Phoenix Nutritionals, Inc.

Warning LetterOpen

Mr. Kaleo Steven Whiting President Phoenix Nutritionals, Inc. 4727 Terrace Drive San Diego , CA 92116-2515 United StatesFEI 3004349112Issued Jul 1, 2021Office of Human and Animal Food Operations-West Division 5

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3004349112.

Violations1

Issue DateJul 1, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Phoenix Nutritionals, Inc.
Location: Mr. Kaleo Steven Whiting President Phoenix Nutritionals, Inc. 4727 Terrace Drive San Diego , CA 92116-2515 United States
FEI Number: 3004349112
Country: United States
Issue Date: July 01, 2021
Issuing Office: Office of Human and Animal Food Operations-West Division 5
Product Type: Drugs
Status: Open

Summary

Phoenix Nutritionals, Inc. was cited for marketing eight nutritional products as unapproved drugs through their websites and social media, including making disease claims such as treating cholesterol imbalance, blood sugar issues, stress, joint problems, inflammation, and immune support—with "Best Immune Support" specifically claimed to mitigate, prevent, treat, or cure COVID-19. These marketing claims established the products as drugs under the Federal Food, Drug, and Cosmetic Act because they were intended for use in the cure, mitigation, treatment, or prevention of disease, violating requirements for FDA approval. The FDA identified the violations by reviewing the company's websites (phoenixvitamins.com and healthyinformation.com) and Facebook page in June 2021, where specific claims linked to shop-now buttons that directed consumers to purchase the products.

Phoenix Nutritionals, Inc. FDA Warning Letter, July 1, 2021