September 23, 2010

FDA Warning Letter to Lipton's: Green Tea is a Drug and Lipton's is in Violation of Federal Law. Wow.

I buy Lipton Green Tea 100% Natural Naturally Decaffeinated - I bet you do, too. It's the little yellow and green box, and sometimes the price is right. Who knew I was buying a drug from a criminal?

However, that's apparently the case, because in August 2010, the FDA sent an official warning letter to Unilever, Inc., the company that provides us all with Lipton Green Tea 100% Natural Naturally Decaffeinated - and the letter's online for us all to read at the FDA website.

Here's some juicy tidbits for you:

"Based on our review, we have concluded that this product is in violation of the Federal Food, Drug, and Cosmetic Act (the Act) ...

"Your website, www.liptont.com. also promotes your Lipton Green Tea 100% Natural Naturally Decaffeinated product for conditions that cause it to be a drug under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)].

"For example, your webpage entitled "Tea and Health," subtitled "Heart Health Research" and further subtitled "Cholesterol Research" bears the following claim: "[F]our recent studies in people at risk for coronary disease have shown a significant cholesterol lowering effect from tea or tea flavonoids ... One of these studies, on post-menopausal women, found that total cholesterol was lowered by 8% after drinking 8 cups of green tea daily for 12 weeks ...."

"The therapeutic claims on your website establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. Your Lipton Green Tea 100% Natural Naturally Decaffeinated product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

"Your Lipton Green Tea 100% Natural Naturally Decaffeinated product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended purposes. Thus, your Lipton Green Tea 100% Natural Naturally Decaffeinated product is misbranded under section 502(f)(1) of the Act in that the labeling for this drug fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)] ."


I could add more, but you're more than able to go read the whole thing for yourself.

As for me, Lipton's Decaf Green Tea may not be my preferred brand, but you can bet I'm gonna be buying an extra box or two -- just because this FDA action makes me mad.

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