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Pico IV Inc.

Received an FDA warning letter over CBD products and health claims

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According to U.S. Food and Drug Administration, Mar 6, 2025 · Read the source · +1 more

Where
California, United States
First reported
Last checked

Summary

On March 6, 2025 the FDA sent a warning letter to Pico IV Inc. (Sacramento, CA) about products it sells that are represented as containing CBD. The letter says the FDA looked at picoiv.com and saw CBD products offered for sale.

The FDA states that the products are unapproved new drugs under the Federal Food, Drug, and Cosmetic Act. The quoted marketing claims concern anxiety, Crohn. The letter asks the company to reply within fifteen working days describing the steps it has taken.

What the source found

  • Letter date March 6, 2025; FDA reference (MARCS-CMS) 700591; issued by the Center for Drug Evaluation and Research (CDER).
  • Website(s) named in the letter: picoiv.com.
  • Alleged violations cited by the FDA: unapproved new drugs products (FD&C Act).
  • Claims quoted by the FDA relate to: anxiety, Crohn.
  • No close-out letter was listed on the FDA warning letters page at retrieval (30 Sep 2026).

Products named

  • CBD products

Timeline

  1. FDA warning letter issued

  2. Letter posted on FDA.gov

Sources

  1. Regulator

    U.S. Food and Drug Administration · Mar 6, 2025

    Warning letter: Pico IV Inc. (700591), March 6, 2025
  2. Regulator

Wording on this page follows the sources. Found an error? See the corrections process in our editorial policy.

Status notes

[dataset] FDA warning letters database (fda.gov), harvested 2026-09-30; letter text read by script, cited as written by the source.

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