By Eric Brand

Recently I’ve been looking into some of the herbal regulations in Canada. Canada has a very distinctive regulatory system emerging for herbal medicine, and the laws governing the sale of finished herbal products are quite different there than they are in the USA. In the USA, herbs are basically regulated as food products rather than drug products, whereas in Canada they appear to have a newly emerging structure wherein herbs are regulated in their own category, in between herbs and drugs. Each system has a different structure of hoops to jump through, and each has its own advantages and disadvantages.

Follow up:

In the USA, Chinese herbal products are regulated as either dietary supplements or raw materials, depending on their form. Dietary supplements are basically a sub-heading under food products, although the category of dietary supplements is subject to more rigorous labeling and more formal cGMP (current Good Manufacturing Practices) regulation. Medical claims are not permitted, though vague “structure-function” claims are allowed. This accounts for the widespread use of vague claims like “supports healthy immune function” on products seen in the health food store.

According to U.S. law, if a product is claimed to diagnosis, prevent, cure, or treat disease, it is no longer legally a dietary supplement, but a drug product. Drug products are subject to a totally different tier of requirements to prove safety and efficacy, which is prohibitively expensive for most herbal products. On the other hand, herbal products that are not ready for direct administration (i.e., bulk whole herbs rather than powders, pills, liquids, gelcaps, etc) are regulated more loosely under general food laws if they are sold as raw materials rather than dietary supplements. This regulatory tier does not permit any structure-function claims, but it also does not require cGMP compliance and does not have restrictions on items like Ma Huang, which cannot be sold as a dietary supplement but is allowed as a raw material.

By contrast, in Canada the regulatory tier that is most similar to dietary supplements represents a middle ground between foods and drugs. It is permitted to make either traditional or modern claims that can be substantiated by evidence, but the registration process is much more arduous. In the U.S., basically an herbal substance is legal if it is not specifically prohibited, whereas in Canada herbal products must be approved before they can be sold. The approval process is complex, cumbersome, and somewhat tragically flawed from the TCM perspective, which makes Canada an undesirable market for most companies.

The situation in Canada is unfortunate because in theory it would seem to represent a reasonable system. The Canadian system provides a way to openly state the medicinal effects of herbal products, whereas the U.S. system basically requires manufacturers to claim that their herbal preparations have no solid therapeutic value (in order to avoid the insurmountable challenges of making a new drug application). The Canadian system also attempts to provide a lot of safety for the end consumer, and puts the interests of the public ahead of the interests of industry.

Unfortunately, the process is so arduous and limiting that the Canadian public will ultimately suffer because fewer products will be available on the market and the prices will doubtless be inflated to cover the costs of dealing with all the bureaucratic procedures (not unlike pharmaceuticals in the U.S.). In such an environment, there will be few opportunities for Mom-and-Pop enterprises and the herbal industry will be dominated by large corporate interests that can absorb the cost and nuisance of the regulations. To me, it looks like a win for big pharma and a loss for the common herbalist, and it “protects the public” by making even relatively safe products like Shi Chang Pu unavailable (presumably because if you give rats daily intra-peritoneal injections of large concentrations of beta-asarone isolated from its essential oil, the rats develop cancer).

Ultimately I see the trend in Canada as a troubling movement towards greater restrictions and ever-increasing bans on valuable medicinal herbs under the guise of protecting the public from themselves. For once, the Canadians are probably wishing that they had the U.S. government in charge, a rare thing indeed for our friends up north.

In truth, the Canadian system does have some major positive sides. They have significant protection for the herbal industry as long as it jumps through the proper hoops, and they require something that is sorely lacking in the U.S.- open information on concentration ratios. In the U.S., there is basically no legal framework that mandates that companies tell the consumer the concentration ratio of herbal products. In other words, herbal pharmaceutical companies can hide the information on the raw herb equivalence of their products to a much greater degree in the U.S. than they can in Canada. I think that it would be a great thing if U.S. companies provided transparency on concentration ratios, so there is at least one aspect that I prefer about the Canadian model.

On the other hand, the Canadian model is hopelessly flawed when it comes to many other TCM issues. For starters, the tea pill is considered to be the gold standard. This is laughable given that tea pills are really the “brass standard”; of all the products on the market, tea pills are the most opaque in terms of their potency and the most questionable in terms of their efficacy.

On the bright side, the Canadian system allows a supplier to make TCM claims (treats spleen vacuity) and they accept TCM theory and classical texts as valid references to explain the treatment rationale. This gives a nod of recognition to the intrinsic value of a medical tradition that has a long and illustrious literary history, such as Chinese medicine. On the downside, however, any modifications of a classical formula must be justified via explanations of every addition and modification, which makes it very difficult to introduce new formulas or customized variations on classical formulas. The vast majority of practitioners use modified formulas and most modern research is done on modified formulas, so limiting the scope of pre-approved combinations strictly to unmodified classical formulas does not realistically reflect the actual way that TCM is practiced.

The legal inability to easily modify formulas is not unprecedented in East Asian medicine. Japan has similar restrictions that limit Kampo formulas to unmodified versions of classical formulas, and the approval process of getting new drug approval to make, say, Gui Zhi Tang with 3 grams of extra Gui Zhi, is much more arduous and costly than the current process in Canada. The strict limits in Japan do create important standards of consistency given that herbs are sold there as prescription-only pharmaceutical drugs (herbs are only able to be prescribed by MDs and pharmacists in Japan), and the laws also may help to preserve classical Kampo formulas and encourage research into them. However, these conservative laws prevent Japanese companies from being as competitive on the international market as their Chinese counterparts, because the range of formulas available is much narrower. Given that Canada has a much more modest indigenous history of herbal medicine (and even traditional native herbs like calamus are apparently banned), it seems a shame to restrict the range of easily accessible formulas to only unmodified classical preparations. This stifles innovation in the herbal industry, slows the arrival of new scientific discoveries, and fails to reflect the clinical reality of the average TCM practitioner.

The Canadian law not only makes introducing customized modern formulas a regulatory burden, it also requires cumbersome labeling that does not necessarily have any intrinsic validity for the product in question. For example, Ge Gen has phyto-estrogens, so it must be labeled with a product warning that is literally like a whole page of risks, broken down by male risks, female risks, risks of both genders, etc. Ge Gen is basically as safe as a vegetable and is rarely used long-term, a drug safety insert longer than that of Viagra seems like overkill to me. For that matter, unlike Viagra, conditions such as impotence, infertility, and low libido are considered to have “insufficient standards of evidence to support traditional use claims.”

To get a grasp of this safety data warning landmine, think about a formula with a dozen ingredients. Probably at least eight of those ingredients would need a half-page disclaimer (ginseng can’t be taken with MAOIs, warfarin, etc). The most common ingredient of all, Gan Cao, will need a crazy disclaimer about hypertension, etc, even though the dose of Gan Cao that is associated with these risks is a level of magnitude higher than what most TCM preparations contain. Making matters even worse, the traditional contraindications must also be factored in (Ma Huang can’t be used for wind-heat instead of wind-cold, etc). This is relatively arbitrary because basically everything in TCM is contraindicated except for when it is indicated, so the list of contraindications could really get carried away. It is doubly arbitrary because it seems to come from only one or two English source texts, and I will be ready to scream into a pillow if I see them requiring a warning about ginseng and caffeine (unless they can actually produce some evidence to justify it).

As mentioned before, one of the requirements for a new product application for a modified version of a classical formula is a rationale for the modifications. Apparently, this must be expressed in the structure of the four roles (sovereign, minister, assistant, and courier). While it is again nice that we see recognition of TCM principles, this division of medicinal roles is often very arbitrary. Many classical formulas were made before the concept of the four roles came into Chinese medicine, and the breakdown of such formulas into the four roles varies a lot from source text to source text. Even a formula that is a textbook example such as Ma Huang Tang has disagreements on the medicinal roles, and Zhang Zhong-Jing certainly never used the terms of the four roles when he crafted the formula. The idea that all TCM products need to strictly conform to the theory of the four roles is very limiting and it forces companies to jump through hoops arbitrarily just to get their products approved.

Finally, they have a bizarre system of identifying the effective yet safe dose of herbal products. On the one hand, this is an improvement from the U.S. system of just requiring a specific, arbitrary dose to be listed on the bottle (the label doses on most TCM products in the U.S. often have no relevance to actual clinical use). However, the way that the calculation is made in Canada is strange. They look at the total daily dose range, the dosage of the product, and the concentration of the product to determine whether the dose is safe yet effective. Sounds good, but then they go on to basically say, if one serving has 10% of the normal daily dose of Bai Zhu, it cannot be said to supplement spleen qi, but if 8 ingredients that supplement spleen qi are used together, it is effective even if each item was used at only 10% of its normal dose range. On the flip side, it would be excessive (dangerous) if the product had four agents that supplement spleen qi together if each item was used at its full standard dose range. Say what? That is just weird logic any way you look at it, and I can’t imagine what would happen in contexts where different source texts were both considered to be authoritative (for example, the Chinese Pharmacopoeia gives the dose of Asian ginseng at 3-9 grams, but the ESCOP Monographs in Europe give a dose range of 0.5-2.0 grams, with over 2 grams being considered overdose).

As much as we tend to complain about the limitations on the herbal industry and the big pharma dominance here in the U.S., I feel pretty lucky that our herbal regulations are as modest as they are. We can still get Ma Huang in a bulk form, we can still use Shi Chang Pu, and we don’t have all the animal product restrictions that they have in a place like the U.K. The situation is Australia is also a major headache, and the practitioners there are said to pay several times the U.S. price for the same herbs. From the rumors I hear in the E.U., they are still lukewarm at best to the idea of permitting poly-pharmacy formulas with many ingredients. This really hurts herbal medicine popular among ethnic minorities (such as Chinese medicine or Ayurveda) and it suggests that the law revolves around the local European herbal medicine at the exclusion of other traditional systems. By and large, the U.S. system is much more sensitive to the needs of ethnic minorities and free industry, and I think that the models of increased regulation out there limit the public’s access to a diverse range of herbal medicines at a reasonable price.

Naturally, the long-term effects of increased prohibition and regulatory restrictions on herbal medicine can only protect the public to a limited degree. The Chinatown markets will remain completely unregulated or they will be forced to go underground, and the few malicious vendors out there will still continue to crop up without following the law. Therefore, the only companies that will be effectively policed by the new measures are companies that don’t really need to be policed, and all of the dangerous vendors will go underground. Banning the use of a safe and effective substance like Shi Chang Pu will do little to prevent its use, and it makes it extremely likely that any true adverse events will be under-reported because of the use of its illegality.

Ah, politics.