Disclaimer
Every notice that belongs on a supplement website, in one place and in plain English.
These statements have not been evaluated by the Food and Drug Administration. BreathiZen is not intended to diagnose, treat, cure or prevent any disease. It is a dietary supplement for adults 18 and over, individual results vary, and this website earns money when you buy through it.
The FDA notice
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
That notice appears in the footer of every page on this website, and it is worth understanding rather than skipping. The FDA does not approve dietary supplements for safety or effectiveness before they go on sale (U.S. Food and Drug Administration). Manufacturing facilities must register with the FDA and follow current Good Manufacturing Practice under 21 CFR Part 111 (Electronic Code of Federal Regulations), but the FDA is explicit that registration is not approval (U.S. Food and Drug Administration).
So if you read anywhere that this or any supplement is "FDA approved", that statement is wrong. The accurate phrase is "made in an FDA-registered facility", and it describes a building.
Medical notice
This website is product information. It is not medical advice, it does not create a clinician relationship, and it cannot account for your history, your medicines or your circumstances.
- Do not use this site to diagnose anything.
- Do not start, stop or change a prescribed medicine because of anything you read here.
- Do not use a supplement in place of a treatment your clinician has prescribed.
- Do not delay getting breathlessness looked at. New or worsening breathlessness is a symptom and belongs in a consulting room.
- Speak to a clinician before starting if you are on any medication, and take the bottle with you.
Talk to a clinician before you start if you take medication for asthma, COPD or high blood pressure, if you take a blood thinner, or if you are due for surgery. Bromelain and green tea can both interact with blood thinners. The NIH's NCCIH publishes plain guidance on how supplements and medicines interact (NCCIH (National Institutes of Health)).
Results notice
Individual results vary. Nothing on this website promises a result, a timeline, or an outcome. A dietary supplement is not a treatment.
No clinical trial of the finished BreathiZen formula exists. The reviews published on this site are the reviews the seller supplied to us, and they describe individual experiences, not measured outcomes. Half of them say week one felt like nothing, and we publish that at the same size as the praise.
Because no ingredient amounts are published, nobody can compare this product with the doses used in the research we cite. That limitation appears on every page of this site that discusses ingredients, and it is the reason our editorial score is 6.4 rather than higher.
Who the product is for
BreathiZen is for adults 18 and over. It is not for children, and it is not for people who are pregnant or breastfeeding.
- Adults 18 and over only.
- Bromelain and green tea extract can both add to the effect of a blood thinner.
- Stop at least two weeks before planned surgery.
- Not for pregnancy or breastfeeding.
- Show the label to a clinician if you take asthma, COPD or blood pressure medication.
- A supplement is not a rescue inhaler and is not a treatment for a lung condition.
How this website earns
Breathizene is the USA Authorized BreathiZen Retailer. We earn money when you buy through this website. That is how the site pays for itself, and it is why the honest sections on this site exist: you should be able to see what we get wrong as well as what we get right.
Practically, that means every Add To Cart button on this site produces revenue for us if you use it. You should read everything here with that in mind, which is exactly why the dose table, the pros and cons, the complaints section and the editorial score exist. A website that sells something and publishes only praise is an advertisement with a table of contents.
Two specific consequences of that disclosure, both of which cost us money: we recommend the single bottle to first-time buyers rather than the six-bottle pack we earn most on, and we publish no review structured data, which means no gold stars beside our search results.
Accuracy and corrections
Product labels, formulations, prices and terms can change. The bottle you receive and the checkout page are authoritative over this website. We take reasonable care to keep these pages current and we correct errors when they are pointed out to us.
When we correct something, the "Last updated" date on that page moves forward and matches the dateModified in its structured data. If you find a mistake, email [email protected] and show us. We would rather be corrected than be wrong.
- Website and corrections
- [email protected]
- Order desk
- +1 (302) 200-3480 — Monday to Friday, 9:00am to 5:00pm Eastern Time
- Office
- 810 Seventh Avenue, Floor 9 New York, NY 10019 USA
- Returns
- 230 Park Avenue, Floor 10 New York, NY 10169 USA
- Last updated
- September 22, 2026
Why supplement disclaimers exist at all
Most people scroll past these. Here is why they are there.
The notices on this page are not decorative legal padding. They exist because dietary supplements occupy a specific regulatory position in the United States, and that position has consequences for what a seller may say and what a buyer should assume.
| Prescription medicine | Dietary supplement | |
|---|---|---|
| Approved before sale | Yes, by the FDA | No |
| Efficacy proven to a regulator | Yes | No |
| May claim to treat a disease | Yes | No |
| Manufacturing rules | cGMP for drugs | 21 CFR Part 111 for supplements |
| Facility registration with FDA | Yes | Yes — registration, not approval |
| Dose standardised across brands | Yes | No |
| Who checks the label is accurate | The regulator, before sale | The manufacturer, and the FDA only after problems appear |
Read that table once and the disclaimers stop looking like boilerplate. They are a plain statement that nobody outside the company has verified this product before it reached you, which is true of every dietary supplement on the market and is the reason this website spends so much of its length on what has and has not been published.
If you have a bad reaction
Short, because it needs to be readable quickly.
- Stop taking it. Do not halve the dose to see whether it settles.
- Write down what happened — what, when, how long after the dose, and what else you took that day.
- Speak to a clinician, particularly for any bleeding or bruising, a rash, swelling, or yellowing of the skin or eyes.
- Call the order desk on +1 (302) 200-3480. A reaction is a valid reason to use the guarantee and the desk handles returns.
- Report it. Serious reactions to a supplement can be reported to the FDA through MedWatch. That reporting system is how problems in this category get identified at all, and it depends on individual people bothering.
References
Every source linked here was opened and checked.
- Braun et al. — 2005. Therapeutic use, efficiency and safety of the proteolytic pineapple enzyme Bromelain-POS in children with acute sinusitis in Germany. In Vivo · PMID 15796206.
- Leelakanok et al. — 2023. Efficacy and safety of bromelain: A systematic review and meta-analysis. Nutrition and Health · PMID 37157782.
- Gupta et al. — 2022. Health-promoting and disease-mitigating potential of Verbascum thapsus L. (common mullein): A review. Phytotherapy Research · PMID 35088467.
- Fink et al. — 2018. Marshmallow Root Extract for the Treatment of Irritative Cough: Two Surveys on Users' View on Effectiveness and Tolerability. Complementary Medicine Research · PMID 30064132.
- Bonaterra et al. — 2020. Anti-inflammatory and Anti-oxidative Effects of Phytohustil and Root Extract of Althaea officinalis L. on Macrophages in vitro. Frontiers in Pharmacology · PMC7090173.
- Hirsch et al. — 2016. Cordyceps militaris Improves Tolerance to High-Intensity Exercise After Acute and Chronic Supplementation. Journal of Dietary Supplements · PMID 27408987.
- Oh et al. — 2018. Consuming Green Tea at Least Twice Each Day Is Associated with Reduced Odds of Chronic Obstructive Lung Disease in Middle-Aged and Older Korean Adults. The Journal of Nutrition · PMID 29378037.
- Townsend et al. — 2013. Effects of Ginger and Its Constituents on Airway Smooth Muscle Relaxation and Calcium Regulation. American Journal of Respiratory Cell and Molecular Biology · PMID 23065130.
- Evans et al. — 2021. A Randomized, Triple-Blind, Placebo-Controlled, Crossover Study to Investigate the Efficacy of a Single Dose of l-Theanine on Stress in a Healthy Adult Population. Neurology and Therapy · PMID 34562208.
- Hanus et al. — 2004. Double-blind, randomised, placebo-controlled study of a fixed combination containing Crataegus oxyacantha and Eschscholtzia californica with magnesium in mild-to-moderate anxiety disorders. Current Medical Research and Opinion · PMID 14741074.
- Zhang et al. — 2014. A Novel Analgesic Isolated from a Traditional Chinese Medicine. Current Biology · PMID 24388848.
- Hemilä et al. — 2013. Vitamin C for preventing and treating the common cold. Cochrane Database of Systematic Reviews · PMID 23440782.
- U.S. Food and Drug Administration. Is It Really 'FDA Approved'?. FDA.gov.
- U.S. Food and Drug Administration. Questions and Answers on Dietary Supplements. FDA.gov.
- Electronic Code of Federal Regulations. 21 CFR Part 111: Current Good Manufacturing Practice for Dietary Supplements. eCFR.gov.
- NCCIH (National Institutes of Health). Know the Science: How Medications and Supplements Can Interact. NCCIH.nih.gov.