FDA Issues 2009 FDA Food Code

December 1, 2009

The Food and Drug Administration today announced the publication of the new FDA Food Code, a model code and reference document that provides a scientifically sound technical and legal basis for regulating the retail and food service segment of the food industry.

State, city, county, tribal, and territorial agencies regulate more than 1 million restaurants, retail food stores, and vending and food service operations in institutions such as schools, hospitals, nursing homes, and child care centers.

What FDA Food Code provides

The model FDA Food Code provides the basis for most of those agencies’ licensing, inspection, and enforcement activities, as well as serves as a model for their food statutes, regulations, and ordinances.

The 2009 edition of the Food Code is the seventh full edition published by the FDA. The previous full edition was released in 2005 with a supplement published in 2007.

Significant enhancements to the 2009 FDA Food Code include:

  1. Each provision in the FDA Food Code is now designated as a “Priority Item,” a “Priority Foundation Item,” or a “Core Item,” to assist the industry and regulatory community in prioritizing their food safety interventions and their inspections.  These designations are based on a qualitative risk assessment and replace the use of “Critical” and “Non-Critical” designations in previous editions of the FDA Food Code.
  2. Cut leafy greens are now included among the foods that require time and temperature control for safety and a new supporting reference document, “Recommendations to Food Establishments for Serving or Selling Cut Leafy Greens,” is summarized in Annex 2.
  3. Requirements are added to improve food worker awareness of food allergen concerns in the food service and retail setting.
  4. Serving hamburgers and other ground meats in an undercooked form upon a consumer’s request is no longer an option for items offered on a children’s menu.
  5. A new definition and criteria are added in a new FDA Food Code section for the non-continuous cooking of foods comprised of raw animal products to address the safety of this cooking method.
  6. Several requirements related to the effective cleaning and sanitizing of equipment and surfaces are enhanced or clarified.

Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189598.htm


FDA Amends Labeling Requirements

December 1, 2009

What final rule requires?

The final rule requires important new organ-specific warnings and related labeling for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products.

The new labeling informs consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using nonsteroidal antiinflammatory drugs (NSAIDs).

Final Rule Requirements

  1. Immediate Container Labeling
  2. See New Warnings Flag
  3. Liver Injury Warning For OTC Acetaminophen Products Containing Multiple Active Ingredients

DATES: Effective Date:

This final rule is effective April 29, 2010.

Compliance Date:

The compliance date for all products subject to this final rule, including products with annual sales less than $25,000, is April 29, 2010.


Arlene Solbeck, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5411, Silver Spring, MD 209930002, 3017962090

Source: http://www.fdanews.com/ext/files/2009-28296_PI.pdf

FDA Issues 22 Warning Letters to Web site Operators

December 1, 2009

FDA’s Office of Criminal Investigations (OCI), in conjunction with the Center for Drug Evaluation and Research and the Office of Regulatory Affairs, Office of Enforcement, targeted 136 Web sites that appeared to be engaged in the illegal sale of unapproved or misbranded drugs to U.S. consumers.


None of the Web sites are for pharmacies in the United States or Canada.

What did the agency issued?

The agency issued 22 warning letters to the operators of these Web sites and notified Internet service providers and domain name registrars that the Web sites were selling products in violation of U.S. law.