Forty-eight hours ahead of that date, the Food and Drug Administration issued a notice “clarifying ” that Dec. 1 is now the “compliance” date for the regulations, not May 5, 2017, as was set by FDA in May 2016.
In no time, FDA Commissioner Robert Califf felt a blunt force on his backside from the boots of members of Congress who cried foul.
“FDA’s action is outrageous,” said Sen. Roy Blunt, R-MO. “You are already aware the effective date fails any test of reasonableness and should not stand.”
Another letter contains 16 signatures from U.S. legislators led by Rep. Cathy McMorris Rodgers, R-WA, who chairs the House Republican Conference. It calls the FDA action “reckless” and says it violates the intent of Congress. FDA’s action is a “fly by night” change that cannot stand.
Then after 48 hours of “confusion,” Califf opted to again clarify the record with the FDA by releasing a statement.
“The U.S. Food and Drug Administration today (Dec. 2) announced that it will soon publish a final rule to formally extend to May 5, 2017, the compliance date for the agency’s 2014 menu labeling regulation, which requires disclosure of certain nutrition information for standard menu items in certain chain restaurants and similar retail food establishments. This extension will align the compliance date with the enforcement date,” Califf said.
Positive reaction from the powerful National Restaurant Association (NRA) quickly followed from Cicely Simpson, executive vice president of government affairs and policy.
“The National Restaurant Association applauds the FDA for issuing this important clarification regarding menu labeling,” she said.
“We have long-advocated for a nationwide federal menu labeling standard that gives customers access to uniform nutritional information at restaurants, that provides certainty to restauranteurs and food service operators over the patchwork of state and local laws. Today’s announcement by the FDA gives the food service industry the time it needs to empower their customers to make the best choices for themselves.”
For his part Califf, who is asking President-elect Trump to retain him as FDA commissioner, says the FDA statements that fueled the political dustup of the 48 hours before Dec.1 can now be tossed out.
“This Constituent Update supersedes any previous FDA statements regarding the compliance date for the menu labeling regulations,” the FDA Dec. 2 statement says.
It explains what’s going on this way: “Section 747 of the Consolidated Appropriations Act, signed on December 18, 2015, prohibited the FDA from using appropriated funds to implement, administer or enforce the menu labeling requirements until one year after the FDA issues final guidance for industry on the menu labeling requirements. On May 5, 2016, the FDA published the final guidance and announced in the Federal Register that enforcement of the menu labeling rule would begin on May 5, 2017.
“While the FDA made clear that it would not begin enforcing menu labeling requirements prior to May 5, 2017, the FDA did not at that time formally make a change to the compliance date through rulemaking. Thus, the compliance date was officially Dec. 1, 2016, as communicated in our Nov. 29, 2016, Constituent Update. To bring the official compliance date into alignment with the enforcement date, the FDA is now announcing that it will issue a final rule to formally extend the compliance date to May 5, 2017.”
NRA’s statement did not address the obvious. Menu labeling, which is required by the Affordable Care Act, might well go away entirely with the incoming Congress, which has made a priority out of “repealing and replacing” the Obamacare law. Pushing off the compliance date means there will be plenty of time for that to occur.
FDA’s cost estimate for menu labeling was $1,000 to $1,800 per restaurant. The National Restaurant Association represents about one million restaurants in the United States.
As drafted, menu the new labeling requirements include listing calorie content for foods sold by restaurants and other food establishments if they are part of a chain of 20 or more locations doing business under the same name and offering for sale substantially the same menu items.
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