Natural Health Products Remain at Risk
by HANS staff
Source: Health Action, Spring 2009
A Canadian company selling natural health products that are readily available in the US was the recent target of an armed raid in Calgary,
Alberta.
On January 15, 2009, Health Canada agents accompanied by armed RCMP
entered the facilities and private residence of the owners of N.A.F.T.A, which sells amino acid, glandular and herbal products. "After their 10-hour search, they took all our computer hard drives, records and our
entire inventory," wrote the owner, Eldon Dahl, a non-practising naturopathic doctor in a letter to N.A.F.T.A. customers.
Because many of the N.A.F.T.A. products, such as progesterone cream and
single amino acids, are considered "by prescription only" in Canada, the company could be charged for criminal conduct.
In the US, where natural health product (NHP) regulations are different,
consumers can legally purchase these products. Naturopathic doctors
(NDs) also use many of these products to help treat patients.
Both US and Canadian naturopathic physicians are trained in the use of bioidentical hormone, herbal, and glandular therapies as part of their education. But nevertheless, Canadian NDs have their access to effective products curtailed by federal regulations. Meanwhile, a medical doctor, who doesn't receive extensive training in these kinds of products, can write prescriptions for them.
This and other problematic aspects of federal NHP regulations were presented to the 300 who attended at a public talk in Vancouver on February 2, 2009, with keynote speaker and constitutional lawyer Shawn Buckley.
"Everybody agrees that the products were illegal," said Buckley of the
N.A.F.T.A. raid, "but I can't believe there's a genuine safety issue. These are products anybody across the border can get in health food stores."
Buckley also spoke about the general state of Canada's NHP industry. He says we're seeing an unprecedented withdrawal of products from the market,which is worrisome for those who rely on NHPs for health. Health Canada once estimated the Canadian NHP industry to have about 40,000 products. Judging by the number of Product License Applications (PLAs) that the Natural Health Product Directorate (NHPD) has received so far, many manufacturers and importers aren't finding the regulations possible or worth the financial and business efforts.
Since the implementation of Natural Health Product Regulations in January
2004, the NHPD has received 31,868 PLAs, according to their January
30, 2009, quarterly report. Of this total, 18,300 applications have been completed but only 8,800 products have been approved.
The two main reported reasons for refusal are failure to meet basic application requirements (36 percent) and failure to respond to a request for further information (24 percent). To be approved, companies must
clinically prove safety and efficacy of their products. However, Buckley pointed out that all but a handful of PLAs have failed over safety issues. Submissions are failing because they didn't provide enough information for efficacy.
"Should we lose 70 to 80 percent of NHPs over health claims? That should be the issue, but it's not," he said. adding that, NHPs, which haven't caused a recorded death in Canada in 140 years, don't pose enough of a risk to justify the regulations. Even without the regulations, the current Food and Drugs Act contains sections that address
fraud, so consumer concerns such as mislabelling are already covered.
The Canadian Health Food Association (CHFA), on January 27, 2009,
released a bulletin to their members clarifying a 2010 application approval deadline that has upset the industry.
After consulting with the Minister of Health and reading Health Canada's
compliance documents, the CHFA has interpreted the 2010 deadline by which NHPs must have their licenses applies only to products with a previous Drug Identification Numbers (DINs). Other than DIN transfers, the CHFA says there is currently no formal deadline for having a product license. However, they add, the NHPD hopes to have their internal backlog of applications cleared up by April 1, 2010.
"Once the backlog no longer exists, it is reasonable to expect that the NHPD will revisit their current compliance approach," wrote the CHFA.
The NHPD, which didn't return interview requests, told alive magazine last January that "compliance action will only target products that present an unacceptable risk to health and/or don't have a product licence application under review with Health Canada."
Melatonin, commonly used as a sleep aid or to reduce jet lag, was one
of the 60 N.A.F.T.A. products that were seized. At time of print, 10 melatonin products from other companies have
been approved for sale in Canada, according to Health Canada's Licensed Natural Health Products Database. The NHPD has stated that consumers will not see a mass removal of products from store shelves.
Whether all at once, or bit by bit, does the end result change? Buckley said he suspects that by the time this process finishes, the NHP industry will be a watered-down version of its former self, with fewer companies and between 10,000 and 20,000 products without the diversity and innovation that we're used to. In other words, many of the products that remain will be single ingredients or repetitive formulas.
Last September, Buckley and the Natural Health Product Protection Association (www.nhppa.org), launched the Charter of Health Freedom.
Among other things, the Charter, which they're collecting petitions for across Canada in the hopes of eventually presenting it to the House of Commons, would revisit existing NHP regulations and create a Ministry of Wellness and an ombudsman position to help protect health freedom of choice. Downloadable petitions are available at www.charterofhealthfreedom. org.
"We're losing our rights and our products because only a small number
of people are committed to action," he told the crowd. He was concerned that the urgent message of the threat to the NHP industry was not getting out to the public.
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