Court Ruling Turns Drugmakers Into Tobacco Companies

[Bill Godshall]

If anyone finds a weblink for the following commentary, please post. Matt Barry (who used to work for CTFK and now works for Bloomberg) interviewed me last week, and sent me this copy.


Court Ruling Turns Drugmakers Into tobacco Companies: Insight

Commentary by Matt Barry

Dec. 29 (Bloomberg) -- A court ruling that electronic cigarettes can be regulated as tobacco products instead of drugs is likely to upend the world of tobacco regulation.

This decision promises to blur the line between tobacco products and various medications, such as nicotine gums and patches, to expand the market for traditional smoking-cessation devices, and to generate additional tobacco tax revenue for governments.

A U.S. Court of Appeals panel ruled Dec. 7 that electronic cigarettes may be sold as tobacco products, rather than quit-smoking devices, which would free manufacturers from U.S. Food
and Drug Administration drug regulations.

As long as they make no claims about helping people stop smoking, manufacturers are enabled by the ruling to sell gums, patches, lozenges and other products that contain nicotine derived from tobacco under looser standards applied to cigarettes.

The FDA appealed the ruling Dec. 20 and asked the full court to hear the case. The agency said the appeals panel erred in defining tobacco products so broadly.

If the decision stands, it means nicotine gum could be marketed like a pack of Altria Group Inc.’s Marlboro cigarettes -- “Welcome to Nicorette Country” -- instead of relying on doctors and pharmacists to recommend its use.

Market Potential

The retail value of U.S. cigarette sales is estimated at $85 billion a year, and sales of nicotine-based smoking-cessation products will be about $755 million in 2010, according to data compiled by Bloomberg.

This change might require drugmakers to display tobacco warning labels and pay tobacco taxes as do cigarette and smokeless-tobacco makers. Tobacco products also are facing increasing regulatory scrutiny, leading to the requirements for graphic warning labels and limits on sales to minors.

The FDA tried to block imports of electronic cigarettes in 2009, saying they were potentially dangerous and being sold as unapproved drug-delivery devices.

Electronic cigarettes look like cigarettes. Users inhale nicotine vapor created by a battery-powered heating element.

Smoking Everywhere Inc., a manufacturer, sued the FDA, saying the devices were safe and weren’t promoted to help people quit smoking. They shouldn’t be regulated as drugs or medical devices, the company said. The case was joined by another manufacturer, Sottera Inc., which pursued it after Smoking Everywhere dropped out. The U.S. District Court for the District of Columbia agreed with the device makers. The FDA appealed.

‘Any’ Tobacco Product

A three-judge panel of the U.S. Court of Appeals in Washington issued the Dec. 7 ruling in favor of the manufacturers. Judge Stephen F. Williams wrote the FDA can regulate electronic cigarettes as tobacco products, not as drugs or medical devices. He cited federal law defining tobacco products as “any product made or derived from tobacco.”

The FDA’s filing in its Dec. 20 appeal says the decision “will both exacerbate the problem of nicotine addiction and undercut an important tobacco-control measure” by hampering development of smoking-cessation products.

If the ruling holds, the list of potential tobacco products is long, encompassing lozenges and nasal sprays as well as nicotine patches, inhalers and gum.

Marketing Less Restricted

Today, these nicotine-based drug products are often sold in conjunction with a doctor’s visit or in pharmacies. The FDA restricts their advertising, health claims and package size.

If classified as tobacco products, they could be sold in packs costing about the same as cigarettes or a tin of smokeless tobacco. They could be marketed in appealing flavors and styles at convenience stores, gas stations, bars and sporting events.

No company has said it will take advantage of this ruling. The maker of Nicorette gum, GlaxoSmithKline Plc, supports the FDA’s position that smoking-cessation products should be
regulated as drugs, said Deborah G. Bolding, a company spokeswoman.

Spokesmen for Altria and Reynolds American Inc. declined to comment.

If smoking-cessation drugs are regulated as tobacco products, they may be taxed like tobacco, too. This could depress sales and generate tax revenue for governments. Federal tobacco taxes in 2010 totaled about $18 billion, according to the Congressional Budget Office.

Warning Labels

If the full appeals court upholds the panel’s ruling, it might trigger a requirement for warning labels. Smoking-cessation product labels aren’t as dire as the familiar cautions about cancer or emphysema on cigarette packs. It’s not clear those warnings are appropriate for products deemed “safe”
drugs by the FDA.

Categorizing nicotine-based drugs as tobacco products would give smokers easier access to alternative forms of nicotine, reigniting a debate over whether smokers unable to quit should use less harmful forms of tobacco. This argument has been captured in reports from the National Academy of Sciences’ Institute of Medicine and the World Health Organization.

It could also encourage nonsmokers’ use of nicotine products designed to deliver more-addictive doses of the drug, something the FDA now prevents.

(Matt Barry is a senior health-care analyst for Bloomberg Government. The views expressed are his own.)

To contact the analyst on this story: Matthew Barry in Washington at +1-202-654-4386 or mbarry24@bloomberg.net

 

[kristin]

Did he completely miss the point about "intended use" in the rulings?? Also follows the belief that "addiction" is bad regardless of the actual health risks being low and turns the focus on the addiction/nicotine rather than the much greater health risks of smoke inhalation.

 

[rothenbj]

"As long as they make no claims about helping people stop smoking,manufacturers are enabled by the ruling to sell gums, patches, lozenges and other products that contain nicotine derived from tobacco under looser standards applied to cigarettes.

The FDA appealed the ruling Dec. 20 and asked the full court to hear the case. The agency said the appeals panel erred in defining tobacco products so broadly.

If the decision stands, it means nicotine gum could be marketed like a pack of Altria Group Inc.’s Marlboro cigarettes -- “Welcome to Nicorette Country” -- instead of relying on doctors and pharmacists to recommend its use." Emphasis mine

Herein lies the problem. The Pharma products are marketed as smoking cessation products when in fact they are nicotine cessation products. Nicotine addiction, like caffeine addiction, in and of itself is not a major health issue, smoking is.

Second, nobody has to rely on doctors and pharmacists to recommend many of the NRT products, most people KNOW they are available and hold out the hope that they will be one of the 2% that will remain smoke free after 20 months.

"Today, these nicotine-based drug products are often sold in conjunction with a doctor’s visit or in pharmacies. The FDA restricts their advertising, health claims and package size."

Again repeated the LIE about doctors and pharmacists. However, the FDA WOULD totally eliminate advertising and health claims if BP wanted to sell their products as tobacco products. Then there is the question of those yummy flavors they can currently use that may addict children to their products.

 

[Bill Godshall]

I sent the following comments to Matt Barry in response to his commentary.

Was disappointed (but not surprised) your op/ed failed to mention the three 800 pound public health gorillas sitting in the room:
- all smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes regardless if they are marketed, regulated, demonized or praised as tobacco products or drug devices,
- smokers have a human right to truthful information about risks/benefits of all tobacco/nicotine products, and to legal access to far less hazardous alternatives,
- public health officials, organizations and professionals have an ethical duty to truthfully inform tobacco/nicotine product consumers and the public about the comparable risks/benefits of different tobacco/nicotine products.

 

[GregH]

I found this quote particularly frustrating, unless I missed something in the commentary:

It could also encourage nonsmokers’ use of nicotine products designed to deliver more-addictive doses of the drug, something the FDA now prevents.

I think he's still talking about the NRTs from BP here. So I'd really like for him to be challenged on how, exactly, he feels the FDA currently prevents someone from going to the local Target or Walmart and buying a box of yummy sounding cappuccino or cinnamon flavored lozenges off the shelf. At least at my local Target, they are positioned on the next to bottom shelf, right at eye level for most children.

 

[Bill Godshall]

Please note that Matt Barry used to work for the Campaign for Tobacco Free Kids (CTFK).

The last time I saw Matt was 5 or 6 years ago (before e-cigarettes were available) when he was giving a presentation at an anti-tobacco conference (might have been the National Conference on Tobacco OR Health) claiming that new smokefree tobacco alternatives:
- weren't SAFE alternatives to cigarettes,
- were being target marketed to addict more youth and to prevent smokers from quitting tobacco, and
- were another reason why Congress needed to enact the FSPTCA legislation (that CTFK's Matt Myers negotiated and agreed to with Philip Morris lawyers in 2003/04).

 

[Our House]

A three-judge panel of the U.S. Court of Appeals in Washington issued the Dec. 7 ruling in favor of the manufacturers. Judge Stephen F. Williams wrote the FDA can regulate electronic cigarettes as tobacco products, not as drugs or medical devices. He cited federal law defining tobacco products as “any product made or derived from tobacco.”

Way for him to leave off the most important part. It's "any product made or derived from tobacco...not intended for therapeutic use."

Talk about quote mining!

 

[ScottB]

I started to parse the "Commentary" to point out the fine lines and careful wording in his attempt attempt to remain fact based, but I quit because I was getting to the point of argument - and there is no point. Posting here is preaching to the choir.

Bill, is there an effective way to communicate - perhaps to Bloomberg - that this guy is a joke? Or are they paying him for the express purpose of stirring the pot with his load of crap? If the latter is the case, how do we (legitimately) screw with Bloomberg?

 

[jamie]

Two links:

North American Quitline Consortium


Bloomberg News Anywhere