FDA To California Attorney General: Hands Off Our Label
The Commissioner of Food and Drugs has sent a letter to California Attorney General Bill Lockyer telling the Attorney General that the Federal Food, Drug and Cosmetic Act (“FDCA”) preempts a lawsuit that he filed in 2004 against a seafood processor for failing to provide Prop 65 warning notices on its canned tuna stating the tuna contains mercury and mercury compounds. Lockyer has obtained settlement agreements with both retail grocers and restaurant chains to post warning notices concerning mercury in non-processed fish sold in the stores and fish served at the restaurants. What’s going on here and what are the implications for our readers who aren’t in the canned tuna business?
First, a brief constitutional law primer. The U.S. Constitution gives Congress the power to regulate interstate commerce. Note that Congress is not required to regulate interstate commerce but is given the option to do so. Over the years, and in particular beginning with the New Deal, the federal courts have given increasingly broader scope to the concept of interstate commerce. Now, virtually any activity, no matter how insular, can be subject to federal regulation.
Congress’ regulation of interstate commerce comes in two forms-- exclusive and non-exclusive—and it is up to Congress to determine which of these forms it will use. Exclusive means that the Federal Government writes all of the rules and regulations pertaining to a subject. The states can’t create different standards. Non-exclusive means that the Federal Government will set minimum standards and the states can impose higher standards. For example, California (and now some other states) have adopted automobile emissions standards that are much stricter than the federal standards. Another recent example of non-exclusive regulation is the banning by several states of the sale of products containing Ephedrine before the FDA took action to do so.
Sometimes it’s not obvious whether Congress adopted an exclusive or non-exclusive standard in which case the courts will be called in to referee.
Getting back to the Commissioner’s letter, it appears to reinterpret a provision in the Nutritional Labeling and Education Action of 1990 (“NLEA”) which is part of the FDCA. The Commissioner’s letter takes the position that such warnings are not acceptable if they are contrary to FDA policies. Specifically, the Commissioner said that the use of Prop 65 warnings on tuna labels would frustrate FDA policies concerning the nutritional benefits of tuna (e.g. omega-3 fatty acids) and the FDA’s program to provide off label information to consumers about mercury in tuna and other seafood. Furthermore, a Prop 65 warning would result in the product being misbranded because such a warning would not provide adequate information to place the warning in context. As of publication of Food & Marketing Law Update, Attorney General Lockyer had not yet responded to the Commissioner’s letter.
The public policy implications of the FDA’s action and whether the Commissioner’s or the Attorney General’s position (assuming he doesn’t agree with the Commissioner), are significant to everyone in the food and supplement industry. One theme that we have extensively commented upon in presentations to industry groups has been the rise of “federalism” by which we mean regulatory actions taken at the state level that affect the formulation, labeling and marketing of food and dietary supplements. Assuming that the Commissioner prevails, can the Attorney General require retail grocery stores to post Prop 65 warning notices at locations were canned tuna is sold?
Neither store shelves nor restaurant menus are subject to FDA jurisdiction, and as noted above, the Attorney General has already taken action to require warning notices at meat counters for certain unprocessed fish products and on restaurant menus. Can the FDA successfully argue that such off label warnings will frustrate its regulatory policies, and if so, will the courts extend the FDA’s exclusive jurisdiction beyond a food’s label? In the age of obesity with some states becoming much more activist regarding the regulation of food, where and how these lines are drawn may be critical to the industry, particularly if national standards become subject to as many as 50 different state standards.
Meanwhile, undeterred by the FDA letter, Attorney General Lockyer has filed another Prop. 65 lawsuit against several fast food chains, snack food manufacturers and food processors for failure to label their processed potato products as containing acrylamide.