CSPI: No Beta-Carotene for Smokers

WASHINGTONThe Center for Science in the Public Interest (CSPI) sent a letter to FDA in early December, asking the agency to require manufacturers of dietary supplements that contain doses of beta-carotene over 5,000 IU/3 mg amount to carry a label warning about possibly increasing the risk of lung cancer. The consumer protection group said supplements with high levels of beta-carotene should be considered adultered and misbranded because they lack warning labels stating they pose a significant risk to smokers or people exposed to asbestos.

The evidence connecting high-dosage beta-carotene supplements to increased rates of lung cancer in smokers is compelling, said David Schardt, senior nutritionist. Obviously, quitting smoking is the most important thing one can do to avoid lung cancer. But smokers and former smokers alike should absolutely not take supplements containing high-potency synthetic beta-carotene. Warning labels would help drive that message home.

Unfortunately, according to industry members, there are greater legal issues to address. "It's fairly clear CSPI doesn't have a good grasp of the labeling laws," said Daniel Fabricant, Ph.D., vice president, scientific and regulatory affairs, Natural Products Association. He noted the requirement for a notice and comment period for making such a substantive rule change, as well as the fact that for a dietary supplement to be considered adulterated or misbranded, the labeling must fail to reveal facts related to normal or customary conditions of use. "For FDA to offer such a warning per the Dietary Supplement Health and Education Act, it would take a great deal of effort by FDA," he said. "In this context, the level of substantiation would be very high, and it would also have to include that smoking was an ordinary condition of use, which is no easy feat."

Fabricant added there are also greater philosophical issues that beg the question as to whether CSPI needs to attribute the real risk where it belongs. "Does this mean all cars should contain warnings for drinking alcohol, or should a fork have a warning that when it is combined with foods rich in saturated fats and cholesterol, it increases the risk for heart disease? At some point CSPI will have to enter the world of adulthood and responsibility."