UNREGULATED, GRAY MARKET AND COUNTERFEIT DENTAL SUPPLIES CAN HARM PATIENTS AND DENTISTS
The internet has made selling unregulated, “gray market” or counterfeit dental supplies easier than ever, and the pandemic brought this problem to the forefront with supply chain issues and the sales of counterfeit respirators and COVID tests.
Using substandard and falsified medical products may cause harm to patients and fail to treat the diseases for which they were intended, and it can lead to loss of confidence in medicines, health care providers and health systems, according to a Fact Sheet from the World Health Organization (WHO) found at https://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products.
According to the WHO, an estimated 1 in 10 medical products in low- and middle-income countries is substandard or falsified.
Unregulated dental supplies
In the United States, the Food and Drug Administration (FDA) regulates medical devices to assure their safety and effectiveness.
“In the United States, the FDA classifies PPE and dental devices as medical devices in the Code of Federal Regulations (CFR) Part 872. Before the products are sold in the United States, they must be cleared or approved by the FDA under Section Sl0(k) of the Federal Food, Drug, and Cosmetic Act. Under this Act, there are civil and criminal penalties for selling nonapproved medical devices in the United States, and the FDA has the authority for an injunction (Section 302), seizure (Section 304), and referral for criminal prosecution (Section 305),” according to the article “Caveat emptor when purchasing dental products online” in the March 2022 Journal of the American Dental Association.
According to the article, dental manufacturers and supply companies are required to ensure that the products they sell comply with regulations. However, online marketplaces have made it difficult to verify the claims that are made about dental supplies, and the FDA has found that many filters used by online marketplaces are inadequate. Many website companies will not take responsibility for the products they sell.
Information on medical devices that have been approved or cleared by the FDA can be found at https://www.fda.gov/medical-devices/products-and-medical-procedures.
Gray market and counterfeit supplies
Gray market dental supplies are products that have been diverted from their intended market and resold by unauthorized distributors.
“The products sold by gray market channels have been diverted from their secured supply chain. They often don’t comply with local laws and are sold in a country where they are not approved for use. They may have compromised quality due to improper handling or storage conditions. In some cases, they are repackaged or relabeled products. In other cases, a product’s expiration date may be changed so it can be sold beyond its original expiration date,” according to Frequently Asked Questions from 3M found at https://www.3m.com/3M/en_US/dental-us/resources/gray-market-products/.
Gray market products will not fall under manufacturer warranties, and manufacturers will not honor promotions or returns.
Counterfeit products are falsified medical products that are almost visually identical to the genuine product and very difficult to detect.
According to the WHO Fact Sheet, some tips for identifying counterfeit products include:
- Examining the packaging for condition, spelling mistakes or grammatical errors.
- Checking the manufacture and expiration dates and ensuring any details on the outer packaging match the dates shown on the inner packaging.
- Ensuring medicine looks correct, is not discolored, degraded or has an unusual smell.
The best way to ensure a product is not gray market or counterfeit is to purchase it from an authorized distributor. Many manufacturers will list authorized distributors on their websites, or dental offices can contact the manufacturer to find out if a distributor is authorized to sell their products.
Risks associated with using unregulated, counterfeit or gray market dental supplies
According to 3M, using unregulated, counterfeit or gray market products can put patient safety at risk because product quality is not guaranteed. It can put a dentist’s reputation at risk, and result in lost productivity because dentists may need to re-do work or investigate why materials aren’t working correctly. It can also lead to lawsuits by dissatisfied patients.
“For example, in 2016, a dentist in the United Kingdom appeared before the General Dental Council after purchasing and using counterfeit products from an online site,” according to the Journal of the American Dental Association. “Despite claiming that he was not aware that the products were counterfeit, the committee deemed that this should have been clear from the products’ low prices and found the general dental practitioner to be acting with financial motivation.”
Report the unlawful sale of medical products
If a website is thought to be illegally selling human drugs or medical devices, this should be reported to the FDA. Reports can be made at https://www.fda.gov/safety/report-problem-fda/reporting-unlawful-sales-medical-products-internet.
Purchase quality products through OhioDDS
The Ohio Dental Association’s group purchasing organization, OhioDDS, has partnered with Midway Dental Supply, Kettenbach Dental and Cintas to provide access to high quality dental supplies, equipment and services to ODA members.
“Obtaining dental supplies through a verified supply chain vendor is immensely important. Manufacturers test their products to ensure positive results for patients, and they hold distributors responsible for adhering to essential guidelines,” said Steven Kizy, CEO of Midway Dental Supply. “Some of the products you use daily require refrigeration, carefully controlled climate condition requirements, and a properly trained warehouse staff. Trusted distributors adhere to the regulations so that you can feel comfortable using the products. I implore you to verify your distribution partner is authorized by the manufacturer to market their product.”
Created and operated by the ODA Services Corp., OhioDDS is a free member-only program that allows ODA members exclusive access to discounted pricing on dental supplies, equipment and services.
ODA members can sign up for OhioDDS at no charge or obligation to order products by clicking here.
