What happened
Original notice title
Applied Health Solutions, Inc. MARCS-CMS 616778, October 22, 2021
From the archived source record
Glucosinolates . . . help lower cancer risks and protect against cardiovascular disease. Even in studies comparing its effectiveness to chlorine bleach, isopropyl alcohol, and colloidal silver, GSE has been found to be superior as an antimicrobial.” • “. . . research showing the effectiveness of GSE against AIDS.” • “All over the world, GSE has been used for killing a wide variety of bacteria (such as: Salmonella, E. coli, Staph and Strep germs), viruses, herpes, parasites, and fungi, including Candida. 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, the B Complex, Daily Detox, CellRenewPRO, CellRenewSTS, Grapefruit Seed Extract CapsulesPlus, and Grapefruit Seed Extract Liquid Concentrate products 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)]. This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction. Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
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
- 1fce0005e01d
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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