Fight to the finish - Third Quarter 2009
Sen. Richard Burr’s battle to stop FDA regulation falls short
TFQ Editorial Staff
In April the House of Representatives passed a bill (H.R. 1256) sponsored by Rep. Henry Waxman that would give the Food and Drug Administratio n (FDA) oversight of the tobacco industry. In mid-June the Senate approved its version of that bill, and President Obama signed it into law on June 22.
Before the Senate bill passed by a 79-17 margin, however, North Carolina Sen. Richard Burr offered alternative legislation by co-sponsoring a bill along with fellow Tar Heel Sen. Kay Hagan, arguing the tobacco industry should not be regulated by an already-overburdened FDA. Lawmakers have been trying to impose government control of the tobacco industry for more than a decade, kept at bay by strong resistance from “Big Tobacco” and its lobbyists. In fact, in 2000, the U.S. Supreme Court ruled that the FDA did not have the authority to regulate tobacco under the current law, and George W. Bush’s administration opposed Congressional efforts to rewrite it.
Under the Waxman bill—now the Family Smoking Prevention and Tobacco Control Act—though, the FDA will now have the authority to examine what goes into tobacco products and be able to ban ingredients it considers too dangerous to health, and it can also place limits on the marketing and sale of tobacco products. The FDA will require companies to reveal the contents of their offerings, and those companies will now have to seek permission to market new products.
The bill also gives the FDA the power to require changes to ingredients, including tar and nicotine; however, even some supporters of the bill feel it falls short in this area. For example, while the bill bans “candy” flavorings such as bubble gum and chocolate, it does not ban the most common flavoring: menthol. And while it allows the FDA to reduce nicotine levels, it does not ban the chemical.
“We will never be able to get rid of the addictive nature of tobacco because we are now forced to maintain the nicotine,” Dr. Michael Siegel of Boston University School of Health says in a CBS News story. “That is a tremendous victory for Philip Morris and Big Tobacco.”
Altria Group, parent company of Philip Morris U.S.A., the largest tobacco company in the U.S., issued a statement supporting FDA oversight. Other tobacco companies opposed the legislation, arguing that FDA limits on new tobacco products could lock in market shares for Philip Morris.
In a final effort to derail the Waxman bill, Sen. Burr attempted to hold a filibuster on the Senate floor, but in the end he was unable to muster enough support for his legislation. Sen. Burr spoke with Tobacco Farm Quarterly about the competing bill and where he sees FDA regulation going from here.
TFQ: The debate about this type of tobacco bill has been floating around Congress for more than a decade. What were the factors that finally led to its passage?
Sen. Burr: The Democrat majority in the Senate, as well as Rep. Henry Waxman’s position as chairman of Energy and Commerce Committee in the House, made it easier for this bill to be brought up and pass through both the House and Senate.
What impact will its passage have on the industry and the tobacco farmer in particular?
The user fees included in H.R. 1256 will cause the price of tobacco products to increase drastically. And when prices go up, consumption goes down. The decrease of product sales means less tobacco purchased from growers. Also, because the bill bans a good number of products currently on the market, tobacco purchased from growers for those products will cease to exist. If the FDA bans any future products from coming to the market, which is a large possibility, farmers will see tobacco sales decline.
Where do you think the Waxman bill was lacking?
The major issue with the Waxman bill was there was absolutely no true health regulation, and it put in place exorbitant fees on the tobacco industry.
What issues did your bill address that the Waxman bill does not?
Primarily, my bill dealt with harm reduction techniques and cessation programs. The Waxman bill did not address either issue. My bill encouraged current smokers to migrate from the most dangerous products to reduced-risk products. According to the American Association of Public Health Physicians, moving the more than 40 million smokers from cigarettes to low-harm smokeless products would reduce death and disease associated with smoking by 90 percent.
Also, cessation programs have proven to work in helping people quit altogether. Our bill mandated states use 20 percent of their master settlement agreement [MSA] payments on cessation programs, where Rep. Waxman’s bill had no cessation provisions at all.
Philip Morris in neighboring Virginia supported the Waxman bill, while North Carolina’s R.J. Reynolds opposed it. Speculation is that this will create an unfair market advantage for Philip Morris and make it more difficult to develop “low-risk” options. Do you see the bill’s passage as having a particularly adverse affect on the North Carolina company?
Absolutely. In the last few years, Reynolds American made the decision to move from being a cigarette manufacturer to being a “total tobacco” company. They were leading the way in harm-reduction products and less risky tobacco products. However, passage of H.R. 1256 completely dismantles the work they have done over the last few years by banning these products. Jobs will surely be lost as a result.
Do you have any feel for how heavy-handed the FDA will be with the tobacco industry?
It largely depends on who is selected to run the tobacco wing that will now be created under the FDA. It will be interesting to see who is put in charge and how they handle this large responsibility.
With the FDA already stretched thin, will it have the ability to efficiently regulate the tobacco industry?
This is one of the main reasons I opposed this bill. The bill does little to achieve the goal of improved public health and will end up doing more harm than good. Regulation of tobacco will divert funds and resources away from the approval of lifesaving drugs and medical devices in order to study a product that should not be under the FDA’s jurisdiction in the first place.
Also, the bill would severely impede the FDA’s core mission to ensure that foods, drugs, medical devices and cosmetics—currently 25 percent of the U.S. marketplace—are safe, effective and properly labeled. Tobacco is an inherently dangerous product, and adding it to the list would stretch the already overburdened agency even more while also significantly conflicting and distracting the FDA from its core mission.
In fact, the bill before Congress could shortchange the FDA’s budget by $2 billion, forcing the agency to move staff and resources away from food and drug oversight. It is ridiculous to ask the FDA, which is the federal government’s primary guarantor of safety and efficacy, to regulate a product that is fundamentally and undeniably unsafe.
Do you think the FDA will try to implement sweeping changes or will change be a long, gradual process?
Some changes will come quickly, like advertising and warning labels. Other changes, like the removal of constituents from cigarettes, will be a very long process, if they ever actually happen at all.
What is your biggest concern for growers who count on tobacco?
I’m concerned that this legislation will impact their annual income, thus threatening the job security of many tobacco farmers. By increasing the price of tobacco products, in turn, tobacco farmers will take a huge hit in sales, drastically reducing their annual income.
Most mainstream media focuses on the cigarette industry. How do you think FDA regulation will affect the cigar industry, which is largely composed of small, family-owned businesses?
According to the authors of the bill, “We’ll fix cigarettes immediately and cigars will come a little later.”