• Quick note - the problem with Youtube videos not embedding on the forum appears to have been fixed, thanks to ZiprHead. If you do still see problems let me know.

Ear candle suit snuffed

MatildaGage

Muse
MatildaGage
Joined
Jan 25, 2010
Messages
799
Here is a really funny article on Lexology about this.

You may have to log in (free) to read the whole thing. I first read it since I subscribe but I just intermittently got to view it while not logged in.

It's worth a read--the article is pretty anti-woo, hilarious. *chuckle*

Essentially there was a lawsuit, Holistic Candlers & Consumers Ass’n v. FDA. Apparently they are a lobbying group. If I'm understanding correctly, FDA issued some warning letters and the group objected. The suit was dismissed because warning letters are not regulatory decisions.

If you're interested in just reading the facts (and willing to miss out on the well-written comedy on Lexology!) then here you go. I searched FDA warning letters but couldn't find them.
 
I have now read the decision and get the distinct impression that someone enjoyed writing it. :D
 
If it helps you to find it: Holistic Candlers & Consumers Ass’n v. FDA, ___ F.3d ___, 2012 WL 5831 (D.C. Cir. Jan. 3, 2012).

Here are some funnies. I haven't seen Lexology make comments like this before but I am rly enjoying it.

1) those who make candles for people to shove in their ears ... and set on fire actually have their own lobbying group (that’s scary – are UFO believers next?); (2) some people actually believe shoving a lit candle in your ear is a healthy thing to do (that’s scarier)...

So why do we care about people who stick lit candles in their ears?

Because – aside from keeping a straight face – the Court of Appeals makes a point about FDA warning letters
Click to expand...

LOL
 
Last edited:
Thx Gord. Here is part of the decision (I assume it's ok to post a large quote here since it's not copyrighted).

A typical warning letter advised the recipient
that FDA considered its candles to be adulterated and
misbranded medical devices because “ased on the labeling
. . . , it appears your ear candles are intended to mitigate or treat
allergies, headaches, colds, flu, sinus congestion, sore throat, ear
infections” and a variety of other medical disorders, yet “you
have not obtained marketing approval or clearance before you
began offering your product for sale.” Letter from FDA to
Harmony Cone (Feb. 17, 2010) (J.A. 42-43) [hereinafter FDA
Warning Letter]; see Letter from FDA to King Cone Int’l (Feb.
17, 2010) (J.A. 45) (stating that the manufacturer’s website
contains claims that the “device is intended to relieve,” inter alia,“vision disorders[,] . . . depression, and attention deficit disorder”); see also J.A. 47, 49 (warning letters to other manufacturers).1 FDA further noted that it “has received medical device reports consistent with the danger to health posed by your device[s,] . . . including reports involving
ruptured tympanic membranes and burns.” FDA Warning Letter
(J.A. 43). The letters advised the appellants to “take prompt
action to correct [the identified] deviations” from the Food,
Drug, and Cosmetic Act (FDCA). Id. (citing, inter alia, 21
U.S.C. §§ 321(h), 351(f)(1)(B), 352(a), 352(f)(1), 352(j)). They
also “request[ed]” that the appellants cease marketing,
promoting, and distributing ear candles and “correct the
problem,” and warned that “[f]ailure to promptly correct these
deviations may result in regulatory action.” Id....The company never responded and never submitted the information required to seek approval or clearance for its ear candles....
Click to expand...
 
It probably does relieve these symptoms for a short while, because the person is suddenly more concerned that their hair is on fire.
 
You must log in or register to reply here.

Back
Top Bottom