At issue: if you can extract a prescription substance from a plant, then the plant is a prescription drug and is only available by prescription. Please pass on to everyone who cares and bring your friends and family. This can be one of those situations where one person tells another who tells another person... and we can all act and fill the Vancouver court room on October 16th through 23rd. it is absolutely essential to defend herbs AND natural health products. See you there.
There is a list of prescriptions substances in the drug regulations. Everyone agrees that you cannot take something listed as a prescription drug and add it to a natural health product. However, this is not enough for Health Canada which came out with an interesting policy in the fall of 2004. According to the new policy, if you can extract a prescription substance from a plant, then the plant is a prescription drug and is only available by prescription.
The list of plants from which you can extract prescriptions substances is long, and includes very common things such as green tea, black tea, and cocoa (chocolate). It also includes common foods such as eggs, carrots, milk, broccoli, etc. No one knows how many plants this new policy will cover.
One concern is that uracil is on the prescription drug list. Most NHPs contains uracil which is the main building block of RNA. If this policy stands, then Health Canada could use uricil as an excuse to drive many NHPs they do not like off of the market.
The Court case is on October 16, 17, 21, 23 and 23 in the Federal Court in Vancouver (701 West Georgia Street, Vancouver).
So far, Health Canada has only targeted red yeast rice, gotu kola, yohimbe bark and cowhage or velvet bean.
If we lose this case, then Health Canada will have a powerful weapon to drive NHPs from the market. It is important for the Court to know that this is important to average Canadians. If we can fill the court room, that sends a message that the case is important.
If no-one shows up, then the Court will assume that this is not important to Canadians. Health Canada will be arguing that the policy is needed to keep Canadians safe. Canadians need to let the Court know that they want access to NHP’s.
Shawn P. Buckley
(of the MacIsaac Group of Law Firms in the Williams Lake, 100 Mile House and
Valemount regions of British Columbia)
and a few comments from the Strauss Herb Company who is the defendant iin this case
A parallelism:
If yohimbe bark in its unaltered state becomes the prescription drug
yohimbine through policy, then poppy seeds would become a controlled
narcotic.
Further to this, Health Canada’s policy completely overrules the NHPD regulations that fully addresses this exact situation:
Under the definition of an NHP (From the NHPD Regulations)
Inclusion list:
Specifically, the schedule of express inclusions indicates that medicinal ingredients of NHPs include:
(a) a plant or plant material, an alga, a bacterium, a fungus, or
non-human animal material;
(b) an extract or isolate of (a), the primary molecular structure of which
is identical to that which it had prior to its extraction or isolation;
(c) a vitamin;
(d) an amino acid;
(e) an essential fatty acid;
(f) a synthetic duplicate of (b) to (e);
(g) a mineral;
(h) a probiotic (a term which is defined in the Regulations and is intended
to capture such things as Lactobacillus acidophilus).
It is important to note that synthetic duplicates of NHPs are included, as mentioned in (f) above.
Inclusion of "an extract or isolate of a plant or plant material, an alga, a bacterium, a fungus, or non-human animal material, the primary molecular structure of which is the same as that which it had prior to its extraction or isolation", is intended to capture NHPs of natural origin and which maintain their original structure. However, the NHPD recognizes that new drug substances may also be derived from nature. In these cases, the substances are often altered chemically after being extracted from the natural source. For this reason, the NHP definition specifies that the substances must be unaltered from what is found in the natural source to be considered an NHP.