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 pageat 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
Eczema and Psoriasis Shampoo 
Neem Seed 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
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

This page was posted on March 28, 2019.

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