In a highly surprising and most unusual decision, FDA on Monday denied a broad-based industry request for an extension for 90 days of the comment periods relating to FDA’s supplemental proposal on “added sugars.” The proposal would establish a Daily Reference Value (DRV) for “added sugars” and require the Nutrition Facts panel to declare the percent Daily Value (%DV), as well as the amount, of “added sugars” per serving. Historically, FDA has only denied requests for extensions of a comment period where there were serious questions of public health or safety, statutory deadlines, or repeated requests representing an attempt to abuse the process. None of those factors are apparent here.
FDA’s initial proposal, published on March 3, 2014, which would require the amount of “added sugars” to be listed in a triple indent format beneath carbohydrates and total sugars, has been extremely controversial. In support of its proposal, FDA conducted consumer research to gauge whether consumers would understand the new line. FDA initially balked at releasing the results and underlying data from the study which, some say, demonstrated a lack of consumer understanding and, in some instances, actual confusion caused by the declaration of “added sugars.” Less than a month ago, FDA finally released the study results and data which it had for over six months.
A full 16 months after its initial proposal, FDA doubled down and proposed to establish a DRV for “added sugars” and require a %DV declaration for “added sugars” based almost exclusively on the recommendations of the controversial report of the 2015 Dietary Guidelines Advisory Committee. In its initial proposal, FDA had concluded that there was no scientific evidence to support the establishment of a DRV for “added sugars.” This latest proposal is even more controversial than the initial one – FDA has never established a DRV for an ingredient (“added sugars” as opposed to “sugars”). Similarly, FDA has never based a DRV on the recommendations of a Dietary Guidelines Advisory Committee; rather, historically, FDA has always relied upon traditional sound science found in clinical trials conducted by or for the Institute of Medicine of the National Academy of Sciences.
Inexplicably, FDA only provided 60 days to comment on its survey and data, and 75 days on the “added sugars” DRV and % DV proposal. It took the agency 16 months between the initial proposal and the supplemental. Yet, the public and regulated industry is only given a maximum of 75 days to comment.
Where’s the fire? Why the highly compressed comment period? Maybe it’s just a matter of FDA making sure it has time to issue a very controversial and scientifically dubious final regulation before President Obama’s term ends.