What happened
Original notice title
C R Supplements, LLC MARCS-CMS 624651, April 20, 2022
From the archived source record
Based on inspectional findings and a review of your website and Facebook page, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Unapproved New Drugs/Misbranded Drugs FDA reviewed your website at the Internet address www.crsupplements.com in March and April 2022, and has determined that you take orders there for your products Calcium, 4X Calcium 4X, Copper, Molybdenum, Potassium, Selenium, Silver, Magnesium, Zinc, Alkalize-U, CR-Oxy+, and Immune Boost Pack. Harmful bacteria, virus and other disease causers do not thrive in an alkaline environment.” 4X Calcium 4X “… [C]ountering body acidity. As a result of good body pH, … Bad Bacteria will decline.” Copper “[Copper] influences how your body perceives pain because it is a necessary part of enkephalin production.” Molybdenum “Molybdenum is essential to the enzymes that change the sulfites into sulfates so they can safely and easily move out of the body. … Sulfites accumulate and can build up to toxic levels. When sulfites reach toxic levels: o Allergy responses like itching, hives, and fainting can happen. o Trouble breathing is another possible sulfite response. A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, Calcium, Copper, Molybdenum, Selenium, Silver, Magnesium, Zinc, Alkalize-U, CR-Oxy+, and Immune Boost Pack fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)]. Adulterated Dietary Supplements The inspection of your facility from December 6, 2021, to December 10, 2021, revealed serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111).
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 25c4d5a540f6
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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