Developing new ingredients for a large company like Pharmachem, we’ve had to be responsible and conservative at every turn, working within established guidelines and with excellent people. Safety is always number-one on our priority list, followed by peer-reviewed clinical science, a long-term scientific pathway, and excellent advice from smart people.
But, the regulatory aspects of this work-- getting to understand what is necessary in each country to acquire regulatory registrations and claims approvals—are of paramount importance in our global outlook. We must protect our core business units, so it’s even more imperative to work within these confines. Plus, it’s the only route to developing ingredients that stand the test of time.
We’re amazed at the number of new ingredients and consumer products alike launched each year with either unsubstantiated claims, or claims that are outright unbelievable, or worse: those which use "borrowed science" to validate them.
We learned most of what we know about this process by working closely with the FDA and our U.S. regulatory counsel Charles Raubicheck in gaining two structure/function claims for our weight-control ingredient, Phase 2 Carb Controller® several years, and many studies, ago. We learned even more working with Cantox on Phase 2’s FDA GRAS status, which, too, was a long-term process.
And, with the excellent help of Dicentra, our Phase 2® very recently received a unique license for two claims from the Natural Health Products Directorate, Ottawa, Canada, to market the ingredient with two health claims.
The process is long, arduous and expensive, and there are no shortcuts, but here are some suggestions.
1. Safety is First
Make sure you do no harm while striving to do some good. Nothing impresses more than safety. And safety is crucial because without it you have nothing.
2. Consider the Category
Start small to make sure that what you have is worth it, that the category is worth it, and that the ingredient may show long-range potential. It’s a shame to waste good money chasing something that doesn’t exist.
3. Do your homework
Government agencies differ in their requirements for making claims. Many companies have invested in what they felt were good studies that still did not meet the parameters for approval established by the governing body. If possible, arrange for a pre-submission meeting with the agency to determine what it wants to see. Doing so will save you a great deal of time and money.
4. Invest in quality research
While double-blind, placebo-controlled human studies are the gold standard, we recommend working with a researcher who has experience in developing the proper protocol for your ingredient and category to ensure safety and efficacy. It is also helpful if the researcher has prior experience developing studies that have been reviewed by the pertinent government bodies. One study is good, but several are usually necessary—with different populations and protocols—to determine dosage, safety and efficacy.
I’ll offer the rest of my tips Monday.