# FDA WARNING_LETTER - 11-11-11 Brands - November 21, 2022

Source: https://www.keypedia.com/records/warning_letter/11-11-11-brands/287789b7-a1b6-440f-8091-6414dfa5ab4e

> FDA WARNING_LETTER for 11-11-11 Brands on November 21, 2022. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: 11-11-11 Brands
- Inspection Date: 2022-11-21
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: The FDA issued a Warning Letter to Mood33 concerning their Hemp Infused Herbal Tea products containing cannabidiol (CBD). The FDA reviewed the company's website and product labels in October 2022 and confirmed the presence of CBD in a collected sample.

The primary violation is that Mood33 Hemp Infused Herbal Tea products are deemed adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i), because they contain an unsafe food additive (CBD). Introducing these products into interstate commerce is a prohibited act under sections 301(ll) and 301(a) of the FD&C Act, 21 U.S.C. 331(ll) and 331(a).

The FDA states that CBD is not approved as a food additive, is not generally recognized as safe (GRAS) for use in conventional foods, and is the active ingredient in an FDA-approved drug (Epidiolex), making its addition to food prohibited under 301(ll). Concerns include potential liver injury, harmful drug interactions, and reproductive issues associated with CBD. The letter also notes that some products contain caffeine, and CBD may affect caffeine metabolism. The product label's failure to list CBD as an ingredient exacerbates the risk of unintended consumption.

## Related Officers

- [Director](https://www.keypedia.com/people/ann-m-oxenham/0013a6c1-4908-4506-9fb8-d0aa522e4ad4)

Company: https://www.keypedia.com/companies/11-11-11-brands/8836f486-7709-4529-b74e-128fc1332e31

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