Florida Firm's OTC Tattoo Pain Relief Get FDA's Unapproved Stamp
This article was originally published in The Pink Sheet
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.
You may also be interested in...
Pain Relief Naturally recalls its Naturally HL Bedsore Relief Cream, Extra Strength PreTAT by TAT Balm Carbomer Free Gel and Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine. Spiked Man of Steel supplement, and out-of-spec moisturizer sold by Walmart, Walgreen's also recalled.
FDA expects Pain Relief Naturally to recall lidocaine-containing hemorrhoid, bed sore and pre-tattoo lotions and sprays. In addition to GMP problems, formulations and labeling for Naturally Healthy Living brand products are noncompliant with US FDA's for external analgesic OTC monograph and other agency rules.
White House, Democrat majority in Congress and likely next FTC chair support the agency wielding the authority, says advertising law attorney Holly Melton. Supreme Court, though, likely will rule in pending cases that a strict reading of an FTC regulation doesn’t grant monetary penalty authority.