Import Refusal By FDA due to labeling violations in more than 5000 products in 2014

Approximately 5029 labeling violations on products offered for import from foreign countries was identified by FDA. Amongst these the most prevalent one is the labeling errors related to nutrition information on food and beverage labels.

Seventy violation codes are existing with FDA regarding labeling issues. FDA may consider the product "misbranded" if any of the product fall under these labeling violations under the Food, Drug and Cosmetic Act and prohibit distribution in United States. If any person is found violating the act then FDA can take criminal action against the person. Also if FDA finds one mistake then it will stop the facility's product entry at the port in future.

FDA has import alert system according to which if a product is found in violation of nutrional labeling requirements 60 or more days after initial violation then the product will be added to import alert and detained without physical examination.

FDA is increasing the number of routine facility inspections to find labeling violations with high risk facility being inspected more frequently as per the Food Safety Modernization Act. The facility will be re inspected at a later date by FDA if any non-compliant labeling is found during the inspection in order to ensure that appropriate changes have been done.

Commonly observed labeling mistake in case of food and beverages is of inappropriate claims. Food and beverages bearing inappropriate disease claims will be regulated as drugs and may be detained by FDA as "unapproved new drug."