The Dissolvable Deficit: FDA and CDC Must Fill Data Void

The FDA Tobacco Products Scientific Advisory Committee (TPSAC) held a public hearing January 18-20 on dissolvable smokeless tobacco products. The information gleaned there will help inform a congressionally mandated report on the subject, due March 23.

The proceedings (agenda here) underscored the dearth of information on dissolvable tobacco use. Committee members repeatedly observed that there is no reliable data on who uses these products and in what context. Are dissolvables temporary or permanent substitutes for cigarettes? Do they promote tobacco initiation among teenagers?

These are legitimate questions for which we need definitive answers. One problem is that dissolvables from major manufacturers have only been in limited markets since 2009, when RJ Reynolds test-marketed Camel Orbs, Strips and Sticks in Indianapolis, Columbus and Portland, Oregon. Testing was discontinued early last year, but Reynolds later launched the products in Denver and Charlotte. In 2011, Altria introduced Skoal and Marlboro Sticks in Kansas. A smaller player, Star Tobacco, has sold Ariva dissolvable tobacco since 2001.

It is not surprising that we know next to nothing about dissolvable tobacco use; little is known about smokeless tobacco use generally, despite the fact that some 6 million U.S. adults consume these products. This information deficit can be blamed on the federal government, and specifically on the Centers for Disease Control and Prevention (CDC).

Each year, the CDC publishes detailed information on U.S. smoking prevalence, based on the annual National Health Interview Survey. What about smokeless tobacco? It turns out that the CDC has only produced detailed smokeless tobacco information twice in the last decade, in 2000 and in 2005, when the NHIS included a special supplement sponsored by the National Cancer Institute. There is a lot of information in these supplements, as I documented in 2009 publication (abstract here).

There has been growing discussion over the past decade about smokeless tobacco as a substitute for cigarettes. The U.S. House of Representatives in 2003 held a hearing titled “Can Tobacco Cure Smoking: A Review of Tobacco Harm Reduction” (my testimony here). It should have been a wakeup call for government officials to collect more information on smokeless tobacco use. Instead, there is evidence that NHIS staff decided to collect less.

In addition to smokeless tobacco information, the 2000 NHIS also collected information on the techniques used by smokers during their last attempt to quit. This data proved that tobacco harm reduction with smokeless tobacco was working. As I noted in a published study (abstract here):

“An estimated 359,000 men switched to smokeless tobacco in their most recent quit attempt. This method had the highest proportion of successes among those attempting it (73%), representing 261,000 successful quitters (switchers)… Switching to ST compares very favorably with pharmaceutical nicotine as a quit-smoking aid among American men, despite the fact that few smokers know that the switch provides almost all of the health benefits of complete tobacco abstinence. The results of this study show that tobacco harm reduction is a viable cessation option for American smokers.”

If the 2000 NHIS survey proved that tobacco harm reduction was viable, what did the 2005 NHIS survey show? Absolutely nothing. NHIS removed the switch-to-smokeless option from the 2005 survey, despite the huge explosion in awareness of and discussion about tobacco harm reduction.

Today, the TPSAC committee is preparing to make important decisions concerning tobacco harm reduction... lacking basic information about smokeless tobacco use and with no current data about transitions between cigarettes and smoke-free products.

This information deficit is unacceptable. The FDA Center for Tobacco Products, generously funded by fees from tobacco manufacturers, must act. At a minimum, it should fund annual use of the 2000 NHIS smokeless tobacco supplement – with appropriate revisions for e-cigarettes – in every annual survey, in order to collect unbiased information about use of smoke-free tobacco products.

Chemical Analysis of Camel Dissolvables Reveals Tobacco, Flavors and Sweeteners

In 2009, R.J. Reynolds test-marketed dissolvable tobacco products in Indianapolis. Chemists at Indiana University-Purdue University Indianapolis, led by Christina Rainey, have just published the results of an extensive chemical analysis of Camel Orbs, Sticks and Strips in the Journal of Agricultural and Food Chemistry (abstract here).

Using several extraction methods, Rainey et al. documented that Camel Orbs, Sticks and Strips contain tobacco, flavors and sweeteners:

1. Tobacco: Measuring the nicotine content of the products, the researchers findings were similar to those reported in Reynolds’ product literature: 1 mg. per Orb, 3.1 mg. per Stick and 0.6 mg. per Strip.

2. Flavors: Rainey et al. found menthol, ethyl citrate, cinnamaldehyde, coumarin, vanillin and carvone. Readers will immediately recognize menthol, cinnamon and vanilla flavors. Carvone is a flavor component of spearmint, caraway and dill, so it also has a long history of use in foods (more here). Ethyl citrate is a derivative of citric acid (lemons and limes); it is a food additive.

Rainey et al. claim that “coumarin is a harmful ingredient and causes liver damage in rodents…and has been banned as a flavor additive to food.” This statement is misleading, as it implies that coumarin is a dangerous chemical that has been added to the dissolvables.

It is true that coumarin is toxic to the liver of rats, but this is due to the fact that rats process this agent via an enzyme system that humans lack. Extrapolating rat liver damage to humans is specious.

It is true that the FDA prohibits adding coumarin to human food (here). Why was it found in Camel dissolvables? It is well known that coumarin is present in some varieties of cinnamon; Rainey et al. found coumarin only in an Orb flavored with cinnamon (more information about coumarin is available here). In 2008, scientists from Germany found coumarin in bakery products and breakfast cereals flavored with cinnamon (here). Should Orbs be considered as dangerous as cinnamon buns and breakfast cereal?

3. Sweeteners: Xylitol and/or sorbitol, non-caloric sweeteners used in many products, were found in all three Camel dissolvables.

4. Others: Rainey et al. note that Orbs contain palmitic and stearic acid, food-grade additives that probably aid in the physical properties of the product (e.g., shape and texture). Strips contain glycerin, a food additive that helps products retain moisture.

In summary, smokers who switch to Camel Dissolvables are consuming smoke-free tobacco products that are consistent with government standards for human foods.

Outstanding News Report On Smokeless Products

KMSP Fox 9 in Minneapolis-St. Paul recently aired an excellent news report on new smokeless tobacco products, including dissolvable Camel Orbs, Sticks and Strips and Camel snus (Click on the image above to see the video).

The station focused on a new Minnesota law that puts all tobacco products behind the counter and out of the reach of children. Kelly Valen, a 43-year-old smoker who blames her addiction on easy cigarette availability, is excited about the law but sadly oblivious to what the rest of the story delivers: information about vastly safer smokeless alternatives.

Discussing types of “tobacco you may not even heard of yet,” the station turned to Mike Sheldon of Clearway Minnesota as an authority on “more innovative and new tobacco products.” He presents an informative display of orbs, sticks, strips and snus, saying “they’re smokeless and spitless, and that’s trying to take away the social stigma of smokeless tobacco products of the past” -- an accurate description of the advantages of these new cigarette substitutes.

KMSP says that while these products aren’t for sale yet in Minnesota, the dissolvables are available in test market cities Indianapolis, Portland, Oregon and Cincinnati. (Actually, they’re available in Columbus, not Cincinnati.) Camel snus is sold nationwide.

It is important for smokers to learn about safer, satisfying, spitless smokeless products, but FDA regulations severely restrict what manufacturers can tell smokers about these innovative new products. Clearway Minnesota and KMSP have contributed to public health with this informative new feature.