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huge285
08-11-2010, 12:11 AM
'Tiger Balm' Gives FDA Officials Headaches




Katie Drummond (http://forums.rxmuscle.com/team/katie-drummond) Contributor
AOL News Surge Desk


(Aug. 10) -- Tiger Balm's (http://www.tigerbalm.com/) "secret herbal formulation" has hit a sore spot among regulators with the Food and Drug Administration (http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm221006.htm), which today released a warning letter to the ointment's maker for improper labeling, testing and manufacturing standards.

Haw Par Corp. Ltd. (http://www.hawpar.com/), which produces the line of balms initially crafted (or so legend has it) by Burmese herbalist Aw Chu Kin in the 1870s, has expanded the balms into sprays, plasters, creams and oils to treat everything from mosquito bites to migraines. As the company website touts the famous product:
Tried, tested and trusted by generations of users, you can rely on Tiger Balm's unique and proven herbal formulation to ease your aches and pains and for your optimal well-being. Be it headaches, rheumatic or arthritic pains, muscle strains and sprains, Tiger Balm has just the pain relief remedy for you.
But that remedy might not be available to American consumers for long. First up on the FDA's lengthy list of quibbles with Haw Par: The company's Tiger Balm patch technically "qualifies as a drug" and therefore can't be sold over the counter without FDA mandate.

Not to mention that its label suggests "a novel delivery system" not yet encountered by FDA officials.

"The label for Tiger Balm includes the additional statement, 'its ingredients penetrate the skin and are absorbed, thus stimulating blood circulation around the area of pain,' " the FDA's letter reads. "We are not aware of any OTC product formulated and labeled like Tiger Balm having been available in the U.S. market."

Not to mention the reported mess that is Haw Par's Singapore-based manufacturing plants, where employees don't speak the language used in instruction manuals, lab tests are incomplete or performed incorrectly and little quality-control oversight has been instituted.

"Your firm has not established scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity," the FDA letter reads.

What would Aw Chu say? Probably that the FDA ought to lighten up. After all, Kin and Co. used actual tiger bones for initial versions of the product. The balm now consists mostly of menthol, camphor and essential oils.

rhino1012
08-11-2010, 04:43 PM
'Tiger Balm' Gives FDA Officials Headaches




Katie Drummond (http://forums.rxmuscle.com/team/katie-drummond) Contributor
AOL News Surge Desk


(Aug. 10) -- Tiger Balm's (http://www.tigerbalm.com/) "secret herbal formulation" has hit a sore spot among regulators with the Food and Drug Administration (http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm221006.htm), which today released a warning letter to the ointment's maker for improper labeling, testing and manufacturing standards.

Haw Par Corp. Ltd. (http://www.hawpar.com/), which produces the line of balms initially crafted (or so legend has it) by Burmese herbalist Aw Chu Kin in the 1870s, has expanded the balms into sprays, plasters, creams and oils to treat everything from mosquito bites to migraines. As the company website touts the famous product:

Tried, tested and trusted by generations of users, you can rely on Tiger Balm's unique and proven herbal formulation to ease your aches and pains and for your optimal well-being. Be it headaches, rheumatic or arthritic pains, muscle strains and sprains, Tiger Balm has just the pain relief remedy for you.
But that remedy might not be available to American consumers for long. First up on the FDA's lengthy list of quibbles with Haw Par: The company's Tiger Balm patch technically "qualifies as a drug" and therefore can't be sold over the counter without FDA mandate.

Not to mention that its label suggests "a novel delivery system" not yet encountered by FDA officials.

"The label for Tiger Balm includes the additional statement, 'its ingredients penetrate the skin and are absorbed, thus stimulating blood circulation around the area of pain,' " the FDA's letter reads. "We are not aware of any OTC product formulated and labeled like Tiger Balm having been available in the U.S. market."

Not to mention the reported mess that is Haw Par's Singapore-based manufacturing plants, where employees don't speak the language used in instruction manuals, lab tests are incomplete or performed incorrectly and little quality-control oversight has been instituted.

"Your firm has not established scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity," the FDA letter reads.

What would Aw Chu say? Probably that the FDA ought to lighten up. After all, Kin and Co. used actual tiger bones for initial versions of the product. The balm now consists mostly of menthol, camphor and essential oils.
I'm glad the FDA is really going after them. Its about time. I'm tired of all these Tiger Balm over doses i have been hearing about. :confused:

Sean Katterle
08-11-2010, 05:19 PM
I just know that, after applying Tiger Balm, ya gotta wash your hands with dishwashing soap or else you're gonna be singing Johnny Cash's "Burning Ring o' Fire" after you hold your ding dong to take a leak.

Tre
08-11-2010, 05:28 PM
Although Tiger Balm is great, I've always been partial to Cramergesic's 'Atomic Balm'.

Ibarramedia
08-11-2010, 06:07 PM
Tiger Balm is just like Bengay

GREENMACHINE23
08-11-2010, 06:36 PM
Tiger Balm got me through the worst back pain in my life while traveling on the road for 16 hours and the weekend that followed. Before I left my house to go on my road trip, I could barely get down the stairs I was in so much pain.
Tiger Balm is a quality product.

rcp1936
08-11-2010, 06:54 PM
Although Tiger Balm is great, I've always been partial to Cramergesic's 'Atomic Balm'.
I used that on a hamstring I tore running the hurdles in HS back in 54
Didn't do diddly --rest did

ODINSOWN
08-11-2010, 07:12 PM
Hands off my Tiger Balm, I remember in the day the gym stinking of that stuff, I love it.

v1hyp
08-11-2010, 07:30 PM
Great stuff!, would be nice if it came in a roll on or sponge app

Sledge
08-11-2010, 08:43 PM
Oh the humanity, think of the tigers.