# FDA WARNING_LETTER - Advanced Spine and Pain, LLC - April 02, 2019

Source: https://www.keypedia.com/records/warning_letter/advanced-spine-and-pain-llc/be4bc497-6728-4db8-b291-4ee4051f553c

> FDA WARNING_LETTER for Advanced Spine and Pain, LLC on April 02, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Advanced Spine and Pain, LLC
- Inspection Date: 2019-04-02
- Product Type: Drugs
- Summary: On March 28, 2019, the FDA issued a Warning Letter to Advanced Spine and Pain, LLC (d/b/a Relievus) after reviewing their websites (www.relievuscbdoil.com, www.relievus.com) and social media (Facebook, Twitter) in February 2019. The FDA determined that Relievus was selling and promoting "CBD Salve," "CBD Oil," and "CBD for Dogs" products.

The "CBD Salve" and "CBD Oil" products were deemed unapproved new drugs, sold in violation of sections 505(a) and 301(d) of the FD&C Act, and misbranded drugs under section 502(f)(1) due to inadequate directions for use. These products are considered drugs because they are intended for disease treatment/prevention or to affect body function, as evidenced by claims on their websites. They cannot be dietary supplements because CBD is an active ingredient in an approved drug (Epidiolex) and has been subject to substantial clinical investigations. Additionally, "CBD Oil" is intended for sublingual use, not ingestion, further disqualifying it as a dietary supplement. If marketed as food, it violates section 301(ll) as CBD has been added to food after substantial clinical investigations.

The "CBD for Dogs" product was identified as an unapproved new animal drug,

## Related Officers

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

Company: https://www.keypedia.com/companies/advanced-spine-and-pain-llc/65f2bda9-8837-472f-a547-902d1f180742