Thursday, September 28, 2023

Sano Ti Amo Hopes To Become One Of The First FDA Approved Cannabis Topicals In The US

AUTHOR: Chris Nani

Sano Ti Amo is a topical product based company in Ohio. Their new signature cream is currently being manufactured in an FDA approved facility and is undergoing the final steps for FDA registration. The cream, R &R Pain Relief cream was created by Co-Owner Paul Amoroso, a licensed Massotherapist, who has treated patients for over twenty years. Paul met Co-Owner Karen DeLuca while he was refining the cream. Karen has over fifteen years of sales experience, helping start-up companies, and product development. 

Q: What is Sano Ti Amo and how did you come up with the idea?

Paul: The name Sano Ti Amo means healing with love because everyone that tried our cream kept saying they loved it. I’ve been developing the cream for years and really wanted to make it perfect. Our goal was to help as many patients as possible. Sano means healing and Ti Amo means love or I love you.

Karen: In addition, since the FDA won’t allow us to use the word ‘healing’ we decided to use our Italian roots instead. We’re both Italian and wanted to reflect that in our company name. Also, we picked the deaf sign of I love you as our logo to go along with our name.

Q: Can you give me a quick background on yourself?

Paul: Ever since I was young, I liked learning about alternative medicine including Eastern medicine, Native medicine, and Ayurvedic medicine. I became a Massotherapist in 1997 and now use seventeen different styles of therapy to help patients. I also learned Chinese herbal techniques and have focused on learning from as many cultures as possible. I own a 44-acre horse farm and part of my inspiration for developing our products has been from treating horses to help them recover faster. One of my goals is to help veterans with PTSD through therapy with horses. I use alternative healing methods as well as traditional therapy with licensed therapists to help veterans recover.

Karen: I started in sales and marketing with Fortune 500 companies like Kellogg’s, M&M Mars, and Pfizer. Eventually, I decided to use my business knowledge in a more direct way. I wanted to become an entrepreneur and have since helped start and run three companies. I’ve started a skincare company, a gluten-free bakery, and now my main focus is on Sano Ti Amo. I also am the author of “Living Your Life in Gratitude” but, aside from my professional life, I love baking. I wanted to make an appealing gluten-free food you wouldn’t find in a grocery store, so someone with a gluten-free or specialty diet still could have the opportunity to have great tasting food and that’s how I came up with Ovenly Delights.

RELATED: A Conversation About Topical Cannabis Massages

Q: What are some of the products you sell?

Paul: Right now, we’re working on a gout and an arthritis cream, but our main product is our Relief & Repair cream. We use a full spectrum hemp oil that has all the cannabinoids in it. Now that federal legalization is occurring, we’re looking at ways to implement cannabinoids into our products. Plus, because our cream is a topical when it’s absorbed through your skin, you won’t feel any high. In other words, you’ll still have mental clarity along with all of the health benefits of the cream.

Q: What makes Sano Ti Amo unique? (talk about FDA cream product/what’s in it)

Karen: Our main product R&R cream has four special ingredients that have never been used before in a topical. What makes our product different is it flushes out the toxins in your body allowing for faster healing. Instead of numbing the skin like other creams, it helps repair the tissues at a deeper level.

Q: Why did you make the cream?

Paul: I wanted a cream for people that could penetrate the skin and go down into the muscle and nervous tissues with the intent of healing and repairing the tissues and not just masking the pain like most pharmacological ones. Pharmaceuticals are designed to mask pain signals temporarily so you end up in an endless cycle of constantly applying topicals and taking orals for the pain.

That’s why I worked with Dr. Ronald Anders, a veterinarian who is a triennially trained Doctor of Veterinary Medicine and he also studied Chinese herbals. Since many of the herbals we use are purified down to their essential oil or concentrated form, they provide our patients with the most potent form of the herbals. Dr. Anders’ style of veterinary medicine is to heal the patient as quickly as possible and not just mask the symptoms. He is world renowned with his practice and works on multi-million dollar breeding animals and show horses.

RELATED: 5 Painful Medical Conditions Topical Cannabis Products Can Relieve

We worked together to combine our knowledge and expertise to create a cream that would not only calm and soothe the muscles and the nervous tissues that report the pain but find the right combination of ingredients that would speed the healing process by increasing the lymph flow first to remove the sludge in the tissues. The cream also increases blood flow so the damaged tissues can repair the micro tears letting the area heal from the inside out.

I also really like helping people. I have worked with over 4,000 fibromyalgia patients over the years and noticed their skin and muscle tissue was different when treating them. I was inspired to help patients with fibromyalgia and started to research the formula for our cream because massages can be expensive when they’re needed every other day. But, with the cream, it can be used as a long term solution for more people as a daily application or as needed. It only takes around fifteen minutes to start feeling the effects and there’s enough in each container for multiple applications.

Q: Are there any side effects from using the cream?

Paul: There have been no known side effects of the cream. However, the cream shouldn’t be used by women breastfeeding or pregnant. We have had our product triple checked by a medical doctor (MD) and medical assistant (MA) with a chemistry background who compared our ingredients against pharmaceutical drugs and interactions between ingredients to ensure our cream would be safe and the ingredients within wouldn’t cause any reactions with our patients. We also took our cream to an FDA registered facility in Streetsboro, Ohio and had their scientists test our product. We wanted to have as many eyes as possible review our product before publicly introducing it.

Q: What kind of feedback have you gotten from clients using the cream?

Paul: A lot of times what we hear is that our product is subtle. It has a delicate scent and it doesn’t have a freezing feel like Bio Freeze or Icy-Hot. Customers also can’t believe how fast acting our cream is for a multitude of things. People recovering from surgeries have said it helps with their pain management and recovery. We also get a lot of people with fibromyalgia who say they have more energy after using the cream. Normally, fibromyalgia requires patients to frequently rest and it causes chronic pain. The cream helps alleviate both and gives patients their lives back.

Karen: I have a friend with CMT (a foot deformity) and he has an extremely tough time walking. He needs braces to help walk and it’s extremely painful. I’ll never forget when he said “You gave me my life back”. The first time he used the cream, his entire team noticed he was walking normally and his pain was reduced. It was a very humbling experience I’ll never forget. Walking is something we take for granted, and, with the chronic pain from CMT, it was amazing to hear the results from him.

Q: The cream is being registered with the FDA now, what advantage does that give Sano Ti Amo?

Karen: It gives the cream credibility. The FDA has strict purity and quality requirements. The FDA registration also allows us to tell people what the cream does. Although we’re restricted with the amount of information we can share right now, having registration with the FDA means we can sell our hemp product virtually in all fifty states without any legal issues. Retailers also don’t have to worry about our product being seized because it is registered, every other product on the shelves could be recalled or seized if it isn’t FDA approved.

RELATED: 8 Things To Know Before Using Cannabis Topicals

Getting FDA registration is definitely an arduous process but it is the only way for us to make medical claims. So far, our product has undergone stability testing to show it has a shelf life of two years but will likely have a four-year shelf life after testing is completed. The stability testing guarantees our product is safe.

Paul: Epidiolex is FDA approved as well and is in every state. What you’ll see moving forward is more and more products being FDA approved because of the credibility it gives their product. For example, labeling products with 100mgs of CBD when it isn’t true – mislabeling ­­– can cause your product to get pulled and fined and customers want consistency in their products. Also anyone with a medical license such as a doctor or nurse can legally use and recommend our product because it will be FDA approved and they won’t have to worry about losing their license.

Q: What was the process like for registering your product with the FDA?

Paul: We first had to become familiar with the FDA registration process, so hiring consultants and experts who know the ins and outs of the process was very helpful. It’s a very complicated process that requires tremendous amounts of time and expertise. Because the FDA isn’t a legal entity, they can only make recommendations but it’s very important to follow their directions to gain approval. It’s very time consuming with tons of hurdles; however, we’re expecting to gain approval within the upcoming weeks.

Karen: We worked extensively with an FDA facility and originally we were told it would take over ten years and around ten million dollars. By working with the facility, we were able to cut the process down to three years and save millions of dollars through our partnership. We were able to convince the facility to work with us by letting their employees test our product and vouching that it was the best product they had ever seen. The chemist at the facility actually took some of our product home for his mother’s swollen foot and within a few hours she could walk again and was able to play with her grandchildren.

Q: Are there any ways to support Sano Ti Amo?

Paul: Absolutely through Indiegogo, we’re looking for funding to help a major production run and launch our product on a larger scale to help as many people as we can that are ready to feel better.

Karen: The Indiegogo campaign is meant to help raise money for our first major production run and it wouldn’t just help Sano Ti Amo but it would help millions of people who suffer from chronic pain. The funds would help us get off the ground and start helping others. Our product is a need based one for patients with conditions like fibromyalgia, shingles, neuropathy, neck & back pain, and even acute injuries to name a few.

This article appeared on Green Market Report.


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