FDA WARNING_LETTER - Careful Cents, LLC - May 19, 2020
Discuss this record with AI
On May 26, 2020, the FDA and FTC issued a Warning Letter to the operator of abeginnersguidetoessentialoils.com for promoting unapproved and misbranded products related to COVID-19. The website, participating in the Amazon Associates program, made claims implying essential oils could mitigate, prevent, treat, diagnose, or cure COVID-19.
These claims cause the promoted essential oils to be unapproved new drugs under FD&C Act section 505(a) and misbranded drugs under section 502. Prohibited acts include introducing or delivering these products into interstate commerce (sections 301(a) and (d)) and misbranding while held for sale after interstate shipment (section 301(k)).
The FDA cited a specific claim: "How to Boost Your Immune System Naturally With Essential Oils to Fight Coronavirus," stating, "You can mix up some essential oils in an ounce of carrier oil to use topically for preventive care or when you are feeling symptoms."
The letter demands immediate cessation of promoting such products and a response within 48 hours via email to [email protected], detailing corrective actions, prevention of recurrence, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction. The firm will be added to FDA's public list of firms with COVID-19 related
ID · 284fb4b8-4ec9-4756-9638-0049f050fd9b
Full citation text and observation details available on the Dashboard.