FDA ConneKTion

Timely updates and insights on the latest issues affecting FDA-regulated companies from Kilpatrick Townsend

Archive for May 2017

Posted on Thursday, May 11 2017 at 8:34 pm by -

New FDA Commissioner Scott Gottlieb, M.D. Sworn in Today

By Carolina M. Wirth

As many of you know, Scott Gottlieb, M.D. was confirmed by the Senate (57 to 42) on Tuesday, May 9, 2017, to serve as the 23rd Commissioner of the Food and Drug Administration (FDA or agency).   Today, he was officially sworn in as Commissioner and begins the task of leading the FDA.

drscottgottlieblHere are a few facts about the FDA’s new Commissioner:[i]

  • Dr. Gottlieb is a physician, medical policy expert, and public health advocate.
  • He previously served as FDA’s Deputy Commissioner for Medical Scientific Affairs and as Senior Advisor to the FDA Commissioner.
  • He worked on the implementation of the Medicare drug benefit when he served as a Senior Advisor to the Administration of the Centers for Medicare and Medicaid Services.
  • He was appointed by the Senate in 2013 to serve on the Federal Health Information Technology Policy Committee, which advises the Department of Health and Human Services on Healthcare Information Technology.

Read the rest of the entry…

Posted on Friday, May 5 2017 at 8:53 pm by -

Compliance Deadline For Menu Labeling Regulation Postponed Due To Implementation Challenges; Further Request for Comments

By: Alyson L. Wooten, Pharm.D.

For those anxious about today’s compliance date for Food and Drug Administration’s (FDA) regulations governing calorie labeling, the compliance deadline has been postponed. FDA has again decided to delay the compliance date for its regulations governing calorie and other nutritional labeling for menus and menu boards at restaurants and similar establishments.  The new date for compliance is May 7, 2018.

Cohen_Simms_FDA_menu_labelingThe additional year is necessary to allow the Agency to reconsider aspects of the regulations to “further reduce the regulatory burden or increase flexibility while continuing to achieve our regulatory objective.”[i]  Further, the Agency stated that “continued, fundamental questions and concerns with the final rule suggest that critical implementation issues, including some related to scope, may not have been fully understood and the agency does not want to proceed if we do not have all of the relevant facts on the matters.”[ii]

The final rule (79 FR 71156; codified at 21 C.F.R. § 101.11) had an original compliance date of December 1, 2014, which was later extended to July 10, 2015 (80 FR 39675), and ultimately to December 30, 2016 (81 FR 96364).

As part of this extension of time, FDA is seeking additional comments regarding the compliance date extension, implementation of the final rule, and three “fundamental issues that continue to pose significant implementation challenges:”[iii]

  • Calorie disclosure signage for self-service foods, including buffets and grab-and-go foods;
  • Methods for providing calorie disclosure information other than on the menu itself, including how different kinds of retailers might use different methods; and
  • Criteria for distinguishing between menu and other information presented to the consumer.

The deadline to submit comments is July 3, 2017.

[i] https://www.federalregister.gov/documents/2017/05/04/2017-09029/food-labeling-nutrition-labeling-of-standard-menu-items-in-restaurants-and-similar-retail-food

[ii] Id.

[iii] Id.