Many people like to complain about government inefficiency, but you
won’t hear that from the Saskatchewan Nutraceutical Network.
The network, which represents producers and processors of medicinal
plants and herbs such as echinacea, says federal officials are on
target and on schedule to soon give Canada the world’s best
nutraceutical regulations.
“It’s actually moving at quite a good pace,” said Kelley Fitzpatrick,
the network’s executive director.
“We could see the labelling regulations come into force as soon as a
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year and a half from now.”
In December, the government published the regulations in the Canada
Gazette, which is the first part of the process to make the rules law.
The regulations lay out how manufacturers must test, prove, manufacture
and license their products. They also detail what kinds of health
claims can be made on the product package.
It is now illegal to make health claims for a product that does not
have a drug identification number, or DIN. Getting a DIN is complicated
and expensive.
The other option for medicinal plant producers is to sell their
products without any health claims, which would confuse consumers who
don’t know what the product is supposed to be used for.
American nutraceutical makers are allowed many things that Canadian
producers are not, such as making indirect health claims and offering
mixtures of vitamins, minerals and nutraceuticals. United States
manufacturers can also release their products onto the market without
getting government approval.
This approach has led to the U.S. industry having many more
nutraceutical products and much better visibility than their Canadian
counterparts.
But Fitzpatrick said the U.S. industry is now reeling from problems
caused by weak regulations. Since some products were untested and made
poorly, many consumers have become skeptical of all nutraceuticals.
“Consumers are saying ‘hey, this doesn’t work.’
“It’s really painted a bad image of the industry, which the industry is
having to recover from.”
Fitzpatrick said the Canadian federal government’s decision to make
nutraceuticals more heavily regulated than food products but less
regulated than pharmaceuticals is the right approach.
“Are they a food? Are they a drug? They don’t fit into either. The
regulations need to be more stringent than for foods, but less
stringent than for drugs.”
Federal officials with the Office of Natural Health Products are now
compiling standards for the manufacturing and health claims of various
natural health products. Specifications of each product will be in a
government list.
When a new commercial form of an existing approved substance comes to
market, the manufacturer will only need to inform the government that
it is releasing the product and that it meets the specifications.
But if a new commercial product contains a substance that is not
already detailed, the producer will have to provide officials with
information about what it does, how it is made and whether it is safe.
Once these regulations become law, Canada will be on the cutting edge
of world nutraceutical production and marketing.
“They go further than anyplace else in the world,” said Fitzpatrick.