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U.S. Department of Health and Human Services

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Enforcement Actions

Driftwood Management, LLC 05-Jul-06

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

Public Health Service
Food and Drug Administration

 

555 Winderley PI ., Ste. 200
Maitland, FI 32751



CERTIFIED MAIL
RETURN RECEIPT REOUESTED

WARNING LETTER
FLA-06-28

July 5, 2006

Nancy L. Werner, Manager
Driftwood Management, LLC
D/b/a Driftwood Health
3412 Clark Road #120
Sarasota, FL 34231

Dear Ms. Werner:

This letter concerns your firm's marketing of the products Black Pepper Oil, Clary Sage Oil, Clove Oil, Fennel Oil, Helichrysum Oil, Lavender Oil, Lemon Oil, Peppermint Oil, Pine Oil, Ravensara Oil, Rosemary Oil, Thyme Oil, and Ylang Ylang Oil, on your website,
www. pureproducts.net. According to information on your website, these "Therapeutic Essential Oils" are intended to prevent, treat, or cure disease conditions. Statements on your website that document these intended uses include, but are not limited to, the following:

Black Pepper Oil

  • "Medicinal Properties: Analgesic, antimicrobial, antiseptic, antispasmodic, antitoxic, bactericide, diuretic . . . stimulant . . . "

  • "Physical Benefits

    • Arthritis

    • Asthma

    • Bronchitis

    • Colitis

    • Emphysema

    • Flu

    • Gastric Spasms

    • Gout

    • Headaches

    • Herpes

    • Migraines "

  • "Psycho-Emotional Benefits . .

    • Clear mild depression "


Clary Sage Oil

  • " "Medicinal Properties: Anti-inflammatory, antiseptic, antimicrobial . . . antispasmodic, antitoxic, diuretic, antifungal . . . immune stimulant"

  • "Physical Benefits

    • Acne

    • Boils

    • Colic . . .

    • Headache

    • High blood Pressure . . .

    • Ulcers . . . "

  • "Psycho-Emotional Benefits

    • Clear mild depression"

Clove Oil

  • "Medicinal Properties : Antiseptic, antibacterial, antiviral . . . Homostatic (blood thinning), anti-inflammatory"

  • "Physical Benefits

    • Arthritis

    • Bronchitis

    • cholera

    • Dental infection

    • Diarrhea

    • Headache

  • Herpes . .

  • Infectious diseases

  • Tuberculosis

  • Viral hepatitis

  • Virus "

Fennel Oil

  • "Medicinal Properties: Bactericide, antiseptic, antimicrobial . . . antispasmodic, antitoxic, diuretic, antifungal . . . immune stimulant"

  • "It has traditionally been used for obesity, which may be due to a type of estrogenic action, which also increases the milk of nursing mothers. Used for infections, [C]onsidered helpful for obstruction of the spleen, liver and gall bladder. "

"Plrysical Benefits

    • Anorexia

    • Asthma

    • Bronchitis . . .

    • Cellulitis

    • Constipation

    • Gum disease "

  • "Add to mouthwash for gum disease or infections."

Helichrysum Oil

  • " "Medicinal Properties: . . . anti-spasmodic, anti-inflammatory, anti-microbial . . . antiseptic . . . anti-bruising, . . . fungicidal, and healing"

  • " "Physical Benefits . . .

    • Arthritis

    • Asthma . . .

    • Chronic bronchitis . . .

    • Fever

    • Headaches

    • Liver ailments

    • Migraines . . .

    • Rheumatism . . .

    • Whooping cough

  • Psycho-Emotional Benefits. . .

    • Anti-depressant

  •  

Lavender Oil

  • " "Medicinal Properties : . . . antidepressant, septic . . . fungicidal, sedative . . . antiinflammatory"

  • "Physical Benefits . . .

    • Asthma

    • Bronchitis . . .

    • Burns . . .

    • Colic . . .

    • Ear ache . . .

    • Headaches . . .

    • Lice . . .

    • Psoriasis

    • Ring worm

    • Skin infections

    • Speed healing "

  • Psycho-Emotional Benefits . . .

    • Help [maniac] depression

    • Lighten feelings of depression"

Lemon Oil

  • " "Medicinal Properties : Bactericide, antiseptic, antimicrobial . . . antispasmodic, antitoxic, diuretic, antifungal . . . immune stimulant"

  • "Lemon stimulates white corpuscles that defend the body against infection. In Spain and other European countries, Lemon Oil has been regarded as a cure-all for infectious diseases such as fever, malaria, and typhoid. "

  • "Physical Benefits

    • Arthritis . . .

    • Circulation . . .

    • Diuretic . . .

    • Gout . . .

    • Hypertension . . .

    • Inflamed joints

    • Obesity "

Peppermint Oil

  • "Medicinal Properties: Analgesic (for pain), anti-injlammatory (for inflammation), antiseptic (destroys and prevents germs), anti-infectious, antimicrobial (destroys pathogens), antispasmodic . . . fungicidal (kills fungus), nervine (strengthen and tone nerves), vasoconstrictor (blood vessels constrict) . . . . ..

  • "Peppermint is one of nature's finest digestives and peppermint herb is great to help oxygenate[s] the blood - therefore it assists invaluably in: healing of circulatory disorders, nervousness, insomnia, flu, headaches, fevers . . . . "

  • "Because peppermint herbs stimulate bile and digestive juice secretion, the peppermint therefore helps in relieving intestinal colic and other associated conditions. "

  • "Physical Benefits . . .

    • Arthritis

    • Asthma . . .

    • Colic . . .

    • Constrict capillaries

    • Headache

    • Hypotension . . .

    • Inflamed joints

    • Laryngitis

    • Migraine . . .

    • Scabies

    • Sinusitis "

Pine Oil

  • "Medicinal Properties: Antiseptic . . . antimicrobial, antiviral, bactericidal, disinfectant, . . . diuretic . . . fungicidal, hypertensive"

  • "A true disinfectant, a strong germ killer, excellent for viral infections and for muscular aches, rheumatism and arthritis. "

  • "Physical Benefits

    • Asthma

    • Bronchitis . . .

    • Circulation . . .

    • Cystitis . . .

    • Flu

    • Gout . . .

    • Laryngitis . . .

    • Rheumatism . . .

    • Scabies

    • Sciatica

    • Sinusitis . . .

    • Urinary infections "

Ravensara Oil

  • "The BEST OIL for Shingles Virus "

  • "Medicinal Properties: Bactericide, antiseptic, antimicrobial, antifungal, nervine "

  • " helps eradicate viral infections. This is the specific oil that may help Shingles, a pesky, recurrent viral infection related to the chicken pox. Although shingles are extremely painful and difficult to treat medically, Ravensara Oil helps get rid of them and eliminate the toxins produced from the illness (and infection generally) and rebuild the immune system. "

  • "Physical Benefits . . .

    • Bronchitis

    • Cholera

    • Flu

    • Hepatitis (viral)

    • Herpes

    • Insomnia

    • Mononucleosis

    • Sinus infection . . .

    • Varicose veins "

Rosemary Oil

  • "Medicinal Properties: Antiseptic, analgesic, anti-bacterial, antiseptic, antispasmodic . diuretic . . . fungicidal, stimulant, nervine . . . hypertensive, parasitic"

  • "Physical Benefits . . .

    • Arthritis

    • Asthma

    • Bronchitis

    • Colitis . . .

    • Gout . . .

    • Headache

    • Liver cleanse

    • Muscle pain

    • Neuralgia

    • Whooping cough "

Thyme Oil

  • "Medicinal Properties : Bactericide, antiseptic, antimicrobial . . . antispasmodic, antitoxic, diuretic, antifungal . . . immune stimulant "

  • "Physical Benefits

    • Asthma

    • Bronchitis . . .

    • Colitis

    • Dermatitis

    • Diarrhea

    • Edema . . .

    • Flu

    • Gout

    • Headaches

    • Infectious disease . . .

    • Insomnia

    • Laryngitis

    • Lice

    • Obesity

    • Urinary tract infections

    • Tonsilitis "

Ylang Ylang Oil

  • "Medicinal Properties .- . . . antidepressant, anti-infection . . . antiseptic . . . euphoric, hypotensive, nervine . . . stimulant"

  • "Physical Benefits . . .

    • Insomnia . . .

    • High blood pressure

    • Hypernea [sic] (abnormally fast breathing)

    • Palpitations . . .

    • Tachycardia "

Black Pepper Oil, Clary Sage Oil, Clove Oil, Fennel Oil, Helichrysum Oil, Lavender Oil, Lemon Oil, Peppermint Oil, Pine Oil, Ravensara Oil, Rosemary Oil, Thyme Oil, and Ylang Ylang Oil, are drugs, as defined by Section 201(g)(1) of the Federal Food, Drug and Cosmetic Act (Act), 21 U.S .C. § 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Moreover, these products are new drugs, as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because they are not generally recognized as safe and effective for their labeled uses. Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of the above-listed "Therapeutic Essential Oils" without approved applications violates these provisions of the Act.

Furthermore, many of the conditions for which these products are offered, such as arthritis, asthma, bronchitis, cholera, high blood pressure, mononucleosis, tonsillitis, tuberculosis, ulcers, and viral hepatitis are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these drugs safely for these intended purposes. Each product's labeling fails to bear adequate directions for these intended uses, causing each product to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1).

The above violations are not intended to be an all-inclusive list of deficiencies. It is your responsibility to ensure that the drug products that you manufacture or distribute meet all of the requirements of the Act and its implementing regulations. Federal agencies are advised of the issuance of all warning letters about drugs and devices so that they may take this information into account when considering the award of contracts.

You must immediately correct these violations. If you do not immediately correct them, you may be subject to enforcement action without further notice. The Act provides for the seizure of illegal products and for an injunction against the manufacturer and distributors of illegal products. Individuals and businesses that violate the Act may also be subject to criminal prosecution.

You must notify this office in writing within 15 working days of receipt of this letter as to the steps that you have taken to correct the above-listed violations and to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be made. Additionally, if your firm does not manufacture the products identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the products is not the manufacturer, include the name of your supplier in addition to the manufacturer. Address your reply to the U.S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, FL 32751, Attention: Shari J. Shambaugh, Compliance Officer.

A description of the new drug approval process can be found on FDA's internet website at http://www.fda.gov/cder/regulatory/applications/default.htm. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857.

Sincerely,

/S/

Emma R.R. Singleton
Director, Florida District