What Does “May Contain Peanuts” Mean, and When is it False or Potentially Misleading?

When Congress passed the Food Allergen Labeling and Consumer Protection Act of 2004 to require source declaration for ingredients derived from major food allergens, Congress chose not to include any requirements with respect to so-called advisory labeling (e.g., “may contain peanuts,” or “processed in a facility that also processes peanuts”).  FDA has always been skeptical of advisory labeling.  Now that its use has grown increasingly widespread, the agency has decided that it’s time to try to rein it in.

On August 8, 2008, FDA announced that it will be holding a public hearing on September 16, 2008 to help the agency in “developing a long-term strategy to assist manufacturers in using allergen advisory labeling that is truthful and not misleading, conveys a clear and uniform message, and adequately informs food-allergic consumers and their caregivers.”  FDA is calling for information on three issues: (1) the circumstances under which manufacturers use advisory labeling; (2) what type of advisory labeling is most effective in helping consumers avoid adverse allergic reactions; and (3) how advisory statements should be worded to be the most effective in communicating the likelihood that an allergen may be present in a food.

In its notice, FDA observes that “manufacturers use advisory labeling for a variety of reasons, such as to advise consumers of the potential presence of an allergen, to avoid the need to develop and use multiple labels, or to reduce legal liabilities.”  From FDA’s perspective, the key question is whether a given claim on a given product is truthful and not misleading under FDC Act § 403(a)(1), which incorporates the definition of “truthful and not misleading” in FDC Act § 201(n) and its admonition against the omission of material facts.  In FDA’s view, “[i]f manufacturers choose to use advisory labeling to inform consumers of the potential presence of food allergens in the finished products, such labeling must be truthful and not misleading and should provide clear, uniform, and accurate information to food-allergic consumers about the potential presence of food allergens.”  FDA squarely states its belief that, “[a]s currently used in the marketplace, advisory labeling may not be protecting the health of allergic consumers.”  It appears most likely that FDA will seek to develop guidance on the use of advisory labeling, but the possibility that FDA will opt to develop a regulation can not be entirely discounted, as FDA’s notice makes reference to the warning and safe handling statements required under 21 C.F.R. § 101.17.  The corresponding Docket No. is FDA-2008-N-0429.

By Ricardo Carvajal & Bryon F. Powell