What happened
Original notice title
Secret Garden of Health & Healing, LLC MARCS-CMS 538408, March 21, 2018
From the archived source record
Based on the inspectional findings, a subsequent review of the product labels collected during the inspection, and a subsequent review of your website at www.secretgardenofhealthandhealing.com, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Unapproved New Drugs/Misbranded Drugs This is to advise you that the FDA reviewed your website at the Internet address www.secretgardenofhealthandhealing.com in February 2018 and has determined that you take orders there for the products: Osha Root, S.G. 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, A V Complete or Anti-Viral, S/S Complete or Staph/Strep, E O Support or End O Me, 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)]. Dietary Supplement CGMP Violations Our investigators observed the following significant violations of FDA’s Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111), which render your dietary supplement products adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)]. Cough Syrup, Bac-ta-Bitters, A V Complete or Anti-Viral, K B Complete or Kidney/Bladder, C D A Complete or Can D da, S/S Complete or Staph/Strep, B-Alergone, E O Support or End O Me, EnnerLite, Cayenne, and BP Formula products did not have therapeutic claims which make them unapproved new drugs and misbranded drugs, these products would be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] for the reasons described below.
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
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 2786fd5fdfd9
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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