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Is PureLung FDA Approved? What FDA Does and Does Not Do
No, and it could not be. FDA does not approve dietary supplements before they are sold. The maker is responsible for safety and for truthful labels. The asterisk on the PureLung front points to the statement that FDA has not evaluated the claims and that the product is not meant to diagnose, treat, cure or prevent disease.
Written by the PureLung label deskUpdated · 5 min read
Does FDA approve supplements?
No. Drugs go through approval before sale. Dietary supplements do not. The company that sells a supplement is responsible for making sure it is safe and that the label is honest, and FDA can act after a product is on the market if it proves unsafe or falsely labelled (FDA, FDA 101: Dietary Supplements).
So when a page says a supplement has "FDA approval", either it is wrong or it means something else.
What about FDA registered?
You may see the words FDA registered on a seller badge. That usually means a facility is registered with FDA, which is a filing, not an approval of the product or of any claim. We do not publish that badge, because no certifier or number is printed on the bottle.
What the asterisk means
The front of the bottle uses asterisks after its phrases. They point to the standard note: these statements have not been evaluated by the Food and Drug Administration, and this product is not intended to diagnose, treat, cure or prevent any disease (FDA, Q&A on Dietary Supplements).
That note is required whenever a supplement makes a structure and function claim. Read it as an honest limit, not as fine print to skip.
Claims a supplement may and may not make
| Type | Example | |
|---|---|---|
| Structure or function | Allowed with the note | Supports a normal body function |
| Disease treatment | Not allowed | Treats a named disease |
| Disease prevention | Not allowed | Prevents a named disease |
| Approval before sale | Not given to supplements | A stamp from the agency on the bottle |
If a page for this capsule mentions a disease by name as something it helps with, it has crossed the line.
If a bottle or an ad breaks these rules, or if you were harmed, FDA takes reports through MedWatch (FDA, MedWatch).
PureLung: 60 capsules a bottlePacks of 1, 3 or 6 bottles · live price shown at checkout · guarantee as printed on the live listing
See packsWhat does the PureLung label say?
The label shows 60 capsules, a serving of 2 and a 600 mg Proprietary Blend of eleven names with no single amount; it names no disease.
| Item | As printed |
|---|---|
| Form and count | Capsules, 60 per bottle; serving size 2 capsules; 30 servings |
| Blend per serving | Proprietary Blend, 600 mg: eleven names, no single amount printed |
| Inactive | Rice Flour, Magnesium Stearate, Silica Dioxide |
| Distributor | MJO, Sheridan, WY 82801 |
What this means for you
FDA's silence is not a warning and not an endorsement. It only means no one has checked before sale. You are the first reviewer, with your clinician. Read the disclaimer page, keep your medicines and read the label on arrival.
3-bottle pack
3 bottles: 180 capsules
Not listed on the packNot listed on the pack a bottle
Shipping shown at checkout · Guarantee as printed on the live listing
Order 3 bottles
6-bottle pack
6 bottles: 360 capsules
Not listed on the packNot listed on the pack a bottle
Shipping shown at checkout · Guarantee as printed on the live listing
Order 6 bottlesPrices are filled in once the live listing is confirmed. A single bottle is also sold. Check your medicines with your doctor or pharmacist before you order, and keep using every inhaler and prescribed medicine.
FAQ01
PureLung questions people ask
Is PureLung approved by any agency?
We found no approval. Supplements are not approved before sale.
Does FDA test supplements?
It can inspect and act after sale, but does not approve each product.
What is GMP?
Good manufacturing practice rules apply to supplement makers. The label does not name a certifier, so we do not claim one.
Can a supplement say it is clinically proven?
Only if a real clinical study of that product exists. We found none for this capsule.
Where do I report a bad product?
FDA MedWatch.
Who wrote this02
Written and reviewed by
Pages built from the label images, seller information and linked NIH, FDA, CDC, FTC and peer-reviewed sources.
Last updated . Read our editorial standards and how we check reviews. This website is the information site for a U.S. authorized retailer for PureLung. It is not the manufacturer or the distributor named on the label. We earn money when you buy through our order links.
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Check your medicines first, keep every inhaler and prescribed medicine, read the directions on the bottle that arrives, then pick a pack of 1, 3 or 6 bottles. The checkout shows the live price, any shipping and the guarantee.
- Checkout runs on the sales site
- Guarantee as printed on the live listing
- Ships from the U.S.