WARNING LETTER
Prairie Dawn Herbs
MARCS-CMS 610094 —
December 10, 2020
Delivery Method:
VIA UPS
Product:
Food & Beverages
Recipient:
Recipient Name
Dawn Brooks
Recipient Title
Owner
Prairie Dawn Herbs
4250 S. Calhan Hwy
Yoder
,
CO
80864-9669
United States
Issuing Office:
Division of Human and Animal Food Operations West IV
United States
December 10, 2020
WARNING LETTER
Ref: CMS Case #610094
Dear Ms. Brooks:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://www.prairiedawnherbs.com in November 2020 and has determined that you take orders there for the products “Chest Tea,” “Ginger Oil,” “Dandelion root Tincture,” “Echinacea purpurea Tincture,” “Antispasmodic Tincture,” “Ginger Tincture,” and “Cayenne Tincture”. The claims on your website, www.prairiedawnherbs.com, 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 diagnosis, 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 product webpage for “Chest Tea,” which states that the product includes the ingredients “Comfrey leaf” and “Mullein leaf”:
o “This tea soothes bronchial spasms and breaks up mucus and congestion.”
o “Chest tea is useful for asthma, bronchitis, pneumonia and whooping cough.”
• On your “The Herb Garden” webpage for “Russian Comfrey”, an ingredient in your “Chest Tea” product:
o “Comfrey… is excellent for the treatment of coughs and pulmonary complaints. It has expectorant properties that are beneficial to the bronchials [sic] and lungs. I have personally used it mixed with Mullein and Lobelia in the treatment of whooping cough with awesome results. The doctor had told my son to expect to be off the football field for six to eight weeks . . . . I’m sure part of this quick recovery had to do with his love of playing football, but I have to give credit to his use of what I now call ‘Chest Tea’.”
o “A strong tea is also valuable in cases of internal bleeding, whether it is from the lungs, stomach, intestines, or hemorrhoids.
o “Comfrey tea is very healing for stomach ulcers.”
• On your “The Herb Garden” webpage for “Mullein”, an ingredient in your “Chest Tea” product:
o “ [A]n excellent remedy for coughs, colds, bronchial congestion, croup . . . asthma.”
o “I have personally used Mullein leaves mixed with Comfrey leaves and Lobelia in the treatment of whooping cough.”
o “Mullein is . . . expectorant.”
• On your “The Herb Garden” webpage for “Ginger”, an ingredient in your “Ginger Oil” and “Ginger Tincture” products:
o “Ginger has strong antibacterial properties and is effective against food borne pathogens of Shigella, E coli and Salmonella.”
o “It is . . . useful for treating colds and flu, as well as upper respiratory infections.”
o “Ginger . . . reduces inflammation and promotes sweating, which is helpful in lowering fever.”
o “It’s expectorant and antihistamine qualities help thin mucus and move it out of the body.”
o “It reduces or eliminates diarrhea, so it is very useful in cases of dysentery.”
o “It has also been used effectively against malaria.”
o “Ginger is also . . . analgesic.”
• On your product webpage for “Dandelion root Tincture”:
o “Dandelion root . . . lowers blood sugar, blood pressure, and cholesterol levels.”
o “It reduces inflammation and has antimicrobial effects against Candida albicans.”
• On your “The Herb Garden” webpage for “Dandelion”, an ingredient in your “Dandelion root Tincture” product:
o “[L]owers cholesterol, blood pressure and blood sugar.”
o “Dandelion root tea has been used to treat liver, gallbladder, urinary tract . . . issues.”
o “Studies are showing that a tincture of Dandelion root can be helpful in the treatment of certain cancers.”
• On your product webpage for “Echinacea purpurea Tincture”:
o “Echinacea . . . has antibacterial properties.”
o “A dropperful of tincture can be squirted at the back of the throat and held there for relief of strep throat.”
• On your “The Herb Garden” webpage for “Echinacea”, an ingredient in your “Echinacea purpurea Tincture” product:
o “[Echinacea]…can be used as a preventative as well as a curative.”
o “Echinacea is very useful in the early treatment of bacterial and viral infections.”
o “Small amounts taken frequently at the first sign of a cold or flu will boost immunity and prevent illness or lessen the duration of an illness.”
o “Echinacea is specifically suited to treat strep throat.”
o “ Echinacea can also be used for infected wounds and the bites and stings of insects and snakes.”
• On your product webpage for “Antispasmodic Tincture,” which states that the product includes “Cayenne powder” as an ingredient:
o “[A]nd is useful for seizures . . .”
• On your “The Herb Garden” webpage for “Cayenne Pepper”, an ingredient in your “Antispasmodic Tincture” and “Cayenne Tincture” products:
o “[I]t equalizes the blood pressure . . .”
o “[U]sed to heal an ulcerated stomach.”
o “[U]seful taken internally and used as a poultice for headaches.”
o “It’s [sic] antiseptic properties help in the healing of wounds.”
o “Cayenne has been used as a specific treatment for Yellow Fever . . .”
o “It is an excellent tonic for warding off any disease.”
• On your product webpage for “Cayenne Tincture”:
o “Cayenne . . . regulates the blood pressure and will quickly stop bleeding when mixed with water and taken orally.”
o “A few drops on the tongue or mixed with water is also helpful in cases of shock.”
Your “Chest Tea,” “Ginger Oil,” “Dandelion root Tincture,” “Echinacea purpurea Tincture,” “Antispasmodic Tincture,” “Ginger Tincture,” and “Cayenne Tincture” products are not generally recognized as safe and effective for the above referenced uses and, therefore, these 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 the FDA, as described in sections 301(d) and 505(a) of the FD&C 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 “Chest Tea,” “Ginger Oil,” “Dandelion root Tincture,” “Antispasmodic Tincture,” “Ginger Tincture,” and “Cayenne Tincture” products are 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 products safely for their intended purposes. Accordingly, your “Chest Tea,” “Ginger Oil,” “Dandelion root Tincture,” “Antispasmodic Tincture,” and “Cayenne Tincture” 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 marketed 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, including 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.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Kathy Tormey, Compliance Officer; P.O. Box 25087, Denver, Colorado, 80225-0087. You may reach Ms. Tormey at Kathleen.tormey@fda.hhs.gov or
(303) 236-3137
if you have any questions about this matter.
Sincerely,
/S/
E. Mark Harris
Acting Denver District Director &
Program Division Director
Office of Human and Animal Food Operations –
Division IV West
Content current as of:
02/02/2021
Regulated Product(s)
Food & Beverages