Inspections, Compliance, Enforcement, and Criminal Investigations

Harrington House Ltd 9/2/16

  

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

Public Health Service
Food and Drug Administration
 College Park, MD 20740 

 

WARNING LETTER
 
 
September 2, 2016
 
VIA EXPRESS DELIVERY
 
Margaret Hardy, President
Harrington House Ltd.
285 Hawthorne Drive
Danville, VA 24541-3619
 
Re: CMS#501665
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.abbeystclare.com/ in July 2016 and has determined that you take orders there for the products Abbey St. Clare Botanical Oil #5: Recovery, Abbey St. Clare Lavender High Altitude French Essential Oil, Abbey St. Clare Australian Emu Oil, Abbey St. Clare Kettle Soap – Certified Organic Formulas, Abbey St. Clare Spot Remover & Blemish Control Poultice, and Abbey St. Clare Pomegranate Protection Hydrating Mist. The claims on your website establish that the products are drugs under sections 201(g)(1)(B) and/or 201 (g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B) and/or 21 U.S.C. § 321(g)(1)(C)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or articles intended to affect the structure or any function of the human body.  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:
 
Abbey St. Clare Botanical Oil #5: Recovery
  • “Minimizes swelling when applied soon after skin trauma.”
  • “Arnica oil… anti-inflammatory used post surgically to mend tissues, reduce pain and swelling, minimize pooling of blood under the skin and aids in its re-absorption”
  • “Cypress essential oil constricts blood vessels and helps relieve pain”
  • “Geranium essential oil aids in arresting the flow of blood from broken vessels and is cellular regenerative”
Abbey St. Clare Lavender High Altitude French Essential Oil 
  • “Useful for headaches (including migraines), insomnia, depression, stress, stiff joints, sore muscles, nervous tension, hair loss, and childbirth.”
  • “Lavender…is an antidepressant and is used to calm a stressed spirit, anxiety, and hysteria.”
  • “Lavender essential oil is a natural antibiotic, antiseptic, anti-inflammatory, and pain reliever. It promotes healing and prevents scarring by stimulating the immune system and cellular regeneration. In addition to treating burns and sunburns, lavender essential oil is useful for relief of arthritis, rheumatism, and general muscle aches and pains.”
  • “Lavender is antibacterial and is often used in formulations for acne and irritated skin. Its cell regeneration properties encourage healing processes to advance more quickly.
  • “Lavender helps eczema, psoriasis, itching, soreness, and irritation.” 
Abbey St. Clare Australian Emu Oil  
  • “Emu oil is anti-inflammatory, anti-bacterial and anti-microbial…”
  • “Insect Bites: Sting and itching is greatly reduced due to the anti-inflammatory properties.”
  • “Keloids: Anti-inflammatory action of oil prevents formation of keloid tissue and significantly reduces recent scarring.”
  • “Wounds: Emu Oil applied to epithelialised wounds appears to reduce scar tissue formation and the anti-inflammatory properties soothes post-surgical wounds” 
Abbey St. Clare Kettle Soap – Certified Organic Formulas 
  • “Activated Charcoal Drawing Soap – Highly absorptive and antibacterial activated charcoal draws impurities to surface to clarify skin. Charcoal is deodorizing, reduces pigmentation, and soothes eczema”
  •  “Honey Butter – …Honey is antibacterial, anti-inflammatory, anti-fungal, antioxidant; enhances healing, reduces scars, and relieves burns.”
  • “Jewelweed Anti-Itch Skin Repair –…relieve itching due to poison ivy/ poison oak or any other skin irritation, including eczema and psoriasis.”
  • “Log Cabin –…helps relieve arthritis, bronchitis, colds, coughs, flu, muscle aches, rheumatism, sinusitis.”
  • “Tea Tree – Antimicrobial tea tree essential oil makes this useful for acne, scrapes, cuts, scratches, athlete's foot, or dandruff.”
Abbey St. Clare Spot Remover & Blemish Control Poultice 
  • “Pascalite clay has provided relief for many different skin problems, including psoriasis, acne, eczema, burns, diaper rash, cuts and scrapes, poison ivy rash, athlete’s foot, and spider bites” 
Abbey St. Clare Pomegranate Protection Hydrating Mist 
  • “Rose hydrosol enhances circulation in the skin for cellular regeneration.”
  • “Melissa hydrosol is anti-inflammatory and anti-fungal. It is used to relieve skin infection and breakouts, and to help eliminate herpes infections.”
  • “MSM…Anti-inflammatory and antimicrobial, it has been helpful in a host of skin disorders including acne, psoriasis, dermatitis, and rashes” 
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 and information demonstrating that the drug is safe and effective. 
 
This letter is not an all-inclusive statement of violations associated with your products or their labeling, and we have not attempted to list here all of the products that are promoted on your website for intended uses that cause them to be drugs.  It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.  We advise you to review your website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.
 
We request that you take prompt action to correct all violations associated with your products, including the violations identified in this letter. Failure to do so may result in enforcement action without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products.
 
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. 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 the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
 
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. You may respond in writing to Ms. Cherlita Honeycutt, Compliance Officer, U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions about the contents of this letter, please contact Ms. Honeycutt at (410) 779-5412 or via fax at (410) 779-5705.
 
 
 
Sincerely,
/S/                                                           
Evelyn Bonnin
District Director
 

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