C R Supplements, LLC

Warning LetterOpen

Susan E. Hull Vice President and Owner C R Supplements, LLC 102 North Main Street #445 Kooskia , ID 83539 United StatesFEI 3013357852Issued Apr 20, 2022Office of Human and Animal Food Operations – West Division 6

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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 3013357852.

Violations15

Issue DateApr 20, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: C R Supplements, LLC
Location: Susan E. Hull Vice President and Owner C R Supplements, LLC 102 North Main Street #445 Kooskia , ID 83539 United States
FEI Number: 3013357852
Country: United States
Issue Date: April 20, 2022
Issuing Office: Office of Human and Animal Food Operations – West Division 6
Product Type: Drugs
Status: Open

Summary

C R Supplements, LLC was cited for marketing multiple dietary supplement products (including Calcium, Selenium, Silver, Magnesium, Zinc, Alkalize-U, CR-Oxy+, and Immune Boost Pack) as unapproved new drugs with disease claims on their website and Facebook page, violating the Federal Food, Drug, and Cosmetic Act. The FDA determined these products were intended for use in the cure, mitigation, treatment, or prevention of disease based on promotional language such as claims that Calcium "helps keep your blood stream and other body liquids alkaline, countering body acid." The violations were identified during an FDA facility inspection conducted December 6-10, 2021, followed by a review of the company's online marketing materials in March and April 2022.

C R Supplements, LLC FDA Warning Letter, April 20, 2022