Brigid Groves, PharmD, MS, Vice President, Professional Affairs, APhA
Young people are dying. Families are grieving. Products capable of causing serious harm are sold in places we visit every day, often in packaging that gives little indication of the risks.
Do I have your attention?
As a pharmacist, I hope so. I am concerned that patients seeking relief from pain, anxiety, or other health challenges may reach for kratom or its derivatives without understanding what they are taking. Concentrated products containing a kratom derivative known as 7-OH are especially concerning because of their powerful opioid-like effects and potential for serious harm. While these products are currently unregulated, FDA advises consumers to avoid them.
We have a responsibility to make sure that warning reaches our community and patients before they decide to try a product that can cause serious harm.
A gummy, tablet, or drink shot purchased at a gas station or convenience store may not look dangerous, especially when packaged in an enticing manner. When something is readily available, people can usually assume someone has checked that it is safe. With these products, that assumption can have serious consequences.
Kratom has not been approved by FDA to treat any medical condition as it is considered a new dietary ingredient without sufficient safety data. Kratom leaf naturally contains trace amounts of 7-OH, which is a highly potent derivative. Products manufactured with added or enhanced 7-OH levels can deliver a much more concentrated exposure. FDA warns against both kratom and the use of its derivatives because of serious risks, including causing liver injury, increasing risk of seizures, and developing or worsening SUD. People seeking relief deserve guidance and treatments supported by evidence.
We are already seeing warning signs. CDC reports that kratom-related exposure reports to poison centers increased approximately 1,200% between 2015 and 2025. Young adults were among those most frequently represented. During that period, poison centers recorded 233 kratom-associated deaths. Most reports referenced a single kratom-related substance, but concerningly, many reported cases included multiple substances such as opioids, alcohol, or benzodiazepines.
Earlier this year, DEA proposed temporarily placing products containing 7-OH above a specified threshold into Schedule I, the most restrictive federal controlled-substance category. APhA supported proposed temporary scheduling while HHS, FDA, and DEA evaluate whether permanent scheduling of concentrated and synthetic 7-OH products is warranted. This may also allow maintaining an evidence-based distinction between traditional kratom products and those intentionally formulated to deliver a higher concentration of 7-OH. In July 2026, DEA announced its intent to temporarily schedule 7-OH and three other substances into Schedule I.
At the end of the day, this is about protecting patients who may have no idea what they are buying.
APhA supports closing loopholes that allow unapproved products with drug-like effects to reach consumers, and we urge federal officials to act. Pharmacists should help inform those efforts by sharing the safety concerns and patterns of use they encounter in patient care.
We also have a responsibility to make this conversation easier for patients.
If a patient uses kratom or a related product, we want them to tell their pharmacist. Encourage patients to tell us what they are taking, why they started, and what other medications or supplements they use. That conversation gives us an opportunity to help patients understand the risks and find appropriate care and treatment options.
Encourage parents and caregivers to talk with the young people in their lives about these products. It’s important we don’t assume they recognize the risks simply because they recognize the name or find them easy to buy at the convenience store at the top of the street.
Pharmacy colleagues: Ask about kratom. A patient may never think to mention something purchased at a gas station during a medication review. Our questions can open a conversation that matters.
People deserve to understand what they are taking and the harm it could cause. We should be speaking clearly, helping patients, and pressing for action now.
Learn more about FDA’s warning on concentrated 7-OH products.