# FDA WARNING_LETTER - Biorica International Corp. - November 07, 2023

Source: https://www.globalkeysolutions.net/records/warning_letter/biorica-international-corp/6e8aefdf-4f36-4c1b-9ca5-5102525bf483

> FDA WARNING_LETTER for Biorica International Corp. on November 07, 2023. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Biorica International Corp.
- Inspection Date: 2023-11-07
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: The FDA issued a Warning Letter to Jacqueline Baxas regarding the product Plaquex® Oral Dietary Supplement, sold via websites https://www.plaquex.com/, https://biorica.biz/en/, and Facebook pages. A May 2023 review of these websites found claims establishing the product as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] due to its intended use in the cure, mitigation, treatment, or prevention of disease.

Specific claims on the websites indicate drug intent. Plaquex® Oral Dietary Supplement is deemed a "new drug" under section 201(p) of the Act [21 U.S.C. 321(p)] because it is not generally recognized as safe and effective for its claimed uses. Introducing or delivering a new drug into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)].

Furthermore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] as it lacks adequate directions

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/biorica-international-corp/1ed66789-2755-4df8-a131-49a1c4188ca3

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