Kessler Petition Seeks Revocation of GRAS Status for Processed Refined Carbohydrates

News coverage of the citizen petition submitted by Dr. David Kessler has been somewhat breathless, so it was nice to read the document first hand when it was posted yesterday in the docket at regulations.gov – and you should do the same. Spoiler alert! In essence, the petition asks FDA to revoke the generally recognized as safe (GRAS) status of a number of substances categorized as “processed refined carbohydrates” because there no longer exists a consensus among qualified experts that current uses of those substances are safe within the meaning of section 409 of the FD&C Act (i.e., that there exists a reasonable certainty of no harm). Whether those substances could continue to be used in food in the long term would depend on the success of food additive petitions that industry would be required to submit to FDA. The Kessler petition thus presses FDA to follow the path trod by the agency when it revoked the GRAS status of partially hydrogenated oils ten years ago, thereby prompting  submission of a food additive petition that was subsequently denied. (Has it really been 10 years?)

The Kessler petition paints a dire picture of the health of the U.S. population, and draws on several lines of scientific argument to conclude that ultra-processed foods (UPFs) and “ultra-processed food technology” encourage food consumption patterns that contribute to a host of diet-related diseases. Rather than struggle over precisely defining UPFs and targeting their consumption directly, the petition argues in favor of targeting processed refined carbohydrates, which are “central to the widespread availability of” UPFs. To the extent that processed refined carbohydrates were previously determined to be GRAS, the petition argues that circumstances have changed such that there can no longer exist a consensus of safety under current conditions of use. The petition argues that those substances “act metabolically in a similar fashion to ‘added sugars’ and small chain saccharides.” Thus, they are “conducive to rapid eating, rapid digestion, fast gastrointestinal transit time, and rapid absorption,” and “stimulate blood insulin and glucose,” thereby resulting in several adverse health effects. Further, the petition argues that “metabolic damage can begin very early in life… as early as the first days of life.” Perhaps most strikingly, the petition argues that any evaluation of safety must take into consideration the already poor metabolic health of the U.S. population.

Some readers might recall that Dr. Kessler was Commissioner of FDA when the agency sought to regulate cigarettes under its then-existing statutory authority, in an effort that narrowly failed to persuade the Supreme Court in FDA v. Brown & Williamson Tobacco Corp. Thus, it comes as little surprise when the petition argues that, “[j]ust as nicotine was central to FDA regulation of tobacco products, processed refined carbohydrates used in industrial food processing are a key component of [UPFs] that the agency needs to address in order to protect the public health from the health risks of these products.”

To give credit where credit is due, this is not the first citizen petition to seek revocation of the GRAS status of substances widely used in processed foods. However, this petition considerably ups the ante by broadening the list of targets, folding in more recent evidence of alleged harm, and playing to a potentially sympathetic regulator by indirectly targeting UPFs. FDA now has 180 days to respond, but given the complexity of the petition, it would be surprising if that response says much beyond “we’re still reviewing your petition.” If a response is significantly delayed, then the petitioner will have to decide whether to sue the agency to compel a response. Here again, the prior fight over partially hydrogenated oils offers a potentially useful precedent.