I. The Statutory Framework

The Federal Food, Drug, and Cosmetic Act (FD&C Act), originally enacted in 1938 and codified at 21 U.S.C. § 301 et seq., grants the Food and Drug Administration comprehensive authority over drugs in the United States. The statute’s reach begins with its definition. Section 201(g)(1), codified at 21 U.S.C. § 321(g)(1), defines “drug” to include:

“(A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary… (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals.”¹

The definition is broad by explicit congressional design. It operates on intent, not chemical composition. It does not require that the article be a tablet, a capsule, or a liquid. It does not require that it be swallowed, injected, or inhaled. It requires only that the article be “intended” to diagnose, cure, mitigate, treat, or prevent disease—or to affect the structure or function of the body. The FDA has applied this definition to everything from dietary supplements marketed with health claims to software applications that diagnose skin conditions.²

Under 21 U.S.C. § 355(a), no person may introduce or deliver for introduction into interstate commerce any “new drug” unless an application has been approved by the Secretary of Health and Human Services. The implementing regulations require submission of a New Drug Application (NDA) supported by substantial evidence of safety and efficacy derived from adequate and well-controlled clinical investigations.³

Separately, 21 CFR Part 207 requires that every establishment engaged in the manufacture, preparation, compounding, or processing of a drug register with the FDA and maintain a listing of every drug in commercial distribution.⁴ The regulations apply to domestic and foreign establishments alike. Failure to register constitutes a prohibited act under 21 U.S.C. § 331(p).

The question is whether an article that has been clinically documented to reduce cortisol, lower blood pressure, restructure neural connectivity, delay dementia, and treat depression—and that is dispensed by a nationwide network of publicly funded facilities to 155 million registered users—falls within this statutory framework. The answer is on the shelf.

II. The Product Identification

The product is a book. More precisely, the product is the act of reading a book—a sustained cognitive engagement with written text that produces documented physiological, neurological, and psychological effects in the human body. The distinction matters. The book is the delivery mechanism. The reading is the active pharmaceutical ingredient.

A book is an article. It is manufactured by publishers, printed by commercial printing facilities, distributed through supply chains, and dispensed to consumers through retail and institutional outlets. It is used by consumers in households, schools, recreational settings, and otherwise. It satisfies every element of the FD&C Act’s definition of an article that can be classified as a drug. The only remaining question is intent.

The Institute of Museum and Library Services, through its annual Public Libraries Survey, reports that approximately 9,000 public library systems operate more than 17,000 individual outlets—main libraries, branches, and bookmobiles—across the 50 states, the District of Columbia, and U.S. territories.⁵ In fiscal year 2023, these facilities served over 155 million registered users, received more than 800 million visits, and circulated items at a rate that has been climbing steadily since the post-pandemic recovery began in 2021.⁶

The American Library Association reports that 97 percent of public libraries offer free Wi-Fi access, 100 percent provide free book lending, and an increasing number have established dedicated “health and wellness” collections, wellness programming, and partnerships with local health departments.⁷ The product is available without a prescription, without age restriction, without dosage guidance, and without a single warning label.

III. The Clinical Evidence: Prong One—Treatment of Disease

Section 201(g)(1)(B) classifies an article as a drug if it is “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” The clinical evidence that reading mitigates, treats, and prevents disease is not contested. It is published in peer-reviewed journals and funded by the National Institutes of Health.

Depression. A 2024 review published in Innovations in Clinical Neuroscience by Correll, Correll, and Correll at Wright State University examined the aggregate evidence for bibliotherapy—the clinical use of prescribed reading materials to treat mental health conditions. The authors found that “meta-analyses show medium-to-large effect sizes that are comparable to traditional psychotherapy modalities for common disorders, most notably depression.”⁸ Among 68 studies analyzed in the foundational Marrs meta-analysis, bibliotherapy demonstrated significant improvements in depression, anxiety, assertion, and sexual dysfunction, with a retention rate of approximately 84 percent.⁹ The positive effects of bibliotherapy on depression persisted up to three years post-intervention.¹⁰

Anxiety. A Cochrane systematic review of 101 randomized controlled trials with 8,403 participants found that media-delivered cognitive behavioral therapy—including bibliotherapy—produced medium effect sizes compared to no intervention (SMD 0.67, 95% CI 0.55 to 0.80) for symptoms of anxiety, and was “not significantly inferior to face-to-face therapy” in direct comparisons.¹¹ A separate randomized controlled trial published in the Journal of Clinical Psychology found that a 10-week mindfulness-based stress reduction bibliotherapy program produced significant decreases in depression, anxiety, stress, perceived stress, and anxiety sensitivity compared to a no-treatment control group.¹²

Dementia. Researchers at Rush University Medical Center, in a longitudinal clinical-pathologic cohort study published in Neurology, found that frequent participation in cognitively stimulating activities including reading was associated with a 33 percent reduction in the risk of Alzheimer’s disease. A one-point increase on the cognitive activity scale was associated with an approximate 47 percent reduction in the risk of developing Alzheimer’s dementia. Among participants who developed dementia, those with higher levels of cognitive activity were diagnosed at an average age of 94, compared to age 89 for those with lower activity levels—a delay of five years.¹³ The study was funded by the National Institute on Aging.

The active ingredient does not merely correlate with reduced disease incidence. It has been studied in randomized controlled trials, with control groups, at NIH-funded research institutions. It has been administered in fixed dosing schedules, with adherence monitoring, using standardized outcome measures. It has been compared head-to-head with established pharmacological and psychotherapeutic interventions. And it has demonstrated efficacy. Under any reasonable reading of the statute, an article that treats depression with effect sizes comparable to psychotherapy and delays dementia onset by five years is an article “intended for use in the… mitigation, treatment, or prevention of disease.”

IV. The Clinical Evidence: Prong Two—Affecting the Structure or Function of the Body

Even if reading did not treat disease, Section 201(g)(1)(C) independently classifies as a drug any article “intended to affect the structure or any function of the body of man.” The neuroimaging evidence that reading structurally alters the brain is unambiguous.

In 2013, neuroscientist Gregory S. Berns and colleagues at Emory University published a study in Brain Connectivity demonstrating that reading a novel produces measurable changes in resting-state brain connectivity. Using functional magnetic resonance imaging, the researchers scanned 21 participants over 19 consecutive days—before, during, and after reading a novel. Significant increases in connectivity were observed in the left temporal cortex, a hub associated with language receptivity and grounded cognition, and in the central sulcus, the primary sensory motor region. These changes persisted for five days after the participants finished the book.¹⁴

“The neural changes that we found associated with physical sensation and movement systems suggest that reading a novel can transport you into the body of the protagonist,” Berns stated. “We already knew that good stories can put you in someone else’s shoes in a figurative sense. Now we’re seeing that something may also be happening biologically.”¹⁵

Separately, research conducted by Mindlab International at the University of Sussex in 2009 found that reading for as few as six minutes reduced physiological markers of stress—including heart rate and muscle tension—by 68 percent. This exceeded the stress-reduction effects of listening to music (61 percent), drinking tea or coffee (54 percent), taking a walk (42 percent), and playing video games (21 percent). Cognitive neuropsychologist Dr. David Lewis, who conducted the study, reported that subjects’ stress levels after six minutes of reading were lower than before the stressors were applied.¹⁶

The product does not merely affect a function of the body. It restructures the organ that controls every other function. Under the FD&C Act, an article that produces measurable, persistent changes in the physical connectivity of the brain is an article that affects the structure of the body. This is not a close call. This is an fMRI.

V. The International Precedent: Books on Prescription

The classification of reading as a therapeutic intervention is not a theoretical exercise. The National Health Service of the United Kingdom has already done it.

The NHS “Reading Well Books on Prescription” program, launched in 2013 and delivered in partnership with The Reading Agency and Libraries Connected, enables general practitioners and mental health professionals to prescribe specific books from an evidence-based list for patients with depression, anxiety, phobias, eating disorders, and other mental health conditions. The prescribed books are dispensed through public libraries. The program operates across England, with five curated lists covering common mental health conditions, dementia, long-term conditions, children aged 7 to 11, and young people aged 13 to 18.¹⁷

In surveys of participating patients, “nearly everyone who had borrowed a book from the Reading Well Books on Prescription core list of 30 book titles said that it had been helpful.” Among GPs and health professionals who prescribed books from the list, nearly all reported improved patient confidence in managing symptoms, and just under half felt the scheme had saved them consultation time.¹⁸

The United Kingdom’s government-endorsed national healthcare system has formally classified the dispensing of library books as a clinical intervention for the treatment of disease. The British general practitioner writes a prescription. The British librarian fills it. The British patient borrows a book and reads it on a dosing schedule recommended by a licensed medical professional. The regulatory framework of a G7 nation has determined that reading is medicine.

The FDA has not responded. The agency that issues warning letters to companies selling cherry concentrate with health claims on their labels¹⁹ has not issued a single communication regarding a publicly funded national healthcare system that prescribes the contents of library shelves as first-line treatment for depression.

VI. The New Drug Application Gap

Under 21 U.S.C. § 355(a), “[n]o person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug.” A “new drug” is defined at 21 U.S.C. § 321(p) as any drug that is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling.

Reading has no labeling. It has never been submitted for premarket review. It has never undergone the Phase I, Phase II, and Phase III clinical trial progression required for NDA approval. The FDA has approved approximately 1,355 new drugs between 1980 and 2022, at an annual average of approximately 31.5 approvals per year, each supported by extensive clinical data packages that typically cost hundreds of millions of dollars to assemble.²⁰

Reading has been the subject of more than 68 randomized controlled trials for depression alone, with combined sample sizes exceeding 8,400 participants, producing effect sizes comparable to approved pharmaceuticals.²¹ If these data were submitted in an NDA for a synthetic molecule that reduced cortisol by 68 percent in six minutes and delayed Alzheimer’s onset by five years, the FDA would fast-track the application, grant it Breakthrough Therapy designation, and the manufacturer’s stock would triple before market close.

Instead, the data sit in PubMed. The drug sits on a shelf marked “Fiction, A–L.” The NDA has not been filed. The clinical evidence exceeds what was available for many drugs the FDA has approved. The regulatory apparatus has simply never looked at it.

VII. The Dispensing Problem

Every state in the United States regulates the practice of pharmacy through a state board of pharmacy. State pharmacy practice acts, which closely mirror the model language of the National Association of Boards of Pharmacy, define the “practice of pharmacy” to include, among other things, the “dispensing” of drugs to patients.²² “Dispensing” is uniformly defined as the act of preparing, packaging, labeling, and providing a drug to a patient or patient’s agent in a suitable container with appropriate information.

A public library selects, catalogs, shelves, and provides books to registered users in a suitable container (the book itself) with an information label (the Library of Congress catalog record) and a usage period (the loan period, typically 14 to 21 days). The librarian reviews the user’s request, locates the appropriate item, verifies the user’s registration, and dispenses the item with instructions regarding the return deadline. In many libraries, the librarian provides “reader’s advisory” services—recommending specific titles based on the user’s expressed needs, interests, or conditions.

There are approximately 139,000 licensed pharmacists in the United States who have passed the North American Pharmacist Licensure Examination and hold active state licenses.²³ There are approximately 141,000 librarians working in public libraries in the United States.²⁴ The number of unlicensed dispensers slightly exceeds the number of licensed ones. The unlicensed ones have a summer reading program.

VIII. The Adverse Event Reporting Failure

Under 21 CFR Part 314.80, applicants who hold approved NDAs are required to report to the FDA any adverse drug experience associated with the use of the drug, whether or not considered drug-related. Serious adverse events must be reported within 15 calendar days. The FDA’s Adverse Event Reporting System (FAERS) received approximately 2.2 million adverse event reports in fiscal year 2025.²⁵

Reading has known adverse effects. These include, but are not limited to: eyestrain, headache, sleep disruption (particularly when the dosage is administered after midnight), emotional distress (particularly with literary fiction depicting trauma, loss, or injustice), neglect of household responsibilities, social withdrawal, and acute anxiety induced by approaching a due date without having finished the book.

More seriously, the cognitive and emotional effects of reading are documented and dose-dependent. High-dosage exposure to certain categories of content has been associated with radicalization, ideological extremism, and measurable shifts in political attitudes—outcomes that would constitute reportable adverse events under any pharmaceutical safety framework.²⁶

No public library in the United States has ever filed an adverse event report with the FDA’s MedWatch system. No publisher has filed a 15-day safety report for a novel that caused a reader to stay up until 4 AM, miss work, and consume an inadvisable quantity of coffee. The reporting gap is not a function of the product’s safety. It is a function of the product’s unregulated status. The FDA cannot monitor the safety of a drug it does not know exists.

IX. The Labeling Deficiency

Under 21 U.S.C. § 352, a drug is misbranded if its labeling fails to bear “adequate directions for use” or if its labeling fails to bear “adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health.” The implementing regulations at 21 CFR § 201.5 require that labeling include dosage, frequency, duration, route of administration, and relevant warnings.²⁷

A book’s labeling consists of a title, an author’s name, a publisher’s imprint, an ISBN, a Library of Congress subject heading, and, occasionally, a blurb from another author asserting that the book is “unputdownable.” None of this constitutes adequate directions for use within the meaning of the statute.

The label does not specify dosage. (Is it 30 pages per evening, as in the Emory University protocol? Six minutes, as in the Sussex study? An entire novel over nine nights?) The label does not specify frequency. (Daily? Weekly? Only when the serotonin dips below therapeutic levels?) The label does not identify the active ingredient. (Is it the narrative structure? The vocabulary? The specific configuration of metaphors in Chapter 7?) The label does not warn against contraindications. (Should Dostoevsky be avoided by patients already taking SSRIs? Should Cormac McCarthy carry a black-box warning for pre-existing anxiety disorders?)

Every drug approved by the FDA ships with a package insert—a dense, multi-page document specifying indications, contraindications, warnings, precautions, adverse reactions, drug interactions, dosage, and administration instructions. Every book approved by a publisher ships with a dust jacket advertising the author’s previous novel and the availability of a book club guide. The informational disparity is approximately fourteen pages wide.

X. The Establishment Registration Failure

Under 21 CFR § 207.17, all manufacturers, repackers, relabelers, and salvagers of drugs must register each domestic establishment with the FDA. The registration must include the establishment’s name, physical address, types of operations performed, and a Unique Facility Identifier.²⁸ Failure to register is a prohibited act under 21 U.S.C. § 331(p).

There are more than 17,000 public library outlets in the United States. Each one receives, stores, catalogs, and dispenses the drug under investigation. Each one operates during fixed business hours with trained personnel. Each one maintains inventory records, tracks dispensing activity, and monitors user compliance through due-date systems and overdue notices. Each one is a fixed facility with a physical address, a name, and a government-issued identifier.

None of them have registered with the FDA. The agency maintains a searchable database of registered drug establishments at its Drug Establishment Current Registration Site. A search for “public library” returns zero results. A search for “New York Public Library”—a system that operates 92 locations and serves 2.7 million registered cardholders—returns zero results. A search for “Library of Congress”—the national library of the United States, which holds more than 173 million items—returns zero results.

The registration gap encompasses every public library in every state. It is not a matter of a few establishments that have fallen behind on paperwork. It is an entire category of drug dispensary that the regulatory apparatus has never identified as such.

XI. The Dosage Control Problem

Every drug approved by the FDA is subject to dosage controls. Prescription drugs specify exact milligram quantities. Over-the-counter drugs print dosing tables on their packaging. Controlled substances are dispensed in counted units with refill limitations. The purpose of dosage control is to ensure that the consumer receives the amount of active ingredient necessary to produce the therapeutic effect without exceeding the threshold for adverse reactions.

Books have no dosage controls. A public library will dispense any quantity of the drug to any registered user, limited only by the borrowing cap established by local library policy. The New York Public Library permits patrons to borrow up to 50 items simultaneously.²⁹ The Chicago Public Library permits 75.³⁰ There is no pharmacist consultation. There is no drug utilization review. There is no check for drug-drug interactions between the Brontë novel the patron borrowed on Tuesday and the self-help book on anxiety they borrowed on Thursday.

The therapeutic dosage established in peer-reviewed research—six minutes for acute stress reduction, 30 pages per evening for neural connectivity changes, weekly engagement for dementia prevention—is never communicated to the user. The librarian does not ask whether the patron is currently taking any other books. The librarian does not verify that the patron is not exceeding the recommended frequency. The librarian stamps the card and moves on.

XII. The Pediatric Exposure Problem

Under the Pediatric Research Equity Act (PREA), codified at 21 U.S.C. § 355c, the FDA requires that new drug applications include assessments of the safety and efficacy of the drug in pediatric populations, unless the applicant obtains a waiver. The purpose of PREA is to ensure that drugs administered to children have been specifically studied in children, because children are not small adults and may respond differently to pharmacological interventions.³¹

Public libraries operate dedicated children’s sections. They employ children’s librarians. They host story-time programs in which the drug is administered orally by a trained adult to groups of children as young as six months. The American Library Association’s “Every Child Ready to Read” program explicitly promotes early and frequent exposure to reading as a developmental intervention—a framing that, under the FD&C Act, constitutes marketing of a drug for a pediatric indication.³²

No pediatric study has been submitted to the FDA. No pediatric labeling has been approved. No age-appropriate dosing has been established. The drug is dispensed to children in picture-book form, chapter-book form, and young-adult form, with the dosage determined entirely by the child’s reading speed and the parent’s bedtime enforcement. The PREA requirements have been exceeded in spirit and violated in every particular.

XIII. The Enforcement Asymmetry

The FDA’s enforcement activity is not constrained by the scale of the violation. The agency has issued warning letters to small businesses selling elderberry syrup with claims that it “supports immune function.” It has sent cease-and-desist communications to companies marketing CBD products with therapeutic claims. It has pursued enforcement actions against homeopathic products, dietary supplements, and aromatherapy diffusers that claim to reduce stress.³³

The common element in these enforcement actions is that the marketed product was accompanied by claims that it treated, cured, mitigated, or prevented disease—claims that, under 21 U.S.C. § 321(g)(1)(B), cause the product to be classified as a drug. An elderberry syrup that “supports immune function” is a drug. A CBD gummy that “reduces anxiety” is a drug. But a 400-page novel that has been clinically demonstrated to reduce cortisol by 68 percent, restructure brain connectivity, and treat depression with effect sizes comparable to cognitive behavioral therapy is not, according to the agency’s enforcement record, a drug at all.

The CDER has averaged approximately 43 novel drug approvals per year over the past decade.³⁴ In the same period, the American publishing industry has released approximately 500,000 new titles per year.³⁵ The regulated pipeline produces 43 approved drugs annually. The unregulated pipeline produces half a million. The difference in regulatory scrutiny between a molecule that lowers blood pressure and a novel that lowers blood pressure is approximately $2.6 billion in clinical trial costs and twelve years of development time.

XIV. Conclusion

The Federal Food, Drug, and Cosmetic Act defines a drug as any article intended to treat disease or affect the structure or function of the body. Reading treats depression with effect sizes comparable to psychotherapy. Reading reduces cortisol by 68 percent in six minutes. Reading restructures the physical connectivity of the brain in ways that persist for days. Reading delays the onset of Alzheimer’s dementia by up to five years. The government of the United Kingdom prescribes it through its national healthcare system and dispenses it through its public libraries.

The United States has 9,000 public library systems operating through more than 17,000 outlets. They serve 155 million registered users. They received over 800 million visits in 2023. They dispense items without a prescription, without pharmacist oversight, without dosage guidance, without adverse event monitoring, and without a single filing in the FDA’s regulatory docket.

The FDA has approved 1,355 new drugs since 1980. It has issued warning letters to companies selling cherry juice with health claims. It has regulated software that diagnoses skin conditions. It has classified nicotine patches, caffeine tablets, and melatonin gummies as drugs subject to its authority. It has not classified a single book.

The most widely dispensed drug in America is not manufactured by Pfizer, Merck, or Johnson & Johnson. It is manufactured by Penguin Random House, HarperCollins, and Simon & Schuster. It is dispensed by 141,000 unlicensed pharmacists who hold master’s degrees in library science instead of doctorates in pharmacy. It is available in hardcover, paperback, large print, audiobook, and e-book formulations. It has never been submitted for premarket review. Its safety profile has never been evaluated by the Center for Drug Evaluation and Research. And it will be dispensed again tomorrow morning at 10 AM, when the library opens, to anyone with a card.

Ergo.