President, Strategic Communications, LLC

Thursday, December 20, 2012

Bah Humbug for FDA

Ho, Ho, Ho. Has FDA been naughty or nice to the food industry in 2012?

Basically, the agency has been neither, but it has been MIA on just about every major food issue, so paraphrasing one of the great TV lines from Seinfeld, "No gifts for you!"
The story is so familiar it has almost become trite – the federal agency that regulates 25% of the nation's GNP, is overwhelmed by issues, short on expert staff and resources and mostly leadership takes a pass on the "F" in FDA, again.

Now, at the very time it's plate is overflowing, FDA like all other federal agencies, face a serious, 8.2% cut in spending as part of the "fiscal cliff" negotiations. According to a recent report by OMB, FDA would see a $318 million budget reduction out of its entire budget. FDA estimates $71 million of that would come out of what's left of the agency’s food program.

Michael Taylor, FDA’s Deputy Commissioner for Foods, said in September he believes sequestration would be “a huge blow to our progress on food safety. . . The Center for Food Safety and Applied Nutrition, which has a central role in implementing the Food Safety Modernization Act, has had the same permanent FTE [full time equivalent] staffing level as it did in 1992, before the explosion of imports, before the overall growth in the complexity and size that we see in the food system, even before FSMA was enacted,” he said. “We need to beef up the staffing at CFSAN and other parts of the program, so anything that forces us backward — you can just imagine the effect that it would have.”

While the food numbers are bleak, the basic problem here, is that FDA has always been dominated by the drug side of the agency. Most days the folks in CFSAN are MIA in terms of decision-making.

Consequently, the following major policy issues rest gathering dust somewhere at the agency's headquarters. The key risk management question FDA refuses to answer is how many people have to die before FDA considers food policy a top-tier issue?

OK, none of the following rise to the level of the fiscal cliff or nominating a Supreme Court Judge, but the following laundry list is long and includes issues that invites the "greed is good people" to emerge or states, such as California and Washington State to make policy for the nation:
  • Dealing with the current "voluntary" disclosure of caffeine of energy drinks and the safety of these beverages marketed to children
  • Determining a no significant risk to human health level for acrylamides
  • Implementing new sections of the Food Safety Modernization Act, which is years overdue
  • Trying to define just what the Hell the term "natural" means
  • Overhauling front panel nutrition labeling and the Nutrition Facts box. What to do with sugar vs added sugars? What do do with partially hydrogenated vegetable oils, which turn into trans fats? The last time FDA did this, it required a massive commitment of manpower and 18 months of work which resulted in more than 2,000 pages of fine print in the Federal Register. The promise of action in 2013 is laughable.
  • Taking any action whatsoever to defend its position that GMO foods present no significant risk to the public
So, what does the future hold? Great year for food lawyers, not so much for anybody else.

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