Inspections, Compliance, Enforcement, and Criminal Investigations

Four Elements Organic Herbals, LLC 3/4/15

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142 

 

March 4, 2015
 
 
WARNING LETTER
 
 
Via UPS Overnight Delivery                         
Refer to MIN 15 – 08
 
 
Jane H. Stevens
Owner
Four Elements Organic Herbals, LLC
P.O. Box 10
North Freedom, Wisconsin 53951
 
Dear Ms. Stevens:
 
From April 25 through May 21, 2014, the U.S. Food and Drug Administration (FDA or we) conducted an inspection of your firm’s facility located at 111 East Walnut Street, North Freedom, Wisconsin. Additionally, we reviewed your websites at www.fourelementsherbals.com and www.fourelementsblog.com in May and August 2014 and have determined that you take orders there for the products HERBAL TEA Power, Energy & Stamina; ORGANIC HERBAL TEA Tulsi TelepaTea; Holy Basil LIP BALM; Holy Basil Organic Hydrosol; ORGANIC HERBAL TEA To Your Health; Hawthorn Fresh Herb Extract; Elderberry Fresh Herb Extract; Immune Blend Fresh Herb Extract; Self Heal Cream; Sweet Violet Moisture Cream; Lemon Lip Balm; Rose Comfrey Moisture Cream; and Unscented Comfrey Moisture Cream. The claims on your product labels and your websites establish that your products are drugs under section 201(g)(1)(B) and/or section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1)(B) and (g)(1)(C), because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or because they are articles (other than food) intended to affect the structure or any function of the body. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You may find the Act and our implementing regulations in Title 21, Code of Federal Regulations (21 CFR), through links on our website at www.fda.gov.
 
Examples of some of the claims observed on your websites that provide evidence that your products are intended for use as drugs include:
 
Regarding Herbalore – Sumac (contained in HERBAL TEA Power, Energy & Stamina)
 
·         “The fruits of sumac are being used in herbalism to treat diabetes.”  [Website Blog]
·         “[The fruits of sumac] may also be useful for high blood pressure and maintaining blood sugar levels.”  [Website Blog]
 
Regarding Herbalore – Tulsi or Holy Basil (contained in ORGANIC HERBAL TEA Tulsi TelepaTea, Holy Basil LIP BALM, and Holy Basil Organic Hydrosol)
 
·         “[T]aken daily to prevent disease”  [Website Blog]
·         [C]an help to open the bronchioles, as in bronchitis, asthma, and congestion from colds.”  [Website Blog]
·         “[R]educes level of cholesterol in blood.”  [Website Blog]
·         “[M]ild antiseptic.”  [Website Blog]
 
Regarding Red Clover – Trifolium pretense (contained in ORGANIC HERBAL TEA To Your Health)
 
·         “ . . . Red Clover is great for . . . strengthening the arteries, which may prevent plaque deposits that can lead to a heart attack or stroke.”  [Website Blog]
·         “[Red Clover] also holds small amounts of coumarin, so keeps the blood from becoming too thick and gummy. Therefore, the possibility of forming blood clots and arterial plaques may be reduced.”  [Website Blog]
·         “ . . . Red Clover is also indicated for skin issues like eczema . . ..”  [Website Blog]
·         “[Red Clover] is also employed in anti-cancer remedies.”  [Website Blog]
 
Regarding Hawthorn (contained in Hawthorn Fresh Herb Extract)
 
·         “Hawthorn has a long history of treating heart problems:  it alleviates the pain of angina, . . . lowers blood lipids . . ..”  [Website Blog]
 
Regarding Elderberry (contained in Elderberry Fresh Herb Extract and Immune Blend Fresh Herb Extract)
 
·         “This astringent quality [found in elderflowers] has been applied for inflammation in the eyes, rheumatism, diarrhea . . ..”  [Website Blog]
·         “[U]sed successfully to treat rheumatism, neuralgia, sciatica, sore throats, coughs, colds and the flu.”  [Website Blog]
 
Regarding Lemon Balm (Melissa Officinallis) (contained in Lemon Lip Balm):
·         “Lemon Balm . . . lifts depression . . . [and] has anti-viral actions . . ..”  [Website Blog]
·         “[B]alm would close up wounds without any peril of inflammation.”  [Website
Blog]
·         “clears out cough by promoting expectoration”
·         “shown to be antiviral, reducing infection . . . while promoting circulation”  [Website Blog]
·         “[L]emon Balm shortens the duration and lessens the symptoms of both kinds of herpes.”  [Website Blog]
·         “[M]ay help reduce the frequency of herpes flareups”  [Website Blog]
 
Regarding Comfrey (contained in Rose Comfrey Moisture Cream and Unscented Comfrey Moisture Cream):
 
·         “Heals the Wound, Knits the Bones”  [Website Blog]
·         “[Comfrey can be] used . . . to heal a wound or a bone break . . ..”  [Website Blog]
·         “[Comfrey] is effective for joint pain, sprains, bruising, pulled muscles and ligaments.”  [Website Blog]
·         “Comfrey is a great remedy for hemorrhoids, ulcers, both internal and external, rheumatoid and osteoarthritis, broken bones, and cancer.”  [Website Blog]
 
Additionally, examples of some of the claims observed on your product labels that provide evidence that your products are intended for use as drugs include:
 
Self Heal Cream:
 
·         “[I]nfused with Self Heal a traditional wound healing herb”  [Product Label]
 
Sweet Violet Moisture Cream:
 
·         “Contains traditional herbs for improving lymph function and breast health.  Great used as a breast cream or for inflamed conditions.”  [Product Label]
 
Your 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 submitted by a drug sponsor to demonstrate 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 HERBAL TEA Power, Energy & Stamina; ORGANIC HERBAL TEA Tulsi TelepaTea; Holy Basil LIP BALM; Holy Basil Organic Hydrosol; ORGANIC HERBAL TEA To Your Health; Hawthorn Fresh Herb Extract; Elderberry Fresh Herb Extract; and Immune Blend Fresh Herb Extract are intended for prevention or treatment of one of more diseases that are not amendable to self-diagnosis or treatment.  Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your HERBAL TEA Power, Energy & Stamina; ORGANIC HERBAL TEA Tulsi TelepaTea; Holy Basil LIP BALM; Holy Basil Organic Hydrosol; ORGANIC HERBAL TEA To Your Health; Hawthorn Fresh Herb Extract; Elderberry Fresh Herb Extract; and Immune Blend Fresh Herb Extract 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.
 
Within 15 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 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 Melissa I. Michurski, Compliance Officer, Food and Drug Administration, at the address on the letterhead.  If you have questions about this letter, please contact Ms. Michurski at (612) 758-7185.
 
Sincerely,
/S/                                                                                                         
Michael Dutcher, DVM
Director
Minneapolis District

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