haniel concepts, inc. – FDA Warning Letter, May 26, 2022
On May 26, 2022, the FDA issued a Warning Letter to Haniel Concepts, Inc. dba Free State Oils, LLC, following a May 2022 review of their websites (www.freestateoils.com, www.facebook.com/freestateoils, www.instagram.com/freestateoils, twitter.com/freestateoils). The FDA determined the company was marketing unapproved and misbranded CBD-containing products for human and animal use, including claims related to COVID-19.
Violations include: - **Unapproved New Animal Drugs:** Products like "Whisper’s Soothing Grains CBD for Farm Animals," "Snoop’s Chews CBD Dog Treats," "Snoop’s Drops CBD Tincture for Dogs," and "Eli’s Drops CBD Tincture for Cats" are marketed with therapeutic claims (e.g., pain, inflammation, anxiety), making them unapproved new animal drugs under FD&C Act sections 512(a) and 501(a)(5). - **Adulterated Animal Foods:** "Whisper’s Soothing Grains CBD for Farm Animals" and "Snoop’s Chews CBD Dog Treats" are considered adulterated under section 402(a)(2)(C)(i) and prohibited under 301(ll) because they contain CBD, an
ID · c44c80f9-7527-4d9b-aab3-75109300e128
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