Replies to post #208117 on Bebida Beverage Company (BBDA)

[Deep Space]

I understand the concern,I just do not share it and that does not mean the FDA will not pay attention,however they usually do not pay attention to companies under 100 million per mslp peak CC.Either way Melatonin is safe imo and I take it and I think its ON the can as it should be.I have no doubt that some kid(God Forbid,I think):) might drink 47 at one time and have a actual Koma,but what do you do about that? In all seriousness I think BW would be on top of this at this point.?

[el lobo]

Koma Unwind has dietary supplement marked clearly on the can. I wish they would make just a plain sugar free soft drink with the great taste of Koma Unwind.

[OlafKjelldsen]

is the drink considered a supplement or soft drink. Supplement listing would make Koma safe from the FDA.

This has been covered at length here in the past.

Koma Unwind is labeled and sold as a dietary supplement, so the FDA effectively has no jurisdiction over its sale. What is in question and at issue within the government, is the loophole of labeling things that are clearly packaged as conventional foods (such as 12oz cans of a soft drink or brownies) as "Supplements" when they are clearly not intended to supplement a meal, but instead, via portion size, be a main component. Whether Melatonin is anecdotally considered safe or not, it is not on the list of "GRAS" (Generally Regarded As Safe) substances and cannot be used as a food additive, as you noted. A judgement closing the loophole of food or drink packaged as conventional food but labeled as a dietary supplement to circumvent its use as an illegal food additive would effectively render Koma Unwind and other similar products "tainted food" are require an immediate removal from all store shelves. A shot-sized product would be unaffected because it is not packaged in a size that could be construed as a "conventional food."

There is supposedly already a Melatonin-free formulation of Koma Unwind, created for the Euro market, called Koma Unwind ZERO.

There are numerous references available to support all of these statements. I have posted them all in the past. Arguments that melatonin is natural (the melatonin in KU is synthetic) and therefore is inherently safe is absurd. Melatonin is a neurohormone. It is not safe to ingest hormones at will.

Good question, thanks for asking. There is no imminent threat, but it is not a non-issue and is worth considering if you are thinking of an investment in a company whose flagship product contains Melatonin.