Bimbo Bakeries recently received a warning letter from the FDA that it “misbranded” certain of its products by including ingredients on the labels that the products don’t actually contain, like sesame seeds and nuts.  Apparently, this “misbranding” was an over-disclosure relating to possible allergens in the product: it appears from the FDA’s letter that Bimbo may have been including prophylactic warnings on its label in lieu of implementing preventive controls to prevent the unintentional inclusion of allergens into its food products.  As the FDA stated in its warning letter, however, “[l]abeling is not a substitute for adherence to good manufacturing practices or implementation of preventive controls.”  It further noted that FDA “recognizes that an advisory statement such as ‘may contain’ could be considered truthful and not misleading in addressing situations where there are low levels of potential unintended allergens present due to cross contact, despite the use of strong [good manufacturing practices]. However, listing a major food allergen in the ingredient statement or ‘Contains’ statement when it is not present in the product formulation does not comply with FDA labeling requirements.”

I’m not an FDA or product liability lawyer so this post is not going to provide a deep dive into food labeling requirements and preventive controls for allergen cross-contact.  But I was intrigued by the idea of over-disclosure from an advertising law perspective. Typically, of course, companies want to accentuate the positive, not warn people against using or consuming their products.  But what if the over-disclosure also acts as a hook and not just a warning?  Or the over-disclosure creates an implied claim about health or safety, whether intended or not.  There are examples of companies potentially over-disclosing in a wide variety of contexts, such as including Prop 65 warnings on products where cancer exposure risk is very small; gluten-free statements on products that are naturally gluten-free; or including, like Bimbo Bakeries, allergen warnings on food and beverages that don’t actually include any of the allergens. 

In some instances, companies may simply be trying to avoid potential enforcement action through strict compliance efforts with applicable regulation.  Some may be trying to stave off a product liability action.  (The soft infant carrier I used when my children were babies now has about a dozen warnings sewn on it.)  Unfortunately, sometimes those extensive required disclosures may in fact be so lengthy and detailed that they wind up communicating very little to a consumer, or even obfuscating the most important information a consumer needs.  Think car financing ads and some drug commercials.  Indeed, even truthful over-disclosure can potentially result in an ad that misleads consumers by confusing them with too much information. Worse, even a truthful over-disclosure can sometimes imply an unsubstantiated product benefit, like touting the absence of cholesterol in a vegetable-based product.

There’s a difference, though, between a truthful over-disclosure and a false or misleading one. As noted above, even truthful disclosures can overwhelm consumers with information and that’s why, as in the financing arena, regulators may push companies to streamline them for clarity. However, over-disclosing with false information, even if included as a warning rather than a product tout, is even more problematic.  Not only does an unsubstantiated warning provide consumers with incorrect information, potentially affecting their purchasing decisions, but it can undercut the impact of the warning or encourage an advertiser to take short cuts in its manufacturing processes.  As the FDA pointed out in its Constituent Update about the Bimbo Bakeries warning letter, consumers must be able to trust the information on product labels in order to make informed choices.  In a litigation-happy climate like ours, over disclosing with warnings may be tempting to stave off claims, but if the disclosures themselves are false or misleading, they can create their own legal or regulatory risks.