Facts About Kratom for Local Environmental Health Agencies
Because kratom and 7-OH products are widely available and advertised, most consumers incorrectly assume that such products are legal to sell and manufacture for consumption and safe to consume.
Consuming kratom is dangerous and can lead to addiction and why selling these products for consumption is illegal when examined in the context of California laws.
Even though kratom and 7-OH products are unsafe and it is unlawful to sell them for consumption, there are many reasons that retailers, manufacturers and distributors continue to offer kratom and 7-OH products, including confusion about the law, misinformation about safety, and consumer demand.
About Kratom and 7-OH
- Kratom is the common name for the leaf of a tropical tree, Mitragyna speciosa.
- Kratom has a complex pharmacological profile with the potential for both sedative, stimulant, and opioid effects.
- 7-hydroxymitragynine, commonly known as 7-OH, is a potent opioid derived from kratom.
- One of the alkaloids in the kratom plant is metabolized to 7-OH in the human body after ingestion. 7-OH and other kratom ingredients may lead to addiction, serious harm, overdose, and/or death.
- Claims that kratom or 7-OH treat pain, anxiety, and opioid withdrawal are unproven.
- Kratom and 7-OH side effects include withdrawal symptoms, insomnia and anxiety, seizures, and fatal respiratory depression.
- Despite its unproven efficacy and potential dangers, an estimated 1.7 million Americans aged 12 and older used kratom in 2021, according to the Substance Abuse and Mental Health Services Administration’s National Survey on Drug Use and Health (PDF).
Kratom and 7-OH are Not Approved by FDA as a Food, Drug, or Dietary Supplement
Kratom and 7-OH are not approved by FDA as a food, drug, or dietary supplement. This point is important because any substance not approved as a food, drug, or dietary supplement by the U.S. Food and Drug Administration (FDA) is not legal to manufacture or sell for consumption.
Foods Containing Kratom or 7-OH are Adulterated
According to California Health & Safety Code 110555, “Any food is adulterated if it is, bears, or contains any food additive that is unsafe within the meaning of Section 110445.” Since kratom and 7-OH are unsafe, foods containing them are considered to be adulterated.
Products Containing Kratom or 7-OH are Not Legal to Sell or Manufacture for Consumption
Neither kratom nor 7-OH can lawfully be marketed in the United States as a food, drug or dietary supplement, and any food containing kratom or 7-OH is adulterated.
Over the past several years, kratom and 7-OH products have become more prevalent in retail outlets and online, often labeled as something other than a food, drug or dietary supplement, or marked "not for human consumption."
Regardless of the naming or labeling, it is clear that they are manufactured and sold for human consumption, and thus must be legally classified under one of those three categories. Since they do not meet these criteria, they are not legal to manufacture or sell for consumption.
Federal, State and Local Roles Related to Kratom or 7-OH
Federal, state and local jurisdictions have all taken enforcement action to seize kratom and 7-OH products.
Federal
State
- CDPH oversees the safety of food, drug, and dietary supplements.
- CDPH investigates complaints regarding kratom or 7-OH and shares findings with relevant authorities.
- CDPH investigates distributors and manufacturers of food products containing kratom or 7-OH and are subjected to the California Health and Safety Code.
- CDPH can offer technical support regarding kratom and 7-OH investigations and enforcement.
- CDPH can support LEHA requests for enforcement at local retailers but may triage limited resources to instances linked to serious injury or death.
Local
- Local Environmental Health Agencies may notice kratom or 7-OH during routine inspections in permitted facilities and can request voluntary removal of foods subject to the California Retail Food Code (CRFC) containing kratom or 7-OH.
- Local jurisdictions can partner with CDPH to provide information they may discover regarding distributors or manufacturers of products containing kratom or 7-OH.
- Local counsel should be consulted to clarify any other local agency authority, including LEHA authority in other settings.
- Other strategies may be available in the local jurisdiction. To explore additional legal remedies, consult with city/county attorneys, law enforcement, district attorneys’ office, and/or contact the CDPH Food and Drug Branch at FDBretail@cdph.ca.gov.
What are Some Best Practices for Impounding an Adulterated Product?
If voluntary discard is not successful and local policy and legal authority support further action, California Health & Safety Code 114393 states that adulterated products can be impounded for up to 30 days if an administrative or legal remedy is initiated to ensure due process and offer an opportunity to correct a violation.