Update, May 13, 2020: Tony Picciano, the company’s CEO, shared a letter from an FDA official, dated May 8, 2020, saying that his firm has addressed the violations contained in the 2015 warning letter.
Updated June 30, 2016, to include information from the manufacturer and updated FDA information.
The FDA this week released a warning letter it sent to A-1 Engineering over its marketing claims for its Neurotris line of cosmetic devices.*
The FDA flagged A1 for marketing claims for its Neurotris SX-Series and Pico Toner that go beyond their classification as a Class I “therapeutic massagers,” which the agency said “are intended for medical purposes, such as to relieve minor muscle aches and pains.”
“Generic devices of this type (electric therapeutic massagers) are intended for medical purposes, such as to relieve minor muscle aches and pains. However, your firm is marketing the devices for different intended uses, including, but not limited to, wrinkle reduction, facial lifting, neck tightening, increased ATP production, increased collagen and elastin, improved circulation, skin tightening, cellulite reduction, enhancement of biological processes, hydrolysis of triglycerides, improving sun damaged skin and skin pigmentation, iontophoresis, fat reduction, and muscle building and toning,” the FDA wrote in the warning letter. The only thing they are allowed to market is the Iontoderma iD-1000 that helps with iontophoresis.
A1 should immediately stop using those claims, the FDA said, or else it would have to seek pre-market approval from the bureau.
The federal watchdog also cited 7 quality control issues at the company’s plant in Irvine, Calif., including failure to maintain device master records, failure to establish and maintain device history records, failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, failure to evaluate potential suppliers on the basis of their ability to meet specified requirements and to document such evaluations, failure to maintain complaint files, failure to establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment and to document maintenance activities and failure to establish Quality System procedures and instructions.
A1 Engineering CEO Tony Picciano told MassDevice.com via email June 29, 2016, that the FDA inspected its facility in Irvine and deemed it “an approved Licensed medical device manufacturing facility that exceeds quality manufacturing standards set forth by UL 60601 medical grade standards to ensure desirable characteristics of products and services such as quality, environmental friendliness, safety, reliability and efficiency.”
In a telephone interview June 30, 2016, Picciano said that A1 has already received FDA approval for the Pico toner, which is the same device as another A1 product that is marketed under a different name.
“It’s the same product, just under a different brand,” he said.
All of the other issues raised in the warning letter have been dealt with except for some of the marketing claims on the Neurotris website, Picciano said. Those changes are slated to be made soon and the company expects the FDA to close out the warning letter soon after that, he said.
*Correction, June 30, 2016: Due to a reporter’s error, this article originally stated that the FDA halted sales of the flagged devices. We regret the mistake. Return to the corrected sentence.