Guide XVI-046

Patent medicines

1850United States and Britain
Client cardCompare
[source: …] where a claim comes from[uncertain] not confirmed in a primary source[synthesis] the writer's reconstruction

1. Introduction

Version followed: the historical record of 19th- and early 20th-century proprietary ("patent") medicines in the United States and Britain as documented by Samuel Hopkins Adams's Collier's series The Great American Fraud (1905–06; Project Gutenberg edition), the British Medical Association's Secret Remedies: What They Cost and What They Contain (London, 1909; Project Gutenberg edition), the US Supreme Court's decision in United States v. Johnson, 221 U.S. 488 (1911), and the US Food and Drug Administration's (FDA) own history pages; current variants as the FDA, the UK Medicines and Healthcare products Regulatory Agency (MHRA) and major news describe them.

What it was. Patent or proprietary medicines were remedies sold directly to the public under a brand name, with a secret formula, through drugstores, grocers, mail order, travelling peddlers and medicine shows, and promoted heavily in newspapers and almanacs [source: White 2014, Chestnut Health Systems]. Sellers claimed their products cured long lists of conditions, from catarrh, consumption and cancer to "female weakness", epilepsy, "nervous" complaints, inebriety and teething [source: BMA 1909, table of contents; Science History Institute record of AMA Nostrums and Quackery]. Investigations showed that many contained alcohol, opiates or cocaine, or cheap and inert ingredients sold at many times their cost [source: Adams 1905–06; BMA 1909; White 2014].

The sellers' idea of how change happened, as their critics recorded it. The advertising promised that a single product could cure many diseases, supported by testimonials; Adams argued that what the buyer actually received was "the faith inspired by the advertisement" plus, in many products, the effects of alcohol or narcotics [source: Adams 1905–06]. The BMA set its chemists' analyses beside the advertisements and called the "juxtaposition of analytical facts and advertising fancies" instructive [source: BMA 1909, preface].

How it was discredited. Chemical analysis and investigative journalism (Adams; the BMA; the AMA's Journal articles collected as Nostrums and Quackery), followed by law: the US Pure Food and Drugs Act of 1906 led many makers to drop narcotics rather than label them, but was "less successful in corralling exaggerated claims"; in 1911 the Supreme Court held that the Act's misbranding clause covered false statements about what a product was, not false claims that it cured cancer; Congress responded with the Sherley Amendment of 1912, which brought therapeutic claims under the Act but required the government to prove them false and fraudulent; after more than 100 people, many of them children, died from an untested proprietary elixir in 1937, the 1938 Federal Food, Drug, and Cosmetic Act required safety testing before marketing [source: FDA, Brief History of the Center for Drug Evaluation and Research; Justia, United States v. Johnson].

Why it matters to a psychotherapist. Patent medicines were a major historical route into opiate and alcohol dependence, especially for middle-class women and for infants given "soothing syrups" [source: White 2014]. Their pattern (secret ingredients, cure-all claims, testimonials, conspiracy framing, sale outside medical channels) survives in unlicensed online "cures", tainted supplements and unapproved psychoactive products sold for mood, anxiety, sleep or addiction [source: FDA, 6 Tip-offs to Rip-offs; MHRA via The Pharmacist 2025; 6abc/ABC News 2025]. Clients meet these through social media, convenience stores and overseas websites. Nerve tonics, sedative powders and serum injections are covered in guide 040, and radioactive and electrical products in guide 045.

2. Framework

This is a framework for the therapist's work, not a treatment protocol. Session numbers follow clinical need [synthesis].

Historical phases of the practice, in outline [source: White 2014; Adams 1905–06; FDA CDER history; Justia]:

  • Expansion (mid to late 19th century): rapid growth of branded remedies sold without prescription and advertised in the press; opiates widely regarded as ordinary household medicine.
  • Exposure (c. 1890s–1911): medical warnings about infants and addicted mothers; Adams's Collier's series (1905–06); the BMA's analyses (1909); the AMA's Nostrums and Quackery (1911 [uncertain: the Science History Institute record lists the digitised copy as volume two, dated 1911]).
  • Regulation (1906–1938): labelling and adulteration rules (1906); the Johnson ruling (1911) and the Sherley Amendment (1912); pre-market safety testing and transfer of drug advertising to the Federal Trade Commission (1938).
  • Afterlife (to the present): health-fraud products, hidden-drug supplements and unlicensed online medicines policed by the FDA, MHRA and others.

Phases of the therapist's work [synthesis]:

  1. Recognition and assessment. Ask about all products the client takes, including supplements, online purchases and "natural" remedies; screen for dependence, delayed medical care, health anxiety and financial loss. Move on once the product, its source, its claims and the client's reasons for using it are clear.
  2. Safety and medical routing. Where there are physical symptoms, possible hidden drug ingredients, withdrawal, pregnancy, children or older adults at risk, route to a physician or pharmacist promptly; act on safeguarding duties. Move on once medical review is arranged and any immediate risk is managed.
  3. Understanding and repair. Explore the needs the product promised to meet (relief from pain, distress, stigma, poor access to care), work on marketing literacy, shame and financial loss, and support engagement with care that has evidence behind it.
  4. Advocacy and follow-up. Support reporting to regulators, help the client keep contact with medical care, and, where relevant, explore family history of dependence linked to such remedies.

3. Guiding principles

  • The therapist never sells, recommends or refers to an unproven remedy. Practical meaning: you do not endorse, supply or suggest unlicensed products, and you do not judge a product's ingredients yourself; you route medical questions to medical professionals [synthesis].
  • Never advise starting, stopping or changing any medicine or product. Practical meaning: if a client wants to stop a product that may contain a hidden drug, they talk to a doctor or pharmacist first; withdrawal can be medically serious [synthesis; source on hidden ingredients and withdrawal: FDA 6 Tip-offs; 6abc 2025].
  • No product treats cancer or any physical disease by its seller's say-so. Practical meaning: a cure claim is a reason for medical review, never a reason to delay it [source: FDA 6 Tip-offs; Johnson dissent and the Sherley Amendment as the historical response].
  • Curiosity before correction. Practical meaning: ask what the product promised and what it has given the client before you inform; people who feel judged hide their use [synthesis].
  • The history is a mirror, not a joke. Practical meaning: people who used patent medicines included educated and well-off buyers, as the BMA noted; treat a client's use without ridicule [source: BMA 1909 preface].
  • Dependence can begin in trusted, legal channels. Practical meaning: screen for dependence even when the client calls the product "just a tonic" or "herbal" [source: White 2014, on iatrogenic and proprietary-medicine addiction].
  • Name the recognisable pattern. Practical meaning: teach the regulator's red flags (cure-all, testimonials, quick fix, "all natural", "miracle", conspiracy) rather than arguing product by product [source: FDA 6 Tip-offs].
  • Safeguard the vulnerable. Practical meaning: products given to infants, children or dependent adults trigger child-protection and adult-safeguarding thinking [synthesis; historical basis: White 2014; State Library of Queensland 2016].
  • Report through official routes. Practical meaning: know MedWatch (US) and the Yellow Card scheme and FakeMeds resources (UK) [source: FDA 6 Tip-offs; MHRA via The Pharmacist 2025].
  • Stay within competence. Practical meaning: you work with beliefs, behaviour, emotion and dependence; pharmacology belongs to prescribers and pharmacists [synthesis].
  • Avoid moralising and avoid conspiracy counter-framing. Practical meaning: state what regulators found, calmly; do not replace one story of hidden enemies with another [synthesis].
  • Repair includes money and dignity. Practical meaning: financial loss and shame are legitimate therapeutic targets [synthesis].

4. Intervention inventory

The interventions below are the psychotherapist's own work; steps not drawn from a cited source are marked [synthesis].

4.1 Historical literacy preparation (for the therapist)

  • Purpose: to recognise the patent-medicine pattern in modern products and to talk about it accurately. Use before working with clients who use unlicensed remedies, supplements or online "cures" [synthesis].
  • Steps: (1) Read the primary exposures in public-domain editions: Adams's The Great American Fraud and the BMA's Secret Remedies (both on Project Gutenberg). (2) Note the recurring features they document: secrecy, cure-all claims, bought or invented testimonials, undisclosed alcohol or narcotics, and advertising leverage over the press (Adams describes contract clauses voiding advertising if hostile legislation passed) [source: Adams 1905–06]. (3) Learn the regulatory turning points: 1906, 1911 (Johnson), 1912 (Sherley Amendment), 1937–38 [source: FDA CDER history; Justia]. (4) Compare with the FDA's current red flags [source: FDA 6 Tip-offs].
  • Example language (illustrative): "A hundred years ago, people were sold tonics with secret ingredients and long lists of cures. Some of today's online products follow the same pattern, which is why I ask about them."
  • Watch for: using history to mock clients; overstating what you know about a specific modern product's contents. It is working when you can name the pattern without naming a verdict on chemistry you have not seen.

4.2 Full remedy and product inventory

  • Purpose: to find products a client would not think to call "medicine". Use at intake and whenever new symptoms, mood changes or sleep changes appear [synthesis].
  • Steps: (1) Ask separately about prescribed medicines, over-the-counter products, supplements, herbal or "natural" products, energy shots, products bought online or from overseas, and products bought in convenience stores or smoke shops (channels named by FDA and news reports) [source: FDA 6 Tip-offs; 6abc 2025]. (2) Record name, source, what it claims to do, how long used and cost, without asking about doses in a way that implies you will advise. (3) Ask whether a prescriber or pharmacist knows about each product. (4) With consent, share the list with the client's physician or pharmacist.
  • Example language (illustrative): "Some of the things people take don't feel like medicine: a sleep gummy, a focus drink, something from a website. Could we list everything, so your doctor has the full picture?"
  • Watch for: reluctance or embarrassment (normalise); products with claims for mood, anxiety, sleep, pain or opioid cravings, which merit prompt medical review [source: 6abc 2025 on unapproved products marketed for addiction, pain or depression]. Working when the client volunteers additional products later.

4.3 Dependence screening for non-prescribed products

  • Purpose: to detect dependence that began through a "tonic" or remedy, as historians document for patent medicines [source: White 2014]. Use when a client uses any psychoactive or unlabelled product regularly.
  • Steps: (1) Ask about craving, increasing use, failed attempts to cut down, use despite harm and symptoms when the product runs out [synthesis]. (2) Use a validated screening instrument your service licenses, without reproducing its items in handouts. (3) If dependence is possible, do not suggest stopping; arrange medical review, since withdrawal from some products can be dangerous and some state restrictions have been followed by increased withdrawal cases [source: 6abc 2025]. (4) Offer referral to addiction services.
  • Example language (illustrative): "When you've run out, what happens in your body and your mood? I ask because some products sold as supplements can cause real withdrawal, and that's something to plan with a doctor rather than alone."
  • Watch for: abrupt self-discontinuation; mixing with other sedating substances; shame-driven minimisation. Working when the client agrees to a medical appointment and reports honestly.

4.4 Red-flag literacy (marketing psychoeducation)

  • Purpose: to give clients a portable way to judge health claims. Use when a client is weighing a product or is repeatedly drawn to new ones [source: FDA 6 Tip-offs].
  • Steps: (1) Ask the client to bring the advertisement or page (not the product). (2) Together, check it against the FDA's six tip-offs: one product cures many things; personal testimonials; quick fixes; "all natural"; "miracle cure", "secret ingredient" or "guaranteed results"; claims that a cure is being hidden [source: FDA 6 Tip-offs]. (3) Add the historical parallel where it helps (Adams's analysis of testimonials as selective, bought or invented) [source: Adams 1905–06]. (4) Let the client draw the conclusion.
  • Example language (illustrative): "Let's look at this page like a regulator would. How many different illnesses does it say it fixes? Whose stories is it using?"
  • Watch for: the exercise feeling like a debate the client must lose. Working when the client starts applying the checks unprompted.

4.5 Medical and pharmacist routing

  • Purpose: to ensure physical risk is assessed by the right professional. Use for any product of unknown content, any physical symptoms, pregnancy, breastfeeding, children, older adults or combined use with prescribed medicines [synthesis].
  • Steps: (1) Explain that some "natural" products have been found to contain hidden prescription drug ingredients [source: FDA 6 Tip-offs]. (2) Encourage the client to take the product packaging to a pharmacist or doctor; offer to write a short note with consent. (3) For urgent symptoms (breathing problems, seizures, collapse, chest pain), direct to emergency services. (4) Follow up at the next session.
  • Example language (illustrative): "I can't tell what's in this, and neither can you from the label. A pharmacist can look at it with you. Would you be willing to do that this week?"
  • Watch for: the client hearing "stop now"; avoidance of doctors because of past dismissal. Working when the appointment happens.

4.6 Delayed-care review

  • Purpose: to address the historical core harm of cure claims: relying on a remedy instead of diagnosis and treatment [source: Justia, Johnson (cancer-cure labels); FDA 6 Tip-offs (cancer, diabetes, Alzheimer's among targeted conditions)]. Use when a client treats a serious or undiagnosed condition with a product.
  • Steps: (1) Ask what condition the product is for and whether it has been diagnosed. (2) Explore barriers to medical care: cost, fear, previous experiences, mistrust. (3) Problem-solve one concrete step towards assessment. (4) Never present the product or therapy as a treatment for the physical condition.
  • Example language (illustrative): "You've been managing this on your own with that remedy. What would make it possible to get it properly checked?"
  • Watch for: fear of a diagnosis driving avoidance (treat that fear as the therapeutic target). Working when assessment is booked.

4.7 Health-anxiety formulation of remedy seeking

  • Purpose: to understand repeated product buying as a reassurance or safety behaviour in health anxiety. Use when buying follows worry spikes [synthesis].
  • Steps: (1) Map triggers, worries, the purchase or dose-taking, short-term relief and longer-term effects on worry and spending. (2) Link to an evidence-based treatment for health anxiety offered by your service. (3) Agree experiments that change the reassurance pattern only for the purchase behaviour, never for prescribed medicines.
  • Example language (illustrative): "It looks like each time the worry rises, a new product brings relief for a few days, then the worry returns. Shall we look at that cycle together?"
  • Watch for: genuine undiagnosed illness (keep medical review in place); exposure-style work needs consent and a clear right to stop. Working when buying decreases and worry tolerance improves.

4.8 Exploring the need the remedy promised to meet

  • Purpose: to understand why the promise was compelling. Historians note that patent remedies were marketed for "women's ailments" and filled gaps in medical care [source: White 2014]. Use with any client attached to a product.
  • Steps: (1) Ask what the client hoped the product would change. (2) Explore what it was like before: pain, distress, not being believed, cost or distance from care. (3) Validate the need while separating it from the product. (4) Identify supported routes to the same need.
  • Example language (illustrative): "Before this, what were you struggling with that nobody seemed to take seriously?"
  • Watch for: grief when the hope is let go. Working when the client can talk about the need without defending the product.

4.9 Client drawn to an unapproved psychoactive product for mood, anxiety or addiction

  • Purpose: to respond to modern products that echo patent "nerve" and "habit" remedies, such as tianeptine products sold as supplements or energy shots, which the FDA has never approved for any medical use in the US, and some of which have claimed to help opioid cravings, pain or depression [source: 6abc 2025]. Use when a client mentions such products.
  • Steps: (1) Ask neutrally how they heard of it and what it is said to do. (2) Share what regulators and news report: unapproved status, poison-control calls rising sharply between 2018 and 2023, and risks to breathing especially when used to self-treat opioid withdrawal [source: 6abc 2025]. (3) Route to medical care and to addiction services. (4) Do not advise on use, stopping or tapering.
  • Example language (illustrative): "The FDA has warned about products like this, and people using them to get through withdrawal have ended up in hospital. I'd like you to have a doctor in on this. What would make that possible?"
  • Watch for: current opioid use, mixing substances, overdose risk (assess suicide and accidental overdose risk; see section 5). Working when the client engages with medical or addiction care.

4.10 Financial exploitation assessment

  • Purpose: to address money lost to remedies. Adams called fraud the foundation of the trade [source: Adams 1905–06]; the MHRA warns that illegal online sellers can expose buyers to bank fraud and identity theft [source: MHRA via The Pharmacist 2025]. Use when spending is high, subscriptions recur or payment details went to unverified sites.
  • Steps: (1) Estimate spend and recurring charges together. (2) Check for subscription traps and unauthorised charges. (3) Encourage contact with the bank and consumer-protection bodies. (4) Address debt stress and shame.
  • Example language (illustrative): "Let's work out what this has cost, not to judge it but so you can decide what to do next."
  • Watch for: coercion by a family member or seller; cognitive impairment in older clients (adult safeguarding). Working when charges stop.

4.11 Shame and self-blame work

  • Purpose: to reduce shame that blocks disclosure and care. The BMA noted in 1909 that wealthier and well-educated people were not immune [source: BMA 1909 preface]. Use when the client calls themself stupid or gullible.
  • Steps: (1) Name how skilled the marketing is and how long the pattern has existed. (2) Separate the client's judgement from the seller's deception. (3) Rebuild trust in their own judgement through the red-flag checks (4.4).
  • Example language (illustrative): "These sales methods have fooled doctors, teachers and journalists for over a century. Being targeted by a skilled pitch isn't a character flaw."
  • Watch for: the client using shame to avoid medical review. Working when self-criticism softens and help-seeking increases.

4.12 Testimonial and social-proof deconstruction

  • Purpose: to loosen the pull of stories and online reviews. Adams documented that testimonials were selective, sometimes bought or invented, and that some endorsers had never used the product [source: Adams 1905–06]; the FDA notes that online reviews can be fake [source: FDA 6 Tip-offs]. Use when a client cites others' recoveries.
  • Steps: (1) Ask who is telling the story, who benefits and who is missing (people for whom it did not work, or who were harmed). (2) Discuss how influencer and affiliate marketing pays for endorsements [synthesis]. (3) Distinguish a moving story from evidence.
  • Example language (illustrative): "Those stories may be heartfelt. What we can't see is the people it didn't help. Who would tell their story?"
  • Watch for: the client feeling that their own community is being attacked. Working when the client asks for evidence before buying.

4.13 Conversations about conspiracy framing

  • Purpose: to respond when a product is sold as a cure "they" are hiding. The FDA lists this as a red flag [source: FDA 6 Tip-offs]. Use when mistrust of medicine drives product use.
  • Steps: (1) Acknowledge real reasons for mistrust in the client's history (dismissal, discrimination, cost) [synthesis]. (2) Ask what would count as good evidence to them. (3) Note the FDA's point that a genuine cure would be widely reported and prescribed [source: FDA 6 Tip-offs]. (4) Keep the relationship ahead of the argument.
  • Example language (illustrative): "You have good reasons not to trust every doctor. I'm wondering whether the people selling this have earned more trust than that."
  • Watch for: escalation into debate; isolation from family who disagree. Working when the client can hold doubt about both sides.

4.14 Safeguarding children and dependent adults

  • Purpose: to protect people who cannot choose for themselves. Historically, opiate "soothing syrups" were given to infants; Adams wrote that they could "stunt or kill helpless infants", the AMA's 1911 Nostrums and Quackery placed one leading syrup under "Baby Killers", and a Queensland inquest in 1896 found narcotic poisoning in an infant regularly given it to induce sleep [source: Adams 1905–06; State Library of Queensland 2016]. Use whenever a child, a person with dementia or another dependent adult is being given an unlicensed product, especially a sedating or "calming" one.
  • Steps: (1) Ask what is given, by whom and why (sleep, teething, behaviour, agitation). (2) Route to the child's doctor, health visitor or pharmacist urgently where a sedating or unknown product is involved. (3) Follow your jurisdiction's child-protection and adult-safeguarding procedures, including mandatory reporting where it applies; consult your supervisor and safeguarding lead. (4) Seek the child's assent and the parent's consent for information sharing where safe; record decisions.
  • Example language (illustrative): "Settling a baby who won't sleep is exhausting. Some products sold for that have hidden ingredients that aren't safe for children, so I'd like you to show this one to the doctor today."
  • Watch for: a parent's exhaustion or postnatal depression behind the use (offer support); signs of deliberate harm (report). Working when the child is medically reviewed and the carer accepts support.

4.15 Reporting to regulators

  • Purpose: to turn individual harm into protection for others. Use when a product caused an adverse effect or is being sold illegally.
  • Steps: (1) US: report adverse events through FDA MedWatch online, by Form FDA 3500B or by phone at 1-800-FDA-1088, and unlawful online sales through the FDA's online form [source: FDA 6 Tip-offs]. (2) UK: report suspected side effects through the Yellow Card scheme, and use the MHRA's FakeMeds website for safe online purchasing [source: MHRA via The Pharmacist 2025]. (3) Misleading advertising may also be reported to advertising regulators (in the UK the Advertising Standards Authority) [uncertain: not verified]. (4) Offer to help the client make the report; with consent, report yourself where your role allows.
  • Example language (illustrative): "What happened to you is exactly what the regulator wants to hear about. Shall we fill in the report together?"
  • Watch for: fear of legal trouble for having bought the product (reassure within what you know; suggest legal advice where needed). Working when a report is made.

4.16 Family-history work on tonics and dependence

  • Purpose: to help clients make sense of family stories of a grandmother's "nerve tonic", a great-uncle's "medicine" or a relative's long dependence. White documents that most opiate users in a 1928 survey were white, middle-aged, educated women and that dependence spread through "respectable" channels [source: White 2014, citing Terry and Pellens 1928]. Use when a client brings such history or intergenerational patterns of dependence.
  • Steps: (1) Gather the family story without diagnosing the dead. (2) Offer historical context about how common and hidden this dependence was. (3) Explore what the family learned (secrecy, stoicism, mistrust of doctors) and how it shows up now. (4) Link to present-day risk and protective choices.
  • Example language (illustrative): "In her time, many respectable women were sold medicines that contained opiates, often without knowing it. How did the family talk about her 'medicine'?"
  • Watch for: retraumatisation around family addiction; certainty where records are thin. Working when the story becomes more coherent and less shameful.

4.17 Supporting engagement with evidence-based care

  • Purpose: to offer a real alternative to the remedy. Use once risk has been assessed.
  • Steps: (1) Identify what evidence-based help exists for the client's need (medical assessment, addiction treatment, psychological therapy for anxiety, depression or insomnia) as your service and national guidelines provide it [synthesis]. (2) Address practical barriers. (3) Keep any medicine decisions with prescribers; the therapist does not advise on starting, stopping or changing medicines.
  • Example language (illustrative): "What you were hoping the tonic would do for your sleep is something we can work on directly, and your GP can look at the medical side."
  • Watch for: the client swapping one unproven product for another. Working when the client is engaged with care.

4.18 A colleague, service or institution promoting remedies

  • Purpose: to meet professional duties when a colleague sells or recommends unproven products to clients. Use when you learn of this.
  • Steps: (1) Recognise that selling products to one's own clients creates a multiple relationship; APA Ethics Code Standard 3.05 (Multiple Relationships) addresses relationships that risk impairing objectivity or exploiting the client [source: APA Ethics Code]. (2) Raise it with the colleague informally where safe, then with your supervisor, clinical lead or the relevant licensing board or professional body following its published complaints route [synthesis]. (3) If a client was harmed, prioritise the client's medical safety and their right to complain. (4) Document facts, not opinions.
  • Example language (illustrative, to a colleague): "I'm concerned that recommending these supplements to clients puts them at risk and blurs our role. Can we talk about it, and if needed take it to supervision?"
  • Watch for: retaliation; minimising by the institution. Working when the practice stops and affected clients are informed.

4.19 Reducing re-exposure to targeted marketing

  • Purpose: to reduce cue exposure for clients who repeatedly buy remedies. Scams spread through social media, messaging apps and direct overseas orders [source: FDA 6 Tip-offs]. Use after a pattern of repeat buying is identified.
  • Steps: (1) Identify where the advertising reaches the client. (2) Plan practical changes (unsubscribing, muting, blocking payment details saved on sites). (3) Agree a delay-and-check rule: no purchase without showing it to a pharmacist or doctor first [synthesis].
  • Example language (illustrative): "Where do these offers find you? Let's make it a bit harder for them."
  • Watch for: buying moving to a new channel. Working when impulsive purchases fall.

4.20 Working with historical or collector interest

  • Purpose: to engage clients whose interest is historical (collecting bottles, family heirlooms, heritage work). Use when the history itself is the topic.
  • Steps: (1) Point to public-domain primary texts and museum and library collections. (2) Distinguish historical interest from use: old remedies should never be tasted or used [synthesis]. (3) Use the history, where the client wishes, for critical thinking about present marketing.
  • Example language (illustrative): "The bottles are fascinating history. What strikes you about how they were sold?"
  • Watch for: romanticising "old-fashioned" cures as safer. Working when interest coexists with clear judgement.

5. Handling problems

  • The client insists the product works. Do not argue efficacy; ask what they notice, what it costs them and whether their doctor knows. Keep medical review as the non-negotiable safety step [synthesis].
  • The client refuses medical review. Explore the reasons (fear, cost, prior dismissal, immigration status) and problem-solve; for imminent risk, follow emergency procedures; for children and dependent adults, safeguarding duties apply regardless of the carer's wishes [synthesis].
  • Possible withdrawal or overdose risk. Never advise stopping; arrange urgent medical care; for breathing problems, seizures or collapse, emergency services. Unapproved products used to self-treat opioid withdrawal carry breathing risks [source: 6abc 2025].
  • Suicide risk. Dependence, debt and untreated illness raise risk. Assess suicide risk using your service's standard approach, without discussing methods; where lethal-means counselling applies, focus on safe storage and removal. Crisis resources: 988 Suicide & Crisis Lifeline (US); Samaritans 116 123 (UK and Ireland) [synthesis].
  • Rupture: the client feels judged or ridiculed. Acknowledge it, own your part, and return to curiosity about their need; avoid jokes about "snake oil" [synthesis].
  • Non-adherence to agreed plans (e.g., keeps buying). Treat it as information about the function of buying (4.7, 4.8), not defiance [synthesis].
  • Overwhelm on learning a product was fraudulent or unsafe. Slow down; ground the client; break next steps into one action at a time [synthesis].
  • Family conflict. Family members may demand the client stop or may themselves be selling or promoting products. Offer a family session focused on safety and communication rather than winning [synthesis].
  • Multi-level or social selling. A client who sells products may face financial loss and social pressure; explore both and support exit planning [synthesis].
  • The therapist's own uncertainty about a product. Say so plainly and route to a pharmacist; do not guess at contents [synthesis].
  • Cultural and traditional remedies. Distinguish respect for a tradition from safety questions about a specific unlicensed product; use cultural humility and, where helpful, the DSM-5-TR Cultural Formulation Interview [synthesis].
  • Older clients and cognitive decline. Repeated purchases may signal exploitation or impairment; consider capacity and adult safeguarding [synthesis].

Harm account

What was actually done

From the mid-19th century into the early 20th, manufacturers in the United States, Britain and elsewhere sold branded remedies with secret formulas directly to the public, claiming cures for wide ranges of diseases, including cancer, consumption, epilepsy, inebriety and infant teething [source: BMA 1909; Justia, Johnson; White 2014]. Investigators reported that many products were largely alcohol, that catarrh powders and infant soothing syrups contained narcotics, and that headache powders contained acetanilid, which Adams linked to heart weakening, dependence and sudden deaths [source: Adams 1905–06]. Opiate-containing syrups were marketed to mothers for teething and sleep and advertised in Queensland newspapers from the mid-1860s to the 1920s [source: State Library of Queensland 2016]. Makers used advertising contracts to discourage newspapers from supporting regulation [source: Adams 1905–06]. In 1937 a manufacturer distributed an untested proprietary elixir whose solvent, diethylene glycol, killed more than 100 people, many of them children [source: FDA CDER history]. Today, regulators report unapproved drugs sold as supplements, energy shots or online medicines, some with hidden prescription ingredients [source: FDA 6 Tip-offs; 6abc 2025; MHRA via The Pharmacist 2025].

How it caused harm

  • Dependence: patent medicines were a major channel for opium, morphine, cocaine and alcohol; a 1928 survey cited by White found most opiate users were middle-aged, educated women, and dependence was both promoted and hidden [source: White 2014].
  • Infant injury and death: Adams wrote that soothing syrups could "stunt or kill helpless infants"; a Queensland inquest in 1896 found narcotic poisoning in an infant regularly dosed to sleep; White records medical warnings in 1888 and 1894 about infants and addicted mothers [source: Adams 1905–06; State Library of Queensland 2016; White 2014].
  • Sudden deaths: Adams documented deaths linked to headache powders [source: Adams 1905–06]; the 1937 elixir deaths led to the 1938 Act [source: FDA CDER history].
  • Delayed treatment: remedies sold as cancer cures were outside the 1906 Act's misbranding clause until the Sherley Amendment of 1912 [source: Justia, Johnson; FDA CDER history].
  • Financial exploitation: the BMA showed products sold at many times the cost of their ingredients [source: BMA 1909]; illegal online sellers today also expose buyers to bank fraud and identity theft [source: MHRA via The Pharmacist 2025].
  • Current harm: poison-control calls about one unapproved product type rose 525% from 2018 to 2023, with about 40% of cases needing medical care [source: 6abc 2025]; the MHRA warns that illegal medicines can cause severe illness, addiction or death [source: MHRA via The Pharmacist 2025].

Recognising it today

  • A product claims to cure many unrelated conditions, relies on testimonials, promises quick or "miracle" results, stresses "all natural" or a "secret ingredient", or says a cure is being hidden [source: FDA 6 Tip-offs].
  • Products for mood, anxiety, sleep, focus, pain or opioid cravings sold in convenience stores, smoke shops, via social media or from overseas websites [source: FDA 6 Tip-offs; 6abc 2025].
  • A client, carer or parent gives a child or dependent adult an unlicensed "calming" or sleep product.
  • A client delays diagnosis of a serious condition while using a remedy.
  • Withdrawal-like symptoms when a supplement runs out; secrecy about purchases; mounting spending [synthesis].

What to do instead and how to help those harmed

  • Medical first: route to a doctor or pharmacist for any product of unknown content, physical symptoms, dependence or withdrawal; emergency services for breathing problems, seizures or collapse. The therapist never advises starting, stopping or changing a medicine or product [synthesis].
  • Report: MedWatch, Form FDA 3500B or 1-800-FDA-1088 and the FDA's unlawful-sales form (US); Yellow Card and FakeMeds resources (UK) [source: FDA 6 Tip-offs; MHRA via The Pharmacist 2025].
  • Safeguard: child-protection and adult-safeguarding procedures, including mandatory reporting where it applies, for children or dependent adults given unknown or sedating products [synthesis].
  • Treat what remains: addiction services for dependence; evidence-based psychological care for the anxiety, depression, insomnia or health anxiety the product promised to fix; work on shame, financial loss and trust (sections 4.3, 4.7, 4.10, 4.11, 4.17) [synthesis].
  • Families: support relatives of people harmed, and family-history work where dependence on tonics runs through generations (4.16) [synthesis].

Sources