Dentists all over the United States are investing in foreign dental laboratories because the services are much cheaper than using a local dental lab. Despite complaints about high levels of lead in products such as dental bridges and crowns, this practice has become very common. In a research study performed by WBNS 10 TV, crown preparations were tested for lead from laboratories located in China, Thailand, and the United States. High levels of lead were found in 5 of 7 crowns made in China. Both crowns from Thailand contained lead, but it wasn’t as high as the Chinese products. The product made in the United States also had a low level of lead in its chemical composition, which raises concern. Dental instruments and high speed handpieces manufactured outside the United States may also be hazardous due to high levels of lead in the composition.
The FDA has been scrutinized for having weak regulations on these imported products. For a long time, the FDA had no official policy for importing dental supplies, materials, and lab work despite surging reports of the possible risks. According to the FDA Food, Drug, and Cosmetic Act (FDCA), all manufacturers, producers, and importers of medical devices are required to register with the FDA and submit a list of the product or service being imported. All importers, except licensed practitioners, are charged a 2.3 percent excise tax. Other than that, foreign dental laboratories are not required to comply with the same rules and regulations as U.S. dental labs. Therefore, the products will still enter the market and the potential risk for harming patients remains.
It’s been proposed that patients and dentists should receive full disclosure about where the products are made and its chemical composition. According to dental economics, the FDA should remove the tax exemption of U.S. dentists importing instruments, materials, and services from foreign countries. Dental Economics also suggests that all imported products should be given a registration number, require foreign labs to register and comply with the same regulations as USA labs.
The dental supply industry has attracted thousands of investors to buy foreign products and resell them in the United States. The products are made available on the market at a fraction of the costs. But as long as the well-being of a patient is the ultimate goal of healthcare, all export and import dental supply practices should fall under FDA regulation standards. The cost of purchasing a cheaper product with no manufacturer regulations isn’t worth the harm it can potentially cause a patient.