Botulism is a rare, life-threatening paralytic illness caused by neurotoxins produced by an anaerobic, gram-positive, spore-forming bacterium, Clostridium botulinum.^[1] Unlike Clostridium perfringens, which requires the ingestion of large numbers of viable cells to cause symptoms, the symptoms of botulism are caused by the ingestion of highly toxic, soluble exotoxins produced by C. botulinum while growing in foods.^[2] These rod-shaped bacteria grow best under anaerobic (or, low oxygen), low-salt, and low-acid conditions.^[3] Bacterial growth is inhibited by refrigeration below 4° C., heating above 121° C, and high water-activity or acidity.^[4] And although the toxin is destroyed by heating to 85° C. for at least five minutes, the spores formed by the bacteria are not inactivated unless the food is heated under high pressure to 121° C. for at least twenty minutes.^[5]

Botulinum neurotoxin is one of the most lethal biological substances known.^[6] While the bacteria themselves are usually harmless, the toxin they create attacks the nervous system and causes botulism, a severe paralytic illness.

C. botulinum bacteria and spores are widely distributed in nature, because they are indigenous to soils and waters.^[7] They occur in both cultivated and forest soils, bottom sediment of streams, lakes, and coastal waters, in the intestinal tracts of fish and mammals, and in the gills and viscera of crabs and other shellfish.^[8]

The incidence of foodborne botulism is extremely low. On average, roughly 145 cases of botulism of all types are reported in the United States each year; of these, about 65% are infant botulism (the most common form), about 20% are wound botulism, and about 15% are foodborne (CDC).^[9] Nonetheless, the extreme danger posed by the bacteria has required that “intensive surveillance is maintained for botulism cases in the United States, and every case is treated as a public health emergency.”^[10] This danger includes a historical mortality rate of up to 65% when victims are not treated immediately and properly, although with prompt antitoxin and modern intensive-care support the case-fatality rate is now low—on the order of a few percent.^[11] Most of the botulism events^[12] that are reported annually in the United States are associated with home-canned foods that have not been safely processed.^[13] Occasionally, though, commercially-processed foods are implicated as the source of botulism events, including sausages, beef stew, canned vegetables, and seafood products.^[14] More recent commercial vehicles have included a nacho-cheese sauce implicated in a 2017 outbreak in California. Separately, ingested spores—classically from honey and, in a 2025 multistate outbreak, from a powdered infant formula—have been linked to infant botulism, in which the spores germinate and produce toxin in an infant’s immature intestinal tract (CDC).

TYPES OF BOTULISM

Botulism is generally classified into several distinct forms, which differ chiefly in how the toxin comes to be present in the body:

• Foodborne:  Caused by eating foods contaminated with the toxin, often from improper home-canning or poorly preserved foods.
• Infant:  Occurs when babies (under one year old) ingest the bacterial spores, which then germinate and produce toxins in the gut.  This is why honey should never be fed to infants.
• Wound:  Happens when C. botulinum spores infect a cut or wound and produce toxins, commonly associated with the use of contaminated injection drugs.
• Iatrogenic:  A rare type that occurs if too much botulinum toxin is injected for cosmetic purposes (like wrinkle reduction) or medical conditions (such as migraine).
• Adult Intestinal Toxemia:  An extremely rare condition in older children and adults where spores colonize the intestinal tract and produce toxin (similar to infant botulism).

WHERE DOES CLOSTRIDIUM BOTULINUM COME FROM?

Soil and Sediment: The Ultimate Natural Reservoir.  Landmark environmental surveys dating back over a century have established that viable C. botulinum spores reside in ground soils, dust, and aquatic sediments across every continent where they have been sought.  The distribution of specific toxin types in infant botulism cases typically reflects the geographic prevalence of those strains in the local soil.  For example, in the United States, Type A spores are predominantly found in the western states, while Type B spores are more densely concentrated in the eastern and mid-Atlantic states.

Airborne Dust and Environmental Displacement.  Because spores are highly resistant to environmental stressors (such as drying, heat, and UV light), they easily become airborne.  Presently, dust inhalation or ingestion is considered a primary, unavoidable exposure route.^[15]  Epidemiological data significantly associates infant botulism cases with residence in windy or dusty locations, as well as proximity to dust-generating activities.

Honey: The Primary Identifiable and Avoidable Food Source.  While environmental exposure is largely unpreventable, honey is universally recognized as the single most significant, avoidable foodborne vehicle for C. botulinum spores.^[16]  C. botulinum is not a disease of the honeybee.  Instead, honey becomes an accidental repository when bees carry environmental dust, water, or pollen contaminated with spores back to the hive.^[17]  Because honey is typically consumed raw (unpasteurized and non-irradiated), and because bacterial spores are uniquely structurally adapted to survive low-moisture environments, the dormant spores remain viable inside the honey matrix indefinitely.  Globally, about 4% of retail honey specimens test positive for Clostridium botulinum spores, though regional rates vary widely. While some localized surveys find no spores, others report contamination rates as high as 10% to 20% depending on the source and processing methods.^[18]

INFANT BOTULISM

Infant botulism is a rare but serious paralytic illness of babies, usually affecting infants younger than one year.  It is caused when an infant swallows spores of Clostridium botulinum, or rarely related toxin-producing Clostridiumspecies, and those spores survive, germinate, and multiply in the immature intestine.  The bacteria then produce botulinum neurotoxin inside the infant’s gut.  In plain terms, the baby does not simply ingest a “germ”; the infant’s bowel becomes the place where the toxin is made.^[19][20]

That mechanism is what separates infant botulism from classic foodborne botulism.  In foodborne botulism, a child or adult typically swallows toxin that has already formed in contaminated food.  In infant botulism, the infant swallows spores, and the toxin is produced after the spores colonize the intestine.  Infants are uniquely vulnerable because their gut microbiome, bile-acid profile, immune defenses, and intestinal motility are still developing, and they do not yet have the mature protective intestinal flora that usually prevent C. botulinum spores from gaining a foothold in older children and adults.^[21][22]  Approximately 95% of cases occur in infants under six months of age, with a median age of around three months.  Most cases are caused by toxin type A or type B.^[23]  Because they are so common, in many individual cases the exact source is never identified.^[24]

SYMPTOMS OF BOTULISM

After their ingestion, botulinum neurotoxins are absorbed primarily in the duodenum and jejunum, pass into the bloodstream, and travel to synapses in the nervous system.^[25] There, the neurotoxins cause flaccid paralysis by preventing the release of acetylcholine, a neurotransmitter, at neuromuscular junctions, thereby preventing motor-fiber stimulation.^[26] The flaccid paralysis progresses symmetrically downward, usually beginning with the eyes and face before moving to the throat, chest, and extremities.^[27] When the diaphragm and chest muscles become fully involved, respiration is inhibited and, unless the patient is ventilated, death from asphyxia results.^[28]

Classic symptoms of botulism include nausea, vomiting, fatigue, dizziness, double vision, drooping eyelids, slurred speech, difficulty swallowing, dryness of skin, mouth, and throat, lack of fever, muscle weakness, and paralysis.^[29]  Throughout all such symptoms, the victims are fully alert, and the results of sensory examination are normal.^[30]

In foodborne botulism cases, symptoms usually begin anywhere between 12 and 72 hours after the ingestion of toxin-containing food.^[31]  Longer incubation periods—up to 10 days—are not unknown, however.  The duration of the illness is from 1 to 10 (or more) days, depending on host-resistance, the amount of toxin ingested, and other factors.^[32]  Full recovery often takes from weeks to months.^[33] And, as earlier indicated, mortality rate can be from 30% to 65%, with rates generally lower in European countries than in the United States.^[34]

Signs and Symptoms in Infants

Infant botulism often begins subtly and then progresses over hours to days.  Constipation is commonly one of the earliest signs, followed by poor feeding, weak suck, weak or altered cry, drooping eyelids, diminished facial expression, reduced gag reflex, poor head control, generalized hypotonia, lethargy, and respiratory difficulty.  CDC’s clinical overview specifically lists constipation, poor feeding, ptosis, sluggish pupils, flattened facial expression, diminished suck and gag reflexes, weak or altered cry, and respiratory difficulty or arrest as typical findings.^[35]  Common signs include:

• Constipation, often for several days;
• Poor feeding, with weak sucking and swallowing;
• A weak, altered, or soft cry;
• Drooping eyelids (ptosis), sluggish pupils, and reduced eye movement;
• Generalized weakness and low muscle tone—the classic “floppy baby”;
• Lethargy and a diminished gag reflex; and
• Breathing difficulty, progressing in severe cases to respiratory failure—the most dangerous complication.

Because these early signs mimic more common conditions, a high index of suspicion matters.  A baby with poor feeding, a weak cry, and increasing floppiness—especially with any breathing difficulty—needs urgent evaluation.^[36]

Botulism in Older Children and Adults

The same toxin can cause serious illness in older children and adults, but the exposure pattern is different.  Foodborne botulism occurs when a person eats food in which toxin has already formed, classically improperly canned, preserved, fermented, or stored low-acid foods.  Wound botulism occurs when spores contaminate a wound and produce toxin in devitalized tissue; in modern U.S. practice, this is often associated with injection-drug use.  Iatrogenic botulism can occur after excessive or improperly administered therapeutic or cosmetic botulinum toxin.  Adult intestinal colonization botulism is rare but can occur when the adult gut is altered by surgery, antibiotics, bowel disease, or other disruptions.^[37][38]

In non-infant botulism, symptoms often begin with cranial nerve findings such as blurred or double vision, drooping eyelids, slurred speech, difficulty swallowing, dry mouth, and facial weakness.  Weakness then typically descends symmetrically from the face and neck to the arms, trunk, and legs.  Patients are usually awake and afebrile, and sensation is usually preserved, which can make the paralysis especially frightening.  Severe cases require intubation and mechanical ventilation.  Id.

DETECTION AND DIAGNOSIS

Although botulism can be diagnosed based on clinical symptoms, its differentiation from other diseases is often difficult—especially in the absence of other known persons affected by the condition.^[39] Once suspected, the most direct and effective way to confirm the diagnosis of botulism in the laboratory is testing for the presence of the botulinum toxin in the serum, stool, or gastric secretions of the patient.^[40] The food consumed by the patient can also be tested for the presence of toxins.^[41] The mouse bioassay (mouse neutralization test), which involves injecting serum into mice and observing for signs of botulism, remains the standard confirmatory laboratory method, although public health laboratories increasingly supplement it with faster molecular and mass-spectrometry–based assays.^[42] This test typically takes 48 hours, while the direct culturing of specimens takes 5-7 days.^[43] Some cases of botulism may go undiagnosed because symptoms are transient or mild, or are misdiagnosed as Guillain-Barré syndrome.^[44]

Botulism is first and foremost a clinical diagnosis.  Laboratory confirmation is important, but treatment should not wait for test results when the clinical picture is concerning.  CDC’s 2021 clinical guidelines emphasize that timely diagnosis is crucial because antitoxin is the only specific therapy and should be administered as quickly as possible. Because the antitoxin works best when given early, clinicians treat as soon as infant botulism is reasonably suspected.^[45]

For infants, definitive testing usually requires stool or enema specimens, which can be tested for botulinum toxin and cultured for C. botulinum.  Testing is specialized and is generally coordinated through state public health laboratories, CDC, and the California Department of Public Health Infant Botulism Treatment and Prevention Program.  CDC advises that this specialized testing often takes days and that clinicians should not delay BabyBIG treatment while awaiting confirmation.^[46]

In outbreak investigations, public health laboratories may also test leftover foods, unopened products, ingredients, environmental samples, and bacterial isolates from patients.  Whole-genome sequencing can compare isolates from patients, products, and ingredients to determine whether they are genetically related.  In the ByHeart outbreak, that genetic comparison was central because isolates from clinical samples, finished formula, base mix, and organic whole milk powder clustered together.^[47][48]

TREATMENT

If diagnosed early, foodborne botulism can be treated with botulinum antitoxin, which blocks the action of toxin still circulating in the blood; in the United States, adult and older-child cases are treated with heptavalent botulinum antitoxin (HBAT), while infant botulism is treated with human botulism immune globulin (BabyBIG).^[49] This can prevent patients from worsening, but recovery still takes many weeks.^[50] The mainstay of therapy is supportive treatment in intensive care, and mechanical ventilation in case of respiratory failure, which is common.^[51]

Infant botulism is highly treatable, and the great majority of babies recover fully.  Care rests on two pillars: specific antitoxin and supportive care.^[52]  Treatment has two parts: neutralizing circulating toxin and supporting the patient while nerves recover.  For infants, the specific treatment is human botulism immune globulin intravenous, known as BIG-IV or BabyBIG.  BabyBIG is FDA-approved for infant botulism types A and B and is obtained in the United States through the Infant Botulism Treatment and Prevention Program.  The treating physician contacts the program for immediate consultation; if the presentation supports infant botulism, BabyBIG is released and treatment begins without waiting for final laboratory confirmation.^[53][54]

The evidence for BabyBIG is strong.  In a randomized, double-blind, placebo-controlled California trial of 122 infants with laboratory-confirmed infant botulism, treatment within three days of hospital admission reduced mean hospital stay from 5.7 weeks to 2.6 weeks.  It also reduced ICU time, mechanical ventilation time, tube or intravenous feeding time, and hospital charges.  In plain language, BabyBIG does not instantly make the baby well, but it stops additional circulating toxin from binding and can substantially shorten the illness.^[55]

Supportive care is equally important.  Infants may need close ICU monitoring, respiratory support, mechanical ventilation, suctioning, prevention of aspiration, nutritional support through nasogastric or other tube feeding, bowel care, occupational therapy, feeding therapy, physical therapy, and careful discharge planning.  Antibiotics are generally not used to treat infant botulism itself because bacterial killing in the gut may increase toxin release; aminoglycosides and certain other medications that impair neuromuscular transmission are avoided because they can worsen weakness.^[56]

For older children and adults with suspected foodborne, wound, or other non-infant botulism, the specific antitoxin is generally heptavalent botulinum antitoxin, obtained through public health authorities and CDC.  As with infants, antitoxin should be given as early as possible, because it neutralizes toxin that has not yet bound to nerves.  Wound botulism also requires wound evaluation and debridement, and antibiotics may be used for wound infection after antitoxin decisions are addressed.^[57][58]

PROGNOSIS, RECOVERY, AND LONG-TERM INJURY

Although a minority of botulism patients eventually recover their pre-infection health, the majority do not. For those who fully recover, the greatest improvement in muscle strength occurs in the first three months after the acute phase of illness.^[59] The outside limit for such improvement appears, however, to be one year.^[60] Consequently, physical limitations that still exist beyond the one-year mark are more probably than not permanent. Recovery from acute botulism symptoms may also be followed by persistent psychological dysfunction that may require intervention.^[61]

According to a recently published study that tracked the long-term outcomes of 217 cases of botulism, a large majority of patients reported “significant health, functional, and psychosocial limitations that are likely the consequences of the illness.”^[62] These limitations included: fatigue, weakness, dizziness, dry mouth, and difficulty lifting things. The victims also reported difficulty breathing caused by moderate exertions, such as walking or lifting heavy items. They were also more likely to have limitations in vigorous activities, like running or playing sports, climbing up three flights of stairs, or carrying groceries. Summarizing its finding, the study concluded that: 

Even several years after acute illness, patients who had botulism were more likely than control subjects to experience fatigue, generalized weakness, dizziness, dry mouth, difficulty lifting things, and difficulty breathing caused by moderate exertion…. In addition, patients…reported worse overall psycho-social status than did control subjects, with patients being significantly less likely to report feeling happy, calm, and peaceful, or full of pep.^[63]

There is, as a result, no question that the damaging effects of botulism are life-long.

Infant Prognosis and Complications

With prompt recognition, BabyBIG, and modern intensive care, most infants survive and recover.  That favorable long-term prognosis, however, should not obscure the severity of the acute illness, which is frightening, often protracted, and frequently requires weeks of intensive hospital care.  The recognized complications include:

• Respiratory failure, apnea, and aspiration—the principal reason a ventilator may be required (on average roughly three weeks when needed);
• Prolonged feeding difficulty—safe oral feeding can take many weeks to return;
• Autonomic effects such as urinary retention, and secondary infections (e.g., pneumonia, ear infection) acquired in the hospital;
• Prolonged general weakness during recovery.^[64][65][66]

A baby with infant botulism may spend days to weeks unable to feed safely, protect the airway, or breathe without support.  Families may experience a prolonged hospitalization, transfer to a tertiary children’s hospital, repeated testing, feeding-tube dependence, ventilator care, and months of follow-up.^[67]  In the 2025 ByHeart-formula outbreak, CDC EIS preliminary data found that approximately two-thirds of evaluated infants required post-hospitalization physical therapy or feeding support.^[68]  Reasonable follow-up commonly includes primary care, neurology as needed, feeding or speech therapy, physical and occupational therapy, nutrition monitoring, developmental surveillance, and assessment for residual weakness, dysphagia, oral aversion, motor delay, or caregiver trauma.  Id.  Lasting neurological after-effects are seldom seen, and most infants regain normal strength and development; severe long-term harm is rare.  Follow-up with neurology and physiotherapy is advisable after a severe episode.^[69]

PREVENTION

Because Clostridium botulinum spores are ubiquitous in the environment, botulism can never be eliminated entirely; the practical goal is to prevent the conditions that let the spores germinate and produce toxin, or that let the toxin reach a susceptible person.  The most effective measures differ sharply by the form of the disease.  Foodborne botulism is, in principle, almost entirely preventable through proper food processing and handling.  Infant and adult intestinal botulism are far less preventable, because they arise from environmental spores that cannot practicably be avoided.  Wound and iatrogenic botulism are prevented by addressing their specific exposures.^[70]

Foodborne Botulism: Safe Home Canning and Food Handling.

The single most important safeguard against foodborne botulism is proper home canning.  Low-acid foods—including all vegetables, meats, poultry, fish, and seafood—must be processed in a pressure canner, the only method that reaches 240° F (116° C), the temperature required to destroy C. botulinum spores; a boiling-water bath, which tops out at 212° F, is adequate only for high-acid foods such as most fruits, pickles, and properly acidified tomatoes.^[71]  As an added precaution, home-canned and other low-acid foods can be boiled for ten minutes before serving to inactivate any toxin that may be present.  Bulging, leaking, cracked, or foul-smelling containers should be discarded without tasting, because even a taste of contaminated food can be fatal and the toxin is frequently present without any visible sign of spoilage.  Several everyday household sources warrant particular care: oils infused with garlic or herbs should be refrigerated and discarded within a few days; potatoes baked in foil should be kept hot or refrigerated rather than held at room temperature; and home-fermented foods and prison-made “pruno” should be avoided.^[72]

Commercially Processed Foods.

Commercially canned and packaged foods rarely cause botulism because federal regulation requires validated thermal processing.  Manufacturers of low-acid and acidified canned foods must register with the FDA and follow mandatory process controls—including the thermal “botulinum cook”—under 21 C.F.R. Parts 113 and 114, and the outbreaks that are occasionally traced to commercial products (historically sausages and canned vegetables, and more recently a commercially distributed nacho-cheese sauce) typically prompt immediate recalls.^[73]

Infant Botulism: Honey Avoidance and the Limits of Prevention.

For infants, the one clearly identified and avoidable dietary source of C. botulinum spores is honey.  The CDC and the American Academy of Pediatrics advise that honey never be given—in any form, including a taste on a pacifier or nipple, or in processed products made with honey—to a child younger than twelve months.^[74]  That guidance carries an important caveat: most infant botulism today is caused not by honey but by the inhalation or ingestion of microscopic environmental dust on which the spores travel, an exposure that cannot practicably be prevented.  Honey avoidance therefore addresses only a minority of cases and cannot eliminate the disease.  Breastfeeding is not a risk—botulinum toxin is not transmitted in breast milk—and a mother who has eaten honey may safely continue to nurse.^[75]

Powdered Infant Formula.

Powdered infant formula warrants separate mention.  Unlike liquid formula, which is heat-treated and sealed to be commercially sterile, powdered formula is not sterile and can carry environmental contaminants introduced during manufacturing.  In the 2025–2026 outbreak associated with ByHeart formula—the first botulism outbreak ever tied to infant formula anywhere in the world—the FDA and the manufacturer focused their investigation on spores that can enter a production facility from soil and dust carried on hands, shoes, and other surfaces.^[76]  Prevention of formula-borne botulism therefore rests principally on the manufacturer and the regulatory system—rigorous environmental monitoring, sanitary controls, and finished-product and ingredient testing—rather than on any step a caregiver can take at home.  For the youngest and highest-risk infants, sterile liquid formula, and reconstitution of powder with water heated to at least 158° F (70° C), reduce the risk of other powdered-formula pathogens, although heat at that level does not reliably destroyC. botulinum spores.

Wound and Iatrogenic Botulism.

Wound botulism is prevented chiefly by avoiding injection drug use—particularly the injecting or “skin-popping” of black-tar heroin—and by the prompt, proper cleaning of significant wounds.  Iatrogenic botulism, caused by an excessive dose of therapeutic or cosmetic botulinum toxin, is prevented by ensuring that injections are administered only by appropriately licensed and trained providers using approved products at approved doses.^[77]

Early Recognition and Reporting.

Finally, early recognition is itself a form of prevention.  Because antitoxin is most effective when it is given before paralysis is complete, and because a single case may signal a contaminated commercial product still on store shelves, clinicians are urged to treat suspected botulism as both a medical and a public-health emergency and to report it immediately to state health authorities and the CDC.  Prompt reporting speeds treatment for the individual patient and can prevent further cases by triggering recalls and outbreak investigations.

---

^[1]           See J. Sobel, et al., Foodborne Botulism in the United States, 1990-2000, Emerging Infectious Diseases, Vol. 10, No. 9, at 1606 (Sept. 2004).

^[2]           James M. Jay, MODERN FOOD MICROBIOLOGY, 466 (6^th Ed. 2000)

^[3]           Id. at 469-71; see also Sobel, supra note 1, at 1606.

^[4]           Sobel, supra note 1, at 1606.

^[5]           Id.

^[6]           Jin, J. (2023). What is botulism? Journal of the American Medical Association (JAMA), 330(1), 90-90. https://jamanetwork.com/journals/jama/issue/330/1

^[7]           Jay, supra note 2, at 467-69.  See also, generally H. Houschild, Clostridium Botulinum, in FOODBORNE BACTERIAL PATHOGENS, at 112-89 (M. Doyle Ed. 1989)

^[8]           Jay, supra note 2, at 467-69.  

^[9]           Sobel, supra note 1, at 1607-09; Jay, supra note 2, at 472-76.

^[10]         Sobel, supra note 1, at 1606-07 (also noting that the CDC maintains a 24-hour clinical consultation and emergency antitoxin release service).

^[11]         Jay, supra note 2, at 474.

^[12]         With botulism, the broader term “event” is used to encompass both outbreaks—i.e., two or more cases of botulism caused by a common-source, as well as individual (or sporadic) cases. 

^[13]         Sobel, supra note 1, at 1610; Jay, supra note 2, at 474.

^[14]         Id.

^[15]         Dabritz, H. A., Chung, C. H., Read, J. S., & Khouri, J. M. (2025). Global occurrence of infant botulism: 2007–2021. Pediatrics, 155(4), e2024068791.

^[16]         Harris, R. A., & Dabritz, H. A. (2024). Infant botulism: in search of Clostridium botulinum spores. Current Microbiology, 81(10), 306. https://link.springer.com/article/10.1007/s00284-024-03828-0

^[17]         Schneider, K. R., Schneider, R. M. G., Kurdmongkoltham, P., & Bertoldi, B. (2025). Preventing foodborne illness: Clostridium botulinum. https://ask.ifas.ufl.edu/publication/FS104

^[18]         Harris, R. A., & Dabritz, H. A. (2024). Infant botulism: in search of Clostridium botulinum spores. Current Microbiology, 81(10), 306. https://link.springer.com/article/10.1007/s00284-024-03828-0

^[19]         CDC. Clinical Overview of Infant Botulism. April 24, 2024. https://www.cdc.gov/botulism/hcp/clinical-overview/infant-botulism.html

^[20]         Rao AK, Sobel J, Chatham-Stephens K, Luquez C. (2021). Clinical Guidelines for Diagnosis and Treatment of Botulism. MMWR Recomm Rep. 2021;70(2):1-30. https://www.cdc.gov/mmwr/volumes/70/rr/rr7002a1.htm

^[21]         CDC. Clinical Overview of Infant Botulism. April 24, 2024. https://www.cdc.gov/botulism/hcp/clinical-overview/infant-botulism.html

^[22]         Rosow LK, Strober JB. Infant Botulism: Review and Clinical Update. Pediatr Neurol. 2015;52(5):487-492. https://pmc.ncbi.nlm.nih.gov/articles/PMC10332751/

^[23]         American Academy of Pediatrics, supra note 3; CDC, National Botulism Surveillance Summary, 2021, https://www.cdc.gov/botulism/php/national-botulism-surveillance/2021.html.

^[24]         American Academy of Pediatrics, supra note 3; American Family Physician (AAFP), Infant Botulism, https://www.aafp.org/pubs/afp/issues/2002/0401/p1388.html.

^[25]         Thomas P. Bleck, Clostridium botulinum (Botulism), in MANDELL, DOUGLAS AND BENNETT’S PRINCIPLES AND PRACTICE OF INFECTIOUS DISEASE 2543, 2544 (5^th ed. 2000). 

^[26]         Id.; Sobel, supra note 1, at 1606.

^[27]         Bleck, supra note 25, at 2545; see also BOTULISM FACT SHEET, National Agricultural Bio-Security Center, Kansas State University, online at http://nabc.ksu.edu/content/factsheets/category/Botulism#f26

^[28]         Bleck, supra note 25, at 2545; Sobel, supra note 1, at 1606.

^[29]         Sobel, supra note 1, at 1606; Jay, supra note 2, at 474.

^[30]         Sobel, supra note 1, at 1606.

^[31]         Jay, supra note 2, at 474.

^[32]         Id.

^[33]         R. Shapiro, et al., Botulism in the United States: A Clinical and Epidemiologic Review, Ann. Intern. Med. 1998; 129:221-28.

^[34]         Jay, supra note 2, at 474.

^[35]         CDC. Clinical Overview of Infant Botulism. April 24, 2024. https://www.cdc.gov/botulism/hcp/clinical-overview/infant-botulism.html

^[36]         Children’s Hospital Los Angeles, supra note 2; Merck Manual, supra note 1.

^[37]         Rao AK, Sobel J, Chatham-Stephens K, Luquez C. Clinical Guidelines for Diagnosis and Treatment of Botulism, 2021. MMWR Recomm Rep. 2021;70(2):1-30. https://www.cdc.gov/mmwr/volumes/70/rr/rr7002a1.htm

^[38]         Jeffery IA, Nguyen AD, Karim S. Botulism. [Updated 2024 Nov 25]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK459273/

^[39]         Bleck, supra note 25, at 2546 (noting that “botulism has a limited differential diagnosis”).

^[40]         Sobel, supra note 1, at 1607; see also FDA/CFSAN Bad Bug Book, Clostridium Botulinum, available at http://vm.cfsan.fda.gov/~mow/chap2.html

^[41]         Id.

^[42]         Bleck, supra note 25, at 2546.  See also, e.g., MMWWR, supra note 1, at 2 (“CDC detected botulinum toxin Type A by mouse bioassay in the man’s serum sample”).

^[43]         Bad Bug Book, supra note 40.

^[44]         Sobel, supra note 1, at 1606; Shapiro, supra note 33, at 223.

^[45]         Rao AK, Sobel J, Chatham-Stephens K, Luquez C. Clinical Guidelines for Diagnosis and Treatment of Botulism, 2021. MMWR Recomm Rep. 2021;70(2):1-30. https://www.cdc.gov/mmwr/volumes/70/rr/rr7002a1.htm

^[46]         CDC. Clinical Overview of Infant Botulism. April 24, 2024. https://www.cdc.gov/botulism/hcp/clinical-overview/infant-botulism.html

^[47]         CDC. Investigation Update: Infant Botulism Outbreak, November 2025. March 4, 2026. https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-nov-2025/investigation.html

^[48]         FDA. Outbreak Investigation of Infant Botulism: Infant Formula (November 2025). Content current as of June 3, 2026. https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025

^[49]         Jay, supra note 2, at 474; Sobel, supra note 1, at 1606.

^[50]         Id.; Bleck, supra note 25, at 2546-67.

^[51]         Sobel, supra note 1, at 1606.

^[52]         Jeffery IA, Nguyen AD, Karim S. Botulism. [Updated 2024 Nov 25]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK459273/

^[53]         CDC. Clinical Overview of Infant Botulism. April 24, 2024. https://www.cdc.gov/botulism/hcp/clinical-overview/infant-botulism.html

^[54]         Scarborough, A. P., Khouri, J. M., Chung, C. H., Dabritz, H. A., & Read, J. S. (2025). International Experience with Human Botulism Immune Globulin for the Treatment of Infant Botulism. Medical Research Archives, 13(10). https://esmed.org/MRA/mra/article/view/7026

^[55]         Scarborough, A. P., Khouri, J. M., Chung, C. H., Dabritz, H. A., & Read, J. S. (2025). International Experience with Human Botulism Immune Globulin for the Treatment of Infant Botulism. Medical Research Archives, 13(10). https://esmed.org/MRA/mra/article/view/7026

^[56]         Rao AK, Sobel J, Chatham-Stephens K, Luquez C. Clinical Guidelines for Diagnosis and Treatment of Botulism, 2021. MMWR Recomm Rep. 2021;70(2):1-30. https://www.cdc.gov/mmwr/volumes/70/rr/rr7002a1.htm

^[57]         Jeffery IA, Nguyen AD, Karim S. Botulism. [Updated 2024 Nov 25]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK459273/

^[58]         Scarborough, A. P., Khouri, J. M., Chung, C. H., Dabritz, H. A., & Read, J. S. (2025). International Experience with Human Botulism Immune Globulin for the Treatment of Infant Botulism. Medical Research Archives, 13(10). https://esmed.org/MRA/mra/article/view/7026

^[59]         Bleck, supra note 25, at 2547. See also P. Wilcox, et al., Recovery of Ventilatory and Upper Airway Muscles and Exercise Performance After Type-A Botulism, Chest, 98:620-26 (1990); J. Mann, et al., Patient Recovery From Type-A Botulism: Morbidity Assessment Following a Large Outbreak, Am. J. Public Health, 71 (3):266-69 (Mar. 1981).

^[60]         Id.

^[61]         Bleck, supra note 25, at 2547. See also F. Cohen, et al., Physical and Psychosocial Health Status 3 Years After Catastrophic Illness—Botulism, Issues Mental Health Nurs., 9:387098 (1988)

^[62]         S. Gottlieb, et al., Long-Term Outcomes of 217 Botulism Cases in the Republic of Georgia, Clin. Infectious Disease, 45: 174-80, at 180 (220&).

^[63]         Id. at 179.

^[64]         Scarborough, A. P., Khouri, J. M., Chung, C. H., Dabritz, H. A., & Read, J. S. (2025). International Experience with Human Botulism Immune Globulin for the Treatment of Infant Botulism. Medical Research Archives, 13(10). https://esmed.org/MRA/mra/article/view/7026

^[65]         Morris, V., Wians, R., Wilson, J., & Stevens, G. (2022). Infant Botulism. Journal of Education & Teaching in Emergency Medicine, 7(2), S48. https://pmc.ncbi.nlm.nih.gov/articles/PMC10332751/

^[66]         Public Health Agency of Canada, supra note 6.

^[67]         Scarborough, A. P., Khouri, J. M., Chung, C. H., Dabritz, H. A., & Read, J. S. (2025). International Experience with Human Botulism Immune Globulin for the Treatment of Infant Botulism. Medical Research Archives, 13(10). https://esmed.org/MRA/mra/article/view/7026

^[68]         CDC EIS Conference. Severity of Illness and Clinical Outcomes of Infants Linked to an Infant Botulism Outbreak Caused by Powdered Infant Formula — United States, 2025. April 17, 2026. https://www.cdc.gov/eis-conference/php/abstracts/infant-botulism-outbreak-caused-by-powdered-infant-formula.html

^[69]         AAFP, supra note 5; Public Health Agency of Canada, supra note 6; Botulism Sequelae: A Systematic Review, PMC, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12798721/.

^[70]         Centers for Disease Control and Prevention, Botulism Prevention, https://www.cdc.gov/botulism/prevention/index.html.

^[71]         U.S. Department of Agriculture, Complete Guide to Home Canning (rev. 2015) (Agric. Info. Bull. No. 539); National Center for Home Food Preservation, University of Georgia.  Pressure canning is the only USDA-recommended method for low-acid foods because it alone reaches 240° F, the temperature at which C. botulinumspores are reliably destroyed.

^[72]         CDC, Botulism Prevention, supra note 70.

^[73]         21 C.F.R. pts. 113–114 (thermal processing of low-acid foods packaged in hermetically sealed containers; acidified foods).

^[74]         CDC, Foods and Drinks to Avoid or Limit, Infant and Toddler Nutrition, https://www.cdc.gov/infant-toddler-nutrition/foods-and-drinks/foods-and-drinks-to-avoid-or-limit.html; American Academy of Pediatrics (advising against honey before twelve months of age).

^[75]         California Department of Public Health, Infant Botulism Treatment and Prevention Program, When to Avoid Honey, https://www.cdph.ca.gov/Programs/cls/idld/ibtpp/Pages/When-to-Avoid-Honey.aspx (describing honey as the one identified and avoidable food reservoir of C. botulinum, while noting that most cases today are not honey-related and that the toxin is not transmitted in breast milk).

^[76]         U.S. Food & Drug Administration, FDA’s Actions to Respond to Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula (2026), https://www.fda.gov/food/outbreaks-foodborne-illness/fdas-actions-respond-clostridium-botulinum-illnesses-associated-consumption-powdered-infant-formula.

^[77]         CDC, Botulism Prevention, supra note 70.