Breathiterol Introduces Breathiterol Spray, a Three-Botanical Oral Dietary Supplement for Respiratory Wellness

Launch is accompanied by a regulatory and labeling statement that sets out the product's status under federal supplement law and what its label does and does not claim

LAKELAND, FL, November 6, 2026 – Breathiterol, a dietary supplement brand distributed by Instituto Experience of Lakeland, Florida, today announced the U.S. introduction of Breathiterol Spray, a once-daily oral spray that combines mullein leaf, ginger root and organic lemon extracts. With the launch, the company published a regulatory and labeling statement that explains how the product is classified under federal law, lists every ingredient on its Supplement Facts panel and states that the finished formula has not been clinically studied.

Breathiterol Spray went on sale in the United States on November 2, 2026. It is sold as a dietary supplement under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the federal law that governs how supplements are made, labeled and marketed. The company said it chose to publish the regulatory statement at launch, rather than after questions arrived, so that consumers, retailers and health care providers could review the product’s status and label from the first day it was available.

Official Website: https://gobreathiterol.com/

“A new supplement in the respiratory wellness category is going to be read closely, and it should be,” said Kevin Learne, Media Relations Manager at Breathiterol. “We decided to put the regulatory position, the complete label and the limits of the research in front of people at launch. Anyone considering the product should be able to see what it is, how it is classified and what we are not claiming, before they see anything else.”

The Breathiterol Launch at a Glance

Product: Breathiterol Spray, a botanical oral spray sold as a dietary supplement

U.S. introduction: November 2, 2026
Regulatory status: dietary supplement under DSHEA; not reviewed or approved by the FDA before sale
Size: 60 mL bottle, 100 servings
Serving: four sprays (0.60 mL), once a day
How it is taken: sprayed into the mouth or onto the tongue and swallowed; not inhaled and not a nasal spray
Active ingredients: one 154 mg proprietary blend of mullein leaf extract 10:1, ginger root extract and organic lemon extract
Not on the label: vitamins, minerals, caffeine or other stimulants
Distributor: Instituto Experience, Lakeland, Florida

The Regulatory and Labeling Statement

The statement published with the launch covers five points.

First, product classification. Breathiterol Spray is a dietary supplement, not a drug. Under DSHEA, the FDA does not approve supplements before they go on sale. The company that markets a supplement is responsible for making sure the product is safe and that its labeling is truthful and not misleading.
Second, claims. Federal rules allow supplement labels to carry statements about how an ingredient relates to normal body structure or function, but not claims that a product diagnoses, treats, cures or prevents a disease. The Breathiterol label carries the standard FDA statement to that effect. The company said it does not describe the product as a treatment for any lung or breathing condition, and that its use of the phrase “respiratory wellness” refers to the category in which mullein has traditionally been used, not to any tested effect of the finished spray.
Third, research status. The finished Breathiterol formula has not been the subject of a published clinical study. The research the company cites concerns the three botanicals individually, in forms and amounts that may differ from a serving of the spray.
Fourth, manufacturing. The label states that the product is made in the USA with globally sourced ingredients. Under 21 CFR Part 111, every dietary supplement made or sold in the United States must be produced under current Good Manufacturing Practice rules covering ingredient identity, quality control and labeling.
Fifth, consumer contact. Federal law requires dietary supplement labels to carry a U.S. address or telephone number so that consumers can report concerns about a product. The company said questions and reports about Breathiterol Spray can be sent to the contact details listed on the bottle and at the end of this release.

What Breathiterol Spray Is

Breathiterol Spray is a liquid supplement for adults, delivered with a metered pump. Each 60 mL bottle holds 100 servings. The label directs users to shake the bottle well and spray four pumps, about 0.60 mL, into the mouth or onto the tongue once a day. The official product page suggests taking it in the morning, before the first meal.

Most mullein products sold in the United States come as dried leaf for tea, as capsules or as tinctures measured with a dropper. Breathiterol uses a pump instead, so each serving is counted in sprays rather than measured or steeped. The bottle resembles a nasal spray, and the company said this is the point it most wants to make clear: the liquid goes into the mouth and is swallowed. Nothing is breathed in, and the product is not an inhaler.

The spray base is purified water and glycerin, with natural flavors, citric acid and two common food preservatives, potassium sorbate and sodium benzoate.

The Full Supplement Facts Panel

Serving size: 4 sprays (0.60 mL)
Servings per container: 100
Proprietary Blend, 154 mg: Mullein (Verbascum thapsus) (leaf) Extract 10:1, Ginger (Zingiber officinale) (root) Extract, Organic Lemon Extract. Daily Value not established.
Other ingredients: Purified water, glycerin, natural flavors, citric acid, potassium sorbate, sodium benzoate.
Directions: Shake well before each use. Spray 4 pumps directly into the mouth or onto the tongue once daily.
Caution: Do not exceed the recommended serving. Pregnant or nursing mothers, children under the age of 18 and individuals with a known medical condition should consult a physician before use.
Storage: Keep away from heat, light and humidity. Store in a cool, dry place and out of reach of children. Do not use if the safety seal is broken or missing.

Two features of the panel affect how it should be read. The “10:1” beside mullein describes how the extract was made: about 10 parts of dried leaf were concentrated into one part of finished extract. It is not a measure of how much mullein is in a serving. And because the three botanicals share one blend weight, the label shows their order by weight, with mullein first, but not the amount of each. Federal labeling rules permit this format. The company said it does not estimate the individual amounts, because the label does not state them.

The Three Botanicals and What Published Sources Report

Mullein leaf. Common mullein is a tall, woolly-leafed plant native to Europe and Asia that is now widespread across North America, where the U.S. Forest Service describes it as a common roadside and open-ground species. Its leaves and flowers have a long history in European and North American folk herbal practice, usually prepared as teas. The European Medicines Agency has assessed mullein flower under its “traditional use” category, which is based on a long record of use rather than clinical trials, and recorded a lack of clinical studies. That assessment covers the flower rather than the leaf. A 2022 review in Phytotherapy Research described the plant’s flavonoids, saponins and other constituents and summarized laboratory and animal research. The University of Michigan Health library states that human clinical trials are lacking for mullein.

Ginger root. Ginger is the most studied of the three. A 2020 systematic review in the journal Nutrients examined 109 randomized controlled trials of ginger across a range of uses and called for better-designed studies. The National Center for Complementary and Integrative Health, part of the National Institutes of Health, describes ginger as generally well tolerated in food and typical supplement amounts and advises people who take medicines to talk with a health care provider before using ginger supplements.

Organic lemon extract. Lemon is a familiar food and a common flavoring. A 2020 review in the journal Plants described the chemistry of lemon fruit and essential oil and its uses in the food, pharmaceutical and cosmetic industries. The Breathiterol panel does not list a vitamin C amount, so the lemon extract should not be read as a measured source of vitamin C.

The company said none of these sources studied Breathiterol Spray or the combination of ingredients in it, and that they are cited to describe each botanical, not to support a claim about the product.

What the Label Does Not Claim

The regulatory statement lists what Breathiterol Spray is not. It is not a drug and has not been approved by the FDA. It is not a substitute for an inhaler or any prescribed medicine. It is not intended to diagnose, treat, cure or prevent any lung or breathing condition. It does not contain vitamins, minerals, caffeine or stimulants.

“We would rather be specific about the limits now than correct a misunderstanding later,” Learne said. “The product is a short, plainly labeled botanical spray. That is what we are introducing, and that is how we describe it.”

Anyone with ongoing breathing or chest concerns should see a health care professional rather than rely on a dietary supplement.

Daily Use and Storage

Because the serving is counted in pumps, the company suggests keeping the bottle in one consistent place, such as beside a toothbrush or coffee maker, so the daily serving is neither missed nor repeated. The bottle should be shaken before each use and stored away from heat, light and humidity. At four sprays a day, one bottle lasts 100 days.

The company advises against moving the liquid into a different container, since the serving on the label is based on the original metered pump.

Who Should Check With a Doctor First

The label asks anyone who is pregnant or nursing, anyone under 18 and anyone with a known medical condition to consult a physician before use. Following NCCIH guidance on ginger, people who take prescription or over-the-counter medicines should also check with a doctor or pharmacist first. The NIH Office of Dietary Supplements advises telling every health care provider about any supplement in use, so the full list can be reviewed together.

Reading Product Descriptions and Reviews

As a newly introduced product, Breathiterol Spray has few public reviews. The company suggests that anyone reading a description or review of the product compare it with the Supplement Facts panel above, check that the item described is the same 60 mL oral spray, and look at whether the page discloses payment or an affiliate relationship. Reading lower-rated reviews alongside higher-rated ones gives a fuller picture of packaging, spray mechanism and support experiences. Reviews describe individual experiences and are not evidence about the formula.

Frequently Asked Questions

What is Breathiterol Spray? A once-daily botanical oral spray sold as a dietary supplement. It contains a 154 mg blend of mullein leaf extract, ginger root extract and organic lemon extract and was introduced in the United States on November 2, 2026.
Is Breathiterol Spray approved by the FDA? No. Under federal law, dietary supplements are not reviewed or approved by the FDA before sale. The company is responsible for the product’s safety and labeling.
Is Breathiterol Spray an inhaler or a nasal spray? No. It is sprayed into the mouth or onto the tongue and swallowed.
What does “respiratory wellness” mean for this product? It describes the category in which mullein has traditionally been used. The company does not claim the spray treats, prevents or relieves any lung or breathing condition.
Has the finished formula been clinically studied? No. Published research covers the three botanicals individually.
What are the ingredients? A 154 mg proprietary blend of mullein leaf extract 10:1, ginger root extract and organic lemon extract, in a base of purified water, glycerin, natural flavors, citric acid, potassium sorbate and sodium benzoate.
Does it contain caffeine or stimulants? No. The label lists no caffeine, stimulants, vitamins or minerals.
How long does one bottle last? One 60 mL bottle holds 100 servings, or 100 days at four sprays a day.
Who makes Breathiterol Spray? The label states that it is made in the USA with globally sourced ingredients and distributed for Instituto Experience of Lakeland, Florida.

References

U.S. Food and Drug Administration. Dietary Supplements.
U.S. Food and Drug Administration. Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, 21 CFR Part 111.
European Medicines Agency, Committee on Herbal Medicinal Products. Verbasci flos (mullein flower): EU herbal monograph.
U.S. Forest Service, Fire Effects Information System. Verbascum thapsus.
Gupta A, et al. Phytotherapy Research. 2022.
University of Michigan Health. Mullein. Health Library.
Anh NH, et al. Nutrients. 2020;12(1):157. doi:10.3390/nu12010157
National Center for Complementary and Integrative Health. Ginger: Usefulness and Safety.
Klimek-Szczykutowicz M, et al. Plants. 2020;9(1):119. doi:10.3390/plants9010119
NIH Office of Dietary Supplements. Dietary Supplements: What You Need to Know.
None of these sources mentions, reviews or endorses Breathiterol.

About Breathiterol

Breathiterol is a dietary supplement brand distributed by Instituto Experience of Lakeland, Florida. Its first product, Breathiterol Spray, is a once-daily botanical oral spray built on mullein leaf, ginger root and organic lemon extracts, introduced in the United States in November 2026. The brand’s stated approach is to publish each product’s complete label, regulatory status and research limits at launch, so that consumers and their health care providers can review every ingredient and claim before use. More information is available on the official Breathiterol website.

Media Contact

Kevin Learne Media Relations Manager, Breathiterol

Company: Instituto Experience

Email: support@customercs.com

Address: Lakeland, FL 33804, USA Website: gobreathiterol.com

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. Individual experiences vary. Consult a qualified health care professional before starting any dietary supplement.