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:
 
 
Under the heading “a few other uses for colloidal silver
 
Under the sub-heading, “a) as a general disinfectant and antibiotic”:
 
Under the heading, “prevention and maintenance”:
 
Under the heading, “sore throat”:
Under the heading, “colds and flu”:
 
Under the heading, “sinus infections”:
Under the heading, “athlete’s foot – toenail fungus, foot odor”:
 
 
Under the heading, “cuts, scrapes and sores”:
 
 
Under the heading, “acne and herpes”:
 
Under “douches and colonics”:
 
 
On the website at www.earthbornproducts.com:
 
On the webpage titled “The Natural Alternative Colloidal Silver Testimonials”:
 
Under the heading, “Prevention”:
 
 
Under the heading “Pseudomonas and Broncheictasis – Part I”:
 
Under the heading “Update – Part II”:
 
Under the heading, “Respiratory Infections”:
 
Under the heading, “Sinus Infections (Mouth, Ear, Nose, Throat & Eyes)”:
Under the heading, “Sinusitis”:
 
Under the heading, “Strep Throat
 
Examples of some of the claims for your brochure entitled “Siberian Chaga Extract” include:
 
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:
 
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:
 
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:
 
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. 
 
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)]. For 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.

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