Wednesday, July 28, 2010

WARNING: FDA Flubs Smokeless Tobacco Warnings


Last month, the FDA appeared to comply with provisions in the Tobacco Act by ordering larger health warnings on smokeless tobacco packages and advertisements; the Act also added a fourth warning. The older three, which have been around for about 25 years, are terribly inaccurate and misleading.

Four warnings are mandated by the legislation, but not the four that the FDA is implementing. Is this a case of sloppy transcription by the agency, or intentional pursuit of the FDA’s own agenda?

Here are the four warnings mandated on page 1,846 of the Tobacco Act (available here):

‘‘WARNING: This product can cause mouth cancer.”

‘‘WARNING: This product can cause gum disease and tooth loss.”

‘‘WARNING: This product is not a safe alternative to cigarettes.”

‘‘WARNING: Smokeless tobacco is addictive.”

Here are the four warnings as they appear on the FDA website and fact sheet (here):

“This product is addictive”

“This product can cause mouth cancer”

“This product can cause gum disease”

“This product is not a safe alternative to cigarettes”

The FDA removed the “WARNING” header; removed “and tooth loss” from the second warning; and changed “smokeless tobacco” to “this product” in the addictive warning.

The smokeless tobacco warnings specified by Congress are inaccurate and misleading to begin with. Can an FDA that mismanages the simple transcription of legislative orders be trusted to appropriately implement the law?

1 comment:

rothenbj said...

Brad,

Are you sure that these message changes are being pushed out to the manufacturers? Is this a change where they originally told the manufacturers they need the legislative warnings and now have changed those warnings to the ones you write about?

The reason I question this is that the Swedish snus I purchased over the last month or so has the legislative type warning on them.

If this were a change they are insisting on, I could see it as a considerable expense to again change labeling.

More importantly, if science is going to be used to create these warnings, aren't all the warnings poorly constructed. I would suggest for Swedish snus the warnings read-

‘‘WARNING: This product is only 98% safer than cigarettes.”

‘‘WARNING: Smokeless tobacco is addictive, but a better alternative than smoking.”

‘‘WARNING: This product can cause mouth cancer at a lower rate than smoking.”

‘‘WARNING: This product can cause gum disease and tooth loss just like aging, but at a lower rate than smoking.”

At the same time, the government should insist that seat belts have warning tags that state

"Seat belts may cause death or disability in an accident"

Same for motorcycle helmets, parachutes, and Chantix as well as a slew of products on the market today.