10 Ketamine Warning Letters Issued

FDA just issued a batch of 10 warning letters to companies selling the drug ketamine online.

I am still surprised when I see drugs openly sold via standard e-commerce, and equally surprised that people actually purchase them.

This group of warning letters highlights that there are many non-compliant operators online selling everything from ketamine to semaglutide. It is a reminder that going the legal, highly regulated route is essential to ensuring safety and product quality.

A little bit about Schedule III drugs: this category also includes things like ketamine, anabolic steroids, testosterone, and lower-dose Tylenol with codeine products. While it is possible to legally purchase Schedule III drugs online, such as when prescribed by a licensed practitioner during a compliant telehealth appointment and dispensed through a DEA-registered pharmacy, none of the companies targeted in this group of warning letters appeared to have followed this path.

Why am I writing about this in Warning Letter Wednesday? Aside from it being a slower week for supplement letters, there may be some correlations in the natural products industry. Far too often, when companies make outrageous marketing claims, it acts as a bellwether for potential product quality and adulteration issues.

There are also two regulatory parallels here for supplement brands to keep in mind:

The “Unapproved New Drug” Trap: FDA cited these sites for introducing “unapproved new drugs” into interstate commerce. This is the same regulatory mechanism FDA uses when a natural product crosses the line from a compliant structure-function claim into an illegal disease claim.

Digital Enforcement is Real: FDA caught all 10 of these companies simply by reviewing their commercial websites. This is a great reminder that conducting a routine compliance scrub of your secondary marketing, including websites, social media, and e-commerce platforms, is just as critical as vetting your physical product labels.