Image
Products Containing 7-OH Can Cause Serious Harm
Tempted to try products containing 7-hydroxymitragynine (also known as 7-OH) – such as tablets, gummies, drink mixes, and shots – sold online and at smoke shops and gas stations? Consider this: 7-OH products are novel potent opioid products that have not been proven safe or effective for any use and should be avoided.
The U.S. Food and Drug Administration recommends that consumers avoid 7-OH products, including conventional foods, dietary supplements, and those claiming to treat an ailment or disorder. While 7-OH occurs naturally in trace amounts in the plant kratom, the FDA’s warning is for products containing 7-OH as an added ingredient or at enhanced levels, which can be dangerous. 7-OH is not approved by the FDA for any medical use and is not lawful as a dietary supplement or when added to conventional foods because it has not met the appropriate safety standard.
Despite that, some companies are distributing and selling unlawful products containing high concentrations of 7-OH to consumers. Unfortunately, these 7-OH products, including foods such as gummies and drink shots, are readily available online and at smoke shops, gas stations, and corner stores. The FDA has sent warning letters to companies for illegally distributing products containing 7-OH.
There Are No FDA-Approved Products Containing 7-OH
Consumers might be tempted to use these products to “treat” ailments such as anxiety, mood disorders, pain and opioid withdrawal. But there are no products containing 7-OH that the FDA has found safe and effective in treating those ailments or for any other use.
In addition, 7-OH products are novel potent opioid products. Exposure to 7-OH could result in serious harm.
The FDA has received reports of harmful effects associated with 7-OH products. These effects include addiction, anxiety, depression, gastrointestinal distress, insomnia, seizures and withdrawal symptoms – such as restlessness, body aches, fatigue, irritability and cold sweats.
Ways to Protect Yourself and Your Family
Consumers should avoid all products containing 7-OH, including those claiming to treat an ailment or disorder. Talk to your health care professional if you need help with opioid addiction, anxiety, mood disorders, pain, or other ailments. There are approved treatments for those and related ailments.
If you believe someone is experiencing an adverse event from a 7-OH product, contact the Poison Help Line (1-800-222-1222) or visit the webPOISONCONTROL® website for help. If someone is unresponsive, dial 911 immediately!
If you have a bad reaction to a product containing 7-OH, let the FDA know. You can report an adverse event by using the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
- Download the form or call 1-800-332-1088 to request a reporting form sent to you in the mail, then complete and return to the address on the form, or submit it by fax to 1-800-FDA-0178.
NOTE: The FDA has also warned consumers not to use kratom because of the risk of serious adverse events, including liver toxicity, seizures and substance use disorder.
For more information, visit the FDA Kratom webpage and the FDA 7-OH webpage.
