-
dipanpatel replied to the topic FDA rules too strict? in the forum Regulatory Basics for Medical Devices 7 years, 6 months ago
I understand where you are coming from when it comes to restrictions. I can see how the FDA can cause unnecessary hindrance. But I’d rather have a strict agency then even if it may cost the industrial companies some time. One aspect of the FDA I do wish was more involved is strict is the dietary supplement sector. “The terms of the Dietary Supplement Health and Education Act of 1994 (DSHEA), supplements with established ingredients (meaning those that had been sold in the United States before 1994) can be marketed without any evidence that they are effective or safe.” I understand this is meant to reduce redundancy but with American spending billions of dollars on supplements, I believe there should be a more active role by the FDA even if the effects of a lot of supplements are similar to placebo.Anything that is said to affect health should fall under the scrutiny of the FDA.