Regulatory Focus™ > News Articles > New House Bill Would Allow Manufacturers to Label Products 'Cancer-Free'

New House Bill Would Allow Manufacturers to Label Products 'Cancer-Free'

Posted 27 July 2012 | By Alexander Gaffney, RAC 

Newly-proposed legislation introduced in the US House of Representatives would allow companies to submit to a voluntary process to label their products "Cancer-Free" if they do not contain known carcinogens.

The bill, The Cancer-Free Label Act of 2012, was introduced by Rep. Ted Deutch (D-FL) and would establish a program within several federal agencies-including the US Food and Drug Administration (FDA)-to "permit the labeling of covered products that do not contain any carcinogens as "Cancer-Free."

Under the program, FDA would be charged with coordinating with other product regulators such as the Environmental Protection Agency (EPA) and the Consumer Product Safety Commission to develop an "easily recognizable label to be affixed to a covered product to signify that the product has been approved for labeling as 'Cancer-Free.' The label would be accompanied by an explanatory statement indicating the product "does not contain known or likely carcinogens that increase your risk of cancer."

Potential Regulatory Problems for Industry?

The bill raises something of a conundrum for pharmaceutical manufacturers, whose products may well be associated with cancer without actually containing a known carcinogen. US regulators might also stand to take issue with the program under its "fair balance" marketing regulations, which require companies to not make unsubstantiated claims or include information that is in any way unbalanced relative to the risk of the product. By being allowed to label a product as "Cancer-Free," manufacturers could find themselves at the receiving end of a warning from FDA's Office of Prescription Drug Promotion (OPDP), which regularly chides companies for even the slightest misstatements.

Some products used to eliminate cancer, such as chemotherapy drugs, are  themselves highly toxic substances and would almost certainly not be eligible for the statement.

Deutch's bill contains provisions to require premarket approval for the statements, and sponsors would be required to apply for the labeling. However, the approval process for such a label would not include any other determinations other than whether the product contains "any substances that display carcinogenicity." Notably, "carcinogenicity" is not defined under the act to include any finding by FDA that a product causes cancer, and instead relies solely upon EPA and National Toxicology Program determinations.

FDA would also be tasked by the legislation to introduce new guidance on how to "prevent the introduction of carcinogens into such covered product during the manufacture, storage and transportation" of a product labeled with the "Cancer-Free" designation.

Read more:

The Cancer-Free Label Act of 2012

Rep. Deutch Unveils Cancer Free Label Act 

h/t The Hill - Dem proposes bill allowing some products to be labeled 'cancer-free'

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