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  5. Duncan's Botanical Products, Inc. - 519077 - 05/08/2017
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WARNING LETTER

Duncan's Botanical Products, Inc. MARCS-CMS 519077 —


Delivery Method:
VIA UPS
Product:
Dietary Supplements
Drugs

Recipient:
Recipient Name
Brent W. Duncan
Recipient Title
Owner and President
Duncan's Botanical Products, Inc.

1231 E. Smithville Road
Bloomington, IN 47401
United States

Issuing Office:
Division of Human and Animal Food Operations East VI (HAFE6)

300 River Place
Suite 5900
Detroit, MI 48207
United States

313-393-8100

Dear Mr. Duncan:

 

On December 13, 2016, the U.S. Food and Drug Administration conducted an inspection of your facility located at 1231 E. Smithville Road, Bloomington, Indiana. Additionally, we conducted a review of your website, www.duncansbotanicals.com in April 2017.   Based on our review of your website, we found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations.  You may find the Act and implementing regulations, Title 21, Code of Federal Regulations (21 CFR), through links on our website, www.fda.gov.

 

In April 2017, we reviewed your website at the internet address, www.duncansbotanicals.com, where you take orders for several of your botanical products.  The claims on your website establish that your Bayberry Bark, Black Haw Bark, Butternut Bark, Cramp Bark, Devils Club, Fringe Tree Bark, Prickly Ash Bark (Northern), Prickly Ash Bark (Southern), Slippery Elm Bark, Sumac Tree Bark, White Oak Bark, Wild Cherry Bark, Witch Hazel Bark, Pokeweed Berry Blue Scullcap (TRUE), Bergamot Herb, Boneset, Bugleweed (Herb), Cleavers Herb, Echinacea Herb, Elderberry Flower, Goldenseal, Grindelia Herb, Heal All Herb, Kansas Snake Root Herb, Lobelia Herb, Maypop-Passion Flower, Milk Thistle, Mullein Leaf, Black Walnut Leaf, Dandelion Leaf Powder, Deer Tongue, American Sarsaparilla, Blood Root, Barberry Root, Beth Root, Burdock Root, Ginseng, New Jersey Tea Herb, Pinkroot Herb, Pipsissewa Herb, Queen of the Meadow, Squaw Vine (Green Color), Pleurisy Root, Pokeweed Root, Skunk Cabbage, Stillingia Root, Wild Ginger Root, Echinacea Root, and Cranesbill-Wild Geranium products are drugs under section 201(g)(1)(B) of 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.

 

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

 

  • Bayberry Bark – Myrica cerifera

    “[U]seful in jaundice, diarrhea…”

    “[Useful for inflammation to the throat”

    “[U]ses of the wax are for dysentery and internal ulcers.”

     

  • Black Haw Bark – Viburnum prunifolium

    “[S]pasmolytic, anti-asthmatic, hypotension”

    “[U]sed as a muscle antispasmodic…”

    “[T]reat mumps.”

    “[T]reat high fevers and as a pain reliever”

    “[A]pplied topically for muscle cramps…”

     

  • Butternut Bark – Juglans cinerea

    “[R]heumatic and arthritic joints, dysentery, constipation, wounds and headaches.”

     

  • Cramp Bark – Viburnum opulus

    “[T]o prevent a miscarriage, and decreases false labor pains.”

    “[S]edative along with antispasmodic, reducing general muscle cramps.”

    “[U]se the stem bark to treat mumps.”

     

  • Devils Club – Oplopanax horridus

    “[A]nalgesic, anti-rheumatic…”

     

  • Fringe Tree Bark – Chionanthus virginicus

    “[T]reat liver and gall bladder diseases.”

     

  • Prickly Ash Bark (Northern) - Zanthoxylum americanum

    “[T]reat dry mouth, tooth decay, toxic shock syndrome, relieves … diarrhea, … and typically helps with leg ulcers.”

     

  • Prickly Ash Bark (Southern) - Zanthoxylum clava-herculis

    “Toothaches and mouth pain.”

    “[L]oss of sensation.”

    “[A]nti-rheumatic, anti-spasmodic”

     

  • Slippery Elm Bark – Ulmus rubra

    “Its reliability in treating cancer has not been proved or disproved”

    “It can be applied to wounds, burns, and scalds.”

    “[U]sed to abort fetuses…”

     

  • Sumac Tree Bark – Rhus Glabra

    “[T]reatment of colds, stomach aches and bleeding.”

    “[T]reatment of diarrhea and dysentery.”

    “It can be used externally for skin sores and rashes.”

    “[T]reating late onset of diabetes.”

     

  • White Oak Bark – Quercus alba

    “Commonly used as … antiseptic”

    “[I]nternal bleeding, diarrhea, pain, swelling, external bleeding, hemorrhoids, varicose veins, burns, abrasions, eczema.”

    “[S]hrink varicose veins and help with a common cold.”

     

  • Wild Cherry Bark – Prunus serotine

    “[E]ase labor pains, diarrhea and lung problems.”

    “[D]ysentery, and hemorrhoids.”

    “[U]sed as an anti-tussive, expectorant…”

     

  • Witch Hazel Bark – Hamamelis virginiana

    “[U]sed as … pain relief, and disinfectant.”

    “[P]oultice for swelling and tumors.” 

    “[A]ids in bleeding of the stomach and constipation.”

    “[T]reatment of … sunburned skin, bruises, swellings, rashes and to stop or reduce varicose veins and hemorrhoids…”

     

  • Pokeweed Berry – Phytolacca Americana

    “[A]nti-inflammatory root is given for swollen sore throat glands.”

    “[P]roteins inhibit flu, herpes, and leukemia.”

    “[U]sed to clear mastitis.”

     

  • Blue Scullcap (TRUE) – Scutellaria lateraflora

    [U]sed for digestive problems as well as … mild sedative for the treatment of anxiety, depression, and insomnia.”

     

  • Bergamot Herb - Monarda fistulosa

    “[U]sed to treat a variety of symptoms of colds, chest and throat discomfort, mild digestive complaints, head aches, anxiety, antiseptic, anti-spasmodic…”

    “[A]pplied as a poultice to skin eruptions, cuts…”

     

  • Boneset – Eupatorium perfoliatum

    “[T]reat flu’s, fevers, colds...”

    “[H]elp with gout, arthritis and epilepsy.”

     

  • Bugleweed (Herb) – Lycopus virginicus 

    “[T]reat flu’s, fevers, colds...”

    “[H]elp with gout, arthritis and epilepsy.”

     

  • Cleavers Herb – Galium aparine

    “[A]nti-inflammatory … febrifuge … vulnerary. 

    “[T]reat skin problems such as seborrhea, eczema and psoriasis and as a general detoxifying agent in serious illness such as cancer.”

     

  • Echinacea Herb – Echinacea purpurea

    “[T]reat respiratory infections, Urinary tract infections, and genital herpes.”

    “[T]reatment of edema … anti-viral, wound healing, anti-cancer, snake bites, boils, abscesses, gangrene, tonsillitis, inflamed gums and mucus problems.”

    “[U]sed to prevent and treat the common cold, influenza and infections.”

    “[C]oughs, colds, sore throats, infections, toothaches, inflammations, tonsillitis, and snake bites....”

    “[S]timulating phagocytosis”

    “[S]top cystitis.”

    “[U]seful for infections of upper respiratory tract such as laryngitis, tonsillitis…”

    “[T]reatment of pyorrhoea and gingivitis.”

    “[T]umor-inhibiting…”

    “[A]nti-tumor, bacteriostatic, and anesthetic activity.”

    “[D]estroy both cancerous cells and pathogens….”

     

  • Elderberry Flower – Sambucus nigra 

    “Flowers are used to treat colds, sore throats, hay fever, and arthritis…”

     

  • Goldenseal – Hydrastis Canadensis

    “[T]reatment of any infection, inflammation and congestion of the lungs, throat and sinuses.”

    “[R]emedy for disorders of the stomach and intestines such as irritable bowel syndrome, colitis, ulcers and gastritis and internal parasites.”

    “[T]reatment of cancer…”

    “[R]espiratory ailments, liver trouble, stomach and intestinal problems.”

    “[W]ounds and ulcers.”

    [A]id in upper respiratory infections, urinary tract infections, GI disorders including gastritis, liver disease, menorrhagia and dysmenorrhea.”

    “[T]reat ulcers, wounds, infections … dandruff, ringworm, skin rashes, sore gums, and herpes.”

     

  • Grindelia Herb – Grindelia robusta

    “Pain … irregular heartbeat, asthmatic, bronchial uses … upper respiratory issues.”

     

  • Heal All Herb – Prunella vulgaris

    “[R]educe blood pressure.”

    “[T]reat sore throats, bleeding gums, hemorrhoids…

    “[U]sed to treat wounds and bruises…”

    “[T]reats fever, diarrhea, sore mouths and internal bleeding.”

    “[A]ntiseptic”

     

  • Kansas Snake Root Herb - Echinacea angustifolia

    “[S]peed wound healing and reduces inflammation”

    “[U]sed it for antiseptic, analgesic, toothaches, sore throats, and to treat poisonous insect and snakebites”

     

  • Lobelia Herb – Lobelia inflate

    “Used for respiratory ailments, such as asthma, bronchitis, pneumonia and cough.”

    “[L]ocal application for sprains, bruises, skin diseases.”

     

  • Maypop-Passion Flower - passiflora incarnate

    “[T]reat stress related ailments such as asthma and high blood pressure.” “[T]witching, spasms, anxiety, shingles, neuralgia, agitation, stress, sciatica, muscle pain and Parkinson's”

     

  • Milk Thistle – silybum marianum

    “[L]iver and gall bladder diseases.”

    “[D]epression, and spleen problems.”

    “It reduces the damage due to alcohol toxins in chronic hepatitis, cirrhosis and cadmium poisoning.”

    “[L]ower cholesterol, reduces insulin resistance in type 2 diabetes who has cirrhosis, reduces growth of cancer cells in breast, cervical and prostate cancers.”

     

  • Mullein Leaf – Verbascum Thapsus

    “[T]reat raspy coughs.”

    “[R]educe eczema, inflammation, and help heal wounds…”

    “[T]reats migraines and earaches.”

     

  • Black Walnut Leaf – Juglans nigra

    “[D]iarrhea, excessive menstrual bleeding, eczema, psoriasis…”

    “[C]ombat infection also effective clearing sinus infections and drying up runny nose.”

     

  • Dandelion Leaf Powder – Taraxacum officinale

    “[T]reat … eczema.”

    “[R]oot reduces inflammation and is an important liver stimulant used against jaundice, gallstones and rheumatic joints.”

     

  • Deer Tongue – Carphephorus odoratissimus

    “[E]ffective in reducing fevers, soothing irritated mucous membranes…”

     

  • American Sarsaparilla – Spikenard - Aralia racemose

    “[U]sed for pain relief; headaches, stomach pain, chest pain, bone fractures…”

    “Blood cleanser such as for gout, rheumatism and syphilis...”

     

  • Blood Root - Sanguinaria canadensis

    “[L]ocal anesthetic … antibacterial, expectorant and antiviral.”

    “Recent studies have focused on skin cancer and its possible therapeutic effects.”

    “[T]reat fever and rheumatism …”

    “[T]reatment of ulcers, ringworm, skin infections…”

     

  • Barberry Root – Berberis vulgaris

    “[U]sed for liver disorders and diseases along with fighting bacterial infections.”

     

  • Beth Root – Trillium erectum

    “Antiseptic; Expectorant; Poultice …is antiseptic…treatment for menorrhagia, irregular periods … pain of periods and excessive vaginal discharge…”

    “[F]or stopping bleeding due to hemorrhage of the lungs or urinary tract and after parturition.”

    “[U]sed for treat[sic] ulcers of the skin, gangrene, insect bites and sings[sic].

    “[T]reat sore nipples.”

    “[U]sed as a poultice for tumors and inflammations and ulcers.”

     

  • Burdock Root - Arctium lappa

    “[B]lood-purifying preventative for colds and flu’s, plus clears toxins that cause rheumatism, skin disorders, kidney stones and cystitis.”

    “antibiotic”

    “[U]sed for boils, scurvy, diabetes, rheumatism…”

    “[H]elpful in treating … psoriasis, eczema, contact dermatitis and wounds”

     

  • Ginseng - Panax quinquefolius

    “Tests have shown that Ginseng inhibits cancer cells…”

    “[T]reatment of chronic cough, low-grade fever, night sweats, and fatigue due to chronic consumptive disease.”

    “[U]sed throughout history to treat many medical conditions and symptoms from … arthritis … depression, anemia, high blood pressure…”

     

  • New Jersey Tea Herb – Ceanothus americanus

    “[E]xpectorant, haemostatic, hypotensive…”

    “[T]reat fevers and problems with the mucous membranes, such as sore throats”

    “[U]se of the bark is to do a skin wash for cancer and venereal sores.”

     

  • Pinkroot Herb – Spigelia Marilandica

    “[T]o rid one of intestinal worms, tapeworm and roundworm”

     

  • Pipsissewa Herb - Chimaphila umbellate 

    “[T]reating urinary tract issues including kidney inflammation, breaking down gallstones and kidney stones…”

    “[U]sed it to treat tuberculosis.”

     

  • Queen of the Meadow - Filipendula ulmaria

    “Used to relieve the symptoms of the common cold, reduce pain, fever,stomach complaints...”

     

  • Squaw Vine (Green Color) - Mitchella repens 

    “Used for menstrual cramps, sore nipples, rheumatism, dysentery, fever, kidney disorders, and other ailments.”

     

  • Pleurisy Root - Asclepias tuberosa

    “[V]ery popular to treat a variety of lung diseases, ulcers, wounds, bruises…”

     

  • Pokeweed Root - Phytolacca Americana

    “[T]he proteins inhibit flu, herpes, and leukemia.”

     

  • Skunk Cabbage - Symplocarpus foetidus

    “[U]sed in the treatment of respiratory diseases, nervous disorders, rheumatism, and dropsy.”

     

  • Stillingia Root - Stillingia sylvatica

    “Used as an anti-emetic … to treat diarrhea, vomiting … menstruation sickness, yellow eyes, hemorrhoids, constipation, laryngitis and cutaneous eruptions…”

     

  • Wild Ginger Root - Asarum canadense

    “Other medicinal treatments using ginger root are as a … antibiotic, antiasthmatic, antitumor, salve…”

     

  • Echinacea Root - Echinacea purpurea

    “[U]sed to treat respiratory infections, Urinary tract infections, and genital herpes.”

    “[A]lso been used for treatment of edema … anti-viral, wound healing, anti-cancer, snake bites, boils, abscesses, gangrene, tonsillitis, inflamed gums and mucus problems.”

     

  • Cranesbill-Wild Geranium - Geranium maculatum

    “[T]he root, is antiseptic…”

    “It is used to treat diarrhea, dysentery, irritable bowel syndrome, kidney complaints, and a wide range of other symptoms.”

Your Bayberry Bark, Black Haw Bark, Butternut Bark, Cramp Bark, Devils Club, Fringe Tree Bark, Prickly Ash Bark (Northern), Prickly Ash Bark (Southern), Slippery Elm Bark, Sumac Tree Bark, White Oak Bark, Wild Cherry Bark, Witch Hazel Bark, Pokeweed Berry Blue Scullcap (TRUE), Bergamot Herb, Boneset, Bugleweed (Herb), Cleavers Herb, Echinacea Herb, Elderberry Flower, Goldenseal, Grindelia Herb, Heal All Herb, Kansas Snake Root Herb, Lobelia Herb, Maypop-Passion Flower, Milk Thistle, Mullein Leaf, Black Walnut Leaf, Dandelion Leaf Powder, Deer Tongue, American Sarsaparilla, Blood Root, Barberry Root, Beth Root, Burdock Root, Ginseng, New Jersey Tea Herb, Pinkroot Herb, Pipsissewa Herb, Queen of the Meadow, Squaw Vine (Green Color), Pleurisy Root, Pokeweed Root, Skunk Cabbage, Stillingia Root, Wild Ginger Root, Echinacea Root, and Cranesbill-Wild Geranium 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)]. 

 

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.

Furthermore, your Bayberry Bark, Black Haw Bark, Cramp Bark, Fringe Tree Bark, Prickly Ash Bark (Northern), Slippery Elm Bark, Sumac Tree Bark, Pokeweed Berry Blue Scullcap (TRUE), Boneset, Bugleweed (Herb), Cleavers Herb, Echinacea Herb, Goldenseal, Grindelia Herb, Lobelia Herb, Maypop-Passion Flower, Milk Thistle, American Sarsaparilla, Blood Root, Barberry Root, Beth Root, Burdock Root, Ginseng, Pipsissewa Herb, Squaw Vine (Green Color), Pokeweed Root, Skunk Cabbage, Stillingia Root, Wild Ginger Root, Echinacea Root, and Cranesbill-Wild Geranium products are intended for treatment of one or more diseases that are not amenable to self-diagnosis and treatment 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, these products 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)].

 

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products.  You are responsible for investigating and determining the causes of the violations identified above 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 and FDA regulations.

 

You should take prompt action to correct the violations cited in this letter.  Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

 

Please respond in writing within 15 working days of your receipt of this letter.  Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations.  You should include in your response 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 action within 15 working days, state the reason for the delay and the time within which you will complete the corrections.

 

Please send your written reply to Boun M. Xiong, Compliance Officer, Food and Drug Administration, at the address on the letterhead.   If you have questions about this letter, please contact Mr. Xiong at (414) 326-3976.

 

Sincerely,

/S/

Art O. Czabaniuk

District Director

Detroit District Office