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DR Vitamins, LLC was cited for selling unapproved new drugs, including ophthalmic products such as "Vision Clarity Eye Drops," "Life Extension Brite Eyes III," "Can-C Eye Drops," and "Longevity Science Visual Ocuity," through their website, Amazon storefront, and social media channels in violation of section 505(a) of the FD&C Act. The company failed to obtain FDA approval for these drug products and did not properly list them with the FDA, rendering them misbranded under section 502(o). The FDA identified ophthalmic products as particularly concerning from a public health perspective because eye drops bypass natural body defenses and pose greater risk of harm to users.