industry, including the power to ban products, reduce nicotine in tobacco products and eliminate label claims like “low tar” and “light.” Tobacco companies are now required to place large, graphic warnings on cartons. The FDA can also make ingredients public and block marketing campaigns, particularly those targeting youngsters.

As of Oct. 1, according to the FDA, “cigarettes and their component parts that contain characterizing flavors (other than tobacco or menthol) or an herb or spice are illegal.”

Interestingly, the FDA went out of its way to say it would not provide a comprehensive list of illegal products. Instead, it provided a description of banned products, which states, “a cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke.”

The agency promised it would employ a range of enforcement and regulatory tools to address violations of the ban by, among others, manufacturers, importers, distributors and retailers. Before taking enforcement action, however, it is the agency’s general practice to issue warning letters to firms to notify them that they or their products are in violation of the law and to give them the opportunity to come into compliance.

“As always, when circumstances are appropriate,” the agency said, “FDA may take enforcement action to protect the public health without first issuing a warning letter.”

What Is and Isn’t
Working from a media briefing conference call and advisory documents posted on the FDA Web site (www.fda.gov), the National Association of Tobacco Outlets (NATO) helped bring some clarity to the announcement, explaining that cigarettes containing an artificial or natural flavor (excluding tobacco or menthol) that is “a characterizing flavor” were banned as of Sept. 22.

In addition, loose tobacco and roll-your-own (RYO) products intended for use in cigarettes can continue to be sold provided the tobacco does not contain a characterizing flavor that is banned under the new FDA law.

Menthol loose tobacco and menthol RYO tobacco, NATO emphasized, remain legal.

The advisory published by the FDA continues to take what NATO Executive Director Thomas Briant described as an “ambiguous” stance when it comes to the question of whether or not flavored little cigars are banned.

“The FDA essentially repeats the sentence that it included in its letter issued Sept. 14 and states in the advisory that the ban applies to all tobacco products with certain characterizing flavors that meet the definition of a ‘cigarette’ in the Food, Drug and Cosmetic Act (FDCA) even if they are not labeled as cigarettes or are labeled as cigars or as some other product,” Briant said.

During the conference call, Briant pointed out, a reporter from the New York Times inquired as to whether the flavored cigarette ban included a ban on flavored little cigars. Dr. Lawrence Deyton, the new Director of the FDA’s Center for Tobacco Products, answered that the issue of a ban on other flavored tobacco products would be “studied” by the FDA in the near future.

“The lack of a definitive ‘yes’ or ‘no’ in the FDA advisory on whether flavored little cigars are banned, plus the statement by Dr. Deyton about the need to study the issue further, can lead a reasonable person to conclude that flavored little cigars are not banned at this time,” Briant said.

The FDA has said that “bona fide” pipe tobacco is similarly not banned.

As CSD has previously reported, NATO had issued a letter requesting that the FDA issue a list by brand name of those flavored tobacco products that are and are not banned. It urged members to sign and send a copy of the letter to Deyton.

Retailers Respond
Robert Perkins, director of marketing for Rutter’s Farm Stores, said that he has been confused about the FDA ban, “but most of our suppliers have done a good job of keeping us informed,” he said.

As for future announcements from the FDA, Perkins remains “anticipatory, whether it’s good news or bad. It most likely will not help us, that’s for sure.”

Other retailers are disappointed the FDA isn’t keeping retailers more informed.

“I don’t know if I’m confused about what the FDA has banned or is permitting because I have not seen any literature specifically from them,” said Iris Yost, vice president of Yost Family 7-Elevens, a 7-Eleven franchisee operating five stores in Las Vegas. “But I think I understand what it is my 7-Eleven merchandising team has asked us to do.”

Yost admitted to being filled with trepidation over the FDA’s new authority. “It’s just getting more difficult,” she said.”I don’t know how anybody is able to feel comfortable about smoking in the United States of America. It’s like it’s a crime.”

In addition to her own stores, Yost is the vice president of 7-Eleven’s Nevada Franchise Owners Association (FOAC) and sits on 7-Eleven’s nation board of franchise owners.

Supply Side
Not surprisingly, manufacturers are also responding to FDA’s announcement. The National Tobacco Co. quickly issued a notice “clarifying” that Zig-Zag cigar wraps are a cigar product and thus not affected by the FDA’s ban on flavored cigarettes or flavored cigarette papers. It read, in part: “Please note that Zig-Zag cigar wraps are a cigar product and are NOT a cigarette product. Zig-Zag cigar wraps are designed to be used with Zig-Zag pipe tobacco cigar blend to allow adult consumers to make their own cigars. As such, these products are NOT impacted by the FDA ban on flavored cigarettes, flavored roll-your-own-cigarette tobacco, and flavored cigarette papers and filters.”

On a similar note, New Image Global issued a notice saying that the ban does not affect any New Image Global products, including the products sold under the Royal Blunts and True Blunts brand names and the EZ Roll cigar wraps.

In late September, the nation’s largest distributor of clove-flavored tobacco products asked a federal court to decide if its new filtered cigars are included under the federal ban on flavored cigarettes. Kretek International Inc., the importer of Djarum brand tobacco products from Indonesia, sued the FDA claiming that the FDA had threatened to ban
its products, causing the company to lose revenue.

How the suits play out and just what approach the FDA plans to take with retailers remains to be seen. CSD

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