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WARNING LETTER

Intelligent Remedies, Inc. MARCS-CMS 681941 —

Delivery Method:
Via Email
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Mr. Steven M. Schorr
Intelligent Remedies, Inc.

P.O Box 448
Puunene, HI 96784-0448
United States

info@intelligentremedies.com
Issuing Office:
Human Foods Program

United States

January 23, 2026

WARNING LETTER

CMS #681941

Dear Mr. Schorr:

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://intelligentremedies.com/ in August and September 2025 and has determined that you take orders there for your products Pryenda, Athrombosyn, Ionophoric Zinc, CHAGAplus, Anxiety Support, Cardimyodin, VIRAsol, Curecumin, and HEMEflow O2. The claims on your website and on other product labeling establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at http://www.fda.gov.

Examples of some of the claims on your website, labels, and promotional materials that provide evidence that your products are intended for use as drugs include:

Pryenda

On the webpage titled “ANTI-VIRAL,” accessible at https://www.intelligentremedies.com/immune-boost:

  • “PRYENDA prevents and reverses cognitive damage caused from prions and is a therapeutic treatment against TSEs and other neurodegenerative diseases like Alzheimer’s and Parkinson’s disease.”

On the product webpage for your Pryenda product, accessible at https://www.intelligentremedies.com/store/Pryenda-p518449037:

  • “Pryenda … known to stop the formation of prions in the brain.”

On the label of your Pryenda product:

  • “Pryenda extracts helps stop the production of prions (misfolded proteins) and may help restore brain function.”

From the Product Information Sheet shipped with orders of your Pryenda product:

  • “Pryenda™ is a Phytotherapeutic extraction of … phytochemicals … known to stop the formation of prions in the brain.”

Athrombosyn
On the webpage titled “ANTI-VIRAL,” accessible at https://www.intelligentremedies.com/immune-boost:

  • “Athrombosyn Phytotherapeutic Extract Formulation is designed to attenuate unwanted blood clotting in the cardiovascular system caused by inoculation-based sources. Contains [a formula of] phytotherapeutic extracts . . . known to attenuate blood clots.”

On the label of your Athrombosyn product:

  • “Anti-Clotting Extract”

Ionophoric Zinc
On the label of your Ionophoric Zinc product:

  • “Organic Anti-Viral Zinc Extract”

On the label of your Ionophoric Zinc product, as depicted on the product webpage, accessible at http://www.intelligentremedies.com/store/Antiviral-1-2-Punch-p518449021:

  • “Anti-Viral Extract”

CHAGAplus
On the product webpage for your CHAGAplus product, accessible at http://www.intelligentremedies.com/store/CHAGAplus-Immune-Support-Extract-p518449028 :

  • “CHAGAplus contains six of the most effective immune supporting herbs with proven effects against colds and influenza.”

From the promotional material entitled “Intelligent Remedies: Full Spectrum Anti-Viral Suite” shipped with orders of your products:

  • “CHAGAplusTM … contains six of the most effective immune supporting herbs with proven effects against colds and influenza …. [T]his formulation can help fight infections.”

Anxiety Support
On the webpage titled, “NURTURE,” accessible at https://www.intelligentremedies.com/maintain:

  • “Anxiety Support is specially formulated to combat anxiety and insomnia. It has other positive effects including … lowering your blood pressure …”

On the label of your Anxiety Support product:

  • “Control Anxiety”

Cardimyodin
On the label of your Cardimyodin product:

  • “Ingredients in Cardimyodin have been known to alleviate heart inflammation.”

VIRAsol
On the webpage titled “Antiviral 1-2 Punch,” accessible at https://www.intelligentremedies.com/store/Antiviral-1-2-Punch-p518449021:

  • Under the heading “Product Details,” regarding your VIRAsol and Ionophoric Zinc products: “These two herbal antiviral extracts are powerhouses in the fight against viruses and the seasonal flu. Virasol™ is designed to stop the virus from getting in while Ionophoric Zn™ prevents infected cells from spreading to healthy ones.”

On the product webpage for your VIRAsol product, accessible at https://www.intelligentremedies.com/store/VIRAsol-Antiviral-Extract-p518449042:

  • “VIRAsol is a blend of the two leading antiviral herbs … along with an array of distinct natural antiviral herbs proven effective against influenza swine flu, dengue, herpes, and HIV.”
  • “Block the infection from taking hold by strengthening the cell wall”
  • “Prevent the virus from docking with the cell”
  • “Shorten the duration of respiratory symptoms”
  • “Receive safe, natural, and effective treatment compared to Tamiflu.”

On the product label of VIRAsol:

  • “Organic Anti-Viral Extract”

From the promotional material entitled “Intelligent Remedies: Full Spectrum Anti-Viral Suite,” shipped with orders of your products:

  • “Virasol contains six of the most effective herbs with proven effects against colds and influenza. These ingredients in this formulation are some of the most powerful herbs for preventing and treating colds and influenza. VIRAsol has been used to breakdown and destroy the protein sheath of a viral cell and help with anti-viral prevention.”

Curecumin
On your website’s blog, in a post entitled “Why Curcumin/Tumeric is called ‘CUREcumin’ (5 reasons),” accessible at https://www.intelligentremedies.com/post/turmeric-curcumin-curecumin (updated December 18, 2022):

  • Under the heading “What are the Benefits of Turmeric/Curcumin?”:
    o “Viral Infections … HIV, Zika, Herpes, and HPV have all shown positive antiviral activity with Curcumin …. ”
    o “Depression … curcumin was shown to have benefits that were similar to Prozac ….”
    o “Cancer … Curcumin … has been found to affect tumor growth, development and spread ….”

HEMEflow O2
From the promotional material entitled “Intelligent Remedies: Full Spectrum Anti-Viral Suite” shipped with new orders of your products:

  • “HEMEflow O2 … is used to treat a variety of blood-related ailments including blood deficiencies, uterine disorders, as well as ischemias of both the heart and brain … . These ingredients [in HEMEflow O2] help to treat and even prevent arthritis and other incidences of chronic inflammation … known to be anticancer, and anti-inflammatory.”

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

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). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your Pryenda, CHAGAplus, Anxiety Support, VIRAsol, Curecumin, and HEMEflow O2 products are intended for treatment of one or more diseases that are not amenable to self-diagnosis, treatment, or prevention without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your Pryenda, CHAGAplus, Anxiety Support, VIRAsol, Curecumin, and HEMEflow O2 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. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

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. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written reply should be addressed to Dr. Aaron Dotson, Compliance Officer, United States Food and Drug Administration, Human Foods Program, Office of Enforcement, 5001 Campus Drive, College Park, Maryland 20740-3835 or via email at HFP-OCE-DietarySupplement@fda.hhs.gov. Please reference CMS # 681941 on any submissions and within the subject line of any emails to us. If you have any questions, you may email at HFP-OCE-DietarySupplements@fda.hhs.gov.

Sincerely,
/S/

Thomas Kuntz
Acting Deputy Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

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