Timed release melatonin maker says adverse events data proves product is safe
Physician’s Seal LLC is the manufactuer of REMfresh, a dietary supplement containing what the company calls CRA melatonin, (continuous release and absorption), a trademarked name for a type of melatonin formulated for a specific prolonged adbsorption profile.
The company, which is based in Boca Raton, FL, claims its formulation matches the natural fluctuating serum melatonin levels in subjects who experience healthy sleep patterns. Called the Mesa Wave pattern, it corresponds to a healthy 7-hour sleep period. The company claims its product helps to mimic the body’s natural melatonin levels over time, making for a more restful sleep.
Melatonin could be seen as a potentially sensitive ingredient for federal regulators. While the ingredient has been on the market for decades, the US Food and Drug Adminintration did address it specifically a few years ago when it sent a warning letter to the maker of Lazy Larry’s Brownies which contained melatonin. Despite the agency’s position that brownies are an inappropriate and potentially unsafe delivery mode for this neurohormone, there are to date a number of melatonin-containing brownie products for sale online.
Taking a step away from brownies
In a move that could perhaps be seen as trying to distance itself from the guerilla bakers, Physican’s Seal is trumping up the proof of safety for its formulation in the form of studies of collected adverse events. REMfresh is packaged in capsules and is sold with a supplements facts panel on the box.
The company has coined a name for the latest compilation: REMSU24 (REMfresh Safety Update at 24 months). The company estimates that more than 320,000 individual consumers used its product during the reporting period.
No serious adverse events were reported. In addition, only 51 non serious adverse events were found in the data set. The most common complaints were six reports of headache, five of nightmares and three reports of dizziness.
The company said that peer reviewed literature on the ingredient does not connect it to any of these effects, reflecting the homogeneous nature of adverse event reporting. The company said these non serious reports are often associated with co morbid conditions of people suffering from chronic insomnia.
“This calculation results in an estimated 0.016 % adverse event reporting rate for REMfresh, which is remarkably low. The outcome does not cause any concern for the safety profile of the product. This confirms the benign safety and tolerability profile of REMfresh seen in prior studies,” said David C. Brodner, MD, chief science officer of Physician’s Seal.
