Caffeine and the Law

By Emily Largent

Generally speaking, law school goes more smoothly when the law student is caffeinated.  Consider that Justice Elena Kagan was known at Harvard Law School as the “coffee dean” for instituting free coffee for students (and, as an aside, expects to be known as the “frozen yogurt justice” for bringing frozen yogurt to the SCOTUS cafeteria).

Last year, the deaths of Logan Stiner and James Wade Sweatt drew attention to another place where caffeine intersects with the law: the regulation (or lack thereof) of powdered caffeine by the FDA.  Both men died after ingesting powdered caffeine.  One teaspoon of powdered pure caffeine is roughly equivalent to 25 cups of coffee.  Manufacturers encourage consumers to take between 1/16 and 1/64 teaspoon (see, e.g., here), though measuring such minute amounts with common kitchen tools may be impossible.  On it’s blog, FDA observes that the people most drawn to powdered pure caffeine are “children, teenagers, and young adults.”  It is not clear how common it is for individuals to overdose on caffeine powder, as the cause of death may be listed as “heart attack” in many cases.

Caffeine powder is usually marketed as a dietary supplement.  Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers and distributors of dietary supplements are responsible for determining that supplements are safe and for ensuring that representations are substantiated by adequate evidence.  Dietary supplements do not need approval from FDA before they are marketed.  Under DSHEA, once a product is marketed, FDA must show that a dietary supplement is unsafe or poses an imminent hazard to public health or safety before it can take action to restrict the product’s use or remove it from the marketplace.

The FDA issued a public alert, advising consumers to avoid powdered pure caffeine, over the summer.  It has also asked companies that sell these products to voluntarily take powdered caffeine off the market, though it is still widely available.  Presently, the agency is assessing whether it can pursue enforcement action as an unapproved drug or some other avenue to get powdered caffeine off the market.  

Do you think that the health hazards of excessive caffeine intake need more attention and better regulation?  If so, what would you propose?  Should the FDA focus exclusively on powdered caffeine or on caffeine more broadly?  Consider that while caffeine is generally regarded as safe (GRAS) at the levels added to soft-drinks, the levels in energy drinks are so much higher, that it is an open question whether GRAS should apply to them.

Emily Largent

Emily Largent is an Assistant Professor of Medical Ethics and Health Policy at the Perelman School of Medicine. She also teaches at the University of Pennsylvania LawSchool. Her research examines ethical and regulatory issues arising in human subjects research and when integration of clinical research is integrated with clinical care; she has a particular focus on Alzheimer’s disease research. Emily received her PhD in Health Policy (Ethics) from Harvard and her JD from Harvard Law School. Prior to that, she received her BS in Nursing from the University of Pennsylvania School of Nursing and completed a fellowship in the Department of Bioethics at the National Institutes of Health.

One thought to “Caffeine and the Law”

  1. Ahhhh!! interesting,… Lets me and you compare, inject Marijuana, and nicotine, into this fray, shall we? 🙂 names Rich Green 🙂 from AZ,…. where weed stores abound, but tuff regulations constrict the BIZZ,…. please respond 🙂 $R$D$

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