Our Story

OUR STORY

 

So you are getting ready to decide how to choose a probiotic for your child or for yourself. There are so many products to choose from, especially online. Your pediatrician, gastroenterologist or pharmacist may have even recommended one. Maybe my story can help you make a decision.

 

I have worked in the pharmaceutical industry pretty much my entire career and have met many types of doctors, but my favorite doctors were the pediatricians. They were the kindest and most caring doctors and I always got a kick out of seeing the kids in the waiting room either playing or sometimes begging their moms not to get a shot!

 

I always wondered where little kids developed their negotiation skills; one could argue in the doctor’s waiting room. It reminded me of my childhood when I was with my mother in the doctor’s waiting room and how I too hated getting that shot; heck I still dread it.

In the pharmaceutical industry, when promoting a drug to doctors, it is all about the studies. The FDA requires companies to provide studies that show the product works and is safe. As some of you may know this process is not required for dietary supplements including probiotics. So that means you really need to do your homework on choosing the right dietary supplement or probiotic for you and your family.

 

I took great pride on being an expert on the studies provided by my company. In 2006, I changed jobs from a very large company to a very small company here in New Jersey that developed and marketed their own adult probiotic. Before 2006, I had never even heard of probiotics.

 

One of the first things I did in my new job as National Sales Director was to visit the gastroenterologists with the salespeople. I noticed the doctors often recommended probiotics and gave their patients  samples that we provided and never asked about studies or whether they worked or not. I found this interesting because it was my first time working with a non-prescription product where I was used to working with Rx products where doctors often asked about efficacy and safety studies. So I asked one the gastroenterologists why he was recommending our probiotic at the time when there were fewer studies that showed that probiotics worked. The doctor’s answer below stuck with me forever and led me to eventually develop FloraTummys:

 

“One reason and one reason only” he said, “because my patients tell me they feel better and that’s all I care about.”

 

This doctor like most gastroenterologists knew that probiotics can do no harm which is part of their oath. So they decided, why not give them a try.

 

I became obsessed with probiotics, how they worked, how they were made, which were the best. At the time when I was still with that small pharma company in NJ, I urged the company executives to invest more time and resources to probiotics because the doctors loved recommending them, they worked, they were safe, many studies were being conducted, and they were the future for overall health. But they continued to focus on the prescription products because they made more money.

 

In 2011 my obsession with probiotics was going to serve me well. I decided to follow my dream and developed FloraTummys® Probiotic Sprinkles specifically for kids. I chose to start with a kids probiotic for several reasons:

 

1. I remembered that happy feeling when I was in the pediatrician offices; the kids in their mothers’ arms with dried up tears on their faces from the shot their moms promised they wouldn’t get. I day dreamed of the kids walking out of the doctor offices holding a cartoon sticker in one hand and a sample of FloraTummys in the other.

 

2. I loved looking at the different friendly packaging of kids’ products in the sample closet and wondered what type of packaging I would use for my product.

 

3. I thought how cool would it be to start my own business making a product that could help kids feel better especially when they were taking antibiotics that made them feel even worse.

 

4. Most companies started with the adult probiotic first then made the kids version just as a line extension. Other than the word “Kids” on box, there was nothing kid-specific about these line extension probiotics.

 

Adult probiotics make up about 80% of the market so the sales potential is much higher. As a result, there was a much larger selection of adult probiotics and not many high quality, kid-specific probiotics.

 

5. Disbelief! I was amazed to learn that the two leading probiotics for kids in powder packets, were both single strain probiotics lacking bifidobacterium and contained sugar and lactose. More studies show the combination of both lactobacillus and bifidobacterium show better results for certain types of intestinal conditions such as diarrhea and that sugar and lactose can worsen diarrhea in kids. What an opportunity I thought to do something good.

 

Some kids’ probiotics also contain artificial flavors and preservatives. Many moms would tell me they would have to throw out food they had mixed with other probiotics because of the “yucky” taste their kids would complain about after trying these out-dated products. I also learned that most kids’ probiotics did not contain a prebiotic. Prebiotics act as a nutritional source for the probiotics, help keep the probiotics lively, survive stomach acids, and help the probiotics work better.

 

Most probiotics are also made overseas. That means the FDA does not regularly inspect their facilities and probiotics are ultra-sensitive to temperature change when shipped overseas. As I mentioned earlier, the FDA does not “regulate” dietary supplements, but they make sure the manufacturing plants here in the US meet their good manufacturing procedures.

 

For these reasons, I decided to start with a probiotic for kids and then add an adult version at a later time (FloraTummys Adult Capsules now available).

 

I made the immediate decision to manufacture FloraTummys for Kids in the USA and in powder packets. Individual packets would ensure freshness, help keep the probiotics lively and make it easy for parents to sprinkle in foods, liquids breast milk, and baby formula. I also made sure that they would mix well and dissolve easily unlike the other probiotics in powder packets.

 

My initial goal was simple: to develop the highest quality probiotic for kids and to naturally help them feel better when they were sick.

 

After about two years post FloraTummys launch, I received a call from a NICU nurse from Antelope Valley Hospital in California. She told me they were using FloraTummys for premature babies to help prevent NEC. You would think this would have excited me but my initial thought was:  “What the heck is she talking about and what’s NEC?”

NEC stands for necrotizing enterocolitis, a very serious and sometimes fatal intestinal infection that affects about 5-10% of premature babies.

 

After the nurse explained it to me and I did my research, I was dumbfounded. Not only can FloraTummys help kids feel better, but now it could help premature babies get out of the hospital sooner and possibly save their little lives.

 

I was eager to learn more about NEC, so in 2016, I attended the Pediatric Pharmacy Advocacy Group (PPAG) conference in Atlanta, attended and organized by hospital NICU pharmacists across the country. Hospital clinical pharmacists (Doctors of Pharmacy) are the smartest, most careful, and skeptical health professionals you will ever meet. During this conference they presented very compelling studies that showed probiotics prevent NEC in preterm babies. The presenters’ recommendations of probiotics along with other expert recommendations closely fit the features of FloraTummys:

 

  • Probiotics with both lactobacillus and bifidobacterium
  • At least 1 billion active cultures
  • Individual powder packets
  • Prebiotic
  • Free of food allergens
  • Made in the USA

FloraTummys® Probiotic Sprinkles for Kids embodies all the above recommendations:

 

  • Lactobacillus acidophilus & Bifidobacterium lactis
  • 5 billion active cultures
  • Individual powder packets
  • Prebiotic (FOS)
  • Non-dairy, gluten and sugar free and free of most food allergens
  • Made in the USA

My initial research resulted in developing a product that hospital pharmacists prefer even though when I developed FloraTummys I didn’t know about NEC. I guess I got a little lucky. I am proud to say that FloraTummys is now being used in several hospital NICUs across the country to help prevent NEC. One hospital already reported a lower incidence in NEC since using FloraTummys. This is unbelievable news to me!

 

So if hospital pharmacists (as I mentioned, the most careful and skeptical health providers) trust FloraTummys then you could too whether it’s just for when your kid is on antibiotics, or you want to help build and support their digestive and immune systems.

 

My vision is to be the Family and Hospital Preferred Probiotic.

 

Frank Melfa is the President and Founder of FloraTummys.

NEC Society Briefing

 

From June 2nd through June 5th of 2019 I attended the NEC (Necrotizing Enterocolitis) Society Symposium in Ann Arbor, Michigan. The NEC Society was formed by a courageous young mother who tragically lost her infant son to NEC in 2012.

This meeting was attended by top neonatologists, nurses, health care professionals, and parents of children that have either died or survived NEC, from all over the world. Unlike other health care conferences, the NEC Society Symposium is led by parents of NEC children.

There were many brilliant scientific presentations from the top world leaders of NEC and heart-breaking stories from these parents. One topic that seemed to gain a lot of attention and at times got very emotional and heated was the use of probiotics for NEC prevention.

When one of the parents who had lost her child to NEC learned during a presentation that probiotics are proven to reduce NEC by 50%, she was quite upset and let the community know it. She said that an effective, inexpensive, and safe tools were available (referring to probiotics), and that they were not to used to try to save her child.

One of the many reasons that doctors and hospitals are not using probiotics is the risk of cross contamination of probiotics in the hospital. In addition to that they are still a relatively new “tool” to help prevent NEC and most hospitals don’t like being the first to try a new concept.

One of the doctors at the NEC Symposium presented trials including  the ProPrems Trial, that investigated the use of probiotics in preterm infants for NEC prevention that showed infants in the control group (those not treated with probiotics) were also colonized with the probiotics used in the treatment groups. Where capsules are broken or powder packets opened, the probiotics were released in air which would explain the colonization of the same probiotic strains in the control groups.

Although this may not have posed a threat to the infants, no hospital wants their studies and units compromised with cross contamination of any substance.

When the conference ended, I flew to my manufacturer in Wisconsin and explained to them the dilemma of cross contamination. After almost 2 years of experimenting we developed FloraTummys Quick Dissolve Probiotic, the first and only quick dissolve probiotic in liquids. FloraTummys Quick Dissolve Tablets are the first and only that dissolve in about two minutes in just about any liquid including breast milk when mixed vigorously in a closed container.

This should help hospitals, doctors and pharmacists gain confidence using quick dissolve probiotic tablets vs breaking capsules using bulk powder. This can help reduce the incidence of cross contamination in hospitals and nursing homes.

FloraTummys Quick Dissolve Tablet is designed for both infants and adults in a healthcare setting. It contains strains of both Lactobacillus reuteri and Bifidobacterium infantis (the strain most commonly found in breast milk) and FOS, a prebiotic which have also shown to help reduce NEC.

Each tablet is individually packaged and barcoded for easy pharmacy use.