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Failure to Strictly Comply with FDA Regulations May Get You Sued

Date: Jul 19, 2013

Are you sure your food labels comply with Food and Drug Administration (FDA) regulations?  Now might be a good time to conduct an extra round of review as lawsuits continue to get filed for even the most minor of labeling errors. 

A federal court recently refused to dismiss a suit based on the claim that a food manufacturer’s labels failed to comply with FDA regulations because certain disclosure statements made on products were allegedly too small and misplaced.[1]  Specifically, the company had been marketing cheese and nut products with nutrient content claims.[2]  The nut product’s label stated the nuts were “wholesome” and a “good source of 5 vitamins and minerals” while the cheese blend label made a fat content related claim.

When making a nutrient content claim, FDA regulations require a disclosure statement directing the consumer to review the nutrition information for the nutrient if that nutrient’s content exceeds a certain level.  FDA regulations state that the disclosure statement must be “immediately adjacent to the nutrient content claim and may have no intervening material.”[3]  The regulations also require the disclosure to be in “easily legible boldface print or type.”[4]  Both the cheese and nut products supposedly contained an amount of fat that rendered the disclosure statements mandatory. 

The company included disclosure statements on the labels.  However, the nut product’s disclosure statement was only on the back of the product rather than on the front of the product’s label where the nutrient content claim appeared.  The disclosure statement on the cheese product was on the same panel of the package as the nutrient content claim, but it was not immediately adjacent to the claim.  The cheese product’s disclosure statement was also criticized for allegedly being too small and not in sufficiently bold font.  The trial court refused to dismiss these claims and allowed them to go forward.

Consumer lawyers are closely scrutinizing food labels.  Labeling and regulatory compliance professionals are advised to take extra care to ensure that food labels conform exactly to FDA requirements.  Keller and Heckman’s attorneys are uniquely positioned to advise companies on food labeling requirements and litigation avoidance strategies.  Please contact us with any questions.



[1] Ivie v. Kraft Foods Global, Inc., No. 5:12-cv-02554-RMW (N.D. Cal. June 28, 2013) (Order Granting-in-Part and Denying-in-Part Defendant’s Motion to Dismiss Second Amended Complaint).

[2]Nutrient content claims are statements made by a food manufacturer about the level of a nutrient in food or otherwise suggest the food may be helpful in maintaining a healthy diet due to the presence of the nutrient.  21 C.F.R. § 101.13(b) (2013).

[3] Id. at § 101.13(h)(4)(ii).

[4] Id. at § 101.13(h)(4)(i).