FDA WARNING_LETTER - Tabatchnick Fine Foods, Inc. - June 17, 2010

On June 17, 2010, an FDA investigator collected a sample of Tabatchnick Fine Foods, Inc.'s Frozen Barley and Mushroom Soup. Analysis revealed the product is misbranded under the Federal Food, Drug, and Cosmetic Act.

Firstly, the product is misbranded because its label is false or misleading. The label declares 40 mg of sodium per serving, but FDA analysis found 205.4 mg (original) and 227.7 mg (check), exceeding the declared value by 414% and 469% respectively, violating 21 CFR 101.9(g)(5).

Secondly, the product is misbranded because it bears an unauthorized nutrient content claim. The label states "LOW SODIUM," which is a nutrient content claim. However, the product's sodium content (at least 205.4 mg per 213g serving) exceeds the 140 mg per Reference Amount Customarily Consumed (RACC) limit for "low sodium" claims (21 CFR 101.61(b)(4)), misbranding it under Section 403(r)(1)(A) of the Act.

The FDA also noted the "No Salt – No Sugar Added" claim, advising compliance with 21 CFR 101.61(c) and 21 CFR 101