FDA Disclaimer & Legal Notices

FDA Disclaimer & Legal Notices

FDA Disclaimer

The products sold on this website are dietary supplements. They are not intended to diagnose, treat, cure, or prevent any disease. These statements have not been evaluated by the Food and Drug Administration.

The information provided on this website, including product descriptions, blog articles, and research summaries, is for informational and educational purposes only. It is not intended as a substitute for professional medical advice, diagnosis, or treatment.

Dietary Supplement Health and Education Act (DSHEA)

Pilly Labs products are classified as dietary supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA). Under DSHEA, dietary supplement manufacturers are responsible for ensuring that their products are safe before they are marketed, that any claims made about them are not false or misleading, and that they comply with all applicable FDA regulations.

As required by DSHEA, all Pilly Labs products bear the following statement: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

Product Claims

All claims made about Pilly Labs products are structure/function claims as permitted under DSHEA and the FTC Act. We do not make health claims or disease claims about our products. Our marketing describes the role of nutrients and ingredients in supporting the normal structure or function of the human body.

When we reference scientific research, we do so for informational purposes. We clearly identify the type of study (human clinical trial, animal study, in vitro), note sample sizes and limitations, and never overstate findings.

Medical Disclaimer

The content on this website is not medical advice. Always consult a qualified healthcare professional before:

  • Starting any dietary supplement regimen
  • Making changes to your current health routine
  • Using supplements alongside prescription medications
  • Using supplements if you are pregnant, nursing, or have a medical condition

If you experience any adverse reaction to a dietary supplement, discontinue use immediately and consult your healthcare provider. You may also report adverse events to the FDA at www.safetyreporting.hhs.gov or by calling 1-800-FDA-1088.

Potential Drug Interactions

Functional mushroom supplements may interact with certain medications. Consult your healthcare provider before use if you are taking any of the following:

  • Blood thinners or anticoagulants (e.g., warfarin, heparin, aspirin) — Reishi, Chaga, and Cordyceps may have mild anticoagulant properties
  • Blood sugar-lowering medications (e.g., metformin, insulin) — Several mushroom species may affect blood glucose levels
  • Blood pressure medications — Reishi may lower blood pressure and could potentiate antihypertensive drugs
  • Immunosuppressant medications (e.g., cyclosporine, tacrolimus) — Mushroom beta-glucans may stimulate immune function, potentially counteracting immunosuppressive therapy
  • Anti-anxiety or sedative medications (e.g., benzodiazepines) — Reishi and other calming mushrooms may enhance sedative effects
  • Chemotherapy or radiation therapy — Some mushroom compounds may interact with cancer treatments; always consult your oncologist
  • Liver-metabolized medications — Some mushroom compounds may affect liver enzyme activity (CYP450 pathways), potentially altering how your body processes certain drugs

This is not an exhaustive list. Always inform your healthcare provider about all supplements you are taking.

Contraindications & Population Warnings

The following populations should consult a healthcare professional before using any Pilly Labs product:

  • Pregnant or nursing women — Safety of mushroom supplements during pregnancy and lactation has not been established in clinical trials
  • Children under 18 — Our products are formulated for adults. Consult a pediatrician before giving supplements to minors
  • Individuals with autoimmune conditions (e.g., lupus, rheumatoid arthritis, multiple sclerosis) — Mushroom beta-glucans may stimulate immune activity, which could exacerbate autoimmune conditions
  • Individuals with mushroom or mold allergies — If you have a known allergy to mushrooms or mold, do not use these products without medical guidance
  • Individuals scheduled for surgery — Discontinue use at least 2 weeks before any scheduled surgery due to potential effects on bleeding and blood sugar
  • Individuals with bleeding disorders — Certain mushroom species may affect coagulation
  • Organ transplant recipients — Immunostimulating properties may interfere with anti-rejection medications

Allergen Information

Pilly Labs products are made from fruiting body mushroom extracts. While mushrooms are fungi (not a major food allergen under FALCPA), individuals with mushroom or mold sensitivities should exercise caution. Our products are manufactured in facilities that may process other allergens. Please review individual product labels for specific allergen information.

FTC Compliance

Pilly Labs complies with the Federal Trade Commission’s guidelines for advertising dietary supplements. Our advertising and marketing materials are truthful, not misleading, and substantiated by available scientific evidence. We do not make guarantees of specific results.

Testimonials & Reviews

Customer testimonials and reviews displayed on this website reflect the individual experiences of those customers. Individual results may vary. Testimonials are not intended to represent or guarantee that anyone will achieve the same or similar results.

Manufacturing & Quality Standards

Pilly Labs products are manufactured in FDA-registered, GMP-certified facilities in the United States. We use 10:1 fruiting body extracts (no mycelium-on-grain fillers) and conduct third-party testing for potency, purity, and contaminants. For more information, visit our Quality & Testing page.

Contact

For questions about our products, ingredients, or these disclaimers, contact us at info@pillylabs.com.

Pilly Labs LLC
1800 Ridge Rd 204 1, PMB 1126
Homewood, IL 60430, United States
Phone: (708) 697-9131

Last updated: June 12, 2026