FDA WARNING_LETTER - Durazo Medical Biomagnetism - June 12, 2020

The FDA and FTC issued a Warning Letter to Save Me Magnets on August 19, 2020, following reviews of their websites and social media on June 12 and August 17, 2020. The company offers "Biomagnetism Magnetic Therapy DIY Kits," which are deemed devices under the Federal Food, Drug, and Cosmetic Act due to claims of mitigating, preventing, treating, diagnosing, or curing COVID-19.

These products are considered adulterated under section 501(f)(1)(B) of the Act because they lack FDA marketing approval, clearance, or authorization (PMA or IDE). They are also misbranded under section 502(o) as the firm failed to notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k). The introduction or delivery of these products into interstate commerce is prohibited under section 301(a) and 301(k).

The FDA previously emailed the firm on June 6, 2020, requesting information, but the firm responded by claiming exemption from FDA regulation as a "private membership association," an argument rejected by the FDA as without merit.

Save Me Magnets must immediately cease selling these unapproved products for COVID-19 related uses. Within 48 hours, the firm must email COVID-19-Task-Force-CDRH@