# FDA WARNING_LETTER - Rooted Apothecary LLC - October 22, 2019

Source: https://www.globalkeysolutions.net/records/warning_letter/rooted-apothecary-llc/a70c5988-306a-4dfc-bf7d-039294f184cb

> FDA WARNING_LETTER for Rooted Apothecary LLC on October 22, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Rooted Apothecary LLC
- Inspection Date: 2019-10-22
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Rooted Apothecary following a July 2019 review of their website and social media, identifying significant violations concerning their cannabidiol (CBD) products. The agency determined that products like “Teeth/TMJ – Essential Oil + CBD Infusion,” “Ears – Essential Oil + CBD Infusion,” “Hemp Capsules, 750 mg,” “Hemp Infused Body Butter,” and “Hemp Oil” are unapproved new drugs, violating sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)). These products are also misbranded under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) due to inadequate directions for use (21 CFR 201.5). Furthermore, “Hemp Capsules” and “Hemp Oil” are not dietary supplements under section 201(ff) of the FD&C Act (21 U.S.C. 321(ff)) because CBD is an active ingredient in an approved drug or subject to substantial clinical investigations. The FDA expressed particular concern about marketing these unapproved drugs for infants and children. Concurrently, the Federal Trade Commission (FTC) found that efficacy claims for the products, asserting to prevent, treat, or cure disease, lack competent and reliable scientific evidence, violating the FTC Act (15 U.S.C. § 41 et seq.). The company must promptly correct all violations and notify FDA and FTC within fifteen working days of specific corrective actions, including documentation and plans to prevent recurrence. Failure to comply could lead to legal action, including seizure, injunction, or consumer restitution.

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)
- [Associate Director](https://www.globalkeysolutions.net/people/mary-k-engle/9426dfba-028c-4d3a-bb62-7bdea653e6bc)

Company: https://www.globalkeysolutions.net/companies/rooted-apothecary-llc/d0b64c40-49cc-403a-b332-319da8426cf5

Office: https://www.globalkeysolutions.net/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c