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The Food and Drug Administration (FDA) has announced that United States Marshals have seized more than 207,000 units of dietary supplements and bulk dietary ingredients that either contain or are solely kratom. Kratom, a tropical tree native to SouthEast Asia, contains compounds that cause psychotropic mind-altering effects. While it is not fully illegal, it is illegal in Florida, and it has serious health effects like seizures and hallucinations. Some have even reported symptoms of psychosis after using kratom. There are no FDA-approved uses of kratom.
The dietary supplements were manufactured by Atofil, LLC, a subsidiary of Premier Manufacturing Products, located in Fort Myers, Florida.
The FDA says of the use of kratom in dietary supplements, “There is substantial concern regarding the safety of kratom…The FDA will continue to exercise our full authority under the law to take action against these adulterated dietary supplements as part of our ongoing commitment to protect the health of the American people.”
Dietary supplements must be regulated through the FDA as they are regulated as food. They contain vitamins and dietary compounds to complement diet, not to be taken as a traditional meal or dietary component. All dietary supplements need label and ingredient review, as well as facility registration.
All FDA device registration and FDA food registration must be done correctly to ensure the safety and regulation of consumable products. Registering with the FDA is not always such a simple task. Some regulations and rules vary from state to state and even from country to county. It can be tough to know how to register effectively, but UReg FDA Registrations can help you do so.
Our team of experts has over 20 years of experience with FDA registrations. We have worked with companies of all sizes, from start-ups to public traded companies, and everything in between. Working with UReg FDA Registration will ensure you are in compliance with the FDA.