WARNING LETTER

Vital Health & Wellness MARCS-CMS 618743 — February 17, 2022

Delivery Method:: VIA UNITED PARCEL SERVICE
Product:: Food & Beverages

Recipient:: Recipient Name

Christopher A. Williamson; Recipient Title

Owner; Vital Health & Wellness; 800 Industrial Park Dr.
Trenton, TN 38382
United States

Issuing Office:: Office of Human and Animal Foods Operations-East V; United States

WARNING LETTER 618743

February 17, 2022

Dear Mr. Williamson:

The U.S. Food and Drug Administration (FDA) inspected your tea processing facility, located at 800 Industrial Park Dr., Trenton, TN 38382 on August 23 and 30, 2021. During the inspection, FDA investigators collected your label for the product Vi-tal Health & Wellness brand Dr. Miller’s Holistic Premium Holy Tea. FDA also reviewed your website at www.vitalhealthandwellness.net in November 2021 and February 2022 and determined that you take orders there for your Vi-tal Health & Wellness brand Dr. Miller’s Holistic Premium Holy Tea. The claims on your website and product label establish that your Vi-tal Health & Wellness brand Dr. Miller’s Holistic Premium Holy Tea is a drug 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 it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.

An example on your product label of some of the claims that provide evidence that your product is intended for use as a drug include:

• “MAY BE BENEFICIAL FOR:… ACID REFLUX…HIGH BLOOD PRESSURE”

Examples of some of the claims on your website’s “Ingredients” page that provide evidence that your product is intended for use as a drug include (the “Ingredients” page identifies Holy Thistle, Persimmon leaves, Malva leaves, Marsh Mallow leaves, Blessed Thistle, Papaya, Ginger and Chamomile as ingredients in Vi-tal Health & Wellness brand Dr. Miller’s Holistic Premium Holy Tea):

• Persimmon leaves
o “ . . . Persimmon leaves have anti-hypertensive, anti-carcinogenic, and anti-mutagen properties.”
o “The [persimmon] leaf … is anti hemorrhagic (stops bleeding), is an effective remedy for hemorrhoids, and strengthens weak blood vessels such as spider veins or varicose veins.”
• Holy thistle
o “Holy thistle has been used medicinally for over 2000 years, most commonly for the treatment of liver disorders such as jaundice, and gallbladder disorders; but also for lactation problems, disorders of the spleen, psoriasis, and mushroom poisoning.”
o “[Holy thistle] has recently been used by HIV-positive patients to protect the liver from diseases such as hepatitis and damage from the drugs taken for HIV or AIDS. . . . Silymarin[, a flavonoid in holy thistle,] has also been shown to regenerate injured liver cells.”
o “Holy Thistle products are popular in Europe and the United States for various types of liver disease, being able to counteract the harmful actions of alcohol on the liver (cirrhosis), and helping the liver return to a healthy state when an alcoholic stops drinking. Some clinical trials indicate that it may improve quality of life and even increase life expectancy in patients with cirrhosis of the liver.”
o “ . . . [D]rinking a cup of Holy Thistle tea twice a day can cure chronic headaches. It is also used for…constipation relief. It is very effective for dropsy….”
• Malva leaves
o “Malva Leaf teas are used in the treatment of renal disorders… and diarrhea. Malva Leaf has been used to treat stomachache, gastroenteritis, irritable bowel, and conditions of the spleen.”
• Marshmallow leaves
o “ . . . Marsh Mallow swells up and becomes slick when it is exposed to fluids. The resulting slippery material coats the linings of the mouth, throat, and stomach to relieve irritation and control coughing associated with respiratory conditions such as smoker’s cough.”
o “ . . . Marsh Mallow has been used to treat sore throats and to alleviate heartburn...”
o “ . . . Marsh Mallow is listed for gastroenteritis, peptic and duodenal ulcers, colitis, and enteritis.”
• Blessed thistle
o “It was cultivated in monastery gardens as a cure for smallpox . . ..”
o “Blessed Thistle has been used for smallpox, malaria, fever, anorexia, dyspepsia, indigestion, constipation, and flatulence.”
o “More recently it has shown to be useful for indigestion, heartburn . . . . Blessed Thistle helps increase appetite in people with digestion or eating disorders such as anorexia . . . .”
o “In herbal medicine, Blessed Thistle is used for cancer, infections, inflammation, gallbladder disease, jaundice, liver disorders, cervical dysplasia, heart ailments, skin ulcers, yeast infections, and diarrhea.”
• Papaya
o “It is rich in Anti-oxidants, the B vitamins, folate and pantothenic acid; and the minerals potassium and magnesium, and fiber. Together, ‘these nutrients…provide protection against colon cancer.’”
o “ . . . [P]apaya contains the digestive enzyme, papain, which is used…to treat…allergies.”
o “Papaya may therefore be a healthy fruit choice for preventing such illnesses as recurrent ear infections, colds, and flu.”
• Ginger
o “For over two thousand years Chinese Medicine has recommended ginger to treat a number of health problems including … coughing, vomiting, diarrhea, and rheumatism.”
o “Ginger is also used in the Ayurvedic and Tibetan systems of medicine for the treatment of inflammatory joint diseases such as arthritis, rheumatism . . . .”
o “Ginger may also ease sore throats, headaches, ulcerative colitis, some types of arthritis pain, and fevers and aches caused by colds and flu.”
• Chamomile
o “This bittersweet herb acts medicinally as an anodyne, anti-inflammatory, antibacterial, anti-allergenic, and sedative.”
o “Chamomile tea can be used to treat … gastrointestinal spasms, inflammatory disease of the gastrointestinal tract, and to treat coughs and colds, fevers and bronchitis.”
o “Chamomile’s mildly sedating and muscle-relaxing effects can help those who suffer from insomnia . . . . ”
o “Chamomile helps to relieve nausea, heartburn . . . . It may also be useful in the treatment of diverticular disorders and inflammatory bowel conditions such as Crohn’s disease.”

Examples of some of the claims on your website’s “TEA AND CANCER PREVENTION – NATIONAL CANCER INSTITUTE” page that provide evidence that your product is intended for use as a drug include:

• “More than 50 epidemiologic studies of the association between tea consumption and cancer risk have been published since 2006. The results of these studies have often been inconsistent, but some have linked tea consumption to reduced risks of cancers of the colon, breast, ovary, prostate, and lung. Green tea contains substances called polyphenols, which scientists think contribute to its anti-cancer activity. Laboratory studies of one polyphenol, catechin epigallocatechin-3-gallate (EGCG), show that it may interfere with several of the processes involved in cell replication, causing tumor cell death (apoptosis). Aug 16, 2017”

Your product Vi-tal Health & Wellness brand Dr. Miller’s Holistic Premium Holy Tea is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” 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 product Vi-tal Health & Wellness brand Dr. Miller’s Holistic Premium Holy Tea is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purpose. Accordingly, Vi-tal Health & Wellness brand Dr. Miller’s Holistic Premium Holy Tea fails to bear adequate directions for its intended use and, therefore, the product is 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 this misbranded drug 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 reply should be addressed to the U.S. Food and Drug Administration; Attn: Christopher N. Dedeaux, Compliance Officer, via email at ORAHAFEAST5FirmResponses@fda.hhs.gov or at 404 BNA Drive, Suite 500, Nashville, TN 37217. You may reach Mr. Dedeaux at 504-846-6122 or via email at Christopher.Dedeaux@fda.hhs.gov if you have any questions about this matter.

Sincerely,
/S/

Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East