While invalidating the proposed regulation of tobacco products by the Food and Drug Administration (FDA), the U.S. Court of Appeals for the Fourth Circuit has also implicitly affirmed the lower court's decision that the FDA lacks authority to regulate obacco advertising.

Indeed, the FDA's inability to regulate advertising is the only point on which the appellate court agreed with the judge below.

Whatever the fate of the FDA's attempt to regulate tobacco products generally - and that effort increasingly looks like it will fail - the likelihood of the FDA successfully regulating tobacco advertising now seems even more remote.

Most readers of this publication are probably aware of the FDA's sweeping proposal to regulate tobacco advertising. Among other things, the FDA sought to prohibit the use of images and colors in most tobacco product advertising. Such advertising was to have been limited to black text on a white background.

Also to be banned were all outdoor advertising for tobacco products within 1,000 feet of a playground or school. This ban was so broad that it included signs on stores stating that they sold tobacco.

The rules also banned all brand-name sponsorships, and the sale and distribution of any branded, non-tobacco merchandise. Finally, unless an advertiser gave the FDA a 30- day advance notice, tobacco advertising was to be prohibited in any medium not specifically approved by the agency.

A coalition of advertising trade associations, tobacco manufacturers, and others challenged these rules on both statutory and constitutional grounds. (Full disclosure - this writer argued the constitutional challenge to the district court.)

Without even mentioning the constitutional issues, however, the North Carolina district court found that the FDA lacked the statutory authority to regulate advertising.

The lower court made this decision despite its finding that, as a general matter, the FDA did indeed have authority to regulate the manufacture of tobacco, as well as the manner in which it is marketed.

The particular basis for the finding that the FDA lacks authority over tobacco advertising was the lower court's interpretation of the word "sale." The authority to regulate the sale of a product, the court essentially said, does not include the power to restrict speech about the product.

On Aug. 14, 1998, the Fourth Circuit reversed the lower court judge on the fundamental point - whether the FDA has the authority to regulate tobacco at all. One judge dissented. Specifically, the majority said that it was not credible to consider tobacco as falling within the statutory definition of a "drug" or "drug delivery device" when that statute was read as a whole.

Given its decision that the FDA lacks authority to adopt any regulations concerning tobacco products, the appellate court did not need to reach the specific question of whether the FDA had authority to govern the advertising of such products. The FDA's lack of power to regulate tobacco at all necessarily means that it lacks the ability to regulate the advertising of such products.

The government has asked all of the judges of the Fourth Circuit to hear the case. A decision on that motion for rehearing en banc is expected shortly. A subsequent appeal to the U.S. Supreme Court is virtually certain.