In an unusual move for the group the U.S. Food and Drug Administration (FDA) recently announced a mandatory recall of a kratom product. Kratom, a natural substance from a plant that is often sold as an herbal supplement, is controversial, and the FDA previously warned about its risks and oversees voluntary recalls. The FDA is recalling one brand of kratom because it considers the product to be a food item that is known to have been contaminated with salmonella.

Kratom and Recommended Recalls

Kratom comes from a tree native to Southeast Asia an, and has long been used medicinally in the cultures of that region. Products made with kratom, mostly those marketed as natural supplements or herbal medicines, have become popular in the U.S. in recent years. The rise in popularity coincides with the increase in addiction to and overdose deaths from opioids, including prescription painkillers and heroin.

Many people buy kratom now as an aid to overcoming opioid addictions. It is used to treat withdrawal symptoms and to prevent relapse. The FDA issued a warning in late 2017 that kratom is itself an opioid and therefore poses a risk to consumers. That it has opioid-like compounds in it helps explain why kratom can be used to manage opioid withdrawal.

The problem is that kratom is not tested or regulated as a drug for treating addiction. It is unregulated, and it can be risky to use it for this reason. Regulations help ensure that drugs are pure, contain the correct amount of active ingredient, and that they have been tested for safety. Several companies complied with the FDA’s 2017 request for voluntary recalls of kratom products, but not all did.

Mandatory Kratom Recall

The FDA does not have the authority to force a recall of a drug, but it can issue a mandatory recall of tainted foods, thanks to a law that was passed in 2011. As occurred in 2017, when the FDA believes there is a safety issue with a food it can request a recall, and most companies comply.

Salmonella was found in powdered kratom made by a Las Vegas-based company called Triangle Pharmaceuticals. The FDA determined that the supplement could be considered a food item and issued a mandatory recall after the company declined to comply with a request for a voluntary recall.

Although the FDA has warned about the use of all kratom products, it was clear in its recent statement that this recall is being ordered only because of the salmonella contamination. Salmonella is a type of bacterium that can cause serious illness in people who consume products contaminated with it. Products included in the recall include those called Raw Form Organics Maeng Da Kratom Emerald Green, Ivory White, and Ruby Red.

The discovery of salmonella was made when samples of the Triangle product were collected and sampled from a retailer in Oregon. State authorities tested the samples and found the bacteria. Triangle refused to comply with the request for a recall of the tainted products but also a request by the FDA to see their records in an attempt to track and stem a salmonella outbreak.

The FDA considers kratom products to be dangerous supplements and herbal medicines that consumers should avoid. There is no way for the agency to recall all kratom because of the concern for opioid abuse, but it has sent a strong warning to consumers. This additional mandatory recall should also be taken seriously, as salmonella can be deadly.