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San Francisco District Office
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: (510) 337-6700
Fax: (510) 337-6701 

 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
WARNING LETTER
 
April 17, 2017
 
CMS# 513213
 
 
Stan Weinberger
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:
 
Astragalus Glycerite
Black Salve
Healthy Prostate & Ovary
Hepato-C
NanoSilver
Normalose
Original Herbal Tea Remedy
ProBoost Thymic Protein A
Siberian Chaga Mushroom Extract
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
 
Sincerely,
/S/ 
Darla R. Bracy
Acting District Director
San Francisco District

This page was posted on July 10, 2017.

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