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WARNING LETTER

July 23, 2021

RE: CMS CASE # 613942

Dear Nicholas P. Gerstner:

This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.teataze.com in March -April 2021 and has determined that you take orders there for the products 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 teas. We have also reviewed your social media website at https://www.facebook.com/teatazetea, which directs consumers to your website www.teataze.com to purchase your products. In addition, we observed that your Clean Green Energy Detox tea is intended to mitigate, prevent, treat, diagnose, or cure COVID-19¹ in people. The claims on your websites establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:

On your website www.teataze.com:

Organic Blueberry White & Green tea:

In the Blog Post: Your Complete Guide to Organic Blueberry White & Green Tea
• “The Healing Benefits of Organic Blueberry White & Green Tea . . . Let’s take a more scientific look at the curative ingredients found in our Organic Blueberry White & Green Tea”
• Under the Heading – “Organic white and green tea health benefits”
    • “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”
• Under the Heading – “Organic blueberries are known to:”
    • “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”
• Under the Heading – “Organic spearmint is excellent the following:”
    • “Fighting infection . . .”
    • “Lowering blood sugar levels”
    • “Relieving sinusitis and congestion”
• Under the Heading – “Organic Lavender”
    • “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.”

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]ur blend includes:”
    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.”

Caffeine-Free Herbal Energy tea, also referenced as Fresh Energy Herbal tea²:

In the Blog Post: Boosting Your Immune System With Tea, Part 2
• “Fresh Energy Herbal … ingredients:”
    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 your 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 your 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 your social media site, https://www.facebook.com/teatazetea, in a February 12 post with a graphic titled “TOP 10 TEA TYPES”:
• “GREEN…treat…allergies”

Your 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)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your 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 intended for treatment or prevention of one or more diseases that are not amenable to self-diagnosis, treatment, or prevention without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your 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 teas fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your response should be sent to U.S. Food and Drug Administration, Attention: Andrew A. Hoopes, Compliance Officer, 8050 Marshall Drive, Suite 205, Lenexa, KS 66214. If you have questions regarding this letter, please contact Compliance Officer Hoopes at (515) 244-0480 ext. 1002 or via e-mail at: andrew.hoopes@fda.hhs.gov.

Sincerely,
/S/

LaTonya M. Mitchell, Ph.D.
District Director, Kansas City District Office
Program Division Director,
Office of Human and Animal Food Operations,
West Division II

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1 There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx. In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19. Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described below, you sell a product that is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. We request that you take immediate action to cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.

2 For example, references to “Fresh Energy Herbal” hyperlink to the Caffeine-Free Herbal Energy tea product page on your website.