FDA Unveils New "Strategic Plan for Regulatory Science"

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August 19th, 2011

The United States Food and Drug Administration (FDA) today released it's new Strategic Plan for Regulatory Science available for download from Obesity PPM by clicking here.   Priorities include developing medical countermeasures to protect threats to global security, stimulating personalized medicine programs, and ensuring agency capability to evaluate innovative technologies.  

This plan is at least in part a reaction to the Institute of Medicine's (IOM) recent report recommending the total retirment of the 510(k) process, Medical Devices and the Public's Health: The FDA 510(k)Clearance Process at 35 Years, available by clicking here.  Despite having been iniated at the request of the FDA, its findings were not well received.

Obesity PPM is beginning its evaluation of the FDA's new strategic plan.  Please stay tuned for Obesity PPM's position on the impact to obesity-focused medical device and pharmaceutical companies, the health care delivery infrastrucuture, and American consumers suffering from obesity.  

FDA Proposes Draft Menu Labeling Requirements, Invites Public to Comment

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Updated July 25th, 2011: Excellent public comment submitted by Starbuck's Coffee Company is available here.

Updated June 22nd, 2011: Reminder that the deadline for public comment on second of the two proposed regulations is fast approaching: July 5th.  Instructions to comment are below.

On Friday, April 1st, the US FDA opened up a forum for public discussion of their two new proposed regulations, lasting until June 6th and July 5th, respectively.  Quite significantly, these regulations specifically remove the rights of state and local governments to impose regulations different from the Federal requirements.

  1. Click here for the full text of FDA-2011-F-0172, proposed regulation that addresses menu labeling in restaurants and retail food establishments.
  2. Click here for the full text of FDA-2011-F-0171, proposed regulation that addresses nutrition labeling for vending machines.  

A regulatory enactment of the Affordable Care Act, these proposed regulations seek to provide consumers with nutritional data to inform their food choices.  The following statement must appear on compliant menus, "A 2,000 calorie diet is used as the basis for general nutrition advice; however, individual calorie needs may vary.”  Unfortunately, by using the word "may," and reflecting calories as percentages of this arbitrary number, this statement continues to enforce the incorrect but commonly held notion that there is a single portion size appropriate for everyone.  

In order to submit comments electronically, visit this page, and:

1. Choose “Submit a Comment” from the top task bar;
2. Enter the following docket numbers in the “Keyword” space: docket number FDA-2011-F-0172 for menu items in restaurants and similar retail food establishments, and docket number FDA-2011-F-0171 for vending machines;
3. Select “Search.”

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