INCOMING BOMBSHELL -- FDA's Latest Tobacco Initiative

Written by Paul Melamud - Validation Manager 

Note: this article is about FDA's implementation of the labeling requirements of the Tobacco Control Act.  For details of FDA's imminent tobacco submission program, click here.

In June of 2009, Congress enacted the Family Smoking Prevention & Tobacco Control Act (FSPTCA), finally giving FDA authority over this real “thorn in their side” set of products.

For those unfamiliar with the bill, highlights include:

• Creation of a new Center within FDA specifically to regulate tobacco products
• Increased labeling requirements – some examples:
• Warning labels must cover 50% of both sides of the pack
• Cigarettes may no longer be labeled “mild”, “light”, or “low”, since this suggests “safer” or “better for you” with no clinical trials to back it up

• Banning of flavored cigarettes (always thought to be targeted to children)
  Restriction of advertising; for instance, none allowed within 1000 feet of schools or playgrounds
• Further restrictions on cigarette vending machines and “illicit trade”
• Requirements for listing cigarette ingredients (similar to food and drug requirements)

In the year that followed, FDA put forth a few regulations (see 21 CFR 1140 et seq.) governing sales, advertising, and labeling of cigarettes and smokeless tobacco products. 

As noted above, the FSPTCA charges FDA to issue final regulations requiring new warning labels for cigarettes by June 22, 2011, requiring compliance within 15 months of the final rule’s issuance.  In fact, the public comment period ends this Tuesday (January 11, 2011).  The proposed rule is Required Warnings for Cigarette Packages and Advertisements.

But these aren’t simply updates to C. Everett Koop’s relatively subdued warning statements (see pictures below, required by the 1984 Comprehensive Smoking Education Act) – these are disturbing and even gory portrayals of what happens from smoking (see examples below; there are a total of 9 proposed by FDA at this time) that will supplement them.  These images will be extremely prominent, encompassing at least 50% of each package (front and back), and 20% of each advertisement.  And manufacturers won’t get to “pick and choose” – all nine warnings must appear an equal number of times on each brand of cigarettes, and must be randomly distributed in all areas in the US in which the product is marketed.  For advertisements, the warning statements are to be rotated quarterly.

FDA expects these new graphics to educate smokers – particularly adolescents – about the dangers of smoking (one article published in the NY Times claims 19.5% of US high school students, or 3.4 million adolescents,  are smokers).  Perhaps understandably, if weakly, some cigarette manufacturers have vowed to fight these graphics, claiming they infringe on free-speech and property rights. 

As covered in an accompanying article on this week's blog, FDA is not simply sitting on its hands waiting for compliance--the January 5th announcement that tobacco firms have to get all of their new premarket notifications in by March or be forced off the market is ample proof that the Obama administration is deadly serious about putting cigarette companies in a headlock.