It was with great resentment that I read about the warning letter the FDA issued recently to Rishi Tea.  The FDA takes the position that Rishi’s website “claims establish these products (tea) as drugs because they were described as intended for use in the cure, mitigation, treatment or prevention of disease.”  They then give examples of statements they believe present tea as a drug:

  1. “The powerful antioxidants found in tea are believed to help prevent cancer (and) lower cholesterol …”
  2. “Recent research suggests that consuming 5-8 cups of Pu-erh Tea each day can reduce cholesterol and plaque of the arteries.”
  3. “Oolong tea is … prized for its cholesterol reducing …”

http://www.flickr.com/photos/crystalflickr/414597272/The FDA goes on to say that oolong tea, ginger, organic botanicals, green tea, 100% premium tea leaf powder, and pu-erh tea products are not GRAS (generally recognized as safe) for the marketed uses claimed on Rishi’s website and are considered “new drugs” under Section 201(p) of the Act. 21 U.S.C. 321 (p). 

I find this absolutely incomprehensible and outrageous.  The FDA believes ginger, which has been used by indigenous peoples for thousands of years, is a “new drug” and not “generally recognized as safe,” and that green tea, which also has been consumed for thousands of years, is not recognized as safe.  The FDA also chooses to dismiss countless research articles that have appeared in hundreds of respected American journals over the last 20 years that conclude that tea is not harmful in any way and most likely extremely beneficial to people for its antioxidant richness and ability to impact many organ systems in the body in a positive and healthy way.  

An article published in the May 15, 2011 issue of the New York Times entitled “Food With Benefits, or So They Say” addresses the issues associated with the labeling of food.  The author points out how big companies like Quaker Oats, Dannon, Kellogg, and General Mills take advantage of marketing to get their customers to purchase their food.  For example, Kellogg had a TV ad which stated “a clinical study showed kids who had a filling breakfast of Frosted Mini-Wheats cereal improved their attentiveness by nearly 20 percent.”  This was shown to be “deceptive,” as the commissioned study compared children who ate Frosted Mini-Wheats for breakfast with children who had only water for breakfast.”  The FTC (Federal Trade Commission) “prohibited Kellogg from making claims about any health benefit of any food again, unless they are backed by rigorous science and are not misleading.”  I believe Rishi’s website is not in any way misleading, nor does it make claims that aren’t back by scientific research.

Why don’t we take a look at the FDA to see what they’re up to and where their allegiance lies?  I always thought of the FDA as our watchdog for health, established to protect the American people from potentially dangerous drugs.  The truth is that over 100,000 people die each year from prescription drugs that are taken according to doctors’ orders because of “side effects.”  ALL prescription drugs have side effects – yes, I said ALL and that includes over-the-counter medications as well.  A simple aspirin can cause microscopic amounts of gastrointestinal bleeding.  So we’re talking about one person dying every five minutes, each and every day, as a result of the side effects of FDA-approved medication.  That’s 270 people a day, taking a drug that the FDA has deemed safe.  This number doesn’t even include the additional thousands of people who die from errors made by doctors, nurses, and pharmasists.  To put this into perspective, this number is more than two times the number of people who die in automobile accidents each year.  But ginger or tea – no – they’re just not ready to say that they’re “safe.”  According to the FDA, there just isn’t enough research to prove their safety.  If this wasn’t so pathetic, it would almost be funny.  So that’s what the FDA is doing to protect us.  Even the National Institute of Health believes that tea is safe and makes this statement on their website.

Although “tea as a food item is generally recognized as safe by the U.S. Food and Drug Administration,” it’s the perception of tea as a “drug” that allows the FDA to sanction Rishi.  How does this happen, you may be wondering?  It all comes down to money.  The pharmaceutical industry spends hundreds of MILLIONS of dollars courting physicians each year.  Doctors are no longer independent gate keepers who protect us from unnecessary drugs.  In fact, drug companies actually pay doctors to sit on their corporate advisory boards and give lectures to other doctors about the benefits of their drugs.  They also pay for up to 80% of continuing education requirements that doctors must meet in order to maintain their licenses.  This clearly ties most doctors financially to the drug companies.  Essentially, they write prescriptions that their financial backers have taught them to write.  To say this represents a flagrant conflict of interest is perhaps an understatement.  When my son-in-law was attending medical school five years ago, I saw that the drug companies started courting doctors very early.  They provided a free lunch to medical students each week, along with other “free” goodies (my son-in-law always brought a bag lunch to these events and never took any of the free stuff).  

http://www.flickr.com/photos/charlesonflickr/3926259585/Another issue that the FDA is involved in is genetically modifed (GMO) foods.  Enter agribusinesses and their vast lobbying powers.  The FDA has given such foods their seal of approval at our expense and has allowed Americans to become guinea pigs in the evolution of GMO foods in our food chain.  The European Union has deemed GMO foods to be too risky, both for personal health and the environment’s.  We are the only first-world country that allows GMO products in the food supply.  And companies don’t even have to inform us that the food we’re eating has been genetically modified! 

So what do we do?  I know I’ve wandered quite far from my original discussion of Rishi Tea, so let’s get back to that.  One option would be for the tea industry to finance a lobbyist to influence the FDA’s attitude toward tea.  That’s the way the game is played apparently.  To go up against the lobbyist for the pharmaceutical companies and the AMA will not be an easy task.  Perhaps a more creative alternative can be explored.  Until the tea industry as a whole can work together to place reasonable pressure on the FDA, I fear nothing will change.  Despite nationally recognized physicians, such as Drs. Mehmet Oz and Andrew Weil, singing the praises of tea for years, the FDA remains steadfast in its denial of the health benefits of tea.  I wonder if a class action suit against the FDA might create a stir sufficient to impact its attitudes – are there any attorneys who might like to comment?

I had the opportunity to speak with Joe Simrany, the President of the U.S. Tea Association, and ask him his opinion about the Rishi letter.  Joe was unaware of the letter, as Rishi is apparently not a member of the Association.  As this issue affects everyone in the tea industry, he did ask me to forward the letter to him.  It appears that Joe has a relationship with the FDA, as he said he speaks with them regularly and had a different attitude about them than I do.  He believes the FDA is “going above and beyond what they’re doing with the tea industry.”  When I pointed out the health claims issue that was addressed in the warning letter, he concluded that the FDA “has zero tolerance for health claims. They fly by the letter of the law rather than the spirit of the law.”  When I pointed out that they stated that tea did not meet the criteria for being GRAS (generally recognized as safe), he felt they had gone too far.  “I don’t know where they’re coming from.  It flies in the face of information we have.”  Again, the FDA warning related to tea being defined as a “new drug,” which allowed the FDA to take a position on tea that is different from their position on tea when viewed as a food. 

Obviously, the FDA needs to make a clear distinction between food and drugs.  Issues related to the development of drugs require significant vigilance.  I consider 100,000 annual deaths from side effects to be an unacceptable statistic and would recommend more thorough testing of drugs for chronic illnesses.  When it comes to foods, however, the requirements should be quite different.  I believe tea has proven itself to be free from harm and, in fact, contributing to health.  I understand the European Union is currently assessing the criteria for food safety and health claims.  From what I’m able to glean, as long as a food has been researched with accompaning published studies that appear in recognized journals, they will allow corresponding health claims to be made without the need for double blind, placebo-controlled studies. 

I did reach out to Rishi in the hopes of getting their feedback on this issue.  Unfortunately, I wasn’t given the opportunity to speak with the owners.  Their spokesperson concluded that the issue at hand relates to the need to test each batch of tea before specific claims can be made.  This would be financially prohibitive for anyone other than a Lipton or a Bigelow.  However, I believe the future of tea in the U.S. is in the Rishi Tea companies of America.  These artisan tea makers have created a revolution in the tea industry that continues to show unprecedented growth, despite the bleak economic outlook.

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