Florida Firm's OTC Tattoo Pain Relief Get FDA's Unapproved Stamp
This article was originally published in The Pink Sheet
Executive Summary
FDA warning based on an inspection of AIG Technologies' facility from September through November 2015. The firm responded without "supporting documentation" to FDA and the agency has been unable to verify the adequacy of its corrective actions.
A.I.G. Technologies Inc. not only is the second drug firm FDA has warned in two months that relieving pain from tattoo procedures is not an indication approved for OTC external analgesics, it's also distributing unapproved Rx dermatology drugs, according to the agency.
A Dec. 5 warning letter from the Division II of the Office of Pharmaceutical Quality Operations in FDA's drug center states that the agency's findings are based on an inspection of A.I.G.'s facility in Deerfield Beach, Fla., from late September through mid-November in 2015.
The firm, which provides Rx and OTC products as a contract manufacturer, responded without "supporting documentation" to FDA inspectors' form 483 findings in December 2015. The agency has been unable to verify the adequacy of A.I.G.'s corrective actions.
FDA says labeling for Derma Numb Tattoo Anesthetic Spray "raises safety concerns relating to the potential for adverse events due to the systemic absorption" of lidocaine.
National Library of Medicine
Labeling for OTC Derma Numb Tattoo Anesthetic Spray, marketed by A.I.G. or Atlas Tat Inc., of Oakland Park, Fla., bears claims including “temporarily relieves pain from tattoo procedures,” “FDA REGISTERED” and “For Professional Use Only,” the warning states.
The claims are noncompliant with FDA's tentative final monograph for OTC external analgesics, which include lidocaine. The TFM's indications for which lidocaine has been tentatively found to be generally recognized as safe and effective are limited to the temporary relief of pain and/or itching, which can be followed on labels by the statement “associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and/or minor skin irritations,” according to the letter.
Lidocaine is not proposed to be GRASE for indications related to tattooing and the ingredient's use as indicated on "Derma Numb labeling raises safety concerns relating to the potential for adverse events due to the systemic absorption of the active ingredient," FDA said. The agency added it is "not aware of any adequate and well controlled clinical trials in the published literature" supporting a determination that Derma Numb is GRASE for its labeled indications.
The agency made the same observation in an October warning to Oregon firm Ridge Properties LLC, which also was warned about making its drug products in a kitchen, using utensils and cookware including a steel pot, blender and spatula. (Also see "Making OTC Topical Drugs In Kitchen Stirs Up Problems For Oregon Firm" - Pink Sheet, 26 Oct, 2017.)
However, unlike its warning to Ridge Properties, FDA does not advise A.I.G. that it expects the firm to recall the products it deemed violative. (Also see "Kitchen-Made Healing Treatments Among Health And Wellness Recalls" - HBW Insight, 7 Nov, 2017.)
No Applications In FDA Files
The warning states that A.I.G.'s dermatology drugs containing sodium sulfacetamide 10% and sulfur 5%, urea 45% or 41% or formaldehyde 10% are Rx products that require pre-market approval but had not been submitted to the agency for evaluation.
"There are no FDA-approved applications on file" for the firm's drugs, the agency says.
According to the warning, indications for the products include:
- sulfacetamide and sulfur: "for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis”;
- urea: “treatment of hyperkeratotic conditions such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratosis and calluses”;
- formaldehyde: “drying agent for pre and post-surgical removal of warts, or for non-surgical laser treatment of warts where dryness is required."
The products also are unapproved new drugs misbranded because the ingredients have not been approved for their labeled indications and, without adequate directions for the ingredients' uses, they are misbranded, FDA warned.
From the editors of the Tan Sheet.