Enforcement News

Warning Letters Citing Color Additive Violations

Matters described in FDA Warning Letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter. If you wish to obtain available additional information on the current status of an issue in a particular Warning Letter on this website, please contact the Agency or the recipient of the letter directly. Inquiries to FDA should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5600 Fishers Lane, Rockville, MD 20857. Instructions for submitting an FOI request are available online.

• Jerusalem Manufacturing Nature Foods & Wholesalers, Inc. (also available in PDF*) September 2, 2008
• Fresh Made Incorporated (also available in PDF*) October 16, 2007
• STM Trading Corporation (also available in PDF*) April 17, 2007
• Tres Leches Factory (also available in PDF*) March 7, 2007
• La Coruna Foods (also available in PDF*) February 5, 2007
• Warning Letter to Black Henna Ink, Inc., Cites Illegal Use of Color Additive (also available in PDF*) August 14, 2006
• Royalston Foods dba Royalston Desserts (also available in PDF*) July 18, 2006
• Roha U.S.A., L.L.C. (also available in PDF*) July 7, 2006
• PepsiAmericas (DakBev, LLC, dba Vending America) (also available in PDF*) May 24, 2006
• Karina Manufacturing Inc., dba Flanes Kopelia, dba Karina Bakery (also available in PDF*) March 30, 2006
• Carrington Laboratories, Inc. (also available in PDF*) December 5, 2005
• Blake Street Manufacturing, LLC, dba Art Coco Chocolate Company (also available in PDF*) July 1, 2005
• RealPure Beverage Group (also available in PDF*) March 10, 2005
• USA Chemicals, Inc. (also available in PDF*) March 1, 2005
• Refrescos Lugo (also available in PDF*) October 26, 2004
• E. Franco & Co. (also available in PDF*) September 14, 2004
• RPM Total Vitality June 29, 2004
• World Class Nutrition June 29, 2004
• Affordable Supplements June 28, 2004
• SmartBodyz Nutrition June 28, 2004
• WowMuscle.com, c/o Prime Nutrition June 28, 2004
• Higher Power, Inc. June 25, 2004
• American Sports Nutrition June 24, 2004
• Refrescos Yaguez, Inc. (also available in PDF*) June 1, 2004
• Bezzerides Co. April 29, 2003
• All Island Saiman LLC April 24, 2003
• Mary's Malasadas, Inc. March 18, 2003
• FCH Enterprises Inc. dba Napolean' Bakery February 12, 2003
• Five Star Noodle Factory January 30, 2003
• E&M Corp. dba Noh Foods of Hawaii December 6, 2002
• Triple A Services, Inc. November 18, 2002
• La Hacienda Fruit October 15, 2002
• Softchrome September 26, 2002
• Sacramento Cookie September 24, 2002
• Silgra Bakery September 19, 2002

Untitled Letters

• BASF Corporation February 5, 2007

Recalls

Color additive violations are a common reason for recalling FDA-regulated products. Recalls are listed weekly in FDA's Enforcement Report.

Import Alerts and Refusals

*PDF Readers are available for free from the Adobe Acrobat web site.