Bebida Beverage Co. has issued a response to a recent warning letter from the U.S. Food and Drug Administration (FDA) that named regulatory violations pertaining to the manufacturing and marketing of the company’s KOMA Unwind Liquid Relaxation product.
In a press release addressed to company shareholders, BeBevCo stated that it has already submitted a response to the FDA and been granted the necessary time to perform the adjustments to ensure KOMA Unwind is in compliance. BeBevCo also asserted that the FDA’s concerns in the warning letter applied to a previous generation of the product’s packaging.
“As we have been making KOMA Unwind Liquid Relaxation for over five years, we have always contested our product is a dietary supplement,” said BeBevCo CEO Brian Weber. “Our packaging has evolved over the years to be in compliance. Last August, our package underwent a five-year celebratory upgrades that included what we thought was everything, however with of all things a change in office phone systems, we are back at the drawing board.”
One of the other violations named in the FDA’s letter was the the product’s representation as a conventional food on its website, namely its description as a “lightly carbonated beverage.”
“One of the other contentions is our website had the word beverage, we all sometimes get caught up in semantics,” Weber added. “You can drink a beverage, but a beverage cannot be a dietary supplement, you can drink a dietary supplement but it can’t be called a beverage. Our new KOMA Unwind Liquid Relaxation website will be launching May 1 and will take these sensitive issues into consideration.
As to the broader ongoing issue of the use of melatonin in beverages, Weber said it’s an area the company will continue to explore.
“The use of Melatonin is prohibited because it is not GRAS approved which only makes one wonder why?” he said. “Why is a product that is found in many foods including: Bananas, Nuts, Beer, Cherries and over 30 more foods not acceptable to be added to a food? How can a product where you can virtually take unlimited tablets with a glass of beer so problematic? Or how can a Norwegian study of 1400 women taking 75 mlg of Melatonin for four years and have zero side effects not be considered a solid study? My answer is simple. I am going to find out!”