Jay Sjerven

In testimony during his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions (HELP) on April 5, Scott Gottlieb, Ph.D., the president’s nominee to be commissioner of the Food and Drug Administration, indicated he may be open to extending the deadline for food manufacturers to be in compliance with the new Nutrition Facts Panel rules so the new label may be introduced at the same time as that currently being developed by the U.S. Department of Agriculture for disclosing presence of bioengineered ingredients.

Currently, all but the smallest of food manufacturers will be required to begin using the new Nutrition Facts Panel on all of their foods by July 26, 2018. The food industry has encouraged the F.D.A. to postpone the compliance date until 2021, pointing out the cost for meeting the later compliance date would be significantly lower, especially when considering it may enable food manufacturers to roll out both the new Nutrition Facts Panel and the mandatory bioengineered food disclosure label at the same time.

In response to a question by Kansas Senator Pat Roberts, who, in addition to serving on the HELP committee, is chairman of the Senate Committee on Agriculture, Nutrition and Forestry, on whether he’d support delaying the compliance date for the Nutrition Facts label, Dr. Gottlieb said, “ I’m philosophically in favor of trying to make sure we do these things efficiently not only because it imposes undue costs on the manufacturers if they’re constantly updating their labels, but we also have to keep in mind it does create confusion for consumers if the labels are constantly changing. So you want to try to consolidate the label changes when you’re making label changes as a matter of public health, so the information is conveyed accurately and efficiently to the consumers.”

Dr. Scott Gottlieb, F.D.A.
Scott Gottlieb, Ph.D., may be open to extending the deadline for food manufacturers to be in compliance with the new Nutrition Facts Panel rules.

Mr. Roberts was the only member of the HELP committee to ask questions specifically relating to the F.D.A.’s food safety mission during a hearing that lasted more than 2.5 hours.

On March 14, 17 food industry associations sent a letter to Thomas Price, Ph.D., secretary of Health and Human Services, requesting that the compliance deadline for the new Nutrition Facts and serving size rules be extended to May 2021 from July 2018.

“We wish to be very clear, our member companies support providing consumers with clear information to help them make healthy choices, and we are committed to implementing these rules,” the associations said. “We believe, however, this can be accomplished with far less complexity and cost.”

The associations said that as demonstrated by the F.D.A.’s regulatory impact analysis for the rules, “additional time will avoid billions of dollars in wasteful spending on duplicative relabeling schemes, allow coordination with planned label updates, provide the F.D.A. time to issue guidance that is critical for implementing key provisions of the rule, and create a timeline that will allow the U.S.D.A. to complete its work on a separate rule mandated by P.L. 114-216, which requires mandatory disclosure of ingredients produced with biotechnology.”

The associations pointed to the F.D.A.’s regulatory impact analysis found that the cost associated with the current two-year compliance deadline may be as high as $4.6 billion and that the cost may be reduced by nearly $2 billion if the compliance deadline were to be four years instead of two years.

“Unfortunately, F.D.A., under the previous administration, chose the option that is 39% more expensive,” the associations commented.

The associations asserted the current compliance deadline “does not sufficiently account for the time, resources and complexity involved in label changes of this magnitude.” They added a further complication was the F.D.A. has yet to issue final guidance on how to define and properly calculate two common food ingredients: dietary fiber and added sugar.

“Moreover, immediately after the July 26, 2018, compliance date for the N.F.L., the U.S.D.A. is mandated to finish the biotechnology disclosure rule on July 29, 2018,” the associations pointed out. ”This means that only three days after over 715,000 covered food and beverage products are required to be in compliance with F.D.A.’s N.F.L. rules, industry must again begin the expensive and time-consuming process to redesign labels and related materials and relabel their products to come into compliance with the biotechnology disclosure rule.

“The most cost-effective approach would be to minimize the number of times packaging must be redesigned, reprinted and relabeled. An extension of the current N.F.L. compliance date to May 2021 is urgently needed in order to ease regulatory burden on the economy.”