Mar. 2 2000
Washington, DC - The U.S. Food and Drug Administration protects the public health by requiring that all foods, drugs, cosmetics, and medical devices – virtually all products we consume or put on our skin – meet minimum health and safety standards. Until the FDA asserted jurisdiction over tobacco in 1996, only one product had a special exemption – tobacco. While we are confident that the FDA is on solid legal ground in asserting jurisdiction over nicotine containing tobacco products, if the Supreme Court does not uphold the FDA’s action, tobacco will once again have this special exemption. If Philip Morris’ Kraft division wants to put a new ingredient in Kool-Aid or Jello or Shredded Wheat or Macaroni and Cheese, it must first test that ingredient to be sure that it is safe and will not cause sickness or injury when the consumer uses those products. It must also tell the FDA what it is adding and how much it is adding and list each ingredient clearly on the product package. If the FDA later discovers that any ingredient in these Kraft products causes harm, it has the power to order the ingredient removed or the product seized. But what about tobacco? The same rules have never applied. Over 40 chemicals have been identified in tobacco products that have been determined to cause cancer. Scientists have discovered arsenic, formaldehyde, lead, benzene and polonium-210 in tobacco products or their smoke. Despite this knowledge, the tobacco industry has not removed these cancer-causing agents voluntarily. Absent the FDA having full authority over tobacco, no federal agency has the authority to require them to do so. Look at a package of Marlboro, do you see a single ingredient listed? The answer is no. How much ammonia is in a tobacco product and does it make that product more addictive? The answer is we don’t know when the tobacco industry started putting ammonia in its products, have not seen the industry’s research on the effect of the ammonia in these products, and don’t know how much is in each brand. If this was any other consumer product, the manufacturer would have been required to tell FDA all of this information BEFORE it added the ammonia. AND Philip Morris would have been required to prove that the ammonia did not cause harm or increase the risk that the product would cause harm. We need to be very clear, tobacco needs to be regulated to the same degree as other products or else millions of consumers are going to continue to be exposed to unnecessary health risks that lead to premature death. At a minimum, this includes: Authority to Reduce and/or Eliminate the Harmful Components of These Products that provides FDA with the authority to decide whether to reduce and, where appropriate, eliminate the harmful components of tobacco products, including nicotine, the component that causes addiction. Authority Over Youth Access and Tobacco Advertising and Marketing that provides FDA with rulemaking and enforcement authority over restrictions on 1) youth access to tobacco products, 2) tobacco advertising and marketing. FDA should not be bound by a fixed set of restrictions that the tobacco industry can then circumvent. It must have the power to adjust to new circumstances and new evidence. Authority to Require Health Information Disclosure that entitles FDA to receive all documents and information in the tobacco industry’s possession relating to health effects of tobacco products, nicotine and its effect on the body, addiction, marketing to children and the effect of marketing on children. Authority Over Ingredients that provides FDA with the authority to require the tobacco industry to provide FDA with a complete list of all tobacco ingredients and additives, by brand and by quantity, and the authority to require that this information be given to the public. FDA must also have the authority to regulate the use of any ingredient or additive that is harmful or which contributes to the harm of the product. Authority Over Health Warnings that provides FDA the authority over health warnings on tobacco product packages and advertisements, including the power to revise and add health warnings and to alter the format including, but not limited to, size, location, and color. Health Claims and Lower Risk Products that provides FDA the authority to prohibit or restrict 1) unsubstantiated health claims, whether directly or indirectly made; and 2) health claims that have the effect of discouraging people from quitting or encouraging them to start and provides FDA the authority over products that they claim reduce the health risk to consumers. Unless Philip Morris is willing to agree to regulation that meets these minimum standards, its statements this week should be seen as a public relations gesture designed to disguise its continuing demand for special treatment.