FDA has a standard, so no Lanham Act claim can be made

OraLabs, Inc. v. Kind Group LLC, 2014 WL 1395954, No. 13–cv–00170 (D. Colo. Apr. 10, 2014)

The court adopted the magistrate judge’s recommendation to deny Kind leave to amend its counterclaims to add a Lanham Act false advertising claim. OraLabs filed a declaratory judgment seeking a ruling that it wasn’t infringing Kind’s design patent and trade dress rights by selling certain lip balm products. Now that OraLabs has begun selling a particular product, Lip Revo, in the US, Kind alleged that the labeling was false and misleading: while OraLabs advertised a net weight of 7 grams, Kind’s test showed actual useable weight of less than 6 grams.

The magistrate found that amendment would be futile because the claim was preempted (precluded) by the FDCA. “When the Lanham Act and the FDCA overlap, any conduct that amounts to a violation of the FDCA is within the Food and Drug Administration’s jurisdiction.” (Noting cert. grant in Pom which may change this a bit.) In particular, claims that require interpretation and application of the FDCA can’t be recognized under the Lanham Act. Here, the FDCA requires that a product’s net weight must be accurately disclosed on the label. Thus, determining whether the 7g representation was false or misleading required interpreting “accurately” in the FDCA. (The “thus” is where all the action is, and it’s underanalyzed. Aren’t there independent standards for figuring out whether 7g is false or misleading?) To figure out whether the representation was accurate enough, the court would need to know how “accurate” the FDA expects net weight statements to be.

Absolute literalism shouldn’t be required; otherwise rounding to the nearest gram would violate the law. If the FDA requires accuracy within one tenth of a gram, the alleged difference could be false and misleading. But if the FDA requires only 1 1/2 grams, 1 gram of difference would be fine. Thus, resolving Kind’s claim would require interpretation and application of the FDA’s definition of “accuracy.” (Again, I don’t see it. Application and interpretation aren’t the same thing; if the FDA’s rule were really this clear, resolving this particular issue should require no interpretation at all and thus no interference with the FDA’s role, any more than a blatantly false claim of FDA approval when a product is in fact unapproved requires interpretation.) Because this was an attempt to enforce the FDCA’s net quantity accuracy requirement, it was preempted (precluded).

Kind argued that its false advertising claim wouldn’t require interpreting the FDCA, and that it could use surveys or other evidence. While surveys might aid in determining whether consumers “actually felt misled when purchasing 6g of Lip Revo while expecting 7g.” (“Felt”? How about “were”?) But that didn’t matter where a claim required direct interpretation and application of the FDCA. Thus, adding this claim would be futile.

This entry was posted in fda, http://schemas.google.com/blogger/2008/kind#post, preemption. Bookmark the permalink.

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