The FDA & Tea

The FDA & Tea

The first most obvious resource for researching health concerns regarding the Tea Industry, as a citizen of the USA, is the FDA.

Searching FDA records for "tea" turns up a lot, here is a quick overview.

First up, a little history:

Milestones in U.S. Food and Drug Law History

In 1202, King John of England proclaimed the first English food law, the Assize of Bread, which prohibited adulteration of bread with such ingredients as ground peas or beans.

In the USA,

Federal controls over the drug supply began with inspection of imported drugs in 1848, although the first federal biologics law, which addressed the provision of reliable smallpox vaccine to citizens, was passed in 1813.

The sixth entry in this long article is...

Tea Importation Act passed, providing for Customs inspection of all tea entering U.S. ports, at the expense of the importers.

That was back in the day when Tea was one of the most important imports to the USA.
More recently, in 1996...

Federal Tea Tasters Repeal Act repeals the Tea Importation Act of 1897 to eliminate the Board of Tea Experts and user fees for FDA's testing of all imported tea. Tea itself is still regulated by FDA.

And, that pretty much sums it up...
Tea is a generally safe food product.
Especially when compared to, for example - peanuts, soy, meat, or shellfish!

Let's see what else they have to say!

How Much Caffeine is Too Much?

According to scientists at the FDA, caffeine can be part of a healthy diet for most people, but too much caffeine may pose a danger to your health. Depending on factors such as body weight, medications you may take, and individual sensitivity, “too much” can vary from person to person.
...decaf coffee typically has 2-15 milligrams in an 8-ounce cup. If you react strongly to caffeine in a negative way, you may want to avoid these beverages altogether.

But, 400 milligrams a day is probably safe for a healthy adult.

The FDA estimates toxic effects, like seizures, can be observed with rapid consumption of around 1,200 milligrams of caffeine, or 0.15 tablespoons of pure caffeine.
In addition, if you’re pregnant, trying to become pregnant, or breastfeeding, or are concerned about another condition or medication, we recommend talking to your health care provider about whether you need to limit caffeine consumption.
The FDA has not set a level for children, but the American Academy of Pediatrics discourages the consumption of caffeine and other stimulants by children and adolescents.
Typically, it can take 4 to 6 hours for your body to metabolize half of what you consumed.

This, the most serious risk associated with pure tea, of overdosing on Caffeine is Extremely Low.

Advisory Letters

The most prominent issue with FDA and tea revolve around merchant health claims and not the product itself.

Products Illegally Marketed for Serious Diseases recommends or suggests the use of Qing Yun Moyeam Tea.. to treat or prevent cancer, COPD, diabetes, heart attacks, hypercholesterolemia, alcoholic liver cirrhosis, and Alzheimer’s. As explained further below, the introduction of these products into interstate commerce for such uses violates the Federal Food, Drug, and Cosmetic Act.

Letter of Denial - Green Tea and Reduced Risk of Cardiovascular Disease (Docket No. 2005Q-0297)

FDA concludes that there is no credible evidence to support qualified health claims for green tea or green tea extract and a reduction of a number of risk factors associated with CVD.

This next letter is now referenced quite often as establishing one of the most important precidents the FDA has offered with regards tea.

Letter Responding to... Green Tea and Reduced Risk of Cancer Health Claim (Docket number FDA-2004-Q-0427)

Based on FDA’s consideration of the scientific evidence and other information submitted with your petition, and other pertinent scientific evidence and information, FDA concludes that there is no credible evidence to support qualified health claims for green tea consumption and a reduced risk of gastric, lung, colon/rectal, esophageal, pancreatic, ovarian, and combined cancers. Thus, FDA is denying those claims.
However, FDA concludes that there is very little credible evidence for a qualified health claim specifically for green tea and risk of breast or prostate cancer. To avoid misleading consumers, this claim must be accompanied by disclaimer language. Therefore, FDA intends to consider exercising enforcement discretion for the following qualified health claim with the accompanying disclaimer:
Drinking green tea may reduce the risk of breast or prostate cancer. FDA does not agree that green tea may reduce that risk because there is very little scientific evidence for the claim.

You can make a qualified health claim, but that doesn't sound very convincing... so, just don't make health claims!

Generally Recognized As Safe (GRAS)

Since Tea has compounds which are often regarded as being beneficial to one's health, a lot of the FDA notices about tea are GRAS Notices for products including tea.

Examples include,

In accordance with... hereby informs the United States Food and Drug Administration... that the intended use of Oil­Soluble Green Tea Extract... as an antioxidant in various food products is Generally Recognized as Safe (GRAS), based on scientific procedures.


“Pharmacokinetics and safety of green tea polyphenols after multiple-dose administration of epigallocatechin gallateand polyphenonE in healthy individuals.”
• Conclusion: oral administration of EGCG or PolyphenonE at a daily dose of 800 mg (based on the EGCG content) for 4 weeks is safe and well tolerated in healthy human subjects

Even if tea and tea extract are GRAS, adding stuff to tea and adding extract to other products can be a dangerous practice which can easily run afoul FDA Labling Requirements!

2018 Recalls, Market Withdrawals & Safety Alerts

07/27/2018             TeaSource             Loose Leaf Tea             Food & Beverages, Allergens, Coffee/Tea , Food & Beverage Safety             Undeclared almonds             TeaSource
02/08/2018             Chapis             Bread Crumbs             Food & Beverages, Allergens, Food & Beverage Safety             Undeclared Wheat, Milk, Eggs, Tree Nuts, and, Soybean             Chapis Spice & Tea

A1 Top World Products LLC MARCS-CMS 568321 — April 10, 2019

Your Doctor’s CholesteroRite product label fails to include the part of the plant from which noni, garlic, and green tea are derived;

Adding drug ingredients to tea is highly illegal and will not be tolerated!

Public Notification: Lingzhi Cleansed Slim Tea Contains Hidden Drug Ingredient

FDA laboratory analysis confirmed that Lingzhi Cleansed Slim Tea contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons.

Public Notification: Toxin Discharged Tea Contains Hidden Drug Ingredient

FDA laboratory analysis confirmed that Toxin Discharged Tea contains fluoxetine. Fluoxetine is an FDA approved drug in a class of drugs called selective serotonin reuptake inhibitors (SSRIs) used for treating depression, bulimia, obsessive-compulsive disorder (OCD), panic disorder, and premenstrual dysphonic disorder (PMDD).

Sometimes tea is included in wider studies of food products, such as...

Exploratory Data on Furan in Food

The presence of furan is a potential concern because, based on high-dose animal tests, furan is considered possibly carcinogenic to humans.

This study, for example, showed low levels of Furan in tea.

Gold Peak Tea Lemon Iced Tea             0.8
Campbell's Condensed Soup Classics Vegetarian Vegetable             91.2
Gerber 1st Foods Sweet Potatoes             93.1

And, sometimes these studies can be taken out of context, such as with concerns about radiation.  

FDA Response to the Fukushima Dai-ichi Nuclear Power Facility Incident

As of March 10, 2014, FDA has tested 1,345 import and domestic samples specifically to monitor for Fukushima contamination. Two hundred and twenty-five of these were seafood or seafood products.  Of the 1,345 samples, two were found to contain detectable levels of Cesium, but the levels were well below the established Derived Intervention Level (DIL) and posed no public health concern.
They were:
Ginger Powder (sample no. 686901, collected April 2011)
Green Tea Bag (sample no. 827430, collected August 2013)

This may seem scary, but remember that the levels were well below the established Derived Intervention Level (DIL). Over 50 Teas were tested in that study. Only one of them had even the smallest detectable levels.

Also consider that Fukushima is not a large tea producing region, and that tea probably wasn't even grown there.

So far this all looks very good!
Tea is Safe!

But, there are still two issues that should concern every serious tea drinker...

CPG Sec. 545.450 Pottery (Ceramics); Import and Domestic - Lead Contamination

BACKGROUND:Some ceramic foodwares have been found to leach significant quantities of lead from potential food contact surfaces. The metal is extractable by foods and can cause a wide variety of adverse health effects including the traditional effects of chronic lead poisoning under continued food use.

The results of the Pesticide Residue Monitoring Program get's it's own article.

Summary of Greenpeace Reports on Pesticide Residue in Tea in China and India. (2012-2014)
I belive that this is an issue that deservers our attention now and for the foreseeable future. Not just for our consumer safety, but also to to further our understanding of the effects of our favourite beverage on the environment.

Learn about MRLs and the need to for intergovernmental cooperation.

Read about how we can do better!