The squeeze on natural health products (NHPs) appears to be taking place in yet another arena-in the courts, where a recent ruling could impact the entire NHP industry.

The case began in 2005, when Strauss Herb Company took Health Canada to court over a new policy interpretation they'd instituted-one that expanded the government's authority over "Schedule F," the list of what's  considered a prescription substance in Canada.

Previously, when Health Canada wanted to make a substance "by prescription only," the procedure involved publishing their intentions in the Canada Gazette and inviting public comment. But in 2004, the regulatorissued a policy declaration giving them the right to declare "any botanical from which a Schedule F substance could be extracted" subject to being arbitrarily declared a prescription product.

Shortly thereafter, manufacturers began to receive letters ordering them
to recall all products containing gotu kola, cowhage, yohimbe bark and red rice yeast because they "contained" a prescription substance as part of their molecular structure.

Because one of Strauss's products contains yohimbe bark, from which the prescription constituent yohimbine can be extracted, and because they wanted to protect the industry, they filed a protest.

In court last fall, Health Canada's policy was challenged. For starters, the list of plant and animal sources used to make NHPs from which a lab can chemically extract a prescription substance is potentially long and includes everything from green and black teas to countless fruits and vegetables. Logically, these foods don't deserve prescription status. Nevertheless, Health Canada's policy would deem them so.

Other points argued relate to how Health Canada's new policy creates
confusion about what constitutes a Schedule F drug, both within the NHP
industry and within the existing regulatory framework.

The judge ruled in favour of Health Canada, which Strauss plans to appeal. Strauss Herb Co. can be reached through www.straussherbco.com or (250) 376-5216.

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