Standardization of Herbs
Answered by: Conrad Richter
Question from: [No Name Given]
Posted on: January 17, 1999

What organization allows an herb distribution company to put the "standardized" label on their product? Is it just a word that anyone can write on the label? Who are the herb police that determine and enforce standardization parameters?

There is no law or regulation in Canada or the United States that specifically controls the standardization of herbs in herbal products of all herbal products. The word "standardized" by itself is not subject to legal control in either country.

In Canada, herbal products are sold either as a "food" or a "drug". When sold as a drug, the Health Protection Branch (HPB) often dictates what the constituent analysis must be in order for a manufacturer to be get the mandatory Drug Identification Number (DIN). There are many herbal products which can only be sold as drugs with a DIN, and these may be required to be standardized under the DIN program. If a DIN product does not meet a certain required constituent analysis, then it can be removed from the market. In practice, however, there is little evidence that the HPB is actively monitoring herbal DIN products for constituents levels.

In Canada, many other herbal products are not required to be sold as drugs; these can be sold as foods at the option of the manufacturer. As foods, these products do not need to be standardized, but manufacturers may choose to do so at their option. Often standardization is used as a marketing tool by herbal product manufacturers. Although the standardization claims are outside the purview of the Food and Drugs Act and Regulations, these products are still subject to labelling laws. So, if a manufacturer makes false claims for potency, theoretically it could be prosecuted under these laws. However, such products are not actively monitored for truth in label claims by the government.

We are not as familiar with the situation in the United States, but it is our understanding that most products are sold at what would be the equivalent to the "foods" category in Canada. Herbal products are sold under the Dietary Supplements and Health Education Act (1994) which liberalized the marketing of most herbal products. If companies claim standardized potency, they are doing so by their own choice, subject only to U.S. labelling laws.

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