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What Are Unapproved Drugs? And Why They’re Found on E-commerce Marketplaces

The FDA’s authority to regulate pharmaceutical drugs was established in 1938 when the FDCA was enacted. Read further to understand the regulatory environment of unapproved drugs. Then contact us for a quick strategy session.

What Are Unapproved Drugs and Who Regulates Them?

Online drug sales are flourishing in the pharmacy market, which has surpassed $1 trillion in annual sales. But many of these online sales are illegal or problematic, posing risks to consumers and the platforms that facilitate the sales of these products.

Unapproved drugs are ones that have not been approved for use in the jurisdictions where they are being sold or shipped. For example, a prescription drug manufactured in Mexico cannot be sold in or shipped to the US unless it has passed the proper regulatory scrutiny for quality, safety, and efficacy in this country.

In the US, the federal Food, Drug, and Cosmetic Act (FDCA) enables the US Food and Drug Administration (FDA) to regulate new drugs marketed in the US to ensure they’re “safe and effective prior to marketing and widespread use in the general population.” A key requirement is that nearly all new drugs (with limited exceptions) obtain FDA approval. Drugs marketed without approval are considered unapproved drugs and violate the FDCA.

The FDA takes a risk-based, two-pronged approach to unapproved drugs by “giving enforcement priority to drugs that pose the highest risk to public health, without imposing undue burden on patients or unnecessarily disrupting the availability of drugs on the market.” It considers unapproved drugs to “pose significant risks to patients because they have not been reviewed by FDA for safety, effectiveness or quality.”

Unapproved Drugs Pose Serious Risk to Consumers

Unapproved drugs are monitored closely but that doesn’t stop bad actors from slipping them into the online e-commerce marketplace ecosystem of products. It’s critical that marketplaces and consumers understand the FDA’s role in approving drugs for safety and efficacy.

Here is the FDA’s list of risks associated with purchasing unapproved drugs online:

  • Unapproved drugs are those with “unproven and untested drug formulations” that haven’t been studied for safety or efficacy.
  • Labeling hasn’t been reviewed for accuracy and may list ingredients not contained in the product and/or nutrition labeling could misrepresent the product.
  • Potentially undocumented safety concerns may not have been addressed during the manufacturing process.

Unapproved drugs can be hard to spot because they can take many forms. Sometimes they are obvious medications, such as misbranded cancer drugs. Other times they are other products with pharmaceutical ingredients, such as skin lightening cosmetics or honey infused with pharmaceutical ingredients for sexual enhancement. That’s why it’s important to track global regulatory warnings about these products.

LegitScript Marketplace Monitoring Alerts Your Marketplace to Unapproved Drug Sales

Are you an e-commerce marketplace looking to reduce the risk of monetary violations for unapproved drugs? LegitScript has the world’s largest database of problematic healthcare products, including unapproved drugs categorized by jurisdiction. We track 175+ regulatory bodies across 100+ countries in dozens of high-risk areas. Reduce the risk of problematic product listings like unapproved drugs that can damage your brand, and confidently grow your business into new categories with LegitScript Marketplace Monitoring.

Contact us for a quick strategy session.