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How 8 Numbers Changed the $3 Billion Natural Health Market
Over the past decade, the number of natural health products (NHP) to hit the shelves, and the number of nutraceutical and supplement companies to enter the market, has increased dramatically due to the rise in popularity of natural health alternatives to mainstream health care. In fact, the Canadian Health Food Association (CHFA) reports 70% of Canadians use NHPs – making it a $3 billion a year industry.
In order to regulate the growing natural health market and protect consumers, Health Canada, the federal department responsible for helping Canadians maintain and improve their health, developed a process that verifies information concerning NHPs. At the heart of the system is the Natural Product Number (NPN), an eight-digit number located on the product label.
Found on all NHPs legally licensed for sale in Canada, this number means that the product has been assessed by Health Canada and deemed to be safe, effective and of high quality. The NPN program began Jan. 1, 2004, and has been introduced in stages and developed over the last decade to its current form where no product without an NPN is allowed in the marketplace.
“It is security for the consumers and ensures that all products and supplements are manufactured according to Health Canada’s Good Manufacturing Practice Guidelines (GMP),” explains Trish Frank, operations and regulatory affairs manager for Pharmanutrients Botanical Corportation. “Our company specializes in nutraceuticals, functional foods, trending ingredients and services needed to compete in today’s marketplace, as well as the regulatory affairs formulation, manufacturing, marketing of our products.”
For added consumer convenience, all the information attached to the NPN, such as product brand name; license holder, medicinal ingredients, dosage, recommended use and associated risks, is completely traceable. Consumers wanting to learn more about a particular natural health product can simply enter the eight-digit NPN found on its label into Health Canada’s Licensed Natural Health Products Database to access detailed information.
A license to sell
In order to receive an NPN, all NHPs must first have a product license, and the Canadian sites that manufacture, package, label and import these products must have site licenses, as well. To obtain product and site licenses, specific labeling and packaging requirements must be met, good manufacturing practices (GMPs) must be followed, and proper safety and efficacy evidence must be provided – but getting a license isn’t easy.
“There is a lot of paperwork,” Trish says. “Health Canada wants to know specifically what is in a product; both medicinal and nonmedicinal ingredients must be listed. Companies have to find the right studies to support the dose used and if there are multiple ingredients, it has to be proven there are no contraindications or safety issues. If there are no studies companies can opt to do their own clinical double blind placebo control studies, which are the type Health Canada is really after. Health Canada does spot checks and verifies in retail the products are made according to the label amounts – if it doesn’t conform they can pull the NPN and, in extreme cases, shut the manufacturer or importer down.”
While manufactures experienced a slight learning curve with the new regulations and labeling system, the process is now widely accepted and has proven beneficial to business, according to Trish. “Following regulation takes time and resources, but it helps us [Pharmanutrients] sleep better knowing we are giving customers safe, effective and proven products,” she says. “Plus, since the NPN clearly states the dosage of each ingredient, it is easy to automatically process orders from any licensed company.”
What has emerged is an evolving regulatory framework that responds to the needs of the industry, has become one world’s most rigorous systems for protecting consumer health and safety, while also providing beneficial guidelines for NHP manufacturers – and it all comes down to just eight numbers.