The Food and Drug Administration is warning consumers to steer clear of Optimized Plant Mediated Solutions (OPMS) Black Liquid Kratom after officials allege the product can be linked to health conditions and death.
The FDA’s announcement comes after an investigation into the product following a slew of reports detailing users’ adverse health events and the death of a 23-year-old Georgia man who died in December 2021. Mitragyna speciosa, or kratom, is a plant that derives from Southeast Asia. Though the product is marketed as “all-natural” and is a plant supplement, it has yet to be approved by the FDA.
Some of the reported health concerns linked to the use of kratom include withdrawals, addiction, increased anxiety, digestive issues and restless leg syndrome. This condition causes patients to feel discomfort in their legs and have a compulsion to frequently move or shift them, especially at night or when resting.
In its warning about Kratom, the FDA said that it has “serious concerns” about it being considered a dietary supplement and an additive to conventional foods. It has not approved over-the-counter drug products containing kratom or associated compounds, mitragynine and the more potent metabolite, 7-OH mitragynine. If using kratom products or those with the presence of kratom alkaloids, the FDA warns there is an increased risk of liver toxicity, substance abuse disorder and or seizures.
The product, used as a supplement and rumored to have therapeutic effects, is still listed for sale on various online markets despite the FDA’s warnings. The FDA encourages consumers not to use these products and, if a person believes they have experienced an adverse health event related to the use of kratom, they should report it to an FDA Consumer Complaint Coordinator as soon as possible.
Leesfield & Partners
The law is clear when it comes to manufacturers and the products they are putting on the market – they have a duty to ensure these items are safe for consumers. In 1994, The Dietary Supplement Health and Education Act (DSHEA) was passed to expand FDA authority over dietary supplements and better define them. Under DSHEA, supplement companies must comply with labeling and quality requirements, and meet safety standards. This means that the companies must clearly and specifically outline necessary information such as a complete ingredient list, of all dietary ingredients in the product, directions for use and the net quantity of contents to tell consumers about the amount of the dietary supplement.
As a law firm with 48 years of personal injury litigation experience out of Miami, Key West and Central Florida Orlando, Leesfield & Partners has seen the devastating effects that companies can have on the lives of consumers. As a buyer, one expects the product they are purchasing will do what its labels claim it will and that it will be safe to consume, use and or install in their homes. However, this is not always the case.
Leesfield & Partners attorneys have extensive experience dealing with corporations who try to skirt liability when something goes wrong with their products. In its decades of practice, the firm has seen products such as firearms going wrong, unsafe children’s toys and automobile defects wreak havoc on unsuspecting individuals and their families.
Leesfield & Partners attorneys handled a case that resulted in the award of $19.8 million to a young man who was left as a high-level quadriplegic after a crash on his Honda motorcycle. The 27-year-old was riding the bike when it spun out of control in a devastating crash. The cause of the crash was revealed to be a defect with the bike’s kickstand. Though this was a defective product, the company refused to settle and, at trial, a jury ruled in favor of Leesfield & Partners’ injured client.
Another major case that resulted in a substantial award for a grieving family and brought about a change in the way a furniture manufacturer labeled its products and warned consumers about the risks was handled by Leesfield & Partners attorneys. This case took place out of Central Florida and involved the death of a 2-year-old due to a furniture tip-over incident at the family’s home. Attorneys with the firm secured a $17.5 million settlement amount for the family and the manufacturer went on to warn users about the need to anchor furniture to the wall to avoid tip-over incidents.
The firm has a long history of representing clients against juvenile and baby products manufacturers. Another case that led to change resulted from the tragic suffocation death of a child in a high chair. Following this case, the industry enacted regulations for highchairs including additional rules for straps and harnesses, tray size and mechanisms as well as clear and specific instructions and warnings.