San Francisco District Office 1431 Harbor Bay Parkway Alameda, CA 94502-7070 Telephone: (510) 337-6700 Fax: (510) 337-6701
RETURN RECEIPT REQUESTED
April 17, 2017
Healing Within Products & Services, Inc.
84 Berkeley Avenue
San Anselmo, CA 94960
Dear Mr. Weinberger,
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.healingwithin.com, from which you take orders for the following products: Astragalus Glycerite, Black Salve, Healthy Prostrate & Ovary, Hepato-C, NanoSilver, Normalose, Original Herbal Tea Remedy, ProBoost Thymic Protein A, and Siberian Chaga Mushroom Extract. As explained further below, introducing or delivering these products for introduction into interstate commerce violates the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Based on the labeling claims on your website, your products marketed as dietary supplements, are drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Examples of such disease claims found in the labeling of these products include, but may not be limited to, the following:
“in China Astragalus is commonly used to treat diabetes.”
“taking astragalus reduces total cholesterol and LDL cholesterol.”
“Astragalus is frequently used to treat or prevent the common cold . . .”
“has anti-bacterial and antiviral properties.”
“Astragalus may be beneficial for people with HIV.”
“Possibly treats hepatitis.”
“Astragalus may have a beneficial effect on colon cancer.”
“The salve will work on malignancies viruses as well as other skin problems such as warts . . .”
“If you are removing a hard Tumor or wart we suggest that you prick the wart or Tumor . . . to help penetration of Black Salve.”
Healthy Prostate & Ovary
“The King of Cambodia has used Crinum for prostate cancer.”
“Crinum is considered the first line of treatment for prostate and ovarian diseases.”
“extracts have been found to stimulate T cell proliferation, more specifically, T cells such as Cd3 and Cd4, as well as co-stimulation of T helper cells (Cd4) cells).”
“clinical trials in Vietnam have demonstrated Crinum to be highly effective for prostate diseases, especially benign prostate hypertrophy, ovarian cysts, and as adjunctive therapies for cancer.”
“Hepato-C has been formulated specifically for Hepatitis C.”
“Hepato-C . . . may help minimize the viral effects of Hepatitis C.”
“colloidal silver was a treatment of choice for many illnesses and infections.”
“colloidal silver will cure about 650 different diseases. It protects against Colds, Flu, and hundreds of diseases”
“Normalose contains Corosolic Acid . . . which has been shown in animal studies and human clinical trials to . . . Reduce blood sugar levels by up to 32% in mild to moderate Type II Diabetics.”
“An important new tool in fighting Syndrome X . . .”
“Have potential for use with Type I Diabetics . . .”
Original Herbal Tea Remedy
“Essiac is a product that is composed of 4 or more herbs, two of which . . . are known to kill cancer cells.”
“She named the tea Essiac Tea. Thousands were cured through her work, especially those with cancer, lupus and chronic fatigue.”
ProBoost Thymic Protein A
“Increasing white blood cell counts-vital in fighting conditions such as cancer.”
“Increases T-cell and B-cell levels critical in helping your immune system respond quickly and aggressively in its battle against infection and disease.”
“It may be effective against malignant melanoma, as well as therapy for chronic viral infections like hepatitis C and possibly some autoimmune diseases.”
Siberian Chaga Mushroom Extract
“The anti-cancer properties of betulin or betulinic acid . . . is now being studied for use as a chemotherapeutic agent. Chaga contains large amounts of betulinic acid . . .”
“Chaga restores the resistibility to harmful organisms and increases its protecting mechanisms directed towards the fight with malignant tumors.”
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.
Furthermore, your products are offered for conditions that 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 layperson can use these drugs safely for their intended purposes. Thus, your products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that their labeling fails to bear adequate directions for use. It is prohibited to introduce or deliver for introduction into interstate commerce a misbranded drug under 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 assure that you comply 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 fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the 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 actions within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your written notification should refer to the Warning Letter Number above (CMS# 513213). Please address your reply to:
Lawton W. Lum, Director of Compliance Branch
San Francisco District Office
1431 Harbor Bay Parkway
Alameda, CA 94505-7070
If you have questions regarding the contents of this letter, please contact Karen L. Robles at 916-930-3674 x 1114 or via email at Karen.Robles@fda.hhs.gov