• Counterfeit or fake products are never safe to use. If you purchase them, you will have no way of knowing what ingredients they actually contain.

• If you take counterfeit or fake medicine, you are rolling the dice with your health. The product may not only fail to treat your condition—it could cause you serious harm.

• Unfortunately, the counterfeiting business is growing. Global criminal networks produce and distribute counterfeits in all major therapeutic areas, in all major geographies and in more than 100 countries. Skirting legal safeguards is big business: counterfeit product sales are estimated to generate between $200 billion and $431 billion in illicit proceeds every year.

• According to an article on the FDA website, the National Association of Boards of Pharmacy (NABP) reports that at any given time, there are roughly 35,000 active online pharmacies – only about 5% of which comply with U.S. pharmacy laws and practice standards. The NABP reports that many are tied to criminal groups: “Most illegal internet pharmacies belong to organized criminal networks, many of which have been the recipients of FDA warning letters. These networks are often complex, global operations that include hundreds – or even thousands – of related websites.”

• Illegal entities are engaging in phishing scams across the internet, phones and social media, claiming to sell weight loss medicines without a prescription. Often, these scammers never deliver anything – they simply pocket your money. Many also steal personal and financial information and use it to commit identity theft later on. Those that do deliver a product don’t provide genuine, FDA-approved medications. Instead, people receive fake or counterfeit products, such as an injection pen filled with insulin or saline or some completely unknown product – all of which may pose potentially serious health risks.

  • In the first four months of 2024, the online security firm McAfee found a 183% increase in phishing attempts centered on GLP-1s – 176,871 phishing attempts and 449 risky websites.

• Counterfeit or fake products are mainly promoted and sold over the internet. This is one reason it’s important to obtain a prescription from your doctor and purchase prescription medicine from a pharmacy you are familiar with. LillyDirect™ offers a medicine delivery service for select prescribed Lilly medicines.

• Counterfeit or fake products may look very similar to genuine Lilly medicines. Knowing what genuine Lilly medicines look like can help you avoid purchasing or using counterfeit products. Visit the Lilly Medicine Verification Web App for more information.

• Compounding is permitted in limited circumstances to address individual patient needs, such as making a medicine without a dye that a patient is allergic to, but it is important to remember that compounded drugs are never FDA-approved. The FDA has explained that “compounded drugs pose a higher risk to patients than FDA-approved drugs” and that “[u]nnecessary use of compounded drugs exposes patients to potentially serious health risks.”

• According to the Obesity Action Coalition, “using a compounded medication is like playing a guessing game with your health. You don’t know what you’re getting, and if something goes wrong, it’s hard to know why.”

• The FDA has explained that “poor compounding practices can result in serious drug quality problems, such as contamination,” which “can lead to serious patient injury and death.” The FDA has also observed “troubling conditions during many of its inspections of compounding facilities including toaster ovens used for sterilization, pet beds near sterile compounding areas, and operators handling sterile drug products with exposed skin, which sheds particles and bacteria, among many others.”

• The National Capital Poison Control warns that “there can be errors in compounding or contamination of the product because compounding pharmacies are not held to the same standards of larger drug manufacturers.”

• The National Association of Boards of Pharmacy (NABP) – which includes State Boards of Pharmacy across all 50 U.S. states, the District of Columbia, Puerto Rico and many Canadian provinces – reported in May 2024 that “illegal actors are taking advantage of high demand and short supply [of incretin medications] in order to sell substandard and falsified versions of these products to patients around the world.” The NABP “has identified thousands of websites that promote the illegal sale of GLP-1 agonists,” including fake Mounjaro^®, Zepbound^®, and tirzepatide. Their “unlawful actions put patients at risk.”

• On June 19, 2024, the World Health Organization issued a Medical Product Alert after identifying falsified batches of injectable incretin products in North America, South America and Europe.

• We have discovered compounded drugs advertised as "tirzepatide" with safety, sterility and efficacy problems. Some have contained bacteria, high impurity levels, different colors (pink, instead of colorless), or a completely different chemical structure than Lilly’s FDA-approved medicines. In at least one instance, the product being offered was nothing more than sugar alcohol.

• Some telehealth providers and compounders are mass marketing untested forms of “tirzepatide” products online, including pill, under-the-tongue (sublingual), and nasal spray versions. It’s important to keep in mind that those formulations were not studied in the clinical trials that led to the FDA’s approval of Mounjaro^® or Zepbound^®, which are approved only for use via under-the-skin injection. That means the FDA has not evaluated or determined that any oral, sublingual or nasal versions of tirzepatide are safe or effective. If you purchase these untested versions, you may get a product that doesn’t work.

• On May 21, 2024, the Australian government announced a complete ban on compounded tirzepatide and other compounded diabetes and weight loss medications due to the “increasing reports of patients coming to harm from [compounded incretin medications] including the hospitalization of a patient in Australia due to a serious adverse event.”

• It’s important to understand both the risks and benefits of a medication before taking it. That’s why anyone who promotes the benefits of a prescription medicine must also disclose the risks posed by the product.

• Online ads about compounded products may be inaccurate or misleading. Some online sellers of compounded "tirzepatide" promote the potential health benefits of their products (for example, stating they will lead to easy weight management) without disclosing any potential side effects or safety risks of their products. These same online sellers may also be making claims that their non-injection (e.g., oral, under the tongue, nasal spray) "tirzepatide" products are effective without any scientific research or testing to support those claims.

• Online sellers of compounded "tirzepatide" also sometimes claim that their “tirzepatide” is manufactured in FDA-approved facilities. While the FDA has the authority to approve medications, it does not approve the facilities in which they are manufactured, and FDA regulations expressly prohibit anyone from making that claim precisely because it is “misleading and constitutes misbranding.”

• "Research purposes only" products are intended solely for scientific research—they should not be used or promoted for medical purposes. Nonetheless, some entities are promoting “tirzepatide” products for weight loss, even though they are labeled “research purposes only” and “not for human consumption.” These warnings indicate that the products have not been purified to pharmaceutical-grade levels and are not appropriate for human use. You should not use these products. They were not made by, studied by or sold by Lilly and they may expose you to significant health risks.

Counterfeit Medicine, U.S. Food & Drug Administration, 2024

Drug Compounding and Drug Shortages, U.S. Food & Drug Administration, 2023

Compounding and the FDA: Questions and Answers, U.S. Food & Drug Administration, 2022

New England Compounding Center Pharmacist Sentenced for Role in Nationwide Fungal Meningitis Outbreak, 2018

Owner and Four Former Employees of New England Compounding Center Convicted Following Trial, U.S. Food & Drug Administration, 2018

FDA Warning Letter to US Chem Labs (Feb. 7, 2024) and Synthetix Inc. DBA Helix Chemical Supply (Feb. 7, 2024)

RogueRx Activity Report: Injectable Weight Loss Drugs: How Illegal Online Drug Sellers Are Taking Advantage of Patients, National Association of Boards of Pharmacy, 2024

Injectable Weight Loss Drugs Illegally Sold Online Pose Danger to Patients, National Association of Boards of Pharmacy, May 1, 2024

Medical Product Alert N°2/2024, World Health Organization, June 19, 2024

Substandard and falsified medical products: Advice to patients and consumers, World Health Organization, December 9, 2019

Maryland Poison Control, What You Should Know About Semaglutide, March 26, 2024

America’s Poison Centers, Glucagon-Like Peptide-1 (GLP-1) Agonists, June 2024

National Capital Poison Center, What is Ozempic?, December 2023.

Protecting Australians From Unsafe Compounding of Replica Weight Loss Products, Government of Australia, Department of Health & Aged Care, May 22, 2024