Mills v. Giant of Maryland, LLC
2006 WL 2165756, 2006 U.S. Dist. LEXIS 53469, 441 F. Supp. 2d 104 (2006)
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Rule of Law:
State law claims seeking to impose warning label requirements on foods with a federal 'standard of identity' are expressly preempted by the Federal Food, Drug, and Cosmetic Act (FDCA) if the proposed warnings are not identical to the federal standard. Additionally, under common law, sellers have no duty to warn of potential adverse reactions, such as those from lactose intolerance, that arise from the inherent qualities of a common food product.
Facts:
- Milton Mills and other plaintiffs suffer from lactose intolerance, a condition that prevents the proper digestion of lactose, the sugar found in milk.
- The plaintiffs were unaware of their condition when they purchased and consumed milk sold by defendants such as Giant of Maryland, LLC and Safeway, Inc.
- After consuming the milk, the plaintiffs experienced adverse gastrointestinal symptoms, including flatulence, bloating, cramps, and diarrhea.
- The milk products sold by the defendants did not contain any warning labels regarding the potential risks or symptoms associated with lactose intolerance.
- Plaintiffs allege that the milk industry and government have minimized information about the prevalence of lactose intolerance, contributing to public ignorance of the condition.
Procedural Posture:
- Milton Mills and other plaintiffs filed a putative class action lawsuit against Giant of Maryland, LLC, Safeway, Inc., and other milk producers in the U.S. District Court for the District of Columbia.
- The complaint asserted claims for negligent failure to warn and products liability, seeking injunctive relief and damages.
- The defendants filed motions to dismiss the complaint for failure to state a claim pursuant to Federal Rule of Civil Procedure 12(b)(6).
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Issue:
Are state law failure-to-warn claims, which seek to require milk sellers to add warning labels about lactose intolerance, preempted by the Federal Food, Drug, and Cosmetic Act because milk is a food subject to a federal 'standard of identity'?
Opinions:
Majority - Kennedy, District Judge
Yes. State law claims seeking to require warning labels for lactose intolerance on milk containers are expressly preempted by the Federal Food, Drug, and Cosmetic Act (FDCA). The court reasoned that the National Labeling & Education Act (NLEA) amended the FDCA to explicitly preempt any state requirement for a food with a federal 'standard of identity' that is 'not identical' to that standard. Because milk has a federally established standard of identity that does not include a lactose intolerance warning, the plaintiffs' common law claims would impose a new, non-identical requirement, which is forbidden. The court rejected the plaintiffs' argument that the NLEA's 'safety' exception applies, finding that the gastrointestinal symptoms of lactose intolerance do not constitute a 'safety' concern as interpreted by the FDA, citing the agency's similar conclusion regarding the side effects of the fat substitute olestra. As an alternative holding, the court found that even if the claims were not preempted, they would fail under District of Columbia common law because sellers have no duty to warn of reactions to inherent properties of common foods, analogizing lactose intolerance to common food allergies for which no warning is required.
Analysis:
This decision significantly strengthens the preemptive scope of the FDCA's labeling regulations, particularly for the many foods subject to a federal 'standard of identity.' It clarifies that state tort claims, such as failure-to-warn, are considered 'requirements' that can be preempted if they would force manufacturers to alter federally compliant labels. The ruling also narrows the path for product liability claims based on inherent food properties by affirming that there is no common law duty to warn against common, non-life-threatening conditions like lactose intolerance. This precedent makes it more difficult for plaintiffs to succeed in lawsuits seeking to compel warnings about common food sensitivities that are not considered 'safety' issues by federal regulators.
