Reda medical devices are the latest to come under scrutiny by regulators, and some experts are wondering if the pills have a role in treating or preventing diseases.
The FDA is looking into the pills and is set to hold a public hearing on their safety and efficacy on May 23.
But the pills themselves aren’t exactly safe, according to the FDA.
In the FDA’s latest safety assessment, the agency said the reda pill had not been studied for safety in people with pre-existing conditions and had not undergone any testing for safety.
While the pill contains ingredients that could lead to allergic reactions, it also has “high potential for effectiveness,” the agency wrote.
This isn’t the first time the FDA has raised concerns about the pills.
In 2016, the FDA received reports of people with chronic conditions who were taking reda pills to treat anxiety, fatigue, and chronic pain.
The agency concluded that the pills “may have caused” certain conditions, but didn’t recommend that consumers stop taking them.
Still, the company is trying to push the idea that the drugs are more than just a headache medicine.
“I know for sure there are many people that use reda for their health care needs,” a spokesperson told the Associated Press.
“But we don’t want to mislead people.”
The company is still working to improve its manufacturing processes, according the spokesperson, but reda is “still not ready for mass production.”
The new FDA safety assessment comes on the heels of a similar investigation into the Reda pills.
More from the Associated Statesman: