How Leapfrog amended the EU Catalogue
When I was looking for a company in the UK to make my chewable tablets, I ran into the first of many hurdles. Large, reputable manufacturers wanted huge volumes, and I wanted to start small and see if Leapfrog gained traction (though it contained Lactoferrin – a powerful, natural anti-viral protein that our bodies synthesise every day – few people know what Lactoferrin is).
“Come back to us when your company is successful,” said one manufacturing salesman with a chuckle; but I knew I wanted to start a relationship with a manufacturer that would last as Leapfrog grew. No breakups.
I happened across one small company in Yorkshire that made chewable tablets, and the CEO was a woman. I got on a train and went to see her face-to-face. I had prepared a speech.
“I’m a small start-up – I have enormous belief in my product, but little capital,” I said. “I want to produce a trial batch of Leapfrog IMMUNE, in smaller quantities than you’ve ever produced before. Give me this chance, and I promise you I will build trust in this brand.”
“Be my partner and help me grow Leapfrog from scratch!”
The CEO said yes. Leapfrog had the chance it needed to launch.
First, though, I had to convince the compliance department about Lactoferrin – an ingredient the manufacturer had never worked with before. In one gut-wrenching email, I was told that lactoferrin was not allowed to be manufactured and sold as a supplement in the UK. It wasn’t listed where it needed to be in the legal domain of the EU Commission, despite assurances I’d had before from others that it was approved.
I found an EU regulatory expert in Belgium who confirmed by email that Lactoferrin was approved by Belgium, but my UK manufacturer needed it to be approved by all member states and confirmed by the EU Commission.
With my heart in my mouth, I called Belgium and asked for help. Approval from all EU member states could take months or years, I had heard, and I was in despair. The regulatory expert asked if it would help if the status of Lactoferrin was clarified in a catalogue of the European Commission? YES! But the compliance department told me not to hold my breath – anything with the EU takes aeons. I felt Leapfrog slipping through my fingers.
It took four days.
Lactoferrin as a supplement was listed where it needed to be within the EU Commission Catalogue. The compliance department was shocked. And Leapfrog was back in business.