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Thursday, July 22, 2010

FDA Warning Letters to Food Companies


Everyone who eats believes they know at least a little bit about food labels; some even think they understand them completely. But folks in the food business know that labels can be surprisingly complicated and sometimes even frustrating.
In the past several months FDA has issued a number of warning letters to food companies and many of these letters list labeling violations:

A letter to Mickey’s Snacks notes that the product is mislabeled because not all ingredients are listed and allergens have not been declared.  The presence of ingredients derived from or including Milk, Wheat, Soy, Eggs, Peanuts, Tree nuts, Fish and Crustacean shellfish must be clearly identified.  The species of fish and tree nuts present must also be declared.  You may read the entire warning letter at:

Twin Oaks Community Foods was cited for many violations, including improperly using the nutrient content claim, “Saturated fat free” and for not listing calories from fat or the levels of trans fats in the product.  The nutrition facts box was also not properly formatted.  Read the details at

Yet another recent warning letter ( enumerates many GMP violations and also cites Oxford Falls, Inc., a producer of condiments and salad dressings, for failure to list all the subingredients that make up the ingredients that they add to their product. One specific example was that the company used Worcestershire Sauce in some products.  Since this sauce is made up of two or more ingredients, each and every one of them must be listed.   This warning letter further cited the company for improper serving size declarations. Serving sizes are set forth in FDA food regulations and must you must use the standard established for your product.  The most interesting violation noted in this letter was the failure to list a zip code as part of the company’s address.  The inspector that wrote this letter is clearly very detail oriented and did not rely on the statement that appears in every FDA warning letter, “The above violations are not meant to be an all-inclusive list of deficiencies…”

Warning letters are serious matters.  Companies that receive them are given 15 days to respond to FDA’s concerns.  Failure to adequately respond can result in seizure of product, injunctions and other actions.  Labeling problems can greatly impact your business.  FDA inspection and enforcement is on the rise and while importers have typically faced a greater chance of inspection, it is becoming more likely that companies in the US will have their facilities inspected after recent high-profile food contamination issues.  Increased inspection means increase scrutiny of labels, since they serve as a sort of table of contents guiding the inspector to areas of concern in your manufacturing process.

At Bioscience Translation & Application we hope that you never face an inspection you are not ready for and we work with our clients to ensure that their product ingredients and labels comply with FDA regulations. We welcome your questions regarding Food regulations including those for baby formula, pet food, medical foods and foods for special dietary uses. Visit us at

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