FDA Regulation of OTC Medications and Dietary Supplements

US Food and Drug Administration (FDA)

Regulates over-the-counter (OTC) medications and dietary supplements for safety and effectiveness in the United States

Drug Facts Label

Mandatory information on OTC products, including active ingredients, uses, warnings, dosage, and directions for use

Dietary Supplement Health and Education Act (DSHEA)

Legislation allowing FDA regulation of supplements as food products and establishing good manufacturing practices

Dietary Supplement and Nonprescription Drug Consumer Protection Act

Mandates reporting of serious adverse events for supplements to the FDA

First Generation Antihistamines

Includes diphenhydramine, chlorpheniramine, and clemastine for relieving upper allergy symptoms

Second Generation Antihistamines

Includes cetirizine, fexofenadine, levocetirizine, and loratadine with improved side effect profiles compared to first generation

Systemic Analgesic and Antipyretic OTCs

Includes acetaminophen, aspirin, ibuprofen, and naproxen for temporary reduction of fever and pain

Topical Analgesic and Antipyretic OTCs

Includes diclofenac for temporary reduction of fever and pain

Antacids

Aluminum hydroxide, calcium carbonate, magnesium hydroxide, and sodium bicarbonate/citric acid provide temporary relief of upset stomach with heartburn/acid indigestion

Histamine 2 Receptor Antagonists (H2RAs)

Includes cimetidine and famotidine for infrequent treatment of heartburn

Proton Pump Inhibitors (PPIs)

Includes esomeprazole, lansoprazole, and omeprazole for frequent treatment of heartburn

Antidiarrheals

Bismuth subsalicylate and loperamide for controlling diarrhea symptoms for a short duration

Antitussives

Dextromethorphan for temporary relief of cough associated with the common cold

Decongestants

Pseudoephedrine for temporary relief of sinus congestion and pressure

Expectorants

Guafenesin to loosen mucus and bronchial secretions to make cough more productive

Smoking Cessation Aids

Nicotine patch, gum, and lozenges to reduce withdrawal symptoms and cravings

Dietary Supplements

Includes vitamins, minerals, herbs, botanicals, and amino acids regulated as food by the FDA

Common Cold Remedies

Echinacea for potential symptom reduction or prevention of cold

Cholesterol-lowering Supplements

Garlic, used to lower cholesterol but inferior to prescription medications

Memory and Cognitive Function Supplements

Ginkgo for intermittent claudication, tiredness in legs, and as an add-on therapy for dementia

Physical and Mental Performance Supplements

Ginseng, claimed to improve physical and mental performance, but evidence of benefit is lacking

Liver Health Supplements

Milk thistle may be effective for liver disease, but further studies are needed for higher doses and alternative formulations

Depression Treatment Supplements

St. John's Wort effective for short-term depression treatment, but serious drug interactions are a concern

Prostate Health Supplements

Saw palmetto may provide benefit for benign prostatic hyperplasia, although conflicting evidence exists

Heart Health Supplements

Coenzyme Q10 used to treat heart disease

Joint Health Supplements

Glucosamine sulfate used to treat osteoarthritis

Sleep Aid Supplements

Melatonin used to treat jet lag and sleep

High-risk Supplements

Ephedra, black cohosh, kava kava, kratom, and sassafras have potential toxicities and specific uses

Cannabis and Derivatives

Used for various medical indications, but legal status and potential for abuse are important considerations

Cannabinoids

Includes endogenous compounds like anandamide and medicinal compounds like dronabinol and nabilone

Schedule 1 Drug

Cannabis is classified as a Schedule 1 drug by the DEA, indicating no accepted medical use and high potential for abuse

Schedule II Drug

Includes dronabinol and nabilone, used as alternative agents for chemotherapy-induced symptoms

Schedule V Drug

CBD is classified as a Schedule V drug, used for seizures associated with specific syndromes