Lexington, KY - A new era in the history of the U.S. tobacco industry has begun with a presidential signature on legislation passed by Congress to give the Food and Drug Administration (FDA) regulatory power over tobacco products.
The Senate passed its version of the Family Smoking Prevention and Tobacco Control Act on June 11, with action from the House following the next day. President Obama signed the bill into law on June 22.
The bill, sponsored by Sen. Edward Kennedy (D-Mass.) and Rep. Henry Waxman (D-Calif.), has been nearly a decade in the making.
Opponents argued such a law would place added stress on an agency already straining to keep up with its mandated tasks, not to mention the concerns tobacco farmers will face. Kentucky's U.S. senators took a hard stand against the proposal during floor discussions, but to no avail.
"Thousands of Kentucky farm families and communities still depend on tobacco to make a living, and I have concerns about the effect this legislation would have on them," said Senate Republican Leader Mitch McConnell. "Mandating the FDA to regulate and approve the use of tobacco would be a distortion of the agency's mission and a tremendous misuse of its overstretched priorities. We should focus FDA resources on protecting the public health, not burdening it with an impossible assignment."
Sen. Jim Bunning said the USDA should be the proper agency to handle such regulations.
"I have always believed that as long as tobacco is a legal commodity, it should be regulated through the USDA, not the FDA," he said. "The FDA has no business on the family farm. And while I agree that we should do all that we can to keep cigarettes out of the hands of our kids, this bill is not the answer. We can and should do better. The only people this bill is going to hurt in the end are the small and honest farmers who depend on tobacco to pay their bills."
Bunning's comments bring back visions from the 1990s of huge banners that hung in tobacco warehouses stating, "Keep the FDA off the farm."
Tobacco companies have largely opposed the bill, with the exception of Phillip Morris, USA (PM). But all have voiced concerns, even using advertisements to convey their message.
Lorillard, the third largest tobacco company in the country, spoke to a number of issues through a print ad that ran earlier this month.
"With the legacy of recent food and drug contaminations still reverberating, the FDA is an agency that is already overwhelmed in its mission to protect Americans," the ad stated.
The comments also included concerns over the possibility of increased black market involvement, as well the legislation being nothing more than "prohibition in disguise."
R.J. Reynolds spokesperson Maura Payne said that company had largely opposed the bill for a couple of reasons.
"It does not set up a formal structure that will educate and encourage adult tobacco consumers to consider switching from a higher risk tobacco product to a lower one. Not all products have the same level of health risk, and we had hoped to see legislation that would make adults who use tobacco aware that there are differences in risk and encourage them to consider moving down that spectrum," she said. "The second area of concern centers around the selection of the FDA as the regulatory authority. Most people recognize that the FDA is struggling to keep up with its very full plate in keeping food and medical supplies safe. There is some concern that further piling on to the agency's accountabilities could cause them to lose focus on the very core mission they have."
Payne also said that Reynolds has had 10 years to decide how to come into compliance with such regulations and will obviously comply, but new product introduction will become difficult to achieve.
"At this stage, we'd like to play as active a role as the agency (FDA) will permit in how the details are set up around the actual implementation. We do expect it will add complexity. But at the end of the day, we believe we can keep continuing to compete for adult tobacco consumers, but it will become that much more difficult for us," she said.
PM has been the one company to support the legislation. Its parent company, Altria Group, released a statement after the Senate vote listing some of the benefits it sees to the bill, as well as concerns.
"This legislation would establish a regulatory structure and standards for the manufacturing and marketing of tobacco products that should provide important benefits to adult consumers for many years to come. We believe that adult consumers should be the primary beneficiaries of a federal regulatory framework: (1) under which all tobacco product manufacturers and importers doing business in the United States would operate at the same high standards; (2) for the pursuit of tobacco product alternatives that are less harmful than conventional cigarettes; and (3) that should provide for transparent, scientifically grounded, and accurate communication about tobacco products to consumers," according to the release.
The statement also noted, "The legislation passed today is not perfect. For example, we have expressed First Amendment reservations about certain provisions, including those that could restrict a manufacturer's ability to communicate truthful information to adult consumers about tobacco products. We also believe that the resolution of certain issues would best be handled by rulemaking processes that involve sound scientific data and public participation. We have made our views known on these provisions throughout the legislative process."
Brian Furnish, director of the Burley Tobacco Grower's Cooperative, said it is too early to know to what extent producers will be affected, but his organization has worked in a practical manner in anticipation of the law.
"We feel like this has been coming for years; it was just a matter of getting the right people in Washington. We know it will affect growers down the road somehow, some way. We just don't know what the changes will be at this point," he said. "In our minds it could be good for us, because we feel like we can make changes faster than other growers in the world."
Furnish also said that the Co-op has provided funding for studies at the University of Kentucky in recognition of the coming regulations - studies to find varieties of tobacco plants that would produce less nicotine and nitrosamines, for instance. Nitrosamines are organic compounds found in various foods and products and thought to be carcinogenic.
"That research is going to be very important. From a grower's standpoint, we feel like we are being proactive, trying to come up with something that will help not only domestically but in the foreign markets as well," he said. "It's going to be a challenge but with any challenge comes opportunity."
That research couldn't come fast enough for some growers. Fayette County farmer Todd Clark is growing about 65 acres of tobacco this year and has been in the business long enough to see many changes. He hopes the new regulations will be nothing more than one more change and not the end of an era.
"I'm concerned about several little things that I've noticed over the last couple of years and I'm concerned of the potential - not the probability but the potential - for burley tobacco, which I raise, being completely removed from the mixture for cigarette blends," he said.
Clark makes this point because nitrosamine levels have been known to be higher in burley tobacco as opposed to other types, mainly because of the method used to cure the plant.
"I think that is the worse case scenario, but being somewhat of a realist, you have to have that in the back of your mind," he said.
It was a tough planting season for most producers as they dodged continuous rain so, for now, Clark said, he thinks most growers are more concerned with taking care of their crop rather than anything going on in Washington.
"I don't think this is the beginning of the end, but I think it's the beginning of change. I'm a first-generation farmer, so my perspective tends to be a little different from other farmers. Because of that, whether it's tobacco, hay, cattle or whatever, I see it as a neverending process of change, and the person who changes first and quickest tends to prosper," he said.