Like all poisonings, alcohol intoxication causes dose-related dysfunctioning and damage, ranging from mild impairments to death. A hangover is a sign or symptom of alcohol intoxication, a disease. “Our hangover prevention pills were crafted by Doctors and Scientists with vast experience in natural supplements.”Ī statement claims to mitigate, treat, cure, or prevent disease if it claims, explicitly or implicitly, that the product has an effect on the characteristic signs or symptoms of a specific disease or class of diseases.O Milk Thistle helps to protect the liver from damage.*”
O White Willow Bark, also called ‘Nature’s Aspirin’, acts as a natural anti-inflammatory agent in the human body.* O Dihydromyricetin (DHM) is derived from the Japanese Raisin Tree (Hovenia Dulcis) – it has been used for centuries as an anti-alcohol herb and hangover cure in Asia.* helps to combat alcohol’s negative effects in the body, including hangover*” “Purple Tree helps to prevent hangover symptoms.DHM is a natural extract that has been used as anti-alcohol herb and hangover cure since ancient medicine.*” “Purple Tree’s science-backed formula includes Dihydromyricetin (DHM), a liver detox and hangover prevention ingredient.“Purple Tree Hangover Cure & Prevention Pills”.“Our hangover prevention pills were crafted by Doctors and Scientists with vast experience in natural supplements.” (Hangover Pills product page)Īlso, claims made on your Amazon sale page provide further evidence that your product is intended for use as a drug.“Purple Tree – Supplement for Hangover Prevention” (Hangover Pills product page).SHOP NOW” (appears next to image of the Purple Tree product on the Journal page) “Purple Tree’s key ingredient is called Dihydromyricetin (DHM), an extract from the Japanese Raisin Tree, which has been used for centuries as an anti-alcohol herb and hangover cure in Asia.” (How it Works page).“Although a hangover cure for heavy-drinking situations like this does not exist, Purple Tree surely helps to mitigate some of the hangover symptoms, if taken beforehand.” (FAQs page).“Yes, Purple Tree is a hangover prevention pill that works.” (FAQs page).Hangovers hinder our work, fitness and family routines, so we embarked on a mission to help health-conscious adults who drink. “Purple Tree® is a natural multivitamin specifically designed to reduce alcohol's negative effects in the body.
You can find the Act and FDA regulations through links on FDA’s home page at Examples of some of the claims on your website that provide evidence that your product is intended for use as a drug include the following As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act. The claims on your website and Amazon sale page establish that the product is a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) because it is intended for use in the cure, mitigation, treatment, or prevention of disease. FDA also observed that you sell this product on at (“your Amazon sale page”).
Food and Drug Administration (FDA) reviewed your website at the Internet address in June 2020 and observed that you take orders there for the product Purple Tree. Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN)
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