A coalition of medical and public health groups which calls itself "Partners for Effective Tobacco Policy" has sent a letter to members of Congress which purports to inform policy makers about the FDA tobacco legislation (H.R. 1376 and S. 666) that has been introduced into the 109th Congress. The letter, dated April 7, compares the authority that FDA would be given to regulate tobacco products with existing authority that the Agency has to ensure the safety of other products.
The coalition, which is headlined by the Campaign for Tobacco-Free Kids, the American Cancer Society, the American Lung Association, and the American Heart Association, also includes a number of other important groups which co-signed the letter, such as the American Public Health Association, American College of Preventive Medicine, Association of Teachers of Preventive Medicine, Society for Public Health Education, American College of Physicians, American College of Cardiology and the American College of Chest Physicians.
In comparing the authority that FDA would be given to regulate tobacco products with existing powers FDA has to regulate the safety of other products, the letter states that H.R. 1376/S. 666 provides "FDA with authority over tobacco products similar to the authority it has over other products. FDA would have the authority to stop tobacco marketing and sales to our children and to subject tobacco products to the same consumer protections, such as ingredient disclosure, product regulation and truthful packaging and advertising, applied to other products. Just as we entrust FDA with the authority to approve every ingredient in food to ensure safety, we should give FDA the same authority to regulate tobacco products."
The Rest of the Story
This letter is misleading and deceptive and will likely have the effect of providing members of Congress with an inaccurate understanding of the nature of the proposed legislation. Any organization that signed on to this letter having first read the text of the letter should be ashamed of itself and I think owes the public health community an apology. I also think that each organization and/or the Partners coalition itself is obligated to send a letter of clarification to our policy makers. I think the letter represents unethical public health conduct, and violates the basic code of public health ethics.
Why? Because the letter misrepresents the nature of the legislation in a profound way, and any professional medical or public health organization that read the letter should have been aware of this. Thus, signing on to the letter must be presumed to represent a willful (i.e., intentional) attempt to deceive policy makers about the true nature of the legislation.
The letter states that the legislation would provide FDA with authority over tobacco products that is "similar to the authority it has over other products." This is, frankly, a bunch of crap. In no way is the authority provided to FDA in this legislation similar to that provided to the Agency for the regulation of other products, such as food and drugs. In fact, it is fundamentally different.
If any of the organizations took the time to read the bill before signing on to the letter, they would have immediately had to notice the very first major provision of the legislation. Section 901(a), entitled "FDA Authority over Tobacco Products," reads: "Tobacco products shall be regulated by the Secretary under this chapter and shall not be subject to the provisions of chapter V." And what is chapter V? It is the entire regulatory authority for ensuring the safety of drugs and devices.
And the bill itself does not give FDA the major aspects of the authority it has over food and drugs.
Most importantly, it cannot remove a tobacco product from the market under any circumstances, even if it is deadly. In contrast, a drug or device can and must be immediately removed from the market if it is found to cause serious health consequences: "If the Secretary finds that there is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death, the Secretary shall issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the device) - (A) to immediately cease distribution of such device." [see 21 U.S.C. chapter IX, section 360(h)(e)(1)]
Unlike its authority over food additives, the Agency is not required to do anything about tobacco additives, even if such additives are known to be deadly. In contrast, food additives are not allowable unless "the proposed use of the food additive ... will be safe: Provided, That no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal." [see 21 U.S.C. chapter IX, section 348(c)(3)(A)]
Unlike its authority over drugs, the Agency is not required to deem a tobacco product as being misbranded, and not allowable, if it is deadly if used as intended. In contrast, a drug is automatically deemed to be misbranded "if it is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof." [see 21 U.S.C. chapter IX, section 352(j)]
Moreover, unlike its authority over drugs, the Agency is not allowed to establish a system by which adverse events related to the use of tobacco products are required to be reported. In contrast, chapter V sets up a system for "receiving reports of adverse events regarding drugs." [see 21 U.S.C. chapter IX, section 355b(a)]
As I think should be obvious, it is very clear that the FDA legislation does not give the Agency authority over tobacco products "similar to the authority it has over other products." In fact, the authority is about as different as one could imagine.
It is also clear that the legislation does not "subject tobacco products to the same consumer protections...applied to other products." This statement, in fact, comes dangerously close to being not just misleading, but grossly inaccurate.
And the statement that "Just as we entrust FDA with the authority to approve every ingredient in food to ensure safety, we should give FDA the same authority to regulate tobacco products" implies that the FDA legislation would give FDA authority to "approve every ingredient" in cigarettes, which is completely false.
In signing this letter, the organizations that make up the "Partners for Effective Tobacco Policy" have, I think, violated accepted standards of professional public health conduct that require public health organizations to provide the public with full and accurate information that is necessary to make decisions on policies. This is what the APHA Public Health Code of Ethics calls the "community-level" equivalent of the individual-level ethical principle of informed consent:
"Public health institutions should provide communities with the information they have that is needed for decisions on policies or programs and should obtain the community’s consent for their implementation. ... there is a moral obligation in some instances to share what is known. For example, active and informed participation in policy-making processes requires access to relevant information. ...Such processes depend upon an informed community. The information obtained by public health institutions is to be considered public property and made available to the public."
The letter has not only failed to inform members of Congress of the critical differences in the regulatory system that H.R. 1376/S. 666 sets up for tobacco products compared to FDA's authority over food and drugs, but even worse, it has completely misled them about these differences.
Note that I am not arguing here that the FDA legislation should necessarily give the Agency authority that is similar to its authority over food and drugs. Such a regulatory framework would most likely require tobacco products to be removed from the market. But the Partners' misrepresentation of the nature of FDA authority over tobacco products as provided by this legislation is inappropriate, irresponsible, and unethical.
I would certainly hope and expect to see a retraction and apology for this letter, either by the entire coalition as a whole, or by each of the 34 organizations that should feel ashamed for having taken part in such a deceptive and inappropriate lobbying endeavor.