FDA Warning Letter to Earthborn Products, Inc.

January 25, 2019
   

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

 Public Health Service
Food and Drug Administration
  Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax (949) 608-4415 

WARNING LETTER

VIA UNITED PARCEL SERVICE                                                                     
SIGNATURE REQUIRED
 
May 2, 2013                                                                                                                    
WL# 36-13
Ms. Sheri L. Braemer, Owner                                                                                                
Earthborn Products, Inc.
3603 1st Ave. Suite 403
San Diego, CA 92103
 
Dear Ms. Braemer:
 
The United States Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, Earthborn Products, Inc., located at 9275 Sky Park Ct. Suite 101 San Diego, CA on September 15th and September 25th, 2012. During the inspection, our investigator collected labels and brochures of your products. Based on our review of these labels and brochures, as well as your website http://www.earthbornproducts.com in March 2013, your Colloidal Silver 100 ppm TDS and Siberian Chaga Extract are promoted for conditions that cause the products to be drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)]. The therapeutic claims on your product labels and website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.
 
You can find the Act and FDA’s regulations through links on FDA’s home page at
http://www.fda.gov.
 
Unapproved New Drug
 
Examples of some of the claims observed in the labeling for “Colloidal Silver 100 ppm TDS” include:
 
 The Universal Alternative and Universal Antibiotic Brochures:
 
  • “Colloidal Silver . . . The Universal Antibiotic . . . The strongest and safest broad-spectrum antibiotic ever known, it has been proven to be useful against over 650 different infectious conditions.”
  • “Colloidal silver…has a prolonged therapeutic action.”
  • “Based on laboratory tests, virus and fungus organisms, together with destructive bacteria are killed within minutes of contact with colloidal silver. Parasites are also killed while in their egg stage.”
 
Under the heading “
a few other uses for colloidal silver”
 
Under the sub-heading, “a)
as a general disinfectant and antibiotic”:
 
  • “Anything that requires the application of a disinfectant, antiseptic…or antibiotic, first try colloidal silver.”
Under the heading, “
prevention and maintenance”:
 
  • “In order for colloidal silver to work as a preventative, it is important that you used it on a daily basis.”
Under the heading, “
sore throat”:
  • “Hold about ½ oz. of colloidal silver in your mouth, for as long as possible, and then swallow. If possible, gargle before swallowing.”
Under the heading, “
colds and flu”:
 
  • “At the first sign of these symptoms, take an amount of colloidal silver that feels comfortable in your mouth (about ½ oz.) and hold it as long as is comfortable before swallowing. Swill inside your mouth, and gargle if possible. Do this three times a day. Also, spray or drip into each nostril.”
  • “Provided one takes the colloidal silver at the onset of the flu, noticeable improvement has been reported in twenty-four hours.”
Under the heading, “
sinus infections”:
  • “Spray or drip into each nostril. Lay on top of the bed with your head hanging over the side and nostrils pointing toward the ceiling. Place five (5) to seven (7) drops into each nostril.”
  • “When first used, there might be a little discomfort, a stinging sensation. This is normal. It is an indication that the colloidal silver is working and is eliminating the cause of the infection.”
Under the heading, “
athlete’s foot – toenail fungus, foot odor”:
 
  • “After washing and drying the foot, spray affected area. Also, small cotton balls can be soaked in colloidal silver and placed between the toes for a while, if this is the only affected area. It is also helpful to take colloidal silver orally in order to provide a systemic effect.”
  •  “For toenail fungus, file the shine off the infected toenail (to increase porosity) and then spray colloidal silver or apply with a cotton ball directly on the toenail surface.”
 
Under the heading, “
cuts, scrapes and sores”:
 
  • “Apply directly onto cuts, scrapes, scratches, and open sores. Dab directly onto skin lesions and eczema, or any skin problem. Moisten cotton ball with colloidal silver and tape over affected area.”
 
Under the heading, “
acne and herpes”:
  • “Place several drops on a cotton ball and apply over affected area. Follow the same procedure for burns, insect bites, warts, rashes, sunburn, razor nicks, etc. Also swallow a couple tablespoons of colloidal silver several times during the day.”
 
Under “
douches and colonics”:
 
  • “May be safely instilled in the vagina for simple vaginal yeast infections, and in the colon to combat bacterial infections. Retain solution inside as long as possible for best results.”
 
On the website at www.earthbornproducts.com:
 
On the webpage titled “The Natural Alternative Colloidal Silver Testimonials”:
 
Under the heading, “
Prevention”:
 
  • “From the time I started taking your colloidal silver, which was during the peak of the cold and flu season…I have not been ill once.”
  • “Since starting to use colloidal silver I have not had a cold or the flu in that time period. My family was skeptical until they were getting sick and I wasn’t …”
 
Under the heading “
Pseudomonas and Broncheictasis – Part I”:
 
  • “My cousin told me of her success with Colloidal Silver for Pseudomonas Aeruginosa a bacterial infection…Last year I was diagnosed with this…I have been taking your 100 ppm Colloidal Silver one oz 3 x a day and I feel like myself again…I also have Broncheictasis which is a bacteria [sic] infection and the symptoms are similar to Pseudomonas. Since I have been on the Colloidal Silver my condition has improved considerably…”
Under the heading “
Update – Part II”:
 
  • “The doctors told me the infection never goes away it can just be controlled…I found your site and read about the Colloidal Silver and that it could kill bacteria Pseudomonas Aeruginosa…I then ordered a gallon jug of Colloidal Silver from you and started taking it … I am enclosing a copy of my last lab report…which shows NO Pseudomonas Aeruginosa.”
Under the heading, “
Respiratory Infections”:
 
  •  “This winter I picked up an infection in my head and chest…I had been struggling for six weeks to shake this infection…I did a search and came across Earthborn’s website…This product [colloidal silver] was shipped quickly to my door…Within two weeks all signs of the infection were gone. I continued to take a single dose each morning for another two weeks to ensure I did not relapse, and now I take a dose for several days any time I feel another stomach, head, nose, throat, or flu symptoms coming on. I have not had another sick day since thanks to your product.”
  • “A friend told me about colloidal silver; the next time [my son] exhibited the first minor cold like symptom, I began giving him colloidal silver. No infection developed and he recovered quickly without any other medication or negative side effects.”
Under the heading, “
Sinus Infections (Mouth, Ear, Nose, Throat & Eyes)”:
  • “I heard about your product from a friend who uses it regularly to prevent his sinus infections. As winter was approaching, I decided to try it myself, since I am prone to sore throat and colds. So far, I have actually been able to stop two sore throats from developing into chest colds, which they always used to do. When I feel a sore throat starting, I just gargle with the silver water and sip it throughout the day, and before the day is over I am fine! WOW! This is incredible! I will never be without it again.”
  • “If any family member gets a sore throat, this stuff knocks it out, simply by taking a mouthful and gargling. Then take another and let it sit against your throat. It really works. Also, it is more effective than any topical anti-biotic ointment for cuts or burns, as it will prevent infection and, if an infection happens to occur, take a Q-Tip and rub this product on it. Infection gone within a day…If you have the onset of the flu or a cold? Drink 8 oz of it and it will knock it out. I hate antibiotics, so this stuff is great for anything an antibiotic should do.”
  • “Prior to using this product I used to suffer from at least 1 sinus infection per year. Since i have been using colloidal silver, none.
Under the heading, “
Sinusitis”:
  • “The use of colloidal silver in a nose spray and with a dropper as directed has completely cleared up my chronic sinusitis which I have endured for years.”
 
Under the heading, “
Strep Throat”
 
  • “I began to take sips of your colloidal silver and I could immediately feel relief…I felt a relief and subsiding bacteria. I took a look at my throat, a lot of the strep was gone. This in about 4 hours.”
Examples of some of the claims for your brochure entitled “Siberian Chaga Extract” include:
 
  •  “Chaga is…a possible treatment for a wide variety of diseases and health problems, including… the flu…HIV and certain types of cancer”.
  • “Recent studies…have shown Chaga to have anti-tumor benefits related to mammary glands and female sex organs.”
  • “Studies…have demonstrated that inotodial, one of the most active ingredients in Chaga, was effective against influenza virus and various cancer cells…”
  • “Chaga shows activity against HIV (protease inhibition).”
Your products are not generally recognized as safe and effective for the uses as noted above, and therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Under section 301(d) and 505(a) of the Act [21 USC §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. 
 
Furthermore, because these products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions for use cannot be written so that a layperson can use the drugs safely for their intended uses. Thus, the labeling fails to bear adequate directions for use, causing these products to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction of misbranded drugs into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
Dietary Supplement CGMP Violations
 
Even if your products did not have these therapeutic claims, which make them drugs, your products are adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Specifically, during our inspection, our investigators observed the following significant violations: 
 
1. For each dietary supplement that you manufacture, you failed to establish product specifications for the identity, purity, strength, composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, have not established any finished product specifications for your finished dietary supplements Colloidal Silver 100 PPM TDS and Siberian Chaga Extract.
 
We have reviewed your response and do not consider it adequate. No supporting documentation was provided to demonstrate compliance.
 
2. You failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(1)(i), and you did not request an exemption from this requirement as provided for by 21 CFR 111.75(a)(1)(ii). Specifically:
  • Your firm manufactures the dietary supplement, Colloidal Silver, however, you did not perform any test or examination to verify the identity of 99.999% Pure Silver (no lot#), which was used in the manufacture of Colloidal Silver 100 ppm TDS Lot #(b)(4)Exp:10/2014.
  • Your firm also manufactures the dietary supplement, Siberian Chaga Extract. You failed to perform any test of examination to verify the identity of (b)(4) ((b)(4)) Lot # (b)(4) Best Before 04 August 2014, which was used in the manufacture of Siberian Chaga Extract Lot# (b)(4)Exp. 10/2014.
 
We have reviewed your response and do not consider it adequate. Your response lacked specificity for your proposed corrective actions, i.e., any investigation that you’ve conducted into obtaining certified standards for your dietary ingredients, standard operating procedures. In addition, no supporting documentation was provided to demonstrate compliance.
 
3. You failed to include in your master manufacturing records written instructions for specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing records as required by 21 CFR 111.210(h)(1). Specifically:
 
  • Your “Make Colloidal Silver Batch” instructions do not include specifications to control the quality of the supplement and do not include packaging and labeling specifications
  • Your “Brewing Chaga Instructions” do not include specifications to control the quality of the supplement and do not include packaging and labeling specifications.
We have reviewed your response and do not consider it adequate. No supporting documentation was provided to demonstrate compliance.
 
4. You failed to prepare a batch production record every time you manufactured a batch of dietary supplement, as required by 21 CFR 111.255. Specifically, on 9/15/2012 you manufactured a batch of
(b)(4) (approximately
(b)(4)) Siberian Chaga Extract Lot#
(b)(4) Exp. 10/2014, however, you did not prepare a batch production record.
 
Further, your batch production records, when you did prepare them, did not include complete information relating to the production and control of each batch of your dietary supplement products as required by 21 CPR 111.260. Specifically, on 9/15/2012 you manufactured a
(b)(4) 
(b)(4) batch of Colloidal Silver 100 PPM TDS Lot #
(b)(4)Exp:10/2014. The only records are notes on a small spiral bound notebook of the results of the Total Dissolved Solids (TDS) you measured during the manufacturing process.
 
We have reviewed your response and do not consider it adequate. No supporting documentation was provided to demonstrate compliance.
 
5. You failed to establish and follow written procedures for the responsibilities of quality control operations, as required by 21 CFR 111.103. Specifically, you have not established written quality control procedures for the quality control operations related to the manufacturing, packaging, labeling, or holding of Colloidal Silver 100 ppm TDS and Siberian Chaga Extract, in order to ensure the identity, purity, strength, and composition of the products prior to releasing them for distribution.
 
We have reviewed your response and do not consider it adequate. No supporting documentation was provided to demonstrate compliance.
 
Misbranded Dietary Supplement
 
Even if your Colloidal Silver 100 PPM TDS and Siberian Chaga Extract products did not have the therapeutic claims referenced above, which make them drugs, they are misbranded dietary supplements, as discussed further below.
 
Your Colloidal Silver 100 PPM TDS and Siberian Chaga Extract dietary supplements are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of your products does not comply with 21 CFR 101.36.
  Specifically, Colloidal silver and Chaga extract are “b3 dietary ingredients” but they are listed in the supplement facts as 100%, not 100 ppm. Colloidal silver and Chaga extract should be listed by their quantitative amount by weight per serving in metric units in accordance with 21 CFR 101.36(b)(3)(ii)(A). 
 
According to 21 CFR 101.36(b)(3),“b3 dietary ingredients” are dietary ingredients for which FDA has not established RDI’s or DRV’s and that are not subject to regulation under 101.36(b)(2) (hereinafter referred to as “other dietary ingredients”) shall be declared by their common or usual name when they are present in a dietary supplement. 
 
Your Colloidal Silver 100 PPM TDS and Siberian Chaga Extract dietary supplements are misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that they are marketed in the United States, however the label does not include a domestic address or domestic phone number through which a responsible person may receive a report of a serious adverse event caused by your dietary supplements.
 
(b)(3)
 
(b)(3)
 
This letter is not intended to be an all-inclusive list of violations at your facilities.  It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations.
 
We also offer the following comments:
 
  • By definition, dietary supplements must be intended for ingestion. See sections 201(ff)(2)(A) and 411(c)(1)(B) of the Act [21 U.S.C. §§ 321(ff)(2)(A) and 350(c)(1)(B)].  However, the labeling for your Colloidal Silver 100 ppm TDS products suggests a number of routes of exposure for these products other than ingestion. For example, your product brochure includes the following statements (among many others):
    • “For simple eye infections, drip in affected eye (two drops).”
    • “SINUS INFECTIONS . . . Spray or drip into each nostril.”
    • “ATHLETE’S FOOT – TOENAIL FUNGUS . . . spray affected area. Also, small cotton balls can be soaked in colloidal silver and placed between the toes for a while.”
    • “Dab directly onto skin lesions and eczema . . .”
    • “May be safely instilled in the vagina for simple vaginal yeast infections, and in the colon to combat bacterial infections.”
We note that only products that are intended for ingestion may be lawfully marketed as dietary supplements. Topical products and products intended to enter the body directly through the skin or mucosal tissues, such as transdermal products, are not dietary supplements. For such products, both disease and structure/function claims may cause them to be new drugs.
 
 
  • 21 CFR 111.8 requires you to establish and follow written procedures for hygienic practices.  However, we note that, on 9/15/2012, the date of your inspection, you did not remove your earrings and necklace before processing Siberian Chaga Extract and Colloidal Silver. You also did not wear a cover such as a hair net, for loose hair before beginning processing. 
  • 21 CFR 111.25 requires that you establish and follow written procedures for fulfilling the requirements for equipment and utensils. However, we note that you do not have written procedures for the following: the calibration scale used for measuring Chaga extract, your cleaning and sanitizing of equipment and utensils for processing Siberian Chaga and Colloidal Silver. Further, you have not determined the suitability of equipment being used to manufacture the dietary supplements Siberian Chaga and Colloidal Silver.
  • 21 CFR 111.14(b)(2) requires you to make and keep documentation of training. However, we note that you have no records for training you have received to process dietary supplements. During the inspection, you indicated you do not have any records for training you received from your mother and you also acknowledged that you have not received training in quality or production and process controls for manufacturing dietary supplements.
  • 21 CFR 101.4(g) requires the ingredient list on dietary supplement products to be located immediately below the nutrition label, or if there is insufficient space below the nutrition label, immediately contiguous and to the right of the nutrition label. However, we note that your Colloidal Silver dietary supplement label lists the “other ingredients” within the supplement facts panel and not outside and directly below or contiguous and to the right of the supplement facts panel.
You should take prompt action to correct the violations specified above and prevent their reoccurrence.  Failure to do so may result in enforcement action by FDA without further notice, including seizure and injunction. 
 
Within fifteen (15) working days from your receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations noted above.  Include in your response documentation to show that correction has been achieved.  If you cannot complete all corrections within 15 working days, please state the reason for the delay and the date by which you will complete the corrections.
 
Please send your written response to this letter to:
 
Blake Bevill
Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA
   92612
 
Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. F
or a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility.  The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
 
If you have any questions about this letter, please contact Jennifer M. Gogley, Acting Compliance Officer, at 949-608-3523.
 
Sincerely,
/S/                                                                                 
Alonza E. Cruse, Director
Los Angeles District
 
 
cc: 
     
Hugo Cornejo, Acting Chief
California Department of Public Health
Food and Drug Branch
PO Box 997413
1500 Capitol Avenue – MS 7602
Sacramento, California 95899-7435
Attn: FDA Correspondence

This page was posted on January 25, 2019.