FDA WARNING_LETTER - G & L Wellness, LLC - December 22, 2020
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The FDA issued a Warning Letter to Ms. Carter regarding products sold on www.glwellness.net, specifically "C BETTER DAILY Adult Regular Formula," "C BETTER DAILY Adult Maximum Formula," "C BETTER DAILY Soothing Formula" (human CBD eye drops), and "C BETTER DAILY Pet Formula" (animal CBD eye drops).
The human CBD eye drops are deemed unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)) because website claims establish their intended use as drugs, and they lack FDA approval. They are also misbranded drugs under section 502(f)(1) (21 U.S.C. 352(f)(1)) due to inadequate directions for use for a layperson.
The "C BETTER DAILY Pet Formula" is an unapproved new animal drug, unsafe under section 512(a) (21 U.S.C. 360b(a)), and adulterated under section 501(a)(5) (21 U.S.C. 351(a)(5)), as it lacks FDA approval, conditional approval, or index listing.
The FDA emphasizes the serious public health risk of ophthalmic products containing toxic substances. The company must promptly address these violations
ID · fe543500-be6c-4434-9b9a-b9323beedf94
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