FDA WARNING_LETTER - Med-Diet Laboratories, Inc. - November 10, 2011

On November 8 and 10, 2011, the FDA inspected Med-Diet Laboratories in Plymouth, Minnesota, and found several misbranding violations on their Med Diet brand low sodium products.

The Brown Gravy Mix and Instant Chicken Flavored Broth & Seasoning Mix were misbranded because their labels failed to declare major food allergens (milk and soybean, respectively) as required by section 403(w) of the Act.

The Beef-Like Soup Base Mix-Clear was misbranded under section 403(r)(1)(A) because it bore a "low sodium" claim but exceeded the 140mg sodium per RACC limit. Its case label was also misbranded under section 403(i)(1) as "Beef-Like" was not an adequate common or usual name, failing to properly characterize its non-beef, natural and artificial flavor.

The Instant Chicken Flavored Broth & Seasoning Mix was misbranded under section 403(i)(2) because both individual packet and case labels failed to list all ingredients.

All three products (Brown Gravy Mix, Beef-Like Soup Base Mix-Clear, and Instant Chicken Flavored Broth & Seasoning Mix) were misbranded under section 403(q)(1) due to inadequate or missing nutrition labeling, including incomplete nutrient information, incorrect formatting, and improper serving size declarations.

Additionally, the Instant