An Update on Tobacco News and Trends
R.J. Reynolds Tobacco Co. said it “strongly disagrees” with the ruling by the U.S. Food & Drug Administration (FDA) that four of the company’s brands—Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13—are “not substantially equivalent” (NSE) to their respective “predicate” products (defined as products that were commercially marketed as of Feb. 15, 2007).
The FDA issued orders Sept. 15 to stop the sale and distribution of the four R.J. Reynolds cigarette products because the company’s submissions for these products did not meet requirements set forth in the federal Food, Drug & Cosmetic Act, the agency said.
It concluded that the products have different characteristics than the predicate products and that the manufacturer failed to show that the new products do not raise different questions of public health when compared to them. Consequently, as of press time, the FDA notified the company that these products can no longer be sold, distributed, imported or marketed in interstate commerce.
“These decisions were based on a rigorous, science-based review designed to protect the public from the harms caused by tobacco use,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “The agency will continue to review product submissions and exercise its legal authority and consumer protection duty to remove products from the market when they fail to meet the public health bar set forth under law.”
Meanwhile, R.J. Reynolds “respectfully disagreed” with the evaluation. “We believe that our substantial-equivalent applications fully satisfied the guidance the agency provided,” said Jeffery S. Gentry, executive vice president of operations and chief scientific officer for Winston-Salem, N.C.-based R.J. Reynolds, in a statement the company issued in response to the ruling. “We supplied the agency with extensive information on each of the products, and responded to all of the agency’s questions. Our product stewardship process is rigorous and ensures that we are producing the highest-quality products that meet regulatory requirements.”
All of the brands included in the order represent a very small portion of R.J. Reynolds’ business, less than 0.4 share of market, the company said. “Our submissions to the agency on these brands were comprehensive, and we believe we effectively demonstrated substantial equivalence. We’re examining all of our options at this time,” Gentry said.
‘Gas & Grass’
Beginning this month, consumers in Colorado Springs, Colo., will be able to fill up their vehicles and purchase medical marijuana in the same place. Native Roots, a Denver-based company, is set to open up two Gas & Grass locations.
The dispensary will have its own entrance and must follow all the same rules and restrictions that apply to all other medical marijuana stores in Colorado. The gas station, like all gas stations, will be open to the public.
Company spokesperson Tia Mattson told KOAA, an NBC affiliate in Colorado Springs, Colo., the gas-station concept simply expands on the other-than-cannabis business idea.
“It’s just one more thing for us to pair up the shopping and convenience of gas with a stop for somebody who is a patient, to knock off both errands at one time,” she said. She expects the store will carry lottery tickets, beverages, cigarettes and other c-store items.
Reacting to criticism of the concept, Native Roots spokesperson Dave Cuesta emphasized that smoking marijuana in the store will be prohibited. “That is a state law, local law. There’re many, many rules and regulations that prohibit any on-site consumption,” he told KXRM, a Fox News affiliate in Colorado Springs, in a separate report.
Native Roots has 11 medical-marijuana dispensaries and retail marijuana stores statewide. The stores have a uniform look with common merchandise and pricing structures. In addition to marijuana products, the stores also sell marijuana-themed shirts, hats and souvenirs.
Also in the business plan are loyalty discounts for marijuana patients buying gas, similar to programs established by grocery and club stores with their own gas stations. —Additional reporting from Melissa Vonder Haar