What happened
Original notice title
Health & Wellness Center International One, L.L.C. dba Hotze Vitamins MARCS-CMS 607276, December 02, 2020
From the archived source record
Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352. We request that you take immediate action to cease the sale of such unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. Some examples of the claims on your websites that establish the intended use of your products, including based on statements about the purported effects of their ingredients, and misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19 include: On your Hotze Vitamins website [www.hotzevitamins.com]: Your blog post titled, “BACK TO SCHOOL: NEW KIDS AND TEEN IMMUNE PAKS” at [see original source] displays images of your products “Dr. Hotze’s Teen Immune Pak products, direct consumers to your website www.hotzevitamins.com to purchase these products, and state: • “Whether your children will be attending school in person or online, the time to start boosting their immune system is now – not only because of the coronavirus but also because of the upcoming cold and flu season. #coronavirus . . .” In a May 27, 2020, post, you link to your May 2020 newsletter titled, “The Coronavirus Fraud: Power, Control and Money” at www.hotzehwc.com/wp-content/uploads/2015/02/Hotze-Healthy-Living-Newsletter-May-2020-1.pdf, which includes the following claims: • “COVID-19 is not the lethal threat it’s made out to be . . . HOTZE’S IMMUNE PAK . . . providing the extra protection needed to help ward off infections. . .” o “Vitamin A is known as an anti-inflammation vitamin because of its critical role in enhancing immune function. . . it can enhance immune function and provide an enhanced defense against multiple infectious diseases.” o “Research shows that zinc-deficient patients had severe immune dysfunctions.” o “Research demonstrates that probiotics can be safe and effective in fighting the common cold and influenza-like respiratory infect
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
- dee6f650a02b
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 →