FDA Issues First Warning Letter Since January

The US Food and Drug Administration (FDA) has sent its first warning letter since January for what it called “serious violations.”
 
The letter, dated May 17, 2018,  was sent to Silver Armor, Inc. Peachtree City, GA, following an FDA inspection of its facility from Oct. 31 through Nov. 11, 2017. FDA said that based on the inspection of the site at 300 Willow Bend Rd., Suite 19, a review of product labels and promotional literature collected, and a review of the company's website (www.silver-armor.com), it identified serious violations of the Act and applicable regulations.
 
According to FDA, 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. . .”
 
FDA also cited the testimonials page of the company’s website, entitled “Real Results.”
 
FDA said the website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of Silver Armor brand Natural Health Immune Support & Protection products for the cure, mitigation, treatment, or prevention of disease.

FDA also noted numerous issues around dietary supplement CGMP violations.

The full letter can be accessed here.