While the FDA is methodical and, some might argue, slow to approve breakthrough drugs, they seem to pay insufficient attention to over-the-counter remedies pushed by various drug companies. Many, if not most, of these medications and supplements are not backed by rigorous, scientific studies.
Rather, the companies rely on "paid testimonials" to convince TV viewers of their product's effectiveness. Smiling couples, weekend athletes and aging businessmen relate the wonderful benefits of using the medication. Of course, fine print beneath their sincere performances (too small for most of us to read) likely plays down those potential benefits and advises input from your physician.
All medications, prescription or not, have potential side effects. If scientific studies have not demonstrated that the drug is effective and safe, the FDA should prevent it from being marketed. In my opinion, false hope, delivered by paid advocates, is fraud, aided and abetted by the inaction of regulatory agencies.