The Natural Products Number was issued for Fruit d’ Or’s Cran Naturelle organic cranberry juice capsules. While some companies in the United States chafe at the restrictions the Canadian market entry system imposes, Stephen Lukawski, marketing director for Fruit d’ Or, said that when adhering to an existing monograph, as is the case for cranberry, the approval process is relatively streamlined.
“There is a timeline based on the complexity of the formulation. Cranberry is traditional use, so it wouldn’t take as long as other products,” he told NutraIngredients-USA.
System adds certainty
“The system with Health Canada allows us to have more credibility with the NPN registrations,” Lukawski said. “Everybody has to jump through the same hoops.”
Lukawski said Fruit d’ Or’s adherence to extensive and rigorous testing, including DNA testing, is an attempt at market differentiation in a crowded cranberry field.
“We want to set a bar of quality that would separate us from other suppliers. We are looking at a farm to table perspective in controlling the quality from plant to finished product. We test the cranberry ever step of the way, and we don’t send it out for drying or milling,” he said.
Cran Naturelle is a multi-functional juice powder that can go into capsules, be used as a beverage base or act as a functional ingredient in things like nutrition bars, Lukawski said.
Rational system under attack
When the NPN registry system was first set up, there was a huge backlog in registrations and a lot of hard feelings. That situation is over now and the system works pretty seamlessly, but now that is all up in the air, said consultant Lionel Pasen, founder of the Toronto-based firm Natural Products Consulting Corp. Last year, Health Canada proposed changes to the way natural health products are regulated, opting for more of a risk-based approach. Industry sources are concerned with the lack of detail in the proposal, and whether some categories of supplements might in effect get lumped in with drugs.
Pasen, who said he has more than 60 years of experience in the natural products business, said the push for new or different regulations tends to come in cycles, and he’s seen them a number of times before.
“It is a rational system as it stands today. However there is quite a push by the so-called bureaucrats with the department that they are not happy with the control they have over natural products,” Pasen said.
“The pharma industry is very opposed to natural products and now they are trying to have a completely different system,” he said.
Drug-like evidence could be required
One thing that is on the docket to change is how health claims are regulated, Pasen said. For example, in categories like joint health, where arthritis drugs are already making detailed health claims based on their pharmaceutical dossiers, other products, such as glucosamine supplements that might seek claims along similar health benefit lines could potentially need to have a similar weight of evidence.
“That’s just not going to fly,”Pasen said. “We want our own regulations that are appropriate to natural products. I deal very well with Health Canada and in general I get along with them. But every five or ten years there is an attempt to squash the natural products industry.”
“The only way to deal with this is to get the consumers en masse to write to the prime minister, the health minister and their members of parliament. The last time we did this we generated 40,000 letters and that was enough [to get the NPN system put into place],” he said.