# FDA WARNING_LETTER - Newhere Inc dba CBDFX - November 21, 2022

Source: https://www.keypedia.com/records/warning_letter/newhere-inc-dba-cbdfx/2a7b5714-4c0b-475d-a86d-db9dc83ae66c

> FDA WARNING_LETTER for Newhere Inc dba CBDFX on November 21, 2022. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Newhere Inc dba CBDFX
- Inspection Date: 2022-11-21
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: The FDA reviewed cbdfx.com and associated social media in October 2022, identifying multiple violations regarding CBD-containing human and animal products.

**Violations and Deficiencies:**

*   **Adulterated Human Foods:** Flavored Chill Shots, Mixed Berry Gummies 1500mg, and CBD Cookies with Protein 20mg are deemed adulterated under section 402(a)(2)(C)(i) of the FD&C Act because they contain CBD, an unsafe food additive. CBD is not approved as a food additive and is not generally recognized as safe (GRAS).
*   **Prohibited Act (301(ll)):** Introducing these human food products into interstate commerce is prohibited under section 301(ll) of the FD&C Act, as CBD is an active ingredient in an approved drug (Epidiolex) and has been subject to substantial clinical investigations.
*   **Unapproved New Drugs (Human):** Numerous CBD-containing human products (e.g., Chill Shots, Gummies, Vape Pens, Tinctures, Balms, Creams) are marketed with claims establishing their intended use as drugs (e.g., for sleep, pain relief, anxiety, COVID-19 protection, depression). These are unapproved new drugs under section 505(a) and 301(d) of the FD&C Act, as no FDA-approved

## Related Officers

- [Director](https://www.keypedia.com/people/ann-m-oxenham/0013a6c1-4908-4506-9fb8-d0aa522e4ad4)
- [Division Director](https://www.keypedia.com/people/neal-bataller/801e1974-b20c-4b7a-ace7-aa4554fce4b6)
- [Carolyn E. Becker](https://www.keypedia.com/people/carolyn-e-becker/ad2daae5-dda1-4b9c-a69a-775997e7b60b)

Company: https://www.keypedia.com/companies/newhere-inc-dba-cbdfx/4c325bf0-671b-4d43-854f-8e6a6687a99d

Office: https://www.keypedia.com/offices/center-for-food-safety-and-applied-nutrition/e04dc4e5-ee4f-4b0d-be8c-1139531ddab2