WASHINGTON -- Yesterday morning, just after the FDA menu labeling rule officially went into effect, FDA released another round of guidance on complying with the rule. The guidance, in question and answer format, is at least partially in response to letters sent to the FDA by NACS and our coalition allies seeking further clarification on many parts of the rule.
One of the questions that NACS has been posing to FDA for some time and until now not received a clear answer on is whether or not branded fuel outlets were covered by this rule. The rule was confusing enough to leave NACS unsure if a store that does not have its own store branding but flies the banner of a major oil company via a branding agreement would be covered. In yesterday’s guidance FDA states that unless that store sells “substantially the same” food as at least 19 other stores with the same brand name they are not covered by this rule. The FDA went on to explain that even if stores sell the same types of foods (such as hot dogs) they would not have “substantially the same” menus unless the recipes used in those foods were the same. This new clarification is welcome news to many small operators who were uncertain of their status under the rule and should relieve the burden of compliance for many branded marketers with fewer than 20 outlets.
Another point that the FDA has clarified in a positive direction with this latest round of guidance is in-store advertisements. In the last round of guidance issued a few months ago, FDA had moved to clarify that advertisements located outside the store were not covered by the rule and therefore did not need caloric disclosures but left open the question on the same or similar ads located inside the store. Yesterday’s guidance makes clear that marketing materials inside the store are similarly not covered by the rule. More welcome news for the industry.
Two other welcome announcements in the guidance include how FDA intends to enforce the rule starting today. Section 6 of the guidance states that the FDA intends to use the first year of the rule as an educational period. Specifically, they state that they do not intend to penalize or recommend criminal penalties for minor violations. A further important distinction in this section is providing time for a covered entity to fix minor problems with compliance. While FDA does not provide a set grace period during which fixes can be made they do state that their intention is to work with the store to provide the appropriate amount of time needed to fix minor compliance problems.
One caveat, particularly to the enforcement announcements, is relevant to states and localities which have passed their own, identical labeling statutes. Most notably these include California and New York City. Nothing in this guidance document prohibits those jurisdictions from moving ahead with enforcement actions on their own. It is NACS’ hope that they would take the lead of the federal government and follow these guidelines on enforcement but they are not legally bound by them.
Overall, this latest round of guidance seems to indicate the FDA moving in the direction of providing additional flexibility in their own enforcement but many issues with the rule remain and NACS will continue to work with the FDA and congressional allies to get a rule in place that works for all covered entities.