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WARNING LETTER

Hanna's Herb Shop MARCS-CMS 569309 — Mar 05, 2019

Hanna's Herb Shop - 569309 - 03/05/2019


Delivery Method:
UPS Overnight
Reference #:
HAF4W(DEN)-19-06-WL
Product:
Dietary Supplements
Food & Beverages

Recipient:
Recipient Name
Mr. Thomas M. Brown
Recipient Title
General Manager
Hanna's Herb Shop

5684 Valmont Rd.
Boulder, CO 80301
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

Office of Human and Animal Foods - Division IV West
P.O. Box 25087
Denver, CO 80225
United States


Dear Mr. Brown,

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the internet address http://www.hannasherbshop.com/ in January 2019 and has determined that you take orders there for the products Kroeger Herb Kolester, Kroeger Herb St. John’s Wort Complete Concentrate, Kroeger Herb Ginko Biloba Complete Concentrate, Kroeger Herb Bilberry Complete Concentrate, Kroeger Herb Holy Basil (Tulsi) Complete Concentrate, Kroeger Herb Kava Kava Complete Concentrate, Aloe Vera Juice (Inner Leaf), Bee Pollen, Kroeger Herb Circu Flow, Kroeger Herb FLT (Flu Tea), Heart Care Blend, Marshmallow Root Cert. Organic, Kroeger Herb Resveratrol Six, Nettles Freeze-Dried, Quercetin Plus w/Bromelain & Vitamin C, Rosehips – Seedless Organic, Kroeger Herb Sinus Blend, St. John’s Wort Herb Cert. Organic, White Willow Bark, and Yellow Dock Root Cert. Organic. The claims on your website establish that these 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 claims observed on your website that provide evidence that these products are intended for use as drugs include the following:

Kroeger Herb Kolester

  • “Major Side Effects of Statins . . . Aside from risks like permanent damage to the liver, nervous system, and muscles other side effects include: Kidney failure, Amnesia, Homicidal impulses, Hostility, Short temper and irritability, Nausea, Weakness, Constipation, Problems sleeping, Inability to walk, Cramping or tingling in legs, Nerve Damage, Temperature regulation difficulties, Erectile dysfunction, Liver abnormalities, Headaches, Rashes or flushing of skin, Dizziness, Diarrhea . . . Avoiding the Side Effects of Statins.” These statements are followed by a picture of Kroeger Herb Kolester and the statement “we want to offer some alternatives to these drugs . . . Kolester is Hanna’s blend of herbs that is designed to keep cholesterol levels healthy . . . with no side effects . . .”

Kroeger Herb St. John’s Wort Complete Concentrate

  • “Used to relieve depression, sleep disorders, nerve pain and viral infections” 

Kroeger Herb Ginko Biloba Complete Concentrate

  • “Used to . . . decrease dementia, depression, impotence, inner ear dysfunction, M.S. & retinopathies.” 

Kroeger Herb Bilberry Complete Concentrate  

  • “Used for . . . diabetic retinopathy, macular degeneration and varicose veins” 

Kroeger Herb Holy Basil (Tulsi) Complete Concentrate

  • “ . . . Holy Basil can also address hypertension, diabetes, and cardiovascular problems.”                                                                                                   

Kroeger Herb Kava Kava Complete Concentrate

  • “Skeletal muscle relaxant, sedative, urinary tract infections, colds, coughs.” 

Bee Pollen 

  • Product is listed in the Allergy & Sinus category 

Kroeger Herb FLT (Flu Tea) 

  • The name of the product 

Kroeger Herb Heart Care Blend (formerly Heartwarmer) 

  • “Hawthorn [an ingredient in the product] has been used to prevent heart disease for centuries. In the 1800s, North American physicians prescribed the herb for both circulatory disorders and respiratory illnesses. The herb, which may help dilate blood vessels, is said to improve blood flow and protect blood vessels from damage. Several studies have been conducted that prove Hawthorn’s effectiveness in improving heart function and treating heart failure. Some evidence shows that Hawthorn may help fight chest pain due to low blood flow. The University of Maryland Medical Center has reported that Hawthorn may be as effective as the leading prescription drugs in treating heart failure.”

Marshmallow Root, Cert. Organic

  • “Pain reliever, expectorant, used in healing and treating of wounds. For mouth infections, bronchitis, asthma, and urinary problems. For bladder infection, pain, or burning when urinating.”

Kroeger Herb Resveratrol Six

  • “Something you may not be aware of are recent studies in Spain revealing the amazing anti-inflammatory affect Resveratrol can have on your system. Chronic inflammation underlies many chronic conditions including heart disease, multiple sclerosis, stroke, arthritis, cancer . . .. Curious how Resveratrol can help you live a healthier life with less inflammation?”

Nettles, Freeze-Dried

  • “dried nettles are . . . widely used for seasonal allergy support.”
  • Product is listed in the Allergy & Sinus product category

Quercetin Plus w/Bromelain & Vitamin C

  • “Quercetin . . .  has anti-inflammatory and anti-histamine properties. It can be helpful with asthma, canker sores, eczema, gout, and hives.”

Rosehips – Seedless, Cert. Organic

  • “Rosehips may help prevent and treat certain illnesses like colds and flu . . . helps to lower cholesterol.” 

Kroeger Herb Sinus Blend

  • Product is listed in the Allergy & Sinus product category 

St John’s Wort Herb, Cert. Organic

  • “Traditionally used for depression, St. John’s Wort can also help with nerve damage, injury or pain including neuralgia. It is also helpful for relieving the pain of shingles when used in a bath.”

White Willow Bark

  • “useful for bladder infections, arthritis, fever, hay fever and inflamed joints and membranes.”

Yellow Dock Root, Cert. Organic

  • “can help with various skin conditions including psoriasis, herpes, eczema . . . It is also a known remedy for liver and gallbladder ailments . . .”

Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of Circu Flow and Aloe Vera Juice (Inner Leaf) for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

Kroeger Herb Circu Flow and Aloe Vera Juice (Inner Leaf)

  • “I was thrilled at the possibility that there might be an alternative to the repeated heart catheterizations I had endured. . . . there were . . . doctors . . . who treated patients with intravenous chelation . . . we were also told about Oral Chelation . . . [I was told to take] three Circu-flow oral chelation capsules before meals three times a day, with 2 tablespoons of Aloe Vera . . . by June 4th, 2001 I was no longer taking nitrostats . . . I have had no chest pains . . . medications other than nitrostat gave me no relief from the severe chest pain . . . The only relief I had was when I started to take Chelation . . . Chelation is designed to take plaque and foreign materials out of the blood vessels . . . ”

The above-listed 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)(1) of the Act [21 U.S.C. § 321(p)(1)]. 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 Kroeger Herb Kolester, Kroeger Herb St. John’s Wort Complete Concentrate, Kroeger Herb Ginko Biloba Complete Concentrate, Kroeger Herb Bilberry Complete Concentrate, Kroeger Herb Holy Basil (Tulsi) Complete Concentrate, Kroeger Herb Kava Kava Complete Concentrate, Kroeger Herb FLT (Flue Tea), Kroeger Herb Heart Care Blend (formerly Heartwarmer), Marshmallow Root Cert. Organic, Kroeger Herb Resveratrol Six, Quercetin Plus w/Bromelain & Vitamin C, Rosehips – Seedless , Cert. Organic, St. John’s Wort Herb Cert. Organic, White Willow Bark, Yellow Dock Root, Cert. Organic, Kroeger Herb Circu Flow, and Aloe Vera Juice (Inner Leaf) 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 these products safely for their intended purposes. Accordingly, your Kroeger Herb Kolester, Kroeger Herb St. John’s Wort Complete Concentrate, Kroeger Herb Ginko Biloba Complete Concentrate, Kroeger Herb Bilberry Complete Concentrate, Kroeger Herb Holy Basil (Tulsi) Complete Concentrate, Kroeger Herb Kava Kava Complete Concentrate, Kroeger Herb FLT (Flue Tea), Kroeger Herb Heart Care Blend (formerly Heartwarmer), Marshmallow Root Cert. Organic, Kroeger Herb Resveratrol Six, Quercetin Plus w/Bromelain & Vitamin C, Rosehips – Seedless , Cert. Organic, St. John’s Wort Herb Cert. Organic, White Willow Bark, Yellow Dock Root, Cert. Organic, Kroeger Herb Circu Flow, and Aloe Vera Juice (Inner Leaf) products fail to bear adequate directions for their intended uses 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 all products marketed by your firm comply with all requirements of federal law, including FDA regulations.

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

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that 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 do not believe that your products are in violation of the 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 written  reply should be directed to the U.S. Food and Drug Administration; Attn: Caroline H. Le, Pharm.D., Compliance Officer, P.O. Box 25087, Denver, Colorado, 80225-0087. You may reach Dr. Le at (303) 236-3045 if you have any questions about this matter.

 

Sincerely,

/S/ 

LaTonya M. Mitchell

District Director, FDA Denver District

Program Division Director

Office of Human and Animal Foods – Division IV West