Empowered Dx in Hot Water with FDA Again Over COVID-19 Test Kits

While the pandemic nears its end, the US FDA remains active in cracking down on drug, device, and diagnostics companies for peddling unauthorized COVID-19 products. As 2022 came to a close, the agency published a new warning letter to Empowered Diagnostics (Empowered Dx) for distributing COVID-19 test kits without approval, clearance, or authorization.¹

The Empowered Dx Warning Letter

Issued on October 6, 2022, the FDA warning letter deals with two of Empowered Dx’s test kits: the CovClear COVID-19 Rapid Antigen Tests and the ImmunoPass COVID-19 Neutralizing Antibody Rapid Tests. “Our inspection revealed that these COVID-19 Test Kits have been distributed in the U.S. without marketing approval, clearance, or authorization from FDA. Accordingly, the products are adulterated under section 501(f)(1)(B) of the [Federal Food, Drug, and Cosmetic Act] Act, 21 U.S.C. § 351(f)(1)(B),” according to the letter.

“These products are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o),” the letter continues, “because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).” The agency also cites statements from the product labeling suggesting that the tests “are authorized for use under an Emergency Use Authorization (EUA).”

Actions: The warning letter orders the Florida-based company to take “immediate action” to stop the unauthorized sale and distribution of the tests, including reviewing its websites, product labels, and other labeling and promotional materials for misleading claims and notifying the agency of the corrective actions taken within 48 hours. The agency also gave the company 15 business days to describe the corrective actions and other steps taken to address quality system concerns cited in the letter. In addition, Empowered must, within 15 business days, describe steps the firm has taken to address quality system concerns, including corrective actions.

This isn’t the first time that Empowered Dx has gotten into hot water with the FDA for COVID-19 product violations. A year ago, the agency issued a Class 1 recall for the tests due to the elevated risk of false results. The warning letter also describes a series of violations cited by inspectors during a pair of inspections of the company’s facilities in February 2022, including failure to:²

• Meet test design requirements;
• Identify and correct the root causes of nonconformances identified;
• Establish procedures for receiving, reviewing, and evaluating product complaints by a formally designated unit;
• Establish procedures for finished device acceptance;
• Establish procedures to ensure that all purchased or otherwise received products and services meet specified requirements; and
• Establish and maintain document control procedures.

Other Recent FDA COVID-19 Product Warning Letters

Empowered Dx wasn’t alone. The FDA issued two dozen warning letters related to COVID-19 products during 2022. The misbranded products included not only diagnostic test kits, but items ranging from nasal mists to cannabidiol oils and rubs. Here’s the entire list of FDA COVID-related warning letters from 2022.

Scorecard: FDA Warning Letters Related to COVID-19 Products in 2022

Date	Company	Violation
Nov. 1	Alternative Health Distribution LLC d/b/a CannaAid	Sale and misbranding cannabidiol (CBD) products as mitigating, preventing, treating, diagnosing, or curing COVID-19
Oct. 24	Lakpura LLC	Sale of medicinal drinks, balms, teas, oils misbranded as treating, relieving COVID-19
Oct. 6	Empowered Dx	Sale of unauthorized COVID test kits: CovClear COVID-19 Rapid Antigen Tests and ImmunoPass COVID-19 Neutralizing Antibody Rapid Tests
Sept. 28	Bespoke Apothecary	Sale of unapproved products: COVID kit and Post Virus Recovery Herbal Tea
June 30	W.H.P.M, Inc.	Sale of unapproved COVID-19 kits: First Sign SARS-CoV-2 Antigen Test Kits, First Sign COVID-19 Surveillance Test kit, First Sign SARS-CoV-2 Antigen Test Packs (bulk products), and cobranded COVISURE SARS-CoV-2 Antigen Test Kits
April 19	Kleenhanz, LLC	Sale of unapproved Kleenhanz® Towelettes topical antiseptic products misbranded as mitigating COVID-19 symptoms
April 6	Sensory Cloud, Inc.	Sale of unapproved product misbranded as treating COVID-19: FEND nasal mist
April 5	CofixRx LLC	Sale of unapproved product misbranded as treating COVID-19: CofixRX Nasal Spray
March 28	CBD Social	Sale of unapproved product misbranded as treating COVID-19: CBD oils
March 28	Functional Remedies, LLC D/B/A Synchronicity Hemp Oil	Sale of unapproved product misbranded as treating COVID-19: Full-Spectrum Hemp Oil and CBD products
March 28	Greenway Herbal Products LLC	Sale of unapproved product misbranded as treating COVID-19: CBD oils
March 28	Cureganics	Sale of unapproved product misbranded as treating COVID-19: CBD products
March 28	Nature's Highway	Sale of unapproved product misbranded as treating COVID-19: CBD products
March 28	UPSY LLC	Sale of unapproved product misbranded as treating COVID-19: CBD products
March 28	Heaven’s Organic LLC	Sale of unapproved product misbranded as treating COVID-19: CBD products
March 25	Iodine Products Inc	Sale of unapproved product misbranded as treating COVID-19: Liquid Mask Spray Anti-Viral and The COVID-Killer
March 24	Applied Biological Laboratories Inc.	Sale of unapproved product misbranded as treating COVID-19: Biovanta Dual Action Throat Spray and Biovanta Triple Action Lozenges
March 15	Iotech International, LLC	Sale of unapproved product misbranded as treating COVID-19: ioRinse RTU and ioCleanse Molecular iodine Hand Cleanser
March 10	Soda Pharm	Sale of unapproved product misbranded as treating COVID-19: Cold/Flu/COVID Pack, Cold and Congestion Loose Leaf Tea, Goldenseal Extract, Cool Down Loose Leaf Tea, Resistance Extract, Ache Ease Herbal Drink Syrup, Pain Release Extract, Headache Blend Extract, Vapor Balm, and the Mustard Plaster
March 7	Viraldine, LLC	Sale of unapproved product misbranded as treating COVID-19: Non-alcohol-based antiseptic products
Feb. 22	My Natural Treatment	Sale of unapproved product misbranded as treating COVID-19: thyme, black seed, eucalyptus, rosemary, and peppermint oil products
Feb. 17	Lusys Laboratories, Inc.	Sale of unauthorized COVID-19 test kits: COVID-19 IgG/IgM Antibody Test and COVID-19 Viral Antigen Test
Feb. 3	Pharmacy2Home/LandiCom Holding LTD	Sale of unapproved drug products misbranded as treating COVID-19
Jan. 3	Amcyte Pharma, Inc.	Sale of unapproved drug product called Nasitrol misbranded as treating COVID-19

References:

1. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empowered-diagnostics-llc-638164-10062022
2. https://www.fda.gov/medical-devices/medical-device-recalls/empowered-diagnostics-recalls-covid-19-tests-due-risk-false-results