FDA warns on-line tea firm about claims of COVID mitigation and different well being advantages

As a part of its enforcement actions, the Meals and Drug Administration sends warning letters to entities underneath its jurisdiction. Some letters should not posted for public view till weeks or months after they’re despatched. Enterprise homeowners have 15 days to answer FDA warning letters. Warning letters usually should not issued till an organization has been given months to years to appropriate issues. The FDA often redacts elements of warning letters posted for public view.

TeaTaze LLC
Wichita, KS

An internet tea firm in Kansas is on discover from the FDA for claims made about its tea’s skill to mitigate, forestall, deal with, diagnose, or remedy COVID-19 in individuals.

In a July 23 warning letter, the FDA described a assessment product of TeaTaze LLC web site in addition to the corporate’s Fb web page in March and April 2021.

The FDA’s inspection revealed that the agency made claims on their web sites that the merchandise should not meals, however fairly medication underneath part 201 of the Federal Meals, Drug, and Beauty Act as a result of they’re supposed to be used within the remedy, mitigation, remedy, or prevention of illness. With sure exceptions not relevant right here, new medication will not be legally launched or delivered for introduction into interstate commerce with out prior approval from the FDA. The FDA approves a brand new drug on the idea of scientific information and data demonstrating that the drug is secure and efficient.

Examples of a number of the web site claims that present proof that the merchandise are supposed to be used as medication embody:

On the agency’s web site www.teataze.com:

Clear Inexperienced Vitality Detox tea:

Within the Weblog Publish: Boosting Your Immune System With Tea, Half 1:

  • “Your immune system is your greatest weapon towards many sorts of diseases, from widespread colds and flu to longer-term circumstances like coronary heart illness, diabetes, and most cancers. Though nobody is impervious to diseases–particularly new viruses, like COVID-19–having a powerful immune system could make it much less prone to get sick and it might enable you to bounce again extra shortly once you do…. our teas are chock-full of powerhouse elements, a lot of that are pure immunity boosters. On this weblog put up . . . we’re going to focus on considered one of our tea blends . . . . Our Clear Inexperienced Vitality Detox mix is likely one of the handiest teas we provide when it comes to serving to you battle off illness.”

    o “Matcha, which is full of… different sickness-fighting nutritional vitamins and minerals”

    o “Dandelion…practitioners of conventional Chinese language drugs often prescribe it to most cancers sufferers”

    o “Sage…. The polyphenols present in sage are linked to more healthy blood sugar, together with decrease threat of most cancers . . . .”

    o “Nettle, a plant that’s been proven thrilling potential in combating prostate most cancers and breast most cancers”

  • “As you may see, Clear Inexperienced Vitality Detox not solely helps with fast considerations like combating viruses, it’s an essential immunity booster normally, aiding you in staving off continual well being circumstances down the street.”

Natural Blueberry White & Inexperienced tea:

Within the Weblog Publish: Your Full Information to Natural Blueberry White & Inexperienced Tea

  • “Catechins and tannins — these are a type of polyphenols/flavonoids that are micronutrieints discovered inside the tea, enriched with cancer-fighting antioxidants . . . .”
  • “Theanine — an amino acid current within the tea that … is usually recognized to deal with nervousness . . . .”
  • “Vitamin E — used to battle infections”
  • “Scale back the “dangerous” LDL ldl cholesterol”
  • “Scale back blood stress and hypertension”
  • “Scale back the event of coronary heart illness”
  • “Anthocyanins in blueberries might have diabetes stopping results”
  • “Reduces urinary tract infections”
  • “Preventing an infection . . .”
  • “Decreasing blood sugar ranges”
  • “Relieving sinusitis and congestion”
  • “Improves temper problems akin to nervousness, . . . and despair”

Ignited Oolong Slimming tea:

Within the Weblog Publish: Ignited Oolong Tea: Substances and their advantages

  • “Wanting elements that assist relieve signs and forestall illness? Then our Ignited Oolong mix is simply the ticket. On this put up, we’re sharing only a few of the ways in which the elements of our Ignited Oolong Slimming have been proven to have the ability to enable you to . . . .”
  • “Oolong tea has additionally been discovered to decrease ldl cholesterol, lower hardening and narrowing of arteries . . . .”
  • “[A]ntioxidants in oolong may also help lower the chance of sure forms of cancers, forestall diabetes, calm continual irritation (thus relieving signs of inflammatory circumstances) . . . .”
  • “Dandelion Root…moderates blood stress…helps regulate blood sugar and stimulate insulin manufacturing . . . .”
  • “Marshmallow Root…Full of…anti-inflammatory compounds . . . .”
  • “Cinnamon…may also help cut back the chance of coronary heart illness, decrease insulin resistance, and enhance fasting blood sugar ranges.”
  • “Fennel Seed…nice for regulating blood stress…cut back constipation…cut back irritation within the lungs and sinuses, resulting in enchancment in allergy signs.”
  • “Nettle… highly effective anti-inflammatory agent, which can additionally decrease blood stress and assist cut back allergy and hay fever signs.”

Caffeine-Free Natural Vitality tea, additionally referenced as Contemporary Vitality Natural tea2:

Within the Weblog Publish: Boosting Your Immune System With Tea, Half 2

    o “Gotu kola…relieve nervousness and despair . . . ”

    o “Ginkgo biloba additionally reduces irritation . . .”

    o “Clove… has been proven to be poisonous to sure forms of most cancers cells…”

    o “Ginger, full of anti-inflammatory properties, has been proven to…relieve chilly and flu-like signs”

    o “Honeybush…its antibacterial…properties”

    o “Fenugreek, which has been proven to control blood stress and ldl cholesterol, and may cut back the chance of diabetes”

    o “Hibiscus, a confirmed blood-pressure reducer with antibiotic properties”

Energy Puer Aged tea (which, in response to the agency’s web site, contains Nan Nuo Puer Tea as an ingredient):

Within the Weblog Publish: Well being Advantages of Tea:

  • “Puehr tea… its power-packed compounds have been proven to scale back ldl cholesterol…it’s a well-liked hangover remedy in China!”

Silver Tranquility White tea (which, in response to the agency’s web site, contains white tea as an ingredient):

Within the Weblog Publish: Well being Advantages of Tea:

  • “White tea… is full of well being advantages, together with anti-viral… properties. The catechins present in white tea have additionally been proven to decrease blood stress and ldl cholesterol, in addition to sluggish the expansion of micro organism that causes pneumonia and different infections.”

Natural Blueberry White & Inexperienced, Clear Inexperienced Vitality Detox, Tokusen Hinshucha Fuji Midori Inexperienced, and Vibrant Inexperienced teas (which, in response to your web site, contains inexperienced tea as an ingredient):

Within the Weblog Publish: Well being Advantages of Tea:

  • “Inexperienced tea accommodates catechins, which may battle viruses, decrease blood stress and ldl cholesterol, inhibit most cancers progress, and even forestall cavities!”

On the agency’s social media website, https://www.fb.com/teatazetea, in a Feb. 12 put up with a graphic titled “TOP 10 TEA TYPES”:

  • “GREEN…deal with…allergy symptoms”

The agency’s Natural Blueberry White & Inexperienced, Clear Inexperienced Vitality Detox, Tokusen Hinshucha Fuji Midori Inexperienced, Vibrant Inexperienced, Caffeine-Free Natural Vitality, Ignited Oolong Slimming, Energy Puer Aged, and Silver Tranquility White tea merchandise should not typically acknowledged as secure and efficient for the above referenced makes use of and, subsequently, the merchandise are “new medication” underneath part 201(p) of the Act [21 U.S.C. 321(p)].

The complete warning letter might be considered right here.

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