After rampant sales of counterfeit masks, coronavirus disease 2019 (COVID-19) testing kits, medicines, and other goods over the past two years, there has been increased attention in Washington this holiday season on the health and safety risks of counterfeit products, particularly those sold online.  

Just before Black Friday, the United States Chamber of Commerce and US Customs and Border Protection launched a “Shop Smart” campaign, providing Americans with tips on how to spot and protect themselves from counterfeit products. A week later, the National Crime Prevention Council and the US Patent and Trademark Office released a collection of new ads for their “Go for Real” anti-counterfeiting campaign, highlighting ways in which counterfeit products can cause serious injury and harm.  

A common theme in both campaigns is the outsize role that e-commerce and third-party marketplaces have played in facilitating the sale of counterfeit products in the US. In many cases, despite policies prohibiting the sale of certain products, these platforms do very little to vet sellers, many of which often operate anonymously, making it incredibly difficult to take action against perpetrators of counterfeit sales. Customers must often rely on vague clues to identify a fake, such as missing sales tax calculations, unusual addresses, slight differences in packaging, and “deals too good to be true.” Too many consumers are not looking for these signs, even when shopping for health care products and medicines online. As noted by a 2021 consumer behavior survey, nearly half of Americans erroneously believe that all websites offering health care services or prescription medications to Americans on the internet have been approved by Food and Drug Administration (FDA) or state regulators. 

In December 2021, FDA released a warning letter after finding 50 male enhancement and weight loss products being sold on Amazon and eBay that had hidden and potentially dangerous ingredients. All of the products purchased on Amazon and 80% of the products purchased on eBay contained undeclared active pharmaceutical ingredients, including sildenafil (the active ingredient in Viagra®), tadalafil (Cialis®), vardenafil (Levitra®), and/or fluoxetine (Prozac®). Several of the Amazon products were also designated as an “Amazon’s Choice” or “#1 Best Seller.” Additionally, FDA warned consumers not to purchase nine sexual enhancement products available on because they also contained hidden ingredients. Because e-commerce marketplaces do not directly sell the products, they have not been held clearly liable for the products’ authenticity, leaving customers and law enforcement without any recourse except to go after the third-party sellers, who often obscure their identities and/or operate from overseas. Adding further confusion for customers, many of these marketplaces have started to move into the consumer health care space, manufacturing and selling their own and others’ over-the-counter medicines and COVID-19 test kits

Recognizing the risks for consumers, Congress has taken several steps this year to protect Americans from counterfeit products by bringing transparency and accountability to e-commerce marketplaces. Introduced in the Senate in March 2021 by Dick Durbin (D-IL) and Bill Cassidy, MD (R-LA), the Integrity, Notification, and Fairness in Online Retail Marketplaces for Consumers Act (S 936) would require online retail marketplaces to authenticate the identity of high-volume third-party sellers by acquiring the seller’s government ID, tax ID, bank account information, and contact information. The bill also requires that online marketplaces make sellers’ names and contact information available to consumers through the sellers’ product listings, allowing customers the ability to make more informed decisions about the sellers and allowing law enforcement to track bad actors. A companion bill was also introduced in the House in October 2021 by Representatives Jan Schakowsky (D-IL) and Gus Bilirakis (R-FL).

Another bipartisan bill, the Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce Act of 2021 (SHOP SAFE Act of 2021) (HR 3429) introduced in both the House and the Senate in May, would amend the Trademark Act of 1946 to hold online third-party marketplaces liable for contributory infringement of a counterfeit mark for cases in which the mark is used without the consent of the registrant “in connection with the sale, offering for sale, distribution, or advertising of goods that implicate health and safety on the platform.” As outlined in the bill, third-party marketplaces would not be held liable if they took certain steps to prevent counterfeit infringement on their platforms. These include but are not limited to verifying the identity, location, and contact information of the third-party seller, verifying that they are designated a registered agent in the US, and implementing practices to screen goods before they are displayed on the site. Thus, the SHOP SAFE Act of 2021 would incentivize these platforms to adopt best practices, some of which several online platforms have promised to adopt voluntarily.   

While the 117th Congress is set to close in a matter of days, it is clear that comprehensive reform of e-commerce and other internet service providers will be a priority in the next session.  

When Congress reconvenes in 2022, expect to see a number of bills reintroduced that are likely to transform the e-commerce landscape. Until then, look to NABP resources for more information on the dangers of misbranded and adulterated health care products and how to counsel patients on related safety issues.