I’m going out on a limb and predicting Glitter Wine in 2014

According to today’s Federal Register (the daily roundup of announcements from the US Government’s agencies), the FDA is “amending the color additive regulations to provide for the safe use of mica-based pearlescent pigments…in distilled spirits…in response to a petition filed by E. & J. Gallo Winery.”

I’m not really sure what to make of that, except that E. & J. Gallo Winery (which according to their website is “the world’s largest family-owned winery and largest exporter of California wine”) had a vision of a world in which wine wasn’t merely white, red or whatever color this is, but instead shimmered with a panoply of magical iridescence, and the FDA wanted to help make that vision a reality.

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I have no idea what the health ramifications are of ingesting mica-based pearlescent pigments. Presumably, if the FDA OK’d it, it means it’s probably fine, although the FDA has been known to make bad calls in the past. Common Sense seems to suggest that we probably don’t need glittery wine, and that rather than amending the color additive regulations to allow for more additives the FDA could revisit some of the controversial color additives already in use.

But who knows? Maybe I am totally wrong and the FDA was right to prioritize green-lighting mica-based pearlescent pigments over their other duties. Its not like they have more pressing things to worry about, procrastinating like a college student watching kitten videos at three in the morning the night before finals until, to pull a hypothetical out of thin air, the Center for Food Safety sued them for taking too long to implement several major provisions of the Food Safety Modernization Act (FSMA). This law, ratified on January 4, 2011, represents the largest overhaul of our food safety system in decades. Its delay, hypothetically speaking, “is putting millions of lives at risk from contracting foodborne illness” and “constitutes unlawfully withheld and unreasonably delayed agency action.”

This suit is actually almost a year old and the court ruled in April, finding that the FDA’s delay in implementing the FSMA was in violation of the Administrative Procedure Act. The judge ordered the FDA and CFS to work together to set a mutually acceptable schedule for implementation. In a turn of events that was surprising to no one, the FDA refused to set any specific deadlines so both parties submitted different timetables to the court. F for group effort on that one kids.

The FDA, explaining that “because there are numerous factors and variables that will affect the length of time required for the development of draft final rules for regulations that have already been proposed, as well as the development of proposed rules that are not yet completed,” concluded “it is not feasible to predict with anything approaching certainty when the final FSMA regulations will be ready to be published.” So they decided to give themselves the “aggressive but achievable” timeline of well into 2014 with the caveat “that future developments, such as the need to supplement the administrative records with additional information, or the need to re-open one or more regulations, may render FDA unable to act within all of these timeframes.” So basically they accomplished the opposite of setting a timeframe.

In response, CFS stated that the FDA’s proposal “utterly fails to comply with the Court’s Order…A deadline is a deadline, a firm parameter with meaningful consequences, not a “target timeframe.” Contrary to Defendants’ mischaracterization, Defendants’ Proposal provides nothing remotely resembling a closed-ended process, not in accordance with the Court’s Order and congressional intent in setting firm deadlines for rulemaking in FSMA.” CFS wants everything finalized by 12/31/13, with final rules submitted by 5/1/14.

Part of the problem here is with the Office of Management and Budget, which the FDA doesn’t have any control over and which likes to sit on finalized rules for a long time with no reason because otherwise our democratic system of government might actually work.

To summarize, this whole fiasco is basically the story of FDA, the hapless undergrad, trying to get a paper extension from stern professor CFS. Thanks to helicopter parent OMB, FDA is probably going to walk away with an Incomplete with option to submit the paper after a long summer break sipping on Glitter Wine™.

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