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08-10-2010, 11:11 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.
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.