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U.S. Department of Health and Human Services

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Enforcement Actions

Healing Ways 8/15/12

  

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

Public Health Service
Food and Drug Administration
 
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone:    949-608-2900
FAX:    949-608-4415

 

 
WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE                                                         
SIGNATURE REQUIRED
 
August 15, 2012                                                                                                         WL 36-12
 
Lewis David Blodgett, Owner
Healing Ways
18-801 Roberts Road, Ste 83
Desert Hot Springs, CA, 92241
 
Dear Mr. Blodgett:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the internet address http://www.healingways.com in July 2012.  Based on this review, FDA has determined that your Silver Colloids, ABC Detox Program, and Shell Powder products are promoted for conditions that cause the products to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. The claims on your website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your products with these claims violates the Act. You can find the Act and the referenced regulations through links in FDA's homepage at www.fda.gov.
 
Examples of some of the claims observed on your product labels obtained from www.healingways.com are as follows:
 
Silver Colloids:
  • “anti-microbial”
 
Shell Powder:
  • “CORRECTIVE: can kill parasites, bacteria and viruses.”
  • “Some Conditions Shell Powder benefits; psoriasis, arthritis/joint pain, osteoporosis, fibromyalgia, eczema, blood sugar imbalance, high blood pressure, high cholesterol…”
 
Examples of some of the claims observed on your website http://www.healingways.com are as follows:
 
Silver Colloids page:
  • ”Use it [Silver Colloids] to get relief from foreign bacteria, viruses, & fungi.”
  • “For a list of pathogens Silver addresses, click here”. The page contains a link another web page entitled “Pathogens Colloidal Silver Addresses”:
    • “Colloidal Silver Pathogenic microorganisms and serious disease conditions which colloidal silver was documented, prior to 1938, to be effective against. (Spellings as cited in the old medical texts):
1. …
20. Cystitis …
24. Dysentery …
26. Enlarged Prostate …
74. Shingles …
87. Typhoid …”
 
Your web site also contains disease claims in the form of personal testimonials, including:
 
  • “I was strugggling [sic] with many infections … Well I started to use the nasal spray colloidal silver morning and eve3ning …Usually at this time of year I am a running Fawcett [sic], but nothing!”
  • “I have suffered with skin lesions for about 10 years …with your product I have been able to heal the lesion and the one on my leg went from infected to drying up and almost gone, the rest of my body lesions are also reducing, as a result of your product …”
  • “When I use the silver colloids on my face I don’t get breakouts … A few years back I had a very bad case of diverticulitis and ulcerative colitis, both very painful. Since I have been using the Healingways silver on a regular basis my intestines have been healed and I no longer have symptoms …”
 
ABC Detox Program page:
  • “Decrease acute and chronic symptoms of dis-ease.”
  • “Taheebo Blend (2 fl. oz.) Pau D’Arco/Taheebo Blend has been successfully used in cancer therapy ...”
 
Your web site also contains disease claims in the form of personal testimonials, including:
 
  • “That is when I found Dr. Blodgett’s Healing Ways Detox program. A friend of mine started having relief from her IBS using the products, so she told me about Dr. Blodgett’s program. I have been on these products since June of 2008 (8months) and have not had ANY bouts of IBS since starting the program… I do not use the diarrhea or nausea medication prescribed by my doctor anymore.”
 
Shell Powder page:
  • “Benefits:”
  • “Corrective: can kill parasites, bacteria and virus.”
 
Your products Silver Colloids, ABC Detox Program, and Shell Powder are not generally recognized as safe and effective for the above referenced uses and, therefore, they are also new drugs under section 201 (p) of the Act [21 U.S.C. § 321 (p)]. New drugs may not be legally marketed in the United States without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C.§ 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
 
Furthermore, your Silver Colloids, ABC Detox Program, and Shell Powder 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 layman can use these drugs safely for their intended uses. Thus, these products are misbranded under 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.  The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
Additionally, the Food and Drug Administration has determined that your facility is subject to the registration requirement in § 415 of the Federal Food, Drug, and Cosmetic Act (the Act) , 21 U.S.C. § 350d, and our implementing regulation at 21 CFR Part 1, Subpart H. During the inspection of your facility you were advised of this requirement.  The failure to register a facility as required is a prohibited act under § 301(dd) of the Act, 21 U.S.C. § 331(dd). Our records indicate that, to date, your facility has not been registered with FDA.
 
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
 
We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this facility's owner, operator, or agent in charge, register the facility with FDA within 30 working days of the date of this letter. Registration may be accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
 
Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the agency at the following address:
 
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
 
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
 
The above violations are not intended to be an all-inclusive list of violations on your website or in your product labeling. It is your responsibility to ensure that all of your products are in compliance with all requirements of the Act and its implementing regulations.
 
You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action on violations may result in enforcement action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.
 
Please notify this office in writing within 15 working days from your receipt of this letter of the specific steps you have taken to correct the noted violations. In your response, include documentation of your corrective actions or steps towards long term, corrective actions. If you cannot complete all corrections within 15 days, please explain the reason for your delay and please include a timetable for the implementation of any remaining corrections.
 
Please send your reply to the Food and Drug Administration, Attention: 
 
Blake Bevill, Director
Compliance Branch
Los Angeles District
19701 Fairchild
Irvine, CA, 92612-2506
 
If you have questions regarding any issues in this letter, please contact David Whitman, Compliance Officer at 858-550-3850 x106.
 
 
Sincerely,
/S/                                                               
Alonza E. Cruse, Director
Los Angeles District
 
cc:
 
California Department of Public Health
Food and Drug Branch
Ingeborg Small, Branch Chief
1500 Capitol Avenue, MS-7602
P.O. box 997435
Sacramento, CA 95899-7435