uncballzer
07-29-2007, 10:40 AM
Saw this in another forum just now (thefiringline.com). Anyone have any thoughts?
A fundamental precept of the Food, Drug, and Cosmetic Act (FDCA) is that any product regulated by the FDA that remains on the market must be safe and effective for its intended use. That is, the potential for inflicting death or physical injury must be offset by the possibility of therapeutic benefit. If tobacco products were “devices” under the FDCA, the FDA would be required to remove them from the market under the FDCA’s misbranding and device classification provisions. In fact, based on such provisions, the FDA itself has previously asserted that if tobacco products were within its jurisdiction, they would have to be removed from the market because it would be impossible to prove they were safe for their intended use.
The reality is that except for tobacco's unique and protected status it would be banned from the market based on the FDCA or classified as an illicit substance (Schedule I) by the DEA. Why should tobacco retain any form of protected status?
It is absurd to ask an administrative agency to ignore the very legislation that created it. The FDA's primary mission is to enforce the FDCA. The currently proposed legislation, which will allow the FDA to regulate tobacco, actually forces the FDA to act contrary to the requirements of the FDCA.
Congress has enacted specific statutes that have served to create a distinct regulatory scheme focusing on the labeling and advertising of tobacco products and thereby removed tobacco from the FDA's purview. But if Congress does pass legislation that places tobacco regulation under the supervision of the FDA with a specific regulatory scheme but the FDA chooses to ban tobacco at a later date based on the FDCA, would this be a constitutional exercise of executive power?
A fundamental precept of the Food, Drug, and Cosmetic Act (FDCA) is that any product regulated by the FDA that remains on the market must be safe and effective for its intended use. That is, the potential for inflicting death or physical injury must be offset by the possibility of therapeutic benefit. If tobacco products were “devices” under the FDCA, the FDA would be required to remove them from the market under the FDCA’s misbranding and device classification provisions. In fact, based on such provisions, the FDA itself has previously asserted that if tobacco products were within its jurisdiction, they would have to be removed from the market because it would be impossible to prove they were safe for their intended use.
The reality is that except for tobacco's unique and protected status it would be banned from the market based on the FDCA or classified as an illicit substance (Schedule I) by the DEA. Why should tobacco retain any form of protected status?
It is absurd to ask an administrative agency to ignore the very legislation that created it. The FDA's primary mission is to enforce the FDCA. The currently proposed legislation, which will allow the FDA to regulate tobacco, actually forces the FDA to act contrary to the requirements of the FDCA.
Congress has enacted specific statutes that have served to create a distinct regulatory scheme focusing on the labeling and advertising of tobacco products and thereby removed tobacco from the FDA's purview. But if Congress does pass legislation that places tobacco regulation under the supervision of the FDA with a specific regulatory scheme but the FDA chooses to ban tobacco at a later date based on the FDCA, would this be a constitutional exercise of executive power?