WARNING LETTER
Silver Armor, Inc. MARCS-CMS 543786 —
- Product:
- Animal & Veterinary
- Recipient:
-
Recipient NameMs. Sue Ann Murray
- Silver Armor, Inc.
300 Willow Bend Rd., Suite 19
Peachtree City, GA 30269
United States
- Issuing Office:
- Atlanta District Office
United States
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Atlanta District Office
60 Eight Street, N.E.
Atlanta, GA 30309 |
May 17, 2018
VIA UPS OVERNIGHT DELIVERY
Ms. Sue Ann Murray, President
Ms. Darlene R. Dennis, Vice President
Silver Armor, Inc.
300 Willow Bend Rd., Suite 19
Peachtree City, GA 30269
Reference: CMS Case # 543786
WARNING LETTER
Dear Ms. Murray and Ms. Dennis:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 300 Willow Bend Rd., Suite 19, Peachtree City, GA 30269 from October 31 through November 11, 2017. Based on the inspection, a review of the product labels and promotional literature collected, and a review of your website, www.silver-armor.com, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You may find the Act and related regulations through links in FDA's home page at www.fda.gov.
Unapproved New Drugs and Misbranded Drugs
Examples of some of the claims on the product labels, accompanying promotional literature, and your website that provide evidence that your products are intended for use as drugs include, but are not limited to the following:
Silver Ramon brand Hand Sanitizer, Citrus, 2 ounce:
• “[A]nti-bacterial and anti-microbial . . . Sanitizes . . .”
• The product name, “Hand Sanitizer”
Silver Ramon brand Hand Sanitizer, Caribbean Breeze, 2 ounce:
• “[A]nti-bacterial and anti-microbial . . . Sanitizes . . .”
• The product name, “Hand Sanitizer”
Silver Ramon brand Hand Sanitizer, Caribbean Breeze, 0.5 ounce:
• The product name, “Hand Sanitizer”
Silver Ramon brand All Natural Mouthwash, organic mint:
• “Natural Antiseptic . . .• Anti-cavity • Anti-gingivitis • Anti-plaque • Reduces tartar buildup . . . • Soothes toothaches, irritated gums & inflammation . . .”
Silver Ramon brand Colloidal Silver Toner:
• “[H]elps to reduce inflammation & minimize breakouts. . . Beneficial for acne, cuts, burns & rashes. . ..”
Silver Ramon brand nanotherapy:
• “[P]romote healthy circulation. . .Improves blood flow • Stimulated hair growth • Relieves dry, itchy scalp. . .revitalize the scalp. . .”
Natural Health Immune Support & Protection:
• “For: Allergies, stuffy nose, sinus infections or irritated sinuses. . .”
First Aid Antiseptic Gel (2 and 4 fl oz):
• “Protect from Bacteria and Infection. . .”
• “Reduce Pain, Inflammation, Scarring and Scar Tissue. . .”
• “Stimulate Production of Stem Cells. . .”
• “Rebuild Damaged Tissue. . .”
• “Uses: Abrasions, Acne, Bites, Blisters, Boils, Burns, Cold Sores . . . Diseased Skin . . . Germ Protection, Infections (Bacterial, Fungal, Viral or Parasitic), Inflammation, Irritations, Itching, Rashes, Skin Conditions, Sores, Sunburn, Post Surgical, Topical Antibiotic, Ulcers, Warts, Wounds, etc. . .”
Silver Armor brand Natural Health Immune Support & Protection ( 4 ounce spray):
• “Eliminate burning, chafing or irritation from skin. . .”
• “Protect from Bacteria and Infection. . .”
• “Reduce Pain, Inflammation, Scarring and Scar Tissue. . .”
• “Rebuild Damaged Tissue. . .”
Silver Armor brand Natural Health Immune Support & Protection (4 ounce drops):
• “Use 1 to 2 drops for eyes and 2-3 drops for ears every hour as needed. Soothes and relieves itching, infections, pain, irritation, and swimmer’s ear. . .”
Silver Armor brand Natural Health Immune Support & Protection, 1 gallon:
Product label –
• “First sign of Illness. . .”
Silver Armor brand Natural Health Immune Support & Protection, 32 fluid
ounce:
Product label –
• “First sign of Illness. . .”
Website –
• “Keep on hand for illness or injury. . .”
Silver Armor brand Natural Health Immune Support & Protection, ½ gallon:
Product label –
• “First sign of Illness. . .”
Silver Armor brand Natural Health Immune Support & Protection, 16 fluid
ounce:
Product label –
• “First sign of Illness. . .”
General from website:
• “[E]effective against the causes of disease. . .”
• “It is the most powerful and safest broad-spectrum antibiotic alternative known to man. . .”
Testimonials page of website, entitled “REAL RESULTS”:
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of your Silver Armor brand Natural Health Immune Support & Protection products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
• “Silver Armor has been very effective when wiping away my seasonal allergies. Every morning I would wake up with swollen eyes and itchy face and wonder what I could do to make this stop. A couple sips of Silver Armor eliminated most of the itching. . .”
• “I have COPDand when I over exert myself I contract bronchitisthat usually lasts about three weeks. I started taking Silver Armor about a month ago and not only has my everyday coughing deteriorated, I have also found that if I feel a bout of bronchitis coming on I double up on my dose taking it in the am and pm, and within a day the congestion has broken up and my coughing subsides. I also use different inhalers for my COPD, last month I tried a new one and it gave me oral thrush, which is basically a yeast infection in the mouth. By rinsing with the Silver Armor each day as well as taking my normal daily dose, it was gone in two days, totally gone! I have also noticed that since I started taking Silver Armor my gums are not sore anymore.”
Research page of website:
• “[P]eople who have low silver levels tend to be frequently sick and have frequent colds, flu, fevers and other illnesses. He stated, "Success (in cancertreatment) depends on silver in the person's body, when silver is present, the cancer cells de-differentiate and the body is restored. When silver levels are non-existent, the cancer growth rate continues because the cells cannot de-differentiate. I suspect a silver deficiency is possibly one of the reasons cancer exists and is increasing at such a rapid rate. . ."
• "[C]olloidal silver is highly anti-viral". In laboratory tests he found that "all fungus, virus, bacterium, streptococcus, staphylococcus, and other pathogenic organisms are killed in three or four minutes. In fact, there is no microbe known that is not killed by colloidal silver in six minutes or less in a dilution as little as five parts per million. . ”
• “[P]revent food poisoning. . . silver was doing something more than killing disease organisms, it was also causing major growth stimulation of injured tissues. Burn patients and elderly patients noticed more rapid healing. He discovered that, "all cancercells change back to normal cells. All strains of pathogens resistant to other antibiotics are killed by colloidal silver. . ."
History page of website:
• “It is used across the globe as a preventative supplement as well as an aide in healing infections. . .”
• “[U]sed to aid wound healing and as sutures to prevent infection in post surgery events. . .”
• “[A]dminister silver nitrate to the eyes of newborns, virtually eliminating the incidence of disease which caused blindness. . .”
• “Allowing colloidal silver to become the mainstay of antimicrobial therapy. . .”
Usages page of website:
• “Allergies:. . . Flu-like Symptoms:. . ..Use for food poisoning, ulcers, parasitic, fungal & bacterial infection. . . Once inflammation has reduced and the symptoms have cleared. . . Use for relief from sinus infection, congestion, allergies, irritated and dry sinuses. . . Warts. . .”
Silver Armor promotional card:
• “Allergies. . .Athlete’s Food. . .used for fungal & bacterial infections. . . for pain & infection. . .relief from itching, infection, dryness, redness, irritation & crusty eyes. . .Flu-like symptoms. . .Use for: food poisoning, ulcer, parasitic, fungal & bacterial infection. . . mouth & gum infection, abscess, cold sores & gargle for sore throat. . .”
Silver Armor promotional brochure:
• “It is used across the globe as a preventative supplement as well as an aide in healing infections. . . used to aid wound healing. . .sutures to prevent infection in post surgery events. . .Silver is …effective against a wide range of pathogens. . . “
• “[S]ilver kills bacterial. . .sore throats, disinfectant, sores. . .universal antibiotic substances. . .effective against hundreds of infectious conditions. It has tremendous anti-microbial power. . .reduce the length and severity of infectious disorders. . .eliminating all known pathogens and guard against opportunistic infections. . .even the most powerful pharmaceutical antibiotics are effective against only a small number of microorganisms, and then only until drug-resistant strains develop. Yet research. . .has shown that silver is bactericidal to nearly 650 different disease-causing organisms, and that silver-resistant bacteria strain do not develop. . .”
• “[M]ost powerful, safest broad-spectrum antibiotic alternative known to man. . .disable over 650 disease causing pathogens. . .to fight colds, flu and other diseases caused by bacteria, virus, fungus, parasites, pathogens and free radicals. . . Proven effective against antibiotic resistant microbes like SARS and MRSA. . . Helps to eliminate streptoccocus (sic) and staphyloccocus (sic) bacteria. . . anti-tumor properties against MCF-2 human breast cancer cells. . .wounds and infections for faster healing and to minimize scarring. . .”
• “Benefits & Uses. . .Allergies. . .Bacteria. . .Congestion. . . Flu-Like Symptoms. . .Lung Infections. . .acne & eczema. . .”
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.
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your Silver Armor brand Natural Health Immune Support & Protection products, 4 ounce spray and 4 ounce drops products and products sold in 1 gallon, ½ gallon, 32 fluid ounce, and 16 fluid ounce bottles, are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner; therefore, adequate directions for use cannot be written so that a layperson can use your products safely for their intended purposes. Thus, these products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
Further, according to 21 CFR 310.548, any OTC drug product containing colloidal silver ingredients that is labeled, represented, or promoted for the treatment and/or prevention of any disease is regarded as a new drug within the meaning of section 201(p) of Act for which an approved application is required for marketing, without which such product is also misbranded under section 502 of the Act [21 U.S.C. § 352].
Unapproved New Animal Drugs (Unsafe and Adulterated)
Moreover, your website and promotional brochures indicate your Silver Armor brand Immune Support and Protection products are also intended for use in the cure, mitigation, treatment, or prevention of diseases in animals. For example, your website at http://www.silver-armor.com/benefits states: “Animals, Give 1 - 2 oz for daily immune support or 2 - 4 oz every 4 hours for illness. Use for eyes, ears, nose, skin, on wounds and bedding.” Your brochure entitled “Next Generation Natural Health” states the following regarding use of your Silver Armor brand Immune Support and Protection products: “Silver helps to destroy bacterial, fungal and viral infections in cats and dogs just as well as it does in human beings.” Because your Silver Armor brand Immune Support and Protection products are intended to cure, mitigate, treat, or prevent diseases in animals, they are drugs within the meaning of section 201(g)(1)(B) of the Act, [21 U.S.C. § 321 (g)(1)(B)]. The products are not generally recognized as safe and effective for the above referenced uses; therefore, they are “new animal drugs” as defined by section 201(v) of the Act, [21 U.S.C. § 321(v)], They are not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. Therefore, these products are unsafe within the meaning of section 512(a) of the Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)]. The introduction or delivery for introduction into interstate commerce of these adulterated drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
Dietary Supplement CGMP Violations
Even if your Silver Armor brand Natural Health Immune Support & Protection products in 1 gallon, ½ gallon, 32 fluid ounce, 16 fluid ounce bottles, 4 ounce drops, and 4 ounce spray did not have therapeutic claims which make them unapproved new drugs, these products, would still be adulterated dietary supplements within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because the products have been manufactured under conditions that do not meet the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation in Title 21, Code of Federal Regulations, Part 111 (21 CFR part 111).
Significant violations of the CGMP regulations for dietary supplements identified during the inspection include, but may not be limited to the following:
1. Your firm failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103 and 21 CFR 111.140(b)(1). Specifically, you have no written procedures for the responsibilities of the quality control operations.
To fulfill the requirements for quality control operations, quality control personnel must ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.105).
We have reviewed your response letter dated November 28, 2017, in which you stated that you are in the process of preparing the required written procedures; however, we are unable to evaluate the adequacy of your corrective action because supporting documentation was not provided. You stated that these processes will be completed by September 30, 2018.
2. You failed to establish a specification for any 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 record, as required by 21 CFR 111.70(a). Specifically, you failed to establish any such specifications. The specifications you must establish include, but are not limited to, the following:
a. Specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b).
b. In-process production specifications for any point, step, or stage in the master manufacturing record where control is necessary to help ensure that specifications are met for the identity, purity, strength, and composition of the dietary supplements, as required by 21 CFR 111.70(c).
c. Specifications for dietary supplement labels (label specifications) and for packaging that may come in contact with dietary supplements (packaging specifications), as required by 21 CFR 111.70(d).
d. Specifications for each dietary supplement product you manufacture for the identity, purity, strength, and 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).
e. Specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specifications that ensure that you used the specified packaging and that you applied the specified label, as required by 21 CFR 111.70(g).
Once you have established the required specifications, you must determine whether the specifications have been met in accordance with 21 CFR 111.73 and 21 CFR 111.75. You must collect representative samples of each unique lot of components, packaging, and labels that you use to determine whether the components, packaging and labels meet specifications established in accordance with 21 CFR 111.70(b) and (d), and as applicable, 21 CFR 111.70(a), as required by 21 CFR 111.80(a).
Further, you must implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.55.
We have reviewed your response letter dated November 28, 2017, in which you stated that your firm is in the process of preparing written specifications; however, we are unable to evaluate the adequacy of your corrective action because supporting documentation was not provided. You stated that these processes will be completed by September 30, 2018.
3. You failed to conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(1)(i). Specifically, your firm has never confirmed through test or examination, the identity of the ingredient “APMEX Silver Bars”, used in the manufacturing of all finished dietary supplements.
We have reviewed your response letter dated November 28, 2017, in which you stated that your firm is in the process of locating a firm to perform an identification test and examination for a dietary ingredient in your products. We are unable to evaluate the adequacy of your corrective action, as you have not established the required component specifications for the dietary ingredients used in your products. Therefore, without established specifications, you will not be able to effectively verify the identity of the dietary ingredient.
4. You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of a dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205. Specifically, you did not prepare a written MMR for any of your Silver Armor brand Natural Health Immune Support & Protection products your firm manufactures, labels and distributes as dietary supplements. Once you have established a master manufacturing record, it must conform to the requirements of 21 CFR 111.210.
We have reviewed your response letter dated November 28, 2017, in which you stated that your firm is in the process of preparing a written master manufacturing record for the dietary supplements your firm manufacture. We are unable to evaluate the adequacy of your corrective action as no supporting documentation was provided. You stated that this corrective action will be completed and implemented by January 31, 2018.
5. 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, you did not prepare batch production records for any of your Silver Armor brand Natural Health Immune Support & Protection products your firm manufactures, labels and distributes as dietary supplements. Once you establish batch production records, they must conform to the requirements of 21 CFR 111.260(a)-(n).
We have reviewed your response letter dated November 28, 2017, in which you stated that your firm is in the process of preparing documentation for batch production records, including batch lot or control numbers for each lot of finished dietary supplement. We are unable to evaluate the adequacy of your corrective action as no supporting documentation was provided. You stated that your firm will begin incorporating this process by January 31, 2018
6. You failed to identify each unique lot within each unique shipment of components that you received in a manner that allows you to trace the lot to the supplier, the date received, the name of the component, the status of the component (e.g. quarantined, approved, or rejected); and to the dietary supplement you manufactured and distributed, as required by 21 CFR 111.155(d)(1). Specifically, your firm does not identify in any manner, components or dietary ingredients received, which are used to manufacture finished dietary supplements.
We have reviewed your response letter dated November 28, 2017, in which you stated that your firm is working on establishing a process to record components and dietary ingredients to create a unique lot that will allow you to trace a specific product to its origin. We are unable to evaluate the adequacy of your corrective action, as no supporting documentation was provided. You stated that this corrective action will be completed and implemented no later than September 30, 2018.
7. You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a). Specifically, your firm did not collect and hold reserve samples of any of the dietary supplements you manufacture and distribute. Further, you must collect and hold reserve samples of each lot of packaged and labeled dietary supplements in accordance with 21 CFR 111.83(b). The reserve samples must:
a. Be held using the same container-closure system in which the packaged and labeled dietary supplement is distributed, or if distributing dietary supplements to be packaged and labeled, using a container-closure system that provides essentially the same characteristics to protect against contamination or deterioration as the one in which it is distributed for packaging and labeling elsewhere;
b. Be identified with the batch, lot, or control number;
c. Be retained for 1 year past the shelf life date (if shelf life dating is used), or for 2 years from the date of distribution of the last batch of dietary supplements associated with the reserve sample, for use in appropriate investigations; and
d. Consist of at least twice the quantity necessary for all tests or examinations to determine whether or not the dietary supplement meets product specifications.
We have reviewed your response letter dated November 28, 2017, in which you stated that your firm has begun to hold components and dietary supplements under appropriate conditions of temperature, humidity, and light. We are unable to evaluate the adequacy of your corrective action, as you did not provide any documentation, such as an SOP, photographs or other evidence to indicate your firm has implemented a process for collecting and holding reserve samples.
8. You failed to hold labels under conditions that will avoid mix-ups, as required by 21 CFR 111.160(e). Specifically, during the manufacturing of your Silver Armor brand Natural Health Immune Support and Protection 16 fluid ounce product, it was observed that various dietary supplement labels were stored commingled with cosmetic labels and labels identified as “Body, Room & Linen Spray".
We have reviewed your response letter dated November 28, 2017, in which you stated that your firm has separated all labels and that each batch of labels is marked so that there is no confusion as to what that label represents. We are unable to evaluate the adequacy of your corrective actions, as you did not provide supporting documentation, such as an SOP, photographs or other evidence to indicate this process has been implemented.
9. You failed to conduct manufacturing operations in accordance with adequate sanitation principles, as required by 21 CFR 111.360. Specifically, your firm does not conduct any sanitation operations in the room used for manufacturing and packaging finished dietary supplements.
We have reviewed your response letter dated November 28, 2017, in which you stated that your firm has added sanitation principals to your manufacturing process, using an EPA registered food safe sanitizer. We are unable to evaluate the adequacy of your corrective actions, as you did not provide supporting documentation, such as an SOP, photographs or other evidence to indicate this process has been implemented.
Misbranded Dietary Supplements
1. Your Silver & Armor brand Natural Health Immune Support & Protection products, labeled as dietary supplements and intended to be ingested, all sizes, 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 product does not comply with 21 CFR 101.36. For example, your product labels list the quantitative amount of silver under the heading %DV. The names and the quantitative amounts by weight of each (b)(3)-dietary ingredient must be presented under the heading "Amount Per Serving" in accordance 21 CFR 101.36(b)(3). Furthermore, if the product is for persons within more than one group, the quantitative amount for each group must be presented in separate columns and each column heading must clearly state the intended group.
2. Your Silver & Armor brand Natural Health Immune Support & Protection products, labeled as dietary supplements and intended to be ingested, all sizes, are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the labels and labeling are missing or incorrect. The subheading "Serving Size" must be placed under the heading "Supplement Facts" and aligned on the left side of the nutrition label in accordance with 21 CFR 101.36(b)(1)(i). Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2.
3. Your Silver Armor brand Natural Health Immune Support & Protection products, labeled as dietary supplements and intended to be ingested, all sizes, are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. “Domestic address or domestic phone number” means a complete address or phone number. The labels for these products do not include a complete address or phone number.
4. Your Silver Armor brand Natural Health Immune Support & Protection products, labeled as dietary supplements and intended to be ingested, all sizes, are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] in that the labels fail to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Your product labels fail to list the zip code required under this part.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of the Act and its implementing regulations.
You should take prompt action to correct all of the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, including without limitation, seizure and injunction.
We also offer the following comments regarding your products:
• We note your Silver & Armor brand Natural Health Immune Support & Protection products, 4-ounce dropper and 4-ounce spray sizes, are intended for use as dietary supplements as evidenced by the statement of identity as a “dietary supplement” and by the presence of a supplement facts label. According to the product label directions, these products are intended for ingestion as well as other delivery methods; for example, “TOPICAL: Clean affected area. Spray a liberal amount to allow for consistent sustained delivery. Let dry naturally.” on your Immune Support & Protection 4-ounce spray product label and “Ears/Eyes: Use 1 to 2 drops for eyes and 2 to 3 drops for ears every hour as needed” on your Immune Support & Protection 4-ounce with dropper product label. The term “dietary supplement” means a product that is intended for ingestion (Section 201(ff)(2)(A)(i)).
• Your Silver Armor brand Natural Health Immune Support & Protection product labels list non-dietary ingredients within the Supplement Facts label. “Other ingredients” should be listed outside and directly below the Supplement Facts box in accordance with 21 CFR 101.4(g).
• Your Silver Armor brand Natural Health Immune Support & Protection products, labeled as dietary supplements and intended to be ingested, 1 gallon and ½ gallon sizes, labels declare the net contents in gallons and ounces, but this must be followed by the metric equivalent in parenthesis [15 U.S.C. § 1453(a)(2) of the Fair Packaging and Labeling Act (FPLA)]. The net contents for your Silver Armor brand Natural Health Immune Support & Protection products, labeled as dietary supplements and intended to be ingested, 16 ounce and 32 ounce sizes, must also be expressed as pint and quart, respectively [15 U.S.C. § 1453(a)(3)(A)(i) of the Fair Packaging and Labeling Act (FPLA) and 21 CFR 101.7(j)(1)].
• Your product labels bear the statement “* Daily Value not established,” but the asterisk does not refer to any dietary ingredient.
• Your product labels bear the FDA disclaimer statement but do not bear a symbol next to all structure/function claims linking the claims to the disclaimer in accordance with 21 CFR 101.93(d).
• Your product labels contain intervening material between the ingredients list and the name and address. An example of intervening material is the statement about EPA. All information appearing on the information panel of the product label should appear in one place without other intervening material [21 CFR 101.2(e)].
You should notify this office in writing within 15 working days of receipt of this letter of the specific steps that you have taken to correct the violations. Include an explanation of each step being taken to prevent recurrence of violations and provide related documentation for review and evaluation. If you are unable to complete correction actions within 15 working days, state the reason for the delay and the time within which you will complete the corrections
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 determining 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.
Your written response should be sent to Patricia F. Hudson, Compliance Officer, U.S. Food and Drug Administration, 60 8th Street, N.E., Atlanta, GA 30309. If you have any questions regarding this letter, please contact Patricia F. Hudson at 404-253-2221 or patricia.hudson@fda.hhs.gov.
Sincerely,
/S/
Ingrid A. Zambrana
District Director
U.S. Food & Drug Adminisration
FDA Atlanta District
Office of Human and Animal Foods- Division 3 East
(Georgia- North Carolina-South Carolina)
Office of Regulatory Affairs