Is this FDA cleared?
2061571
It is a customizable mouth guard. I don't think it needs to be FDA approved. My husband used it and liked it. He didn't snore as much and felt better in the mornings when he's used it. Sometimes he did spit it out during the night but still it was better than nothing and much quieter than a CPAP!
1996302
Keep in mind the FDA does not always know what is best! It once approved a diet pill that ended up killing people. So, approval from the FDA doesn't mean that much anyway. Better to use your own judgement and check into things yourself.
1333011
yes it is listed on the product...if that is a problem, talk to your doctor,it may not be revelent
773731
I did not see a certification from any recognized agency. You may ask the BulkSupplements if they have any testing in place. However it should be noted that supplements are not inspected by a national agency such as the FDA. Supplements fall under "Caveat emptor".
75066
I do not know if it is, but I like the product. It dissolves better than others I've tried. Since this is a supplement, I doubt it is FDA approved. Most are not.
1273322
It does not say anywhere on the bottle FDA approved. That doesn't mean it's not, it's just not listed on the bottle. You may have to check the "BIO TECH Pharmacal, Inc website, www.BioTechPharmacal.com or call 1-800-345-1199 this was listed on the bottle, to see if they have any information to provide you on the B2-400mg Riboflavin
761221
To be perfectly honest with you Ernesto, we got cleared via EWG several years ago.. and I thought we were still over there! :) It may be that we need to renew yearly or since the new FDA mandates of 2013. I never thought to check. We are a small company and have nearly doubled in size this year so we scramble at this point just to keep production, shipping and orders rolling smoothly. We appreciate the heads up on this, and will look into getting back up over there ASAP, since it's a valid concern you bring up (and it would certainly bring us more sales). The people who cruise EWG are mostly certainly our target demographic! Many regards.. Deb
1003829
Just checked the packaging and it does not indicate the source. My understanding is, with the FDA, and the FTC, and whatever other bureaucracy manages this, that the source need only be indicated if it is not the U.S. If I am incorrect in that regard, I would welcome the correction.
159017
It shouldn't be...they wouldn't be allowed to sell it easily under FDA, and California, regs. I see that someone called Lenox and they said they meet federal lead standards. Best to call Lenox directly.
721485
the capsule possibly has fillers etc........the powder is 100%, reagent grade
391954
FDA means food and drug administration so as this is a device it is not subject to approval by the FDA so No it is not approved by the FDA
793189
My package had a "Use By" date of March 2018. Vendor was Mr. Medical. Results probably vary with each vendor.
1373548
It is not FDA approved it says it right in the description on the Amazon page.Product DescriptionPackage Quantity: 1*These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, or cure any disease.
1985167
No it is not. It says on the back label that the statements have not been approved by the Food and Drug Administration.
303682
Looking on my box, it says "FDA Registered". I looked this up and one website says: A misconception of the actual legal marketing status of a product can arise when a company says that its system has been "registered" with the FDA (possibly denoting marketing approval or clearance in the minds of those unfamiliar with FDA terminology and processes) when in actual fact the company has only filed an "establishment registration" and/or a "medical device listing" with the FDA. Such a filing is no more than filling out a one-page administrative form and paying a fee in the case of establishment registration. Inergetix , inc website
1640115
We are FDA cleared and are in leading hospitals across the United States. For clinical evidence please visit our website at AnyWound.com and select Clinical at the top header.
2207757
Yikes. I wish I'd seen this before ordering: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm365989.htm