May. 22 2012
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.