Object lesson in how industry can frustrate public health policy efforts


Date: Sat, 26 Sep 2009 17:08:05 -0400
From: Robert Robinson
Subject: (2): Severe Loopholes in FDA Tobacco Law Emerge As Even Its Supporters Realize that the Law Accomplishes Nothing

Yerger, Valerie wrote:
I don't know if it's just me, but I'm embarrassed as a member of the tobacco control movement. . . .

I was embarrassed as a United States citizen when I was sitting in talks at the World Conference on Tobacco or Health this past March in Mumbai, India when discussions came up about the FCTC's [FCTC=WHO Framework Convention on Tobacco Control] Article 5.3, which would protect our public policies from any tobacco industry influence. I tried during those discussions not to be obvious as I looked around the room for others from my country to see if they, too, showed any slight indication of, what my great-grandmother Ma Prim would have called, "shamefacedness".

Okay, so the United States hasn't yet ratified the FCTC, but I'm told this is just a matter of time because under Obama's leadership, Congress is likely do so. (BTW, does anybody know when? Just curious.)

As far as I'm concerned we had prior warnings, of which few of us took notice.

For example, in 2005 my UCSF colleagues Patricia McDaniel and Ruth Malone published a paper of their research of tobacco industry documents that provided evidence of how Philip Morris plotted a plan (which they now have apparently implemented) to collaborate with the public health community to get tobacco products regulated through the FDA. That paper was published years ago! (See Tob Control, 2005 Jun;14(3)193-200.)

Other tobacco documents research has warned us of the "divide and conquer" tactics strategically utilized by Philip Morris (who? Can we all say, Philip Morris) to "carefully orchestrate efforts" to exploit existing differences of opinion within tobacco control, weakening its opponents by working with them." (See Tob Control, 2006 Jun;15(3):215-23.)

Now, we are faced with loopholes in this darn FDA legislation? Go figure!

I remember having that initial email exchange with Bill Robinson of the National African American Tobacco Prevention Network (NAATPN) about the exclusion of menthol from the list of banned flavorings. Maybe others had noticed too back then, but the conversations didn't grow in strength and loudness until Bill made this a priority for NAATPN and got others such as Dr. Louis Sullivan on board.

So, now what?

Seems to me we have a huge piece of paper with colored drawing of a picture we want, but it has been messed up. We're trying to erase and start over, but the paper is now all wrinkled and crumbled because we've tried to erase, redo, erase, etc. and now there are holes in it because we've made such a mess of it. It's a bit too late to crumble up the paper and throw it away and start with a fresh new piece of paper. Or is it?

Just my two cents as I end my week. I will continue being conscious and educating those I can about doing the same. This just, for me, affirms how we need to really help ourselves cause ain't nobody coming on any white horses anytime soon to do for us. We have the mind, body, community and even the economy to do so. We just gotta get to a place where we know these things are so and act accordingly.

Valerie Yerger


From: Robert Robinson [rgrbob@earthlink.net]
Sent: Friday, September 25, 2009 2:05 PM
Subject: Severe Loopholes in FDA Tobacco Law Emerge As Even Its Supporters Realize that the Law Accomplishes Nothing

Siegel, Michael wrote:
This commentary may be a sentinel one, because it is now clear that even supporters of the Family Smoking Prevention and Tobacco Control Act are starting to realize that the law contains so many loopholes to protect Big Tobacco that it accomplishes nothing. This realization will only increase over time, as the many ways in which the Campaign for Tobacco-Free Kids has protected Philip Morris will gradually become apparent to even the most ardent supporters of this disastrous federal tobacco policy.

The commentary appears today on my tobacco policy blog, at: tobaccoanalysis.blogspot.com/2009/09/severe-loopholes-in-fda-tobacco-law.html.

Severe Loopholes in FDA Tobacco Law Emerge As Even Its Supporters Realize that the Law Accomplishes Nothing

As the FDA tobacco law's implementation commences, even supporters of the bill are beginning to realize that the law actually accomplishes nothing because of the severe loopholes that needed to be included in the bill to retain Philip Morris' support and get the bill passed. Most notable so far is the implementation of the law's ban on cigarette flavorings.

Touted by anti-smoking groups as "breaking the cycle of addiction" to tobacco products and keeping "another generation from falling prey to Big Tobacco�s deadly products," it became apparent yesterday that the new law actually doesn't remove a single Big Tobacco product from the market. Both Philip Morris and R.J. Reynolds confirmed that they have no products on the market which are covered by the cigarette flavoring ban.

Instead, the law forced the removal of some minor products made by small manufacturers that make up less than 0.2% of the overall cigarette market and which are hardly smoked by any youths. It is quite clear that the law will have zero impact on youth addiction to cigarettes and will reduce youth smoking by zero percent.

There are actually three major loopholes in the cigarette flavoring ban provision of the law.

First, the bill bans all the flavorings which are not actually used in the brands of cigarettes popular among youths (like pineapple, cherry, and chocolate), but exempts the one flavoring that is actually very popular among young people (menthol). While menthol cigarettes make up about 25% of the market, the cigarettes covered by the flavoring ban make up less than 0.2% of the market, and even less of the youth market.

Second, the bill only bans flavorings that are a "characterizing flavor" of the cigarette. Some cigarette manufacturers are arguing that their flavored cigarettes are allowable under the law because the flavoring being used in not a "characterizing flavor" of the product.

Third, the bill only bans flavorings in cigarettes, not in cigars or cigarillos. Even the New York Times, which strongly supported the legislation, has realized that the flavoring ban is not having its intended effect and now admits that the loopholes in the law are unacceptable. As the Times editorializes: "It makes no sense to ban flavors in cigarettes and then allow the industry to addict young people to flavored cigars."

The Times complains that: "Disturbingly, there are signs that some manufacturers, distributors and retailers may try to circumvent the ban by shifting young smokers to other flavored tobacco products, such as small cigars that may not quite fit legal definitions of a cigarette but can be made every bit as attractive to young smokers with a dash of chocolate, vanilla or fruit flavoring."

However, these manufacturers are not circumventing the law. They are actually following the clear dictates of the law, and the clear intention of the Philip Morris/Campaign for Tobacco-Free Kids Alliance which crafted the law, which was to ban flavorings in products without having any impact on actual tobacco sales: in other words, to ban flavored products that are actually not used very much, as opposed to flavored products which are a critical part of the market, especially for young people.

On this point, the FDA is now facing its second legal challenge to the Family Smoking Prevention and Tobacco Control Act: Kretek yesterday filed suit against the FDA to prevent the Agency from enforcing a ban on flavored cigars. Kretek is the leading importer of clove-flavored cigars.

The FDA, boxed into a corner because of the clear language and intent of the Philip Morris Monopoly Act, which exempts cigars from the flavoring ban, hedged and hawed to try to scare manufacturers of cigars and little cigars that their products are subject to the flavoring ban. Kretek will have no part of this attempt to re-write the clear meaning of the statute, and it is taking the FDA to court to make sure that the FDA does not misinterpret the clearly expressed desire of Congress, Philip Morris, and the public health groups to exempt cigars from the flavoring ban.

So because of the severe loopholes in the law, the FDA is already facing two lawsuits and the game has hardly just begun.

The first lawsuit against the FDA, which argues that the law violates the companies' First Amendment rights by restricting its truthful communication with consumers in an overly broad manner, was bolstered yesterday when it became apparent that R.J. Reynolds had broken the law by merely informing the public that it was complying with the cigarette flavoring ban, something which the law does not allow cigarette companies to do if it might lead consumers to believe that the products are now less harmful.

Since the Campaign for Tobacco-Free Kids and a host of other groups and policy makers, including the FDA and Health and Human Services Department themselves are informing the public that flavored cigarette products represent a special hazard, it could easily be construed that the law would not allow Reynolds to tell consumers that it is in compliance with the cigarette flavoring ban.

Reynolds wrote that all of its products "are in compliance" with the cigarette flavoring ban. But according to the law, cigarette companies may not make "any express or implied statement or representation directed to consumers with respect to a tobacco product, in a label or labeling or through the media or advertising, that either conveys, or misleads or would mislead consumers into believing, that the product is safe or less harmful by virtue of its compliance with regulatory requirements set by the Food and Drug Administration."

That this simple, truthful, and appropriate statement by Reynolds might well be viewed in violation of the law is strong evidence that the law's infringement upon the free speech rights of cigarette companies is overly sweeping, and therefore unconstitutional.

The Rest of the Story

It is only a few months into its implementation, but the Family Smoking Prevention and Tobacco Control Act of 2009 is turning out to be a royal disaster. The law has accomplished absolutely nothing. Its loopholes -- compromises inserted by the public health groups to appease Philip Morris and protect its profits -- are so large that they ensure that the law will accomplish nothing.

Even supporters of the bill are beginning to realize that the hype over the bill's benefits was largely propaganda and they are urging the FDA to misinterpret the statute because it is clear that the statute as written is ineffective.

Meanwhile, the FDA is already mired in lawsuits that will tie up needed resources and will end up undoing even more of the legislation.

The Family Smoking Prevention and Tobacco Control Act of 2009 is full of sound and fury, but it signifies nothing. And while the intentions of the anti-smoking groups which crafted and supported the legislation may have been good, there was a fair amount of idiocy in thinking that any legislation crafted by and strongly supported by Philip Morris would do anything significant to protect the public's health.

Michael Siegel, MD, MPH
Department of Community Health Sciences
Boston University School of Public Health

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