Call old Dr. D crazy (there may be some truth to that); however, it appears the United States Department of Justice (DOJ) and FDA are on a serious mission to bring the bad guys to justice for violating the Food, Drug, and Cosmetic Act (a.k.a. the Act). A few years ago, it seemed like prosecutions for violating the Act were few and far between. Now it seems like transgressions made by bad Chief Jailable Officers (CJO) are occurring weekly. A couple of years ago, the doctor wrote about contact lenses being classified as a medical device and the formal investigation headed up by the FDA and a number of other agencies appropriately entitled “Double Vision.” The purpose of Operation Double Vision was to stop misbranded contact lenses, including cosmetic lens use to change the appearance of eye color, to a screeching halt. Unfortunately, the CJO named in this week’s guidance probably did not read Dr. D’s article on the perils of importing misbranded contact lens into the United States. In fact, this CJO clearly took a flippant (look-it-up) approach toward compliance when the decision was made to violate the Act. Enjoy!

Department of Justice Press Release – September 9, 2016 (Excerpts)

“The owner and operator of Candy Color Lenses, a major online retailer of colored contact lenses in the United States, pleaded guilty yesterday to running an international operation importing counterfeit and misbranded contact lenses from suppliers in Asia and then selling them over the internet without a prescription to tens of thousands of customers around the country.”

Please Note: you can follow the link at the end of this week’s guidance to visit the full DOJ press release.

Case Summary

According to the DOJ’s press release, Dmitriy V. Melnik (Las Vegas, NV) negotiated a plea agreement, which resulted in a guilty plea being entered before U.S. District Judge James C. Mahan (District of Nevada). The guilty plea was for one count of conspiracy to traffic in counterfeit goods and the introduction of misbranded medical devices into interstate commerce. It should be noted, Melnik grossed well over $1 million dollars from his illegal activities at the expense of unsuspecting customers. However, the customer complaints started pouring in when it became apparent that the quality of these counterfeit lenses was questionable and the instructions for use were deficient. Additionally, some of the lenses were tested and found to be contaminated with potentially hazardous bacteria.

Compliance for Dummies

Medical devices fall into three classes in the United States (Class I, II, and III) driven by product risk. Class I devices are deemed low risk and require device manufacturers to register as an establishment with the FDA and pay an annual registration fee ($3,872 for 2016). There is typically no FDA review and approval for Class I devices; however, the device establishment is required to list a Class I device with FDA using the agency’s Unified Registration and Listing System (FURLS).  Class II and Class III devices require formal review and either clearance (Class II) or approval (Class III) by the FDA. If a device is not appropriately cleared or approved, entering such a device into interstate commerce is a violation of the Act and the devices are considered misbranded. If the violation of the Act is deemed to be willful then bad things will happen to CJO’s that perpetrate such crimes. Just ask Mr. Melnik.

In the United States, contact lenses are classified as medical devices by FDA. In fact, if a soft contact lens (a.k.a. Ophthalmic Device) is intended for extended use, the device class is ratcheted up from Class II to Class III, according to 21 CFR, Part 886.5925. Similar to tongue depressors, dentures, hearing aids, etc., most of us do not think of contact lenses being a medical device. They are medical devices and for a very good reason. If the lenses are manufactured from inferior materials or not properly cleaned (sterilized), the risk to the end user increases significantly. In fact, permanent damage, including loss of vision, can occur due to infection.

Takeaways

For this week’s guidance, the doctor will leave the readers with just one takeaway: It is incumbent upon each of you to take ownership of your health. By now, the message radiating in the media is the cost of healthcare (medical devices and pharmaceuticals) is skyrocketing. There are no real bargains, and if an individual claims to have one associated with a medical device, be extremely cautious. In fact, Dr. D strongly recommends visiting www.fda.gov when you have questions pertaining to a specific device or the device’s manufacturer. In closing, thank you again for joining Dr. D, and I hope you found value in the guidance provided. Until the next installment of DG, cheers from Dr. D., and best wishes for continued professional success.

References

1. Code of Federal Regulation. (April 2015). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
2. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system   regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
3. Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
4. FDA. (September 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Owner of major online colored contact lens business pleads guilty in largest-ever investigation of counterfeit and misbranded contact lenses in the United States. Accessed September 12, 2016. Retrieved from http://www.fda.gov/ICECI/CriminalInvestigations/ucm520446.htm