Inspections, Compliance, Enforcement, and Criminal Investigations

Healing Scents 7/29/16

  

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

Public Health Service
Food and Drug Administration
 
Chicago District Office
550 W. Jackson Blvd., 15th Floor
Chicago, IL 60661
Telephone: (312) 353-5863
Fax: (312) 596-4187 

 

July 29, 2016
 
WARNING LETTER
CHI-11-16 
 
VIA UPS OVERNIGHT DELIVERY
SIGNATURE REQUIRED
 
Kathleen Hembree, Owner
Healing-Scents
1986 Will James Rd.
Rockford, IL 61109
 
 
Dear Ms. Hembree:                                        
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://healingscents.com/index.php in June 2016 and has determined that you take orders there for the products Age Spot Eraser, Eczema and Psoriasis Shampoo, Need Seem Oil, Hypertension Massage Formulas Oil or Lotion, Heart Herbs, Cholesterol Regulation Herbs, Diabetes Regulation Herbs, Prostate Healer Herbs, High Blood Pressure Herbs, Respiratory Ailment Herbs, Stomach/Intestinal Herbs. 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:
 
Age Spot Eraser
  • “Frankincense essential oil has antibacterial and anti-inflammatory benefits to the skin, making it ideal for acne-prone skin.”
  • “Lavender essential oil...helps regenerate skin cells so is great for …sun spots, and scarring.”
  • “Myrrh essential oil… has strong anti-inflammatory properties… Myrrh can also help heal sun damage, chapped skin, rashes, and eczema.” 
Eczema and Psoriasis Shampoo 
  • “Specially formulated shampoo for those who have Eczema or Psoriasis in the scalp area.”
  • “The essential oils are "essential" to help control eczema or psoriasis and heal the scalp.”
Neem Seed Oil 
  • “Neem is anti-viral, anti-fungal, and anti-inflammatory.”
  • “Neem produces pain-relieving, anti-inflammatory and fever-reducing compounds that can aid in the healing of cuts, burns, sprains, earaches, and headaches, as well as fevers.”
  • “Several studies of Neem extracts in suppressing malaria have been conducted, all supporting its use in treatment.” 
Hypertension Massage Formulas Oil or Lotion
  • “These essential oils can lower your blood pressure and help hypertension.” 
Heart Herbs 
  • “Use of this blend may help prevent and/or reduce the symptoms of many heart disease related conditions, including atherosclerosis, angina, neuritis, neuralgia, rheumatism, liver problems, arteriosclerosis, prevent coronary heart disease, congestive heart disease…”
  • “Hawthorn berry—boasts a century of effective use in cardiovascular disease. Helps dilate the blood vessels away from the heart, lowering blood pressure and reducing the heart's burden.”
  • “Motherwort—A hypotensive...”
  • “Cayenne—Helps lower blood cholesterol levels; to reduce blood pressure, cardiac problems, lipid levels.”
Cholesterol Regulation Herbs
  • “These herbs help the body lower high serum cholesterol and to help prevent the deposition of dietary cholesterol on arterial walls.”
  • “Apple Pectin [an ingredient in your product]—[D]ecreasing cholesterol…”
  • “Hawthorn berries [an ingredient in your product]—Slowly eats away cholesterol deposits and provides relief from concurrent hypertension.”
  •  “Black Cohosh [an ingredient in your product]– Reduces hypertension through vasodilation of peripheral veins.”
Diabetes Regulation Herbs
  • “Promotes the body's ability to reduce high blood sugar.”
  • “For Hyperglycemia: 3 capsules, 3 times per day.”
  • “Bilberry [an ingredient in your product]—Used by many naturopathic doctors to treat sugar diabetes and ailments of the kidneys and gallbladder.”
  • “Raspberry Leaf [an ingredient in your product]—Has a proven hypoglycemic action.”
  • “Gymnema sylvestre [an ingredient in your product]—The leaves are said to be used as a remedy for diabetes…and to cure diabetes and stress related disorders.”
  • “Parsley…the herb is very effective in remedying liver diseases.”
  • “Uva Ursi [an ingredient in your product]—[U]rinary antiseptic action. Relieves cystitis, nephritis and kidney stones.”
  • “Bladderwrack [an ingredient in your product]—Effective against nephritis, bladder inflammation, cardiac degeneration, obesity, thyroid problems.” 
Prostate Healer Herbs 
  • “To help provide systematic relief of prostate problems. Helps the body overcome the effects of an enlarged and/or inflamed prostate.”
  • “USE: Inflamed prostate: 2–8 capsules daily…Enlarged prostate: 3–6 capsules daily.”
  • “This blend helps fight prostatitis and enlargement in at least four ways. 1. Stimulates urine flow. 2. Reduces inflammation and infection. 3. Decreases the size of the enlarged prostate. 4. Prevents these conditions.”
  • “Parsley [an ingredient in your product]—Diuretic recommended for enlarged prostate, painful and incomplete urination. Stimulates urination and provides relief.”
  • “Saw Palmetto Berry [an ingredient in your product]—Acts directly on the enlarged prostate to reduce inflammation, pain and throbbing.
  • “Corn Silk [an ingredient in your product]—[R]educes painful symptoms and swelling from several inflammatory conditions of the bladder, kidneys, female system and well as hepatitis and all edematous conditions.”
  • “Mullein [an ingredient in your product]—A demulcent to soothe irritated mucous membranes. Reduces swelling and pain. Kills bacteria.”
  • “Buchu leaf [an ingredient in your product]—Known to reduce swelling of the prostate. Soothe the lining membrane of the urethra and alleviate painful urination. It has been proven to help control bladder and kidney problems and the incontinence that is associated with prostate problems.”
  • “Bladderwrack [an ingredient in your product]—Effective against nephritis, bladder inflammation, cardiac degeneration, obesity, thyroid problems.”
  • “Kelp [an ingredient in your product]—[T]o treat disorders of the genital urinary tract, including kidney, bladder, prostate and uterine problems. Normalizes and remedies the enlarged prostate. Daily kelp ingestion gradually reduces the prostate in older men to the point that urination becomes painless.”
High Blood Pressure Herbs 
  • “Purpose: Helps the body reduce high blood pressure (hypertension)… Helps lower serum cholesterol. Other applications: hives, shingles, erysipelas, insomnia.”
  • “USE: High blood pressure: 23 capsules, 34 times per day… High Cholesterol: 4 capsules daily…”
  • “Skullcap…Used to help normalize cholesterol and blood pressure levels… helps with sleep disorders…”
  • “Garlic… Regularly eating garlic could have dramatic benefits in heart disease due to atherosclerosis.”
  • “Black Cohosh… hypotensive effects…”
  • “Kelp… antibiotic and hypotensive… Can give significant improvement in blood pressure readings…”
  • “Cayenne [an ingredient in your product]—Helps lower blood cholesterol levels, to reduce blood pressure, cardiac problems, lipid levels.” 
Respiratory Ailment Herbs 
  • “Purpose: To relieve the distress of respiratory ailments such as pneumonia, asthma, bronchitis, croup, tuberculosis, colds, flus, hay fever, emphysema… Also for allergies, fevers, colitis, cancer.”
  • “Lungwort… Good treatment for chronic bronchitis. Helps to treat coughs from whooping cough and other infections. It also works to treat problems with asthma. Was used to treat tuberculosis.”
  • “Pleurisy root [an ingredient in your product]—Treatment of colds, flu, bronchitis, tuberculosis, pleurisy… Healing in pneumonic fevers, colds, catarrh.”
  • “Slippery Elm bark… remarkably effective against sore and inflamed mucous membranes.”
  • “Plantain [an ingredient in your product]-Used in cases of chronic bronchitis…”
  • “Chickweed [an ingredient in your product]—Gives relief for bronchitis, whooping cough, colds, sore throats, flu, and tuberculosis. Has antibiotic properties against respiratory pathogens. Useful against blood diseases, gout, joint disease.” 
Stomach/Intestinal Herbs
  • “IBS, Colitis,Crohns, Diverticulitis, Indigestion, Inflammation…Diarrhea, Ulcers”
  • “Purpose: Soothe and heal gastrointestinal tract disorders.”
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. 
 
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 Hypertension Massage Formulas Oil or Lotion, Heart Herbs, Cholesterol Regulation Herbs, Diabetes Regulation Herbs, Prostate Healer Herbs, High Blood Pressure Herbs, Respiratory Ailment Herbs, Stomach/Intestinal Herbs 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, Hypertension Massage Formulas Oil or Lotion, Heart Herbs, Cholesterol Regulation Herbs, Diabetes Regulation Herbs, Prostate Healer Herbs, High Blood Pressure Herbs, Respiratory Ailment Herbs, Stomach/Intestinal Herbs 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)].
 
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. Please respond in writing to Russell Riley, Compliance Officer, Food and Drug Administration, 550 W. Jackson Blvd., 15th Floor, Chicago, IL 60661. Refer to the Unique Identification Number (CMS# 499219) when replying. If you have questions regarding the content of this letter, please contact Mr. Riley via email at russell.riley@fda.hhs.gov or by phone at (312) 596-4219.
 
                                                                                                                                                           
Sincerely,
/S/ 
William R. Weissinger                                   
District Director

 

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