Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Your kratom and kava products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.
Passage 2On your webpage entitled, “Kratom for Anxiety and Depression: Does It Work”; https://shotofjoy.com/blogs/kratom/kratom-for-anxiety: • “In addition to depression and anxiety, it is believed that kratom can cure the following conditions[,] Tiredness hypertension[,] Opioid addiction[,] Withdrawal symptoms[,] Post-traumatic stress disorder (PTSD)” • “Fighting Depression and Anxiety with Kratom[,] Kratom has been widely used by people around the world to relieve stress and other symptoms of depression . . .”
Passage 3On your webpage entitled, “10 Awesome Kava Benefits to Know”; https://shotofjoy.com/blogs/kava/kava-benefits?_pos=1&_psq=10%20%20awe&_ss=e&_v=1.0: • “Here are ten amazing kava benefits you should be aware of . . . May Alleviate ADHD Symptoms[,] Kava may be beneficial to people who suffer from attention deficit hyperactivity disorder (ADHD). In a small clinical trial, children with ADHD who took kava supplements outperformed those who took a placebo in terms of attention, hyperactivity, and impulsivity. . . . May help with depression symptoms[,] Kava has been studied for its ability to help with depression symptoms. Kava was found to be effective in reducing depression symptoms in people with major depressive disorder in a clinical trial. . . . May Help with Cardiovascular Health[,] Kava may help with cardiovascular health by lowering blood pressure and increasing cholesterol levels. In a clinical trial, people with high blood pressure who took kava supplements had lower blood pressure than those who took a placebo.”
Passage 4On your webpage entitled, “Kava Effects on Brain: Beginner’s Guide”; https://shotofjoy.com/blogs/kava/kava-effects-on-brain: • “Neuroprotection: Kava has preventive properties against strokes. Two of Kava's constituents, dihydromethysticin and methysticin, have similar potency to the Alzheimer's disease treatment Memantine.” • “Antidepressant effects have also been observed in kava preparations. Several of the studies establishing this antidepressant effect also revealed that Kava posed no safety issues at the levels and period evaluated. Unlike a number of well-known antidepressants. Kava has also been demonstrated to improve cognition and focus. In one study, researchers indicated that Kava's capacity to prevent the reuptake of noradrenaline in the prefrontal cortex may be responsible for its cognitive enhancing effects. Moreover, Kava protects and may possibly treat a variety of cancers. One of the components of Kava, Flavokawain B, decreases prostate tumor growth and prevents malignancy, according to research.”
Passage 5On your webpage entitled, “Authentic Polynesian Kava Drink Recipes”; https://shotofjoy.com/blogs/kava/polynesian-drinks: • “Beyond its cultural significance, kava is known for its medicinal properties. The active compounds called kavalactones found in the kava root contribute to its . . . depression-relieving effects.”