Everymarket Inc. – FDA Warning Letter, Sep 3, 2024
On August 27, 2024, the FDA issued a Warning Letter to Mr. Christopher Baton regarding products offered on everymarket.com. The FDA reviewed the website in July 2024 and obtained samples of "Vail-Bon Jie Yang Wan."
The FDA found that "Vail-Bon Jie Yang Wan" and "Ossos-Sans" are unapproved new drugs, violating sections 505(a) and 301(d) of the FD&C Act. Laboratory analysis confirmed "Vail-Bon Jie Yang Wan" contains undeclared dexamethasone and chlorpheniramine, making it a misbranded drug under section 502 and a violation of section 301(a). Dexamethasone is a corticosteroid with potential serious side effects, and chlorpheniramine is an antihistamine that can cause drowsiness.
Both products are considered drugs under section 201(g)(1) due to their intended uses, such as treating urticaria, eczema, arthritis, and osteoporosis, as evidenced by claims on their labeling. Since they are not generally recognized as safe and effective for these uses, they are "new drugs" under section 201(p) and lack FDA approval.
The misbranding of "Vail-Bon Jie Yang Wan" stems from its labeling failing to disclose the presence of dexamethasone and chlorpheniramine, rendering it false or misleading per
ID · e86f776a-f967-4adc-af8e-f63fe0e4445a
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.