Novo Nordisk terminates collaboration with Hims & Hers Health, Inc. due to concerns about their illegal mass compounding and deceptive marketing
- Novo Nordisk demonstrates strong commitment to patient safety and product integrity
- Company has sufficient supply to meet current and projected Wegovy demand
- Proactive measures taken against illegal drug manufacturing and distribution
- Continued collaboration with compliant telehealth companies through NovoCare Pharmacy
- Loss of distribution partnership with major telehealth provider
- Potential reputation impact from association with company allegedly involved in illegal practices
- Ongoing challenges with knockoff products in the market threatening market share
- Safety concerns over unauthorized Chinese-manufactured ingredients in circulation
Insights
Novo Nordisk terminates Hims & Hers partnership over illegal compounding concerns, protecting Wegovy's market position amid resolved shortages.
Novo Nordisk's termination of its month-old collaboration with Hims & Hers represents a significant defensive maneuver in the highly competitive GLP-1 market. The timing is particularly notable as it follows the FDA's April 2025 declaration that Wegovy® shortages have been resolved, eliminating the regulatory justification for compounded alternatives. This strategic decision demonstrates Novo Nordisk's commitment to protecting both patient safety and its valuable intellectual property.
The allegations against Hims & Hers are substantial – engaging in "illegal mass compounding" and using "foreign illicit active pharmaceutical ingredients" from Chinese suppliers that lack FDA authorization. By framing this as a patient safety issue rather than purely a commercial concern, Novo Nordisk is positioning itself as an ethical actor while simultaneously eliminating a potential market competitor.
The company's statement that it will continue working with "select telehealth organizations that share our commitment to safe and effective medical treatment" indicates this isn't a retreat from digital health channels, but rather a targeted action against specific practices. This suggests Novo Nordisk recognizes the importance of telehealth for expanding access to Wegovy® while maintaining control over how its products reach patients.
For Novo Nordisk, this public stance against compounded alternatives could strengthen its market position now that supply constraints have eased, potentially increasing demand for authentic Wegovy® through authorized channels including its NovoCare® Pharmacy.
Novo Nordisk's action highlights regulatory enforcement in compounding practices and safety concerns with unauthorized semaglutide sources.
This termination reveals the complex regulatory landscape surrounding compounded medications in the United States. The press release directly addresses a critical regulatory distinction – the law which prohibits mass sales of compounded drugs under the false guise of "personalization". Traditional pharmaceutical compounding is legally permitted to address individual patient needs when commercial products are unsuitable, but not as a mechanism for mass-producing alternatives to patented drugs.
Novo Nordisk's allegations involve potential violations of these compounding regulations, with claims that Hims & Hers engaged in "illegal sham compounding" despite the FDA's determination that Wegovy® supplies are now sufficient to meet market demand. This suggests potential regulatory action could follow, as the FDA typically prioritizes enforcement when patient safety concerns intersect with improper compounding practices.
The reference to the Brookings Institute report highlighting unregulated foreign suppliers introduces another regulatory dimension – the oversight of pharmaceutical ingredient supply chains. The press release specifically notes these suppliers "were never inspected by FDA" or had "drug quality assurance violations" when inspected.
This case may become a benchmark for how regulatory authorities address the growing intersection of telehealth services, compounding pharmacies, and high-demand medications. Novo Nordisk's proactive stance signals increasing industry attention to enforcement of compounding regulations, particularly when shortages of approved drugs are resolved.
- Collaboration of over one month has ended based on Hims & Hers deceptive promotion and selling of illegitimate, knockoff versions of Wegovy® that put patient safety at risk
- Novo Nordisk won't stop taking action to protect Americans from the dangers of illicit foreign active pharmaceutical ingredients in knock-off drugs
- Efforts will continue to make authentic, FDA-approved Wegovy® directly available through NovoCare® Pharmacy to select telehealth organizations that share our commitment to safe and effective medical treatment for patients living with chronic diseases
In late April, the FDA resolved the Wegovy® shortage based on its conclusion that Novo Nordisk is fully meeting current and projected nationwide demand for this medicine. In support of transitioning patients from knock-off compounded versions to authentic, FDA-approved Wegovy® through NovoCare® Pharmacy, Novo Nordisk began collaborating with telehealth companies. Over one month into the collaboration, Hims & Hers Health, Inc. has failed to adhere to the law which prohibits mass sales of compounded drugs under the false guise of "personalization" and are disseminating deceptive marketing that put patient safety at risk.
"Novo Nordisk is firm on our position and protecting patients living with obesity. When patients are prescribed semaglutide treatments by their licensed healthcare professional or a telehealth provider, they are entitled to receive authentic, FDA-approved and regulated Wegovy®," said Dave Moore, Executive Vice President, US Operations of Novo Nordisk Inc. "We will work with telehealth companies to provide direct access to Wegovy® that share our commitment to patient safety – and when companies engage in illegal sham compounding that jeopardizes the health of Americans, we will continue to take action."
Novo Nordisk is deeply concerned and is continuing to take proactive measures to keep US patients safe from knock-off drugs made with foreign illicit active pharmaceutical ingredients. Based on Novo Nordisk's investigation, the "semaglutide" active pharmaceutical ingredients that are in the knock-off drugs sold by telehealth entities and compounding pharmacies are manufactured by foreign suppliers in
More information can be found on semaglutide.com.
About obesity
Obesity is a serious chronic, progressive, and complex disease that requires long-term management.1-3 One key misunderstanding is that this is a disease of just lack of willpower, when in fact there is underlying biology that may impede people with obesity from losing weight and keeping it off.2,3 Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.4,5
The prevalence of overweight and obesity is a public health issue that has severe cost implications to healthcare systems.6,7 In the US, about
About NovoCare® Pharmacy
NovoCare® Pharmacy provides cash-paying patients who have been prescribed Wegovy® with the ability to schedule shipments of their Wegovy® prescriptions directly to their home. Beyond convenient home delivery, NovoCare® also supports patients with benefit verification, refill reminders, and access to live support from a NovoCare® case manager. More information about NovoCare® Pharmacy is available at NovoCare® pharmacy | NovoCare®.
About Wegovy® (semaglutide) injection 2.4 mg
What is Wegovy®?
WEGOVY® (semaglutide) injection 2.4 mg is an injectable prescription medicine used with a reduced calorie diet and increased physical activity:
- to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and with either obesity or overweight.
- that may help adults and children aged 12 years and older with obesity, or some adults with overweight who also have weight-related medical problems, to help them lose excess body weight and keep the weight off.
Wegovy® contains semaglutide and should not be used with other semaglutide-containing products or other GLP-1 receptor agonist medicines.
It is not known if Wegovy® is safe and effective for use in children under 12 years of age.
Important Safety Information
What is the most important information I should know about Wegovy®? Wegovy® may cause serious side effects, including:
- Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, Wegovy® and medicines that work like Wegovy® caused thyroid tumors, including thyroid cancer. It is not known if Wegovy® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people
- Do not use Wegovy® if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
Do not use Wegovy® if:
- you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- you have had a serious allergic reaction to semaglutide or any of the ingredients in Wegovy®
Before using Wegovy®, tell your healthcare provider if you have any other medical conditions, including if you:
- have or have had problems with your pancreas or kidneys
- have type 2 diabetes and a history of diabetic retinopathy
- have or have had depression, suicidal thoughts, or mental health issues
- are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)
- are pregnant or plan to become pregnant. Wegovy® may harm your unborn baby. You should stop using Wegovy® 2 months before you plan to become pregnant
- are breastfeeding or plan to breastfeed. It is not known if Wegovy® passes into your breast milk
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Wegovy® may affect the way some medicines work and some medicines may affect the way Wegovy® works. Tell your healthcare provider if you are taking other medicines to treat diabetes, including sulfonylureas or insulin. Wegovy® slows stomach emptying and can affect medicines that need to pass through the stomach quickly.
What are the possible side effects of Wegovy®?
Wegovy® may cause serious side effects, including:
- inflammation of your pancreas (pancreatitis). Stop using Wegovy® and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back
- gallbladder problems. Wegovy® may cause gallbladder problems, including gallstones. Some gallstones may need surgery. Call your healthcare provider if you have symptoms, such as pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools
- increased risk of low blood sugar (hypoglycemia), especially those who also take medicines for diabetes such as insulin or sulfonylureas. This can be a serious side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar and check your blood sugar before you start and while you take Wegovy®. Signs and symptoms of low blood sugar may include dizziness or light-headedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, or feeling jittery
- kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration
- severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Wegovy®. Tell your healthcare provider if you have stomach problems that are severe or will not go away.
- serious allergic reactions. Stop using Wegovy® and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat
- change in vision in people with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Wegovy®
- increased heart rate. Wegovy® can increase your heart rate while you are at rest. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes
- depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you
- food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Wegovy® may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Wegovy® before you are scheduled to have surgery or other procedures
The most common side effects of Wegovy® may include: nausea, diarrhea, vomiting, constipation, stomach (abdomen) pain, headache, tiredness (fatigue), upset stomach, dizziness, feeling bloated, belching, low blood sugar in people with type 2 diabetes, gas, stomach flu, heartburn, and runny nose or sore throat.
Please see Medication Guide and Prescribing Information, including Boxed Warning, for Wegovy® at https://www.novo-pi.com/wegovy.pdf
About Novo Nordisk
Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs over 10,000 people throughout the country across 12 manufacturing, R&D and corporate locations in eight states plus Washington DC. For more information, visit novonordisk-us.com, Facebook, Instagram, and X.
Novo Nordisk is committed to the responsible use of our semaglutide-containing medicines which represent distinct products with different indications, dosages, prescribing information, titration schedules, and delivery forms. These products are not interchangeable and should not be used outside of their approved indications. Learn more at semaglutide.com.
Contacts for further information
Media: | |
| Ambre James-Brown (Global) |
| |
+1 609 613 0568 | Jacob Martin Wiborg Rode (Global) |
+45 3079 6656
| Ida Schaap Melvold (Global) +45 3077 5649
|
Max Ung (Global) |
References:
1. Kaplan LM, Golden A, Jinnett K, et al. Perceptions of barriers to effective obesity care: results from the national action study. Obesity. 2018;26(1):61-69.
2. Bray GA, Kim KK, Wilding JPH; World Obesity Federation. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Rev. 2017;18(7):715-723.
3. Garvey WT, Mechanick JI, Brett EM, et al. American association of clinical endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity. Endocr Pract. 2016;22 (Suppl 3):1-203.
4. Centers for Disease Control and Prevention. Adult obesity facts. Last accessed: June 2025. Available at: https://www.cdc.gov/obesity/adult-obesity-facts/index.html.
5. World Obesity Federation. World Obesity Atlas 2023. Last accessed: June 2025. Available at: https://www.worldobesity.org/resources/resource-library/world-obesity-atlas-2023.
6. Centers for Disease Control and Prevention. Risk Factors for Obesity. Last accessed: June 2025. Available at: https://www.cdc.gov/obesity/risk-factors/risk-factors.html.
7. Centers for Disease Control and Prevention. Why it matters. Last accessed: June 2025. Available at: https://www.cdc.gov/obesity/php/about/?CDC_AAref_Val=https://www.cdc.gov/obesity/about-obesity/why-it-matters.html.
8. Centers for Disease Control and Prevention. Obesity and Severe Obesity Prevalence in Adults: United States, August 2021–August 2023. Last accessed June 2025. Available at: https://www.cdc.gov/nchs/products/databriefs/db508.htm
View original content to download multimedia:https://www.prnewswire.com/news-releases/novo-nordisk-terminates-collaboration-with-hims--hers-health-inc-due-to-concerns-about-their-illegal-mass-compounding-and-deceptive-marketing-302488189.html
SOURCE NOVO NORDISK INC.
FAQ
Why did Novo Nordisk (NVO) terminate its partnership with Hims & Hers Health?
What are the safety concerns with Wegovy knockoffs according to Novo Nordisk?
Is there still a Wegovy shortage in 2025?
How will NVO distribute Wegovy after ending the Hims & Hers partnership?
What actions is Novo Nordisk taking against illegal Wegovy knockoffs?
