Gaitan Morales Assists Food Companies in Correcting Labeling, in Response to FDA Warning Letters

March 16, 2010 - PRLog -- Gaitan Morales, PLLC to Assist Food Companies in Correcting Labeling Errors, in Response to FDA Commissioner’s Open Letter to Industry

On March 3, 2010, FDA Commissioner, Dr. Hamburg, issued an open letter to the food industry calling for more reliable food labeling;  while also specifically warning 17 food manufacturers that the labeling for 22 of their food products violate the Federal Food, Drug, and Cosmetic Act (FDCA).[1][2].

In the Warning Letters, the FDA Commissioner highlights the importance of providing reliable nutrition information on food labeling, stating that “ready access to reliable information about the calorie and nutrient content of food is even more important, given the prevalence of obesity and diet-related diseases in the United States."

Violations cited in the Warning Letters include unauthorized health claims, unauthorized nutrient content claims, and the unauthorized use of terms such as “healthy,” and other terms for which the FDA has provided specific regulatory definitions.  The Warning Letters allow affected food companies only 15 business days to inform the FDA of their Corrective Action Plan (CAP) to remedy the existing food labeling deficiencies.  

Since being appointed FDA Commissioner, Dr. Hamburg has made nutrition labeling a priority for the FDA.  In October, 2009 Dr. Hamburg issued a statement encouraging food companies to to conduct a thorough review of their food labeling to ensure compliance with FDA regulations, accuracy and truthfulness.  The Warning Letters are the most recent enforcement action by the FDA to protect consumers and improve food labeling standards.
The FDA continues to review its policies and regulation regarding calorie and nutrient labeling on the front of food packages.  It is expected that the FDA will implement front-of-package labeling standards for food in the near future, with the expectation that the food industry will welcome the new measures and quickly take advantage of the front-of-package label area to make health and nutrient claims that will make their food products more attractive to consumers.

If you have questions about food compliance or how to respond to an FDA Warning Letter, you may contact Ann Marie Gaitan, Esq. at amgaitan@gaitanmorales.com.  Mrs. Gaitan is assisting food companies with food labeling compliance issues such as calorie and nutrition labeling, nutrient content claims, qualified health claims, and other labeling provisions.  Mrs. Gaitan can assist your company in responding to an FDA Warning Letter, or taking further action when the FDA takes additional enforcement action against your company.  

[1] See Open Letter at http://www.fda.gov/Food/LabelingNutrition/ucm202733.htm
[2] See FDA Warning Letters at http://www.fda.gov/Food/LabelingNutrition/ucm202859.htm

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About Gaitan Morales, PLLC: We are a boutique law firm dedicated to serving the needs of clients in the health and nutrition industries. Our FDA attorneys represent manufacturers, importers, processors and distributors of food and dietary supplement, drug, cosmetics, and medical device products with all their compliance needs. Gaitan Morales, PLLC, is your regulatory and business partner.