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FDA Import Refusals: Top 5 Labeling Violations

Labeling violations are one of the leading causes of food import refusals to the United States by the U.S. Food and Drug Administration (FDA).  According to OASIS, FDA’s import refusal database, FDA has identified approximately 5,029 labeling violations on products being offered for import so far in 2014 alone.  Registrar Corp has compiled a list of the five most commonly committed labeling violations.

1. “The article appears to be misbranded in that the label or labeling fails to bear the required nutrition information.”

Over a thousand import refusals in 2014 have been fully or partially due to missing nutritional information.  FDA requires that most food and beverages are labeled with a specifically formatted nutrition facts panel.  The nutrition facts panel displays information such as a serving size, the number of calories the product contains, and the percentage of your suggested daily fat intake it contains. FDA takes nutrition labeling very seriously.  There is even an import alert regarding nutritional labeling violations.  If a product is found to be in violation of certain nutritional labeling requirements, it is noted in FDA’s PREDICT system.  If the same product is found to be in violation again 60 or more days after the initial violation, that product will be added to the import alert and be subject to detention without physical examination (DWPE)

2. “It appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient.”

FDA requires that every ingredient contained within a food or beverage be disclosed on the label in descending order of the prominence of the ingredient.  However, FDA does not require you to reveal the exact formulation as that may be considered a trade secret.

3. “Required label or labeling appears to not be in English per 21 CFR 101.15(c)”

FDA requires that all words, statements, and other information on labels appear in English.  A label may include other languages along with English, but if a foreign language is used anywhere on the label, all of the information on the label must appear in that language as well.

4. “The food is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regulations.”

FDA requires that a net quantity statement (a statement that provides the amount of food in a container or package) appears on the bottom 30% of the principal display panel (PDP) of a food label. The net quantity statement should only take into account the food, not the weight of the container, the packaging materials, etc.  The minimum type size for the net quantity statement depends on the size of the PDP.

5. “The food is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.”

FDA requires that the name and address of the manufacturer, packer, or distributor be listed on a food label.  Unless the listed name is the manufacturer, the label must also state the firm’s relationship to the product (“manufactured for”, “distributed by”, etc.). The address must include the city, state, zip code, and if the firm’s address is not listed in the current city directory or phone book, the street address.  The name and address are generally required to be placed together on the label.

If FDA discovers that your product has one of these five violations or any of the other 70 FDA labeling violations, FDA will consider the product to be “misbranded” and may refuse your product entry into the United States.  It is a prohibited act to distribute a misbranded product in the U.S. under the Food, Drug, and Cosmetic Act, and FDA can bring a civil or criminal action against a person who commits a prohibited act.

Along with checking at ports of entry, FDA will examine product labels during routine facility inspections.  The Food Safety Modernization Act (FSMA) mandated that FDA increase the number of foreign inspections it conducts each year.  By 2016, all facilities distributing products in the U.S. can expect to be inspected every 3 to 5 years, with high risk facilities being inspected most frequently.   If FDA finds a non-compliant label during an inspection, not only will the agency deem the product misbranded, but they also may decide to reinspect your facility at a later date to ensure the labels have been brought into compliance. If so, FDA will charge $217 USD per hour for reinspections of domestic facilities and $305 USD per hour for reinspections of foreign facilities.

Registrar Corp can help assure that your product labels are FDA compliant through our label review service.  Our Regulatory Specialists will cross reference your food labeling against thousands of pages in the Code of Federal Regulations and will return to you a modified, print-ready label, along with a detailed report explaining the recommended changes.  Additional reviews of the same label within 90 days of the initial report are offered free of charge.

For more information about FDA food and beverage label regulations, contact Registrar Corp at +1-757-224-0177 or receive online Live Help from a Regulatory Advisor: http://www.registrarcorp.com/livehelp.





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