What happened
Original notice title
Natural Relief Inc. MARCS-CMS 659048, October 18, 2023
From the archived source record
Based on our inspection, subsequent review of product labeling collected during the inspection, and review of your firm’s website, www.natrelief.com, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Unapproved New Drugs and Misbranded Drugs FDA reviewed your website, www.natrelief.com in June 2023 and determined that you take orders for Edema NatRelief 6 and BP NatRelief 11. 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, BP NatRelief 11 fails to bear adequate directions for its intended use and, therefore, the product is 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 this misbranded drug violates section 301(a) of the Act [21 U.S.C. 331(a)]. Adulterated Dietary Supplements Even if your Edema NatRelief 6 and BP NatRelief 11 products were not unapproved new drugs and misbranded drugs, these products would be adulterated dietary supplements under section 402(g)(1) of the Act. The facility inspection 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). These violations cause your dietary supplements to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. You failed to establish limits on those types of contamination that may adulterate or may lead to adulteration of the finished dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(b)(3). b.
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
- 8bc0605668ff
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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