Nu Mark Test-Marketing a New Nicotine Disc as a Smoking Alternative; How Will the FDA Handle This and Other Reduced Risk Products?

The following topic is discussed on the tobaccotoday blog roll by Michael Siegel.


Nu Mark
, an Altria company, has announced that it is now test-marketing (in limited distribution in Virginia) a new tobacco product in the form of mint-flavored discs. These discs contain nicotine that is derived from tobacco; however, there is no tobacco per se in the product. Obviously, these are non-combustible products. They are chewed by the user. The product is called VERVE™.

According to the VERVE™ Fact Sheet: “Nu Mark, an Altria company primarily focused on responsibly developing and marketing innovative tobacco products for adult tobacco consumers, is introducing VERVE discs. This is a new kind of tobacco product designed to appeal to adult smokers interested in innovative types of spit-free tobacco product alternatives to cigarettes. Based upon our research, we believe that approximately 30% of adult smokers are interested in such alternatives. Adult tobacco consumers put the product in their mouth, chew on it and should properly dispose of it when they are done. Primary ingredients are tobacco-derived nicotine, non-tobacco cellulose fibers, flavorings and a polymer. … Each VERVE disc contains approximately 1.5 mg of nicotine. The amount of nicotine an adult consumer receives depends on how the consumer uses it, including how hard the product is chewed and the amount of time it is kept in the mouth. The amount of nicotine in a VERVE disc is lower than the range of nicotine typically found in pouched smokeless tobacco products currently on the market.”

To protect from youth access to the product, it is sold in child-resistant packaging. The package also displays a prominent warning to keep it away from children. It is directed to be sold only to adults, and only in a clerk-assisted transaction (i.e., not through a self-service display).

Because this is a tobacco product as defined under the Tobacco Act (it is derived from nicotine), it will — when introduced for interstate commerce — most likely be subject to FDA regulation as a novel type of smokeless “tobacco” product. While the FDA has not yet promulgated regulations for these “middle-ground” products (including electronic cigarettes) that meet the definition of a tobacco product but are not cigarettes or smokeless tobacco products as defined by the Tobacco Act, the agency is expected to release its regulatory plan for such products this summer.

Given the fact that VERVE contains no tobacco and that the only significant exposure is to nicotine, the product is clearly much safer than cigarettes. But here’s the key question: Will Altria be allowed to inform consumers that the product is safer than cigarettes? And if not, what will the company have to do in order to be able to provide such (obviously) truthful information to consumers?

The Rest of the Story

The answer depends on how the FDA chooses to handle the application of modified risk tobacco product issues to these innovative non-cigarette, non-smokeless tobacco products such as electronic cigarettes, which deliver tobacco-derived nicotine but do not contain tobacco.

Let me just state at the outset that the worst thing the FDA could do is issue a deeming regulation that treats these “non-tobacco, tobacco products” (i.e., VERVE, electronic cigarettes) the same way as traditional tobacco products. Most importantly, FDA must not make these products subject to the provisions of section 911 (the modified risk tobacco product provisions) of the Act.

If products like VERVE and electronic cigarettes are made subject to section 911, it will place a nearly insurmountable barrier in front of the successful marketing of these products as truly reduced risk products that could potentially save many lives by transitioning smokers off of cigarettes.

In this commentary, I discuss the reason why section 911 would be a death knell for both VERVE and electronic cigarettes. I refer mainly to VERVE here since that is the topic at hand, but the argument applies equally well to electronic cigarettes.

In order to be approved as a modified risk product under section 911, Altria would have to demonstrate the likelihood that the marketing of VERVE will: (1) cause smokers who would otherwise have quit to use VERVE instead; and (2) cause nonusers of tobacco to start using VERVE (especially youth), which could then lead to nicotine addiction and subsequent tobacco use.

How can one find out whether the marketing of VERVE as a reduced risk product would cause smokers who would otherwise have quit to use VERVE instead of quitting? The only way to do this scientifically is to actually market VERVE as a reduced risk product and then observe what happens. Importantly, one would have to conduct a clinical trial with a control group that does receive VERVE in order to know what the cessation rates would have been in the absence of VERVE. This would require a huge sample size.

But the study is impossible to carry out in the first place. Why? Because the only way to observe the effects of marketing VERVE as reduced risk product would be to actually market VERVE as a reduced risk product. But Altria could not do that until it received approval from the FDA. And to receive that approval, it would first have to present the evidence of a trial in which VERVE was marketed as a reduced risk product.

In other words, this is a catch-22 situation. If section 911 were applied to VERVE, then Altria could not market the product as a reduced risk product until it received FDA approval, but could not receive FDA approval until it marketed the product as a reduced risk product.

What about the “reduced exposure” provisions of section 911? Could Altria market VERVE not as a reduced risk product, but as a reduced exposure product? No – not if the FDA applies section 911 in its current form to these intermediary products. In fact, one could argue that Altria would not even be allowed to inform consumers that VERVE is free of tobacco, as that would be considered a “reduced exposure” claim under the statute.

In order to have such a reduced exposure claim approved by the FDA, Altria would first have to demonstrate that consumers do not interpret the absence of tobacco as an indication that the product is safer. But that’s preposterous. First of all, no consumer in their right mind is going to fail to consider a product safer than other “tobacco” products when informed that it contains no tobacco. But more importantly, even if they did, consumers are not going to buy the product if they don’t think it is any safer. How can a company market a product which is a safer alternative to cigarettes without being able to have consumers think that it is a safer alternative to cigarettes?

Again, section 911 creates a catch-22. You can only market a product as reduced exposure if consumers will not believe it is any safer. But if consumers will not believe it is any safer, then what is the value of marketing the product?

As expected, the Campaign for Tobacco-Free Kids has reacted negatively to the introduction of VERVE, warning the public about the potentially risky contents of this new product. The Campaign was quoted as stating: “In the absence of FDA review of the contents of the product, the American public is essentially being asked to be human guinea pigs.”

It is not the contents of the product that are of concern. After all, there are only four: nicotine, cellulose, polymer, and mint? Which of these four products does the Campaign believe needs to be immediately reviewed by the FDA for use among smokers who are otherwise going to be inhaling upwards of 10,000 chemicals and 60 carcinogens in each puff?

No, the concern is not about the contents of VERVE, it is about the potential effects on the behavior of current smokers and nonsmokers. Will smokers who might otherwise have quit decide to use VERVE along with their cigarettes? Will youths be attracted to VERVE and then become addicted to nicotine and advance to cigarette use? These questions can be answered, but they do require a natural experiment (i.e., the introduction of VERVE into the market).

The Campaign for Tobacco-Free Kids and other anti-smoking groups are so protectionist about allowing new entries onto the market that they are essentially protecting the most hazardous known tobacco product (cigarettes) from competition from what are certainly safer products (i.e., electronic cigarettes and other non-tobacco nicotine-delivering products, like VERVE).

Hopefully, the FDA will decide not to apply section 911 to non-tobacco products that fall under the jurisdiction of the Tobacco Act by virtue of their use of tobacco-derived nicotine. A more reasonable approach would allow the use of much less stringent scientific evidence requirements than outlined in section 911.

The rest of the story is that while section 911 is touted as being necessary to prevent tobacco companies from making dishonest representations to consumers, the application of section 911 to electronic cigarettes and other non-tobacco, nicotine-containing products like VERVE will actually force companies to do that very thing: misrepresent the truth about a product by failing to communicate the most essential aspect that the consumer needs to know: the fact that the product contains no tobacco and involves no combustion of tobacco and is therefore much safer than cigarette smoking.

Interesting as the following article was just recently published by Lou Maiellano – http://www.tobaccotoday.info/2012/04/17/redrawing-the-battle-lines/

What are your thoughts on Michael Siegel’s discussion?

14 comments ↓

#1 popgoesweasal on 05.24.12 at 6:39 AM

Lou are you saying that companies can only sell these products if they make health claims (and that is why 911 compliance will kill them)?

I don’t agree, but, of course 911 will apply to ALL PRODUCTS. Why would the FDA allow unsupported health claims. 911 should apply, though the regulations for 911 need to be re-fashioned into something sensible.

#2 Lou on 05.24.12 at 10:31 AM

Pop – No this is a post that appears on the blog roll a feature on the blog (scroll down the right side) that just wanted to put in the mix. The points are made by Michael Siegel.

#3 Candy Girl on 05.24.12 at 1:06 PM

So- what is VERVE? It appears to be a gum-like product- a consumer chews it and then disposes of it. However, no mention of “gum” is in the article- but, of course, nicotine gum is an FDA approved NRT product. And, interestingly, VERVE is compared to “pouched smokeless tobacco products currently on the market” in the release. Altria is clearly intending this to be a tobacco product under the FSPTCA, despite the fact that there is zero tobacco- just tobacco-derived nicotine. Here is where the federal court decision that stymied the FDA’s attempts to regulate e-cigarettes as drug products is huge. The decision made clear that nicotine-containing products are tobacco products despite the absence of leaf tobacco. This move by Altria will likely hasten the FDA’s initiative to construct a regulatory framework for regulating what are currently unregulated tobacco products- e-cigs, dissolvables, hand gels and, now VERVE!

#4 Annie on 05.24.12 at 3:28 PM

Is de nicotine schadelijk als je een infarct heb gehad. Zo niet vind ik het een fantastische uit vinding

#5 Bill Godshall on 05.24.12 at 5:41 PM

After urging Altria to develop and market new smokefree nicotine products, I’m pleased the company has done so.

VERVE is a tobacco product (as defined in the FSPTCA) that is very similar to nicotine gums/lozenges marketed by drug companies for smoking cessation.

But VERVE isn’t a smokeless tobacco product (as defined in the FSPTCA), and as such, isn’t subject to Chapter IX regulations (just like e-cigarettes, cigars, pipe tobacco, shisha/hookah tobacco, nicotine skin cream, some dissolvables, etc.).

Also similar to e-cigarettes, VERVE isn’t subject to federal tobacco taxes, nor to tobacco tax laws in nearly every state. And although Altria won’t market VERVE to minors, most state laws prohibiting tobacco sales to minors don’t include VERVE.

Although VERVE may prove very effective at helping smokers reduce cigarette consumption and/or quit smoking, Altria’s introduction of this new unregulated tobacco product will likely prompt tobacco harm reduction opponents (CTFK, ACS, AHA, ALA, Legacy, Sens. Durbin, Lautenberg, Rosenthal, Brown, Merkley, etc.) to further pressure Obama appointed tobacco harm reduction opponents at DHHS and FDA (which falsely claim that all tobacco products are as hazardous as cigarettes) to quickly propose and approve “deeming” regulations that would apply Chapter IX regulations to all currently unregulated tobacco products.

But unless the FDA exempts various sections of Chapter IX in the agency’s “deeming” regulation, the sale of e-cigarettes and VERVE would be banned, internet sales of e-cigarettes would probably be banned, it would be a federal felony for any e-cigarette company to truthfully claim the e-cigarettes are less hazardous than cigarettes (and may ban truthful claims that e-cigarettes are “smokefree”), and more than 90% of e-cigarette companies and many cigar companies would likely disappear.

We need to urge members of Congress (especially Republicans) to prevent the FDA from issuing a “deeming” regulation unless/until the agency first acknowledges that all smokefree tobacco products are far less hazardous than cigarettes. As long as the FDA falsely insists that all smokefree tobacco products are just as hazardous as cigarettes http://www.fda.gov/TobaccoProducts/R…/ucm255658.htm, the agency cannot be trusted to develop tobacco product regulations that protect consumer and public health.

VERVE Fact Sheet at
http://vapersforum.com/showthread.php?p=932360#post932360

Altria to test market new nicotine product “Verve” in Virginia
http://www2.timesdispatch.com/business/news/2012/may/23/tdbiz01-altria-to-test-market-new-nicotine-product-ar-1935376/
http://www.nu-mark.com/

The future of Big Tobacco: Tobacco-free products?
http://theweek.com/article/index/228338/the-future-of-big-tobacco-tobacco-free-products

Altria tests smokeless product that contains no tobacco
http://www2.journalnow.com/business/2012/may/24/wsbiz01-altria-tests-smokeless-product-that-contai-ar-2304913/

Mike Siegel on Altria’s new nicotine product
http://tobaccoanalysis.blogspot.com:80/2012/05/nu-mark-test-marketing-new-nicotine.html

Group funded by nicotine gum/lozenge makers (CTFK) denounces Altria’s very similar new chewable nicotine lozenge, urges FDA to issue “deeming” regulation that would ban it and other far less hazardous smokefree alternatives to cigarettes.
http://www.prnewswire.com/news-releases/altrias-new-nicotine-lozenge-shows-need-for-fda-to-regulate-all-tobacco-products-so-consumers-arent-big-tobaccos-guinea-pigs-152727415.html

#6 Bill Godshall on 05.24.12 at 5:44 PM

The correct weblink for the FDA’s MRTP webpage where FDA continues to falsely claim “To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, improve safety or cause less harm than other tobacco products.” and “Claiming less harm or reduced risk of disease from using tobacco products misleads consumers to think that these products are safe to use.” is
http://www.fda.gov/TobaccoProducts/ResourcesforYou/ucm255658.htm

#7 Candy Girl on 05.24.12 at 7:55 PM

Note too that the nicotine content of this product is less than US snus and less than FDA-approved NRT products- i.e. gum, patches, lozenges. This is consistent with what I have been saying- tobacco companies do not want you to quit, just give you something to do when you can’t smoke. And, as I have stated with my e-cig posts- this what tobacco companies will do with e-cigs- voluntarily and deliberately keep the nicotine content at or below the levels of FDA approved NRT products. This will ensure the blessing (if the not the explicit approval) of the FDA and leave nicotine products at much higher levels to the pharmaceutical companies. The tobacco companies are happy. Pharmaceutical companies are happy. But, public health suffers. After all, it’s tobacco and pharma- FDA stakeholders- that fund the FDA.

#8 FanofBill on 05.24.12 at 8:07 PM

Bill, I hope Altria sends you a royalty check for orchestrating their strategy! Good for you and them!

#9 Candy Girl on 05.24.12 at 8:55 PM

Not surprised to see a product like this introduced by a tobacco company; but, I am surprised it’s Altria. I would have bet that RJR would have been the first- given its acquisition of Niconovum in late 2009. Niconovum has a stable of gums, lozenges and mouth sprays that could be reformulated and marketed in the US in similar fashion to Altria’s VERVE.

#10 Miami Heat on 05.25.12 at 9:54 AM

Curious what is going on with RJR?

#11 Copenhagen Charley on 06.05.12 at 1:24 AM

I love it! The old horse is looking to recreate the offer! I just hope it delivers enough nicotine to satisfy not like their Snus product which does very little for the user!

#12 Bill Godshall on 06.07.12 at 3:38 PM

Verve also costs far less than nearly identical NRT products.

Don’t know what’s going on with Niconovum, as I’ve been urging Tommy Payne to market at least one or two of Niconovum’s products as unregulated tobacco products since 2009 (instead of applying to FDA to market as smoking cessation aids).

#13 Bill Godshall on 06.07.12 at 3:49 PM

Still waiting for Candy Girl to explain his/her unsubstantiated and irrationale assertion that the FDA will allow NRT products to have more nicotine than tobacco products.

To date, the FDA has not acted upon several citizen petitions and other requests urging the agency to deregulate NRT products, including to allow NRT to contain/emit larger doses of nicotine.

The purported reason FDA limits the amount of nicotine in NRT products is to prevent them from creating nicotine addiction.

Meanwhile, cigarettes and many smokeless tobacco products (e.g. Copenhagen) have long emitted far greater levels of nicotine (than do FDA approved NRT products).

Since cigarettes are far more hazardous than smokefree tobacco products, any FDA nicotine restictions in tobacco products should first occur in cigarettes (to make them less addictive), not in far less hazardous smokefree alternatives (as doing so would protect cigarette markets by making smokefree alternatives less desirable to smokers).

#14 Candy Girl on 06.08.12 at 9:48 PM

Bill- as we discussed off-line, it’s not my assertion that is irrational, it’s the direction that I believe the FDA will take. You’re way too rational and committed to common sense. After all, this is the FDA we’re talking about.

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