Is This the Year for FDA Regulation of Tobacco Products?

By David B. Clissold –

It seems likely that the answer will be “yes.”  The Family Smoking Prevention and Tobacco Control Act (H.R. 1256) is on a fast-track under the new administration.  The bill passed the House Energy and Commerce Committee by an overwhelming margin on March 4, 2009, two days after it was introduced by Representative Henry Waxman (D-CA).  It is now headed to the full House of Representatives.  The bill is very similar to legislation introduced last year by Mr. Waxman, which stalled in the Senate.

The bill would give FDA the authority to regulate tobacco products, including cigarettes and smokeless tobacco.  The bill mimics portions of the Federal Food, Drug, and Cosmetic Act (“FDC Act”), which currently regulates food, drugs and medical devices, and thus includes concepts that will be familiar to those who interact with FDA on a daily basis.  However, most elements of the new law may seem like a foreign language to those in the tobacco industry, particularly many small businesses.  The bill adopts the general structure of the FDC Act by first defining a tobacco product, and then describing the conditions that would cause a tobacco product to be “adulterated” or “misbranded.”  Adulteration and misbranding charges traditionally form the basis of FDA enforcement action against the food, drug and medical device industries.  As with some foods, the bill provides a “standard of identity” for cigarettes that would, among other things, prohibit the addition of an herb or spice such as strawberry, clove, cinnamon, or vanilla, although “menthol” is specifically permitted.  Other tobacco products could be subject to a standard of identity to be established by FDA.  As with drug, device, and food manufacturers, manufacturers of tobacco products would also be subject to certain registration requirements for manufacturing and processing facilities, and would be required to identify the products handled at each facility.  All registered facilities would be subject to FDA inspection at least every two years. 

Manufacturers would be required to submit to FDA a list of ingredients in every brand of cigarette.  If requested by FDA, manufacturers would be required to submit “any and all documents” relating to research activities for tobacco products, ingredients, components, and additives, including marketing research and underlying financial information. 

The bill would “freeze” the world of tobacco products as it existed on February 15, 2007.  Any tobacco product that was not marketed before that date would be a “new” tobacco product.  In order to market a “new” tobacco product, a manufacturer would have to obtain premarket approval from FDA via an application containing full reports of all information concerning the health risks of the new product.  Alternatively, a manufacturer would have to show that the “new” product was “substantially equivalent” to a tobacco product marketed before that date.  At any time, FDA could refer the application to a Tobacco Products Scientific Advisory Committee.

Labeling requirements for cigarettes and smokeless tobacco, particularly required Warning statements, would be controlled by FDA.  Although already subject to enforcement by the Federal Trade Commission ("FTC"), certain retail establishments would also be brought under FDA jurisdiction, particularly with respect to advertising restrictions.  Under the bill, FDA and FTC would “coordinate” their enforcement and advertising powers.  FDA would issue new regulations regarding the sale, distribution, advertising and promotion of tobacco products.  Retailers in violation of such regulations would be subject to civil penalties (0-$250 for a first offense depending on whether the retailer has an “approved training program,” and up to $10,000 for a sixth violation within a 48-month period).  The bill would authorize FDA to collect “user fees” (a new tax) from manufacturers, although the government’s current authority to tax cigarettes apparently remains unchanged.  With respect to product liability, the bill expressly does not affect the law of any State.

Of the many bills proposed over the last few weeks affecting FDA, (check our FDA Legislation Tracker), this one seems to have a very high priority in the administration and the full support of public health groups.  Some “fine tuning” is likely to result when the measure is considered by the Senate, but we predict that the general structure is likely to survive.  WARNING: FDA may be hazardous to the health of tobacco product manufacturers and retailers.