Admittedly, the topic of weight loss isn't the ideal “Turkey-Day” conversation starter. Nevertheless, when the discussion relates to a boom in counterfeits that are raising serious safety concerns, it warrants our attention.  

By now, you have probably heard at least passing reference to a new class of game-changing drugs for diabetes and obesity treatment. These include Novo Nordisk's drugs, Ozempic and Wegovy, which each contain the active ingredient semaglutide. While Novo's two drugs currently are approved by the U.S. Food and Drug Administration (FDA) to treat diabetes, the drugs are commonly prescribed for use in weight loss. Likewise, Eli Lilly's drug, Mounjaro, received FDA approval just last week for the treatment of obesity.

While novel therapies aimed at combating the growing U.S. obesity epidemic may lead to a major public health win for Americans, there is also a growing dark underbelly of the weight loss drug craze. The massive demand for the weight loss drugs is driving a global surge in counterfeit versions, particularly Ozempic and Wegovy.  

Novo Nordisk previously issued detail guidance on how to spot counterfeit Ozempic and Wegovy products, and cautions that authentic products may be purchased only through authorized distributors. In addition to potentially fatal health consequences for the consumer that uses them and direct financial liability for the manufacturer, counterfeit pharmaceutical products cause waves of harm through the supply chain and larger ecosystem, including loss of profits to authorized pharmacies and retailers, loss of consumer trust and brand reputational harm for the manufacturer, sizeable expenditures of resources by customs and law enforcement agencies, and potential diversion of resources from additional product innovation and development. U.S. Customs and Border Protection (CBP) seizes counterfeit goods at the U.S. border, and the agency can detain or destroy the products and issue fines to repeat offenders of up to double the MSRP value of the product. CBP also partners with U.S. Immigration and Customs Enforcement's Homeland Security Investigations to prosecute criminal enterprises that violate U.S. trade laws.

Counterfeit drugs also raise serious safety concerns that have caught the attention of FDA. As of this month, over 42 adverse events have been reported to FDA that mention use of counterfeit semaglutide, including 28 "serious" adverse events, including the hospitalization of three Americans, according to FDA's reporting system.

The adverse event reports linked to counterfeit drugs comes as both Ozempic and Wegovy are listed on FDA's drug shortage list. The drug shortage issue raises additional complications, as FDA permits drug compounders to manufacture and sell unapproved semaglutide to Americans during the shortage, even though such versions have not undergone the same rigor of FDA review. The concern over increased compounding prompted FDA to issue a letter to drug compounders in October warning of potential FDA violations associated with a different version of semaglutide salts that do not appear on the drug shortage list.

While FDA generally avoids criminal action for regulatory violations, the agency does not shy away when it comes to counterfeit drugs that may pose safety risks. FDA's Office of Criminal Investigations has pursued over 130 enforcement actions between 2016-2021 according to a published study, including those involving arrests and product seizures. 

Despite these efforts, the problem continues to grow as weight loss drugs remain a major demand for millions of Americans. The vast majority of counterfeit goods seized by CBP are trafficked through ecommerce channels; consumers should be vigilant when purchasing pharmaceutical products from online sources. FDA offers some (albeit limited) guidance on what consumers can look for in evaluating potential safety risks with online pharmacies. However, consumers can guard against health risks by educating themselves on the attributes of the genuine product (such as those published by Nova Nordisk), being selective about the distribution channels from which they purchase products, and examining the brand indications on the product itself before ingestion.