Food and Drug Administration regulation will give the tobacco industry “stability, predictability and uniformity,” but won't extend to the farm, says Philip Morris, the world's largest cigarette maker.

In an interview with the Southeast Farm Press, Michael A. Farriss, Philip Morris vice president of leaf, outlined why the company believes FDA regulation would be positive for the industry. He underscored the view that regulation of the tobacco industry would amount to regulation of cigarette makers only — and urged growers to get involved in the process.

Philip Morris believes, Farriss says that the proposed legislation should address at least six basic principles and build upon the framework of the Master Settlement Agreement (MS):

  1. Cigarettes should be regulated as cigarettes, not as food, or, as medical devices, which the FDA attempted to do in 1996.

  2. Regulation should not equal prohibition.

  3. Regulation should define reduced risk products and establish guidelines for communications about them.

  4. FDA should continue to address broad issues of disclosure so that consumers remain informed about critical health issues.

  5. Regulation should be built on the framework of the tobacco settlement agreements in working to prevent youth smoking.

  6. FDA should require that ingredients added by manufacturers do not increase the inherent risks or addictiveness of smoking and insure that cigarettes are made using good manufacturing practices.

PM's promotion of FDA regulation is an about face from its previous position of almost six years ago, but has been brought on by a change of circumstances in relation to tobacco, society and the public health community over the last several years. In 1995, the FDA said it had the authority to regulate tobacco. The assertion amounted to a maelstrom of opposition from the tobacco community, erupting into lawsuits and slogans urging “Keep the FDA off the farm.”

About a year later, the storm produced MSA among cigarette manufacturers and Attorneys General of 46 states and five territories. Earlier agreements were reached with Mississippi, Florida, Texas and Minnesota. Tobacco companies agreed to pay $200 million to the states over 25 years. Philip Morris points out that the MSA contained a number of advertising, marketing and operational restrictions similar to those contained in the 1996 FDA tobacco rule.

FDA's attempt to regulate tobacco docked at the Supreme Court. A 5-4 Supreme Court decision in March 2000 — which said Congress never intended for FDA to regulate tobacco — set the issue sailing for the legislative arena and Congress.

Philip Morris supports legislation to grant FDA “meaningful and effective authority to regulate the manufacture and marketing of cigarettes,” Farriss says. “That's what we mean when we say we're for FDA. We're for regulation of cigarette producers and marketers, but not regulation over tobacco growers or their farms.”

Without regulation, the tobacco industry could face separate regulation from each state as well as numerous localities, Farriss says. “Regulation would give the industry stability from having one framework.”

Farriss says that PM starts with the premise that regulation is not a bad thing. “It's a good thing,” he says. “It's important to make things better and a uniform set of standards,” including warning labels, would do that.

In effect, FDA regulation would provide a roadmap for cigarette companies, “one codification of rules that establish standards and procedures on how we do our business,” Farriss says.

Chief among those regulatory elements, Farriss says, is a definition of reduced risk products. “There's a lot of talk about what ‘light, low tar,’ and ‘ultra light’ mean,” the PM executive says. “FDA is in the best position to define what that means and inform consumers.”

Without a “codification” of cigarettes, it would become confusing for the consumer. Potentially, each of the 50 states, as well as numerous local governments could adopt their own regulation. “It lessens the message if you hear seven different things,” Farriss says. Regulation would provide one standard for cigarette companies to follow and provide a market environment that is “much more uniform in nature.”

He compared the change in thinking about FDA regulation to how some producers have come to view contracting in a positive light.

Other tobacco companies also support FDA regulation. In a newsletter to producers, PM asked for opinions regarding FDA regulation. By and large, the opinions were in support of PM's position, Farriss says.

While “meaningful and effective” regulation would benefit manufacturers, it also gives growers “predictability,” Farriss says. “That doesn't mean, however, that FDA would be on the farm.”

With that in mind, Farriss is asking growers to communicate their opinions through grower organizations to their representatives in Congress.

“I don't think the FDA drives changes at the farm level,” Farriss says. FDA regulation of the tobacco industry would bring “no more regulation to the farm base. We would make changes.”

To illustrate further, Farriss points to the nitrasamine issue. “There's no FDA in the nitrasamine issue,” Farriss says. “Philip Morris was at the forefront of making that happen.

“No one party can dictate a solution to this complex issue,” PM says in a white paper on the issue. “Voices from across the political and economic spectrums — from consumers to growers and retailers, from manufacturers to the public health community — need to be heard.”

In talking about legislation, the PM executive mentioned Senate Bill 190, legislation introduced by Sen. Bill Frist, R-Tenn. A similar bill in the House, House Resolution 2180, has also been introduced. The Frist bill contains many of the same principles PM would like to see in legislation to regulate tobacco.

“The time to get engaged in the process is now,” Farriss says. The best regulation, he believes, is “done by us and not to us, the collective tobacco industry, health advocates.”


e-mail: cyancy@primediabusiness.com