As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems. The FDA frequently redacts parts of warning letters posted for public view.
TeaTaze LLC
Wichita, KS
An online tea company in Kansas is on notice from the FDA for claims made about its tea’s ability to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.
In a July 23 warning letter, the FDA described a review made of TeaTaze LLC website as well as the company’s Facebook page in March and April 2021.
The FDA’s inspection revealed that the firm made claims on their websites that the products are not foods, but rather drugs under section 201 of the Federal Food, Drug, and Cosmetic Act because they are intended for use in the cure, mitigation, treatment, or prevention of disease. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA. The FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
Examples of some of the website claims that provide evidence that the products are intended for use as drugs include:
On the firm’s website www.teataze.com:
Clean Green Energy Detox tea:
In the Blog Post: Boosting Your Immune System With Tea, Part 1:
- “Your immune system is your best weapon against many kinds of illnesses, from common colds and flu to longer-term conditions like heart disease, diabetes, and cancer. Although no one is impervious to illnesses–especially new viruses, like COVID-19–having a strong immune system can make it less likely to get sick and it can help you bounce back more quickly when you do…. our teas are chock-full of powerhouse ingredients, many of which are natural immunity boosters. In this blog post . . . we’re going to highlight one of our tea blends . . . . Our Clean Green Energy Detox blend is one of the most effective teas we offer in terms of helping you fight off disease.”
o “Matcha, which is packed with… other sickness-fighting vitamins and minerals”
o “Dandelion…practitioners of traditional Chinese medicine frequently prescribe it to cancer patients”
o “Sage…. The polyphenols found in sage are linked to healthier blood sugar, along with lower risk of cancer . . . .”
o “Nettle, a plant that’s been shown exciting potential in fighting prostate cancer and breast cancer”
- “As you can see, Clean Green Energy Detox not only helps with immediate concerns like fighting viruses, it’s an important immunity booster in general, aiding you in staving off chronic health conditions down the road.”
Organic Blueberry White & Green tea:
In the Blog Post: Your Complete Guide to Organic Blueberry White & Green Tea
- “Catechins and tannins — these are a form of polyphenols/flavonoids which are micronutrieints found within the tea, enriched with cancer-fighting antioxidants . . . .”
- “Theanine — an amino acid present in the tea that … is commonly known to treat anxiety . . . .”
- “Vitamin E — used to fight infections”
- “Reduce the “bad” LDL cholesterol”
- “Reduce blood pressure and hypertension”
- “Reduce the development of heart disease”
- “Anthocyanins in blueberries may have diabetes preventing effects”
- “Reduces urinary tract infections”
- “Fighting infection . . .”
- “Lowering blood sugar levels”
- “Relieving sinusitis and congestion”
- “Improves mood disorders such as anxiety, . . . and depression”
Ignited Oolong Slimming tea:
In the Blog Post: Ignited Oolong Tea: Ingredients and their benefits
- “Wanting ingredients that help relieve symptoms and prevent disease? Then our Ignited Oolong blend is just the ticket. In this post, we’re sharing just a few of the ways that the ingredients of our Ignited Oolong Slimming have been shown to be able to help you . . . .”
- “Oolong tea has also been found to lower cholesterol, decrease hardening and narrowing of arteries . . . .”
- “[A]ntioxidants in oolong can help decrease the risk of certain types of cancers, prevent diabetes, calm chronic inflammation (thus relieving symptoms of inflammatory conditions) . . . .”
- “Dandelion Root…moderates blood pressure…helps regulate blood sugar and stimulate insulin production . . . .”
- “Marshmallow Root…Packed with…anti-inflammatory compounds . . . .”
- “Cinnamon…can help reduce the risk of heart disease, lower insulin resistance, and improve fasting blood sugar levels.”
- “Fennel Seed…great for regulating blood pressure…reduce constipation…reduce inflammation in the lungs and sinuses, leading to improvement in allergy symptoms.”
- “Nettle… powerful anti-inflammatory agent, which may also lower blood pressure and help reduce allergy and hay fever symptoms.”
Caffeine-Free Herbal Energy tea, also referenced as Fresh Energy Herbal tea2:
In the Blog Post: Boosting Your Immune System With Tea, Part 2
o “Gotu kola…relieve anxiety and depression . . . ”
o “Ginkgo biloba also reduces inflammation . . .”
o “Clove… has been shown to be toxic to certain types of cancer cells…”
o “Ginger, packed with anti-inflammatory properties, has been shown to…relieve cold and flu-like symptoms”
o “Honeybush…its antibacterial…properties”
o “Fenugreek, which has been shown to regulate blood pressure and cholesterol, and can reduce the risk of diabetes”
o “Hibiscus, a proven blood-pressure reducer with antibiotic properties”
Power Puer Aged tea (which, according to the firm’s website, includes Nan Nuo Puer Tea as an ingredient):
In the Blog Post: Health Benefits of Tea:
- “Puehr tea… its power-packed compounds have been shown to reduce cholesterol…it’s a popular hangover cure in China!”
Silver Tranquility White tea (which, according to the firm’s website, includes white tea as an ingredient):
In the Blog Post: Health Benefits of Tea:
- “White tea… is filled with health benefits, including anti-viral… properties. The catechins found in white tea have also been shown to lower blood pressure and cholesterol, as well as slow the growth of bacteria that causes pneumonia and other infections.”
Organic Blueberry White & Green, Clean Green Energy Detox, Tokusen Hinshucha Fuji Midori Green, and Vibrant Green teas (which, according to your website, includes green tea as an ingredient):
In the Blog Post: Health Benefits of Tea:
- “Green tea contains catechins, which can fight viruses, lower blood pressure and cholesterol, inhibit cancer growth, and even prevent cavities!”
On the firm’s social media site, https://www.facebook.com/teatazetea, in a Feb. 12 post with a graphic titled “TOP 10 TEA TYPES”:
- “GREEN…treat…allergies”
The firm’s Organic Blueberry White & Green, Clean Green Energy Detox, Tokusen Hinshucha Fuji Midori Green, Vibrant Green, Caffeine-Free Herbal Energy, Ignited Oolong Slimming, Power Puer Aged, and Silver Tranquility White tea products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)].
The full warning letter can be viewed here.
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