Secret of the Islands – FDA Warning Letter, Jul 26, 2021
On August 10, 2021, the FDA issued a Warning Letter to Secret of The Islands, Inc., following a review of their website (secretoftheislands.com) and Facebook page (facebook.com/SecretoftheIslands) on July 26, 2021. The FDA found that the company was offering various salt scrub products for sale, claiming they could mitigate, prevent, treat, diagnose, or cure COVID-19.
These claims render the products unapproved new drugs under section 505(a) of the FD&C Act (21 U.S.C. § 355(a)) and misbranded drugs under section 502 (21 U.S.C. § 352). The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d) of the FD&C Act (21 U.S.C. § 331(a) and (d)).
Examples of violative claims include: "The world’s first & only doctor approved anti-bacterial & anti-viral salt scrub that kills/deactivates the Coronavirus" and "Due to the Coronavirus, there is a shortage of 12 oz jars."
Secret of The Islands, Inc. is required to take immediate action to cease the sale of these unapproved and unauthorized products.
ID · dc2cff8b-3408-4e23-b97a-a77bc837ab29
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