What happened
Original notice title
Muscle Sports Products, LLC MARCS-CMS 625731, September 23, 2022
From the archived source record
Based on our review, FDA identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act). Unapproved New Drugs and Misbranded Drugs FDA reviewed your website at www.musclesport.com in May 2022 and September 2022 and has determined that you take orders there for the products CardioBurn For Her Powder, Rhino Rampage Capsules™, Joint Revolution™ Capsules, STRESS B-COMPLEX, IMMUNITY + Powder, and Apple Cider Vinegar Capsules. With all the concern about the #coronavirus make sure your immune system is #optituned with Immunity + by Optitune! . . . #coldandfluseason” o “CORONAVIRUS OUTBREAK SUPPLEMENTING WITH IMMUNITY+ . . . Supplementing with Immunity+ can help you strengthen your immune system, speed up illness recovery, &decrease the risk of infection. 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, CardioBurn For Her Powder, IMMUNITY + Powder, and HYPEX Powder 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.
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
- FDA closeout listed
- Source checked
- Jul 16, 2026
- Record revision
- f25a2e0c9d88
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.
Sources, dates, and coverage →