When is a Website Considered Labeling?

By Ricardo Carvajal –

Our colleagues at the Drug and Device Law Blog recently blogged on the decision in Wilson v. Frito-Lay North America, Inc., a false advertising case out of the Northern District of California in which the court held that statements on a food company’s website did not constitute labeling even though the labels of some products included a reference to the website.  That piqued our interest because FDA has repeatedly asserted in warning letters (see here, here, and here) and other communications that a website referenced on a product’s label constitutes labeling, on the theory that the website “accompanies” the product within the meaning of FFDCA § 201(m).

The court acknowledged that “statements not actually printed on a label itself can constitute ‘labeling’ for FDCA purposes.”  However, because the website did not explain or supplement the individual products, the court found that the website did not “accompany” the products.  In the court’s view, the mere inclusion of the website address on the products’ label was insufficient to render the website labeling, absent some connection between the products and the language on the website.

Intriguing though this analysis may be, it must be noted that the plaintiffs failed to cite any authority for their assertion that websites constitute labeling.  Query whether the court would have viewed the issue differently if presented with FDA’s perspective.  We may yet find out, as plaintiffs were given leave to amend – if they can point to website language that constitutes labeling.