# FDA WARNING_LETTER - Ora, Inc. - October 31, 2019

Source: https://www.keypedia.com/records/warning_letter/ora-inc/366ddf1b-3c3b-43b6-b646-1c16ab6ac3c2

> FDA WARNING_LETTER for Ora, Inc. on October 31, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Ora, Inc.
- Inspection Date: 2019-10-31
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On November 22, 2019, the FDA issued a Warning Letter to Sunflora, LLC, following a review of their websites (sunflora.org, cbdrx4u.com) and social media (instagram.com/yourcbdstoreofficial/) from July to October 2019. The letter identified multiple violations related to the marketing and sale of products containing cannabidiol (CBD).

The FDA determined that Sunflora's "Sunmed Tincture," "Sunmed Water Soluble," "Sunflora CBD Daytime Ageless Moisturizer," "Sunflora CBD Nighttime Ageless Serum," and "Sunmed Topical Relief Cream" are unapproved new drugs, sold in violation of sections 505(a) and 301(d) of the FD&C Act, and are misbranded drugs under section 502(f)(1) due to inadequate directions for use. Promotional claims on their websites established drug intended use, such as treating pain, anxiety, and inflammation.

Additionally, "SunMed Bacon Dog Treats," "SunMed Pet Bark Bits Beef," "SunMed Dog Lamb Bits," and "SunMed Pet Tincture" were deemed unapproved new animal drugs, unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act. Claims indicated intended use for animal health issues like anxiety and pain.

## Related Officers

- [Director](https://www.keypedia.com/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)
- [Director - Division of Compliance](https://www.keypedia.com/people/eric-m-nelson/301ef659-ae6a-41c5-9a3e-9cfbc0369670)
- [Director](https://www.keypedia.com/people/william-a-correll/f9e634a2-8e56-4c9b-984c-304f0c7db122)

Company: https://www.keypedia.com/companies/ora-inc/d11882cf-8c73-4ece-8820-7dff1d2cb932

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