As you may know, Altria has announced the launch of a new tobacco lozenge that it will begin marketing in June. Yet another in the plethora of new and novel products introduced by the tobacco companies, this latest one makes it all the more essential that FDA’s Center for Tobacco Products use its authority to assert jurisdiction over ALL tobacco products and regulate them accordingly. Our statement on the new product appears below, followed by a clip on the new product in today’s Wall Street Journal.

FOR IMMEDIATE RELEASE: May 22, 2012

CONTACT: Vince Willmore, 202-296-5469

Altria’s New Nicotine Lozenge Shows Need for FDA to Regulate All Tobacco Products so Consumers Aren’t Big Tobacco’s Guinea Pigs

Statement of Matthew L. Myers

President, Campaign for Tobacco-Free Kids

WASHINGTON, D.C. – Tobacco giant Altria’s launch of a new nicotine lozenge underscores the need for the Food and Drug Administration to quickly extend its regulatory authority to all tobacco products and prevent tobacco companies from continuing to treat American consumers as guinea pigs in their constant quest for higher profits. Without effective FDA regulation, there is nothing to stop Altria from marketing its new product in ways that lure and addict kids, discourage current tobacco users from quitting or mislead the public, as tobacco companies have done for too long.

According to a report today by The Wall Street Journal, Altria plans to begin selling its nicotine lozenge in Virginia in June. According to the report, "the chewable, mint-flavored disc will provide nicotine extracted from tobacco.” The report stated that the product will be made of cellulose fibers and a polymer, resemble a cough drop, release nicotine as a user sucks or chews on it, and have to be thrown away after use.

The 2009 law granting the FDA authority over tobacco products specifically directed the agency to regulate cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. It also authorized the FDA to extend its jurisdiction to other tobacco products, which the law defines as "any product made or derived from tobacco that is intended for human consumption” (and that doesn’t meet the statutory definition to be regulated as a drug or device). The FDA announced in December 2010 that it intended to issue regulations asserting jurisdiction over all tobacco product, but almost a year and a half later, it has yet to do so.

The FDA has taken far too long to act, and its failure to do so has given tobacco companies the opportunity to introduce novel products that circumvent the law. Altria’s new product underscores the need for the FDA to quickly assert authority over all tobacco products so there are no gaps or loopholes in the law and all tobacco products are regulated to protect public health.

By asserting jurisdiction over this and all tobacco products, the FDA can take appropriate action to protect public health. Among other things, the agency has the power to review new tobacco products before they are allowed on the market, restrict marketing and sales especially to kids, require health warnings, mandate disclosure of contents of and research about products, and prohibit any health claims without FDA review. In an example of the proverbial fox guarding the chicken coop, Altria is currently determining what warnings and sales restrictions to place on its new product. These decisions should be made by the FDA, an agency charged with protecting the public health, and not by a tobacco company motivated by sales and profits.

It is especially critical that the FDA act to prevent Altria from making any health claims about its new product without going through the rigorous scientific review and meeting the tough public health standard set by the 2009 law. The law prohibits tobacco companies from making any health claims – for example, that a product is less harmful – without first providing the FDA with the scientific evidence to show that the product "as it is actually used by consumers, will (A) significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and (B) benefit the health of the population as a whole,” taking into account both users and non-users of tobacco products. The FDA must ensure that any reduction in harm to individual tobacco users is not offset by increasing the number of people, including kids, who start using tobacco or reducing the number of current tobacco users who quit. This rigorous standard is needed to prevent a repeat of tobacco industry deception and ensure that that any future health claims about tobacco products are supported by sound science and do in fact reduce the death and disease caused by tobacco use.

Effective FDA regulation of all tobacco products is critical to reducing the terrible toll of tobacco use, which kills more than 400,000 Americans annually and is the number one cause of preventable death in the United States and around the world.
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New From Altria: A Nicotine Lozenge

By Mike Esterl

22 May 2012

The Wall Street Journal

(Copyright (c) 2012, Dow Jones & Company, Inc.)

U.S. tobacco giant Altria Group Inc. is moving into uncharted territory: the tobacco-less nicotine product.

The maker of Marlboro will launch a nondissolving, lozenge-shaped nicotine disc called Verve in coming days, the latest foray by Big Tobacco into experimental smokeless products amid falling sales for traditional cigarettes.

Unlike the smokeless products sold by Altria and its chief U.S. tobacco rival, Reynolds American Inc., Verve won't contain tobacco. Instead, the chewable, mint-flavored disc will provide nicotine extracted from tobacco.

This is a crucial distinction. Richmond, Va.-based Altria is betting that approach will permit it to market the product with milder health-warning labels than those affixed to cigarettes and smokeless tobacco.

Nicotine is addictive and has been tied to cardiovascular problems, high blood pressure and diabetes. But unlike tobacco, it hasn't been linked to cancer.

Government-mandated labels on mainstream smokeless tobacco products such as moist snuff and chewing tobacco highlight the risks of cancer, tooth decay and gum disease, warning consumers, "This is not a safe alternative to cigarettes."

Altria plans to begin selling Verve in more than 50 stores in Virginia by early June, but it hasn't decided whether to roll out the product nationally.

Smokeless products represent less than one-tenth of tobacco-industry sales, but they are an increasingly important battleground. The smokeless category is growing at about 7% annually, while U.S. cigarette volume has been contracting at roughly 4% a year.

Altria, the largest U.S. tobacco company by sales, already boasts a roughly 55% share of the smokeless-product market based on its Copenhagen and Skoal moist snuff brands.

Reynolds, the maker of Camel cigarettes and Grizzly moist snuff, controls about a third of the country's smokeless market.

Smokeless product makers are hunting for the next big thing because snuff is messy, requiring users to spit out loose tobacco after placing it between their cheek and gums.

In recent years, big tobacco companies have marketed alternative smokeless products such as snus, a spit-less tobacco pouch, and dissolvable tobacco "sticks," "strips" and "orbs" that also don't require spitting.

Lorillard Inc., the maker of Newport cigarettes and the third-largest U.S. tobacco company, said last month that it will acquire electronic cigarette company Blu ECigs. E-cigarettes, a growing niche product, turn nicotine-laced liquid into vapor.

"I don't think anyone's found the magic smoke-free product," said John R. Nelson, Altria's chief technology officer.

A Verve disc, which resembles a cough drop, releases nicotine over roughly 15 minutes as a user sucks or chews on it. It doesn't require spitting to avoid swallowing tobacco. But the disc of cellulose fibers and a polymer also doesn't dissolve, so users will have to throw it away after use.

The new product will be sold in a package of 16 discs, each containing about 1.5 milligrams of nicotine, less than many other smokeless products contain. It will sell for about $3 in stores in Virginia, where a pack of 20 Marlboro cigarettes retails for around $4.50. The product will be sold to adults only.

Altria is rolling Verve out as the U.S. Food and Drug Administration is trying to slap larger, more graphic warning labels on cigarettes, including an image of a person smoking through a hole in the neck. A federal judge recently put those plans on hold after some cigarette companies sued the FDA, arguing the labels went too far.

Altria says it has shared its new product plans with the FDA. The government agency confirmed it had been contacted by Altria but declined to comment on how it might regulate such a product.

The new product in some ways resembles gum and lozenges that contain nicotine but no tobacco and are sold by pharmaceutical companies to help wean smokers off cigarettes. But such pharmaceutical aids, also called nicotine-replacement therapies, are meant to be used for only a few months.

Matthew Myers, president of Campaign for Tobacco-Free Kids, an anti-smoking group, said the health impact from long-term use of nicotine isn't known.

Altria will include a warning label on the new product, telling consumers that nicotine can increase "heart rate, blood pressure and aggravate diabetes."

The label will also warn nicotine "can harm your baby if you are pregnant or nursing" and "cause dizziness, nausea and stomach pain."

Source: Vince Willmore,  Vice President, Communications,  
Campaign for Tobacco-Free Kids