Regulating Cannabis as a Traditional Herbal Medicine

Regulating Cannabis as a Traditional Herbal Medicine

Comments to the FDA on CBD & Cannabis

Many countries around the world have robust systems that govern traditional and herbal medicines, as well as pharmaceutical drugs. 48 The United States, however, does not have a specific entity governing plant medicines, which fall under the weak regulatory purview of the Dietary Supplement Health and Education Act (DSHEA) of 1994.

This Congressional legislation has facilitated significant advances in expanding the supplement industry and carving out a unique category of products between “food” and “drug.’’ But the DSHEA has failed to implement an adequate regulatory mechanism to ensure the quality and safety of herbal supplements in the United States. 495051525354

Manufacturers are supposed to submit documentation to the FDA showing that new supplements are safe and accurately labeled. However, if the FDA does not review the materials within a 75-day review period, the products are allowed to market regardless - without confirmation of regulatory compliance. The DSHEA does not require that these products be tested for safety or purity until after serious injury or death have been reported.

Responding with alacrity to reports of adverse events hasn’t been a strong suit of the DSHEA system. The lack of rigorous regulatory oversight has resulted in several dangerous supplements being widely marketed for years after reports of serious consequences were initially noted by the FDA. It took nearly ten years, over 150 deaths, and a court battle to remove Ephedra, a popular performance enhancer in the ‘90s and ‘00s, from the marketplace. 55

Consumer safety organizations contend that anywhere between 20-70% of supplements are mislabeled and do not contain what they say they do. 5657 Moreover, there has been significant evidence of supplement contamination with pharmaceuticals, as well as pesticides. The National Institutes of Health has advised caution when it comes to consuming health supplements, warning that many have been tainted with contaminants. 58

Underfunded Enforcement

A majority of consumers, including health professionals, make the errant assumption that supplements available on the market have been tested for safety and efficacy by the government and that any adverse effects are indicated on the label. 59 This is simply not the case. Lethal outcomes from supplements are very much the exception, not the rule. 60 But without adequate testing requirements there is little consumers can do to confirm that the products they buy are uncontaminated and properly labeled.

The federal government has consistently failed to establish procedures for ensuring that supplements going to market are safe and of high quality. A significant factor that undermines DSHEA enforcement efforts is inadequate funding. Only a tiny fraction of the $920 million budget of the FDA’s Center for Food Safety and Nutrition is allocated towards policing the $31 billion supplement industry. 6162

Under the DSHEA, nearly 70% of manufacturers were in violation of the established Good Manufacturing Practices (GMPs) in 2013. 63 In order to ensure the safety of CBD and cannabis products, the adherence to established GMPs would need to be strictly enforced. Ethical operators manufacture safe and effective CBD products. But allowing producers to be responsible for their own quality control leads to poor manufacturing practices and fraud, as evidenced by data about pesticides, heavy metals, and other contaminants found in CBD products throughout the unregulated market. A more rigorous, proactive approach to supplement regulation is advisable. 64

Mislabeled products, pesticides, and contaminants – these problems plague the fledgling CBD industry. Data presented at the FDA hearing on May 31, 2019, showed that many CBD products available online contained significantly different levels of CBD than those listed on the label, as well as potentially harmful unlisted compounds.

It’s hard to see how this would improve if CBD and other cannabis products are regulated as supplements under the auspices of the DSHEA. Some have argued in favor of this approach. 565 But it doesn’t appear that the existing regulatory system for supplements provides a robust enough framework to ensure that only safe, high-quality cannabis products get to market.

Not Just a Drug

The foundational documents of the FDA clearly indicate that a drug “is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.” Additionally, a drug is defined as “an article (other than food) intended to affect the structure or any function of the body of man or other animals.” 66

By this definition, many people in the United States utilize herbal supplements in general and CBD products in particular in ways that would qualify their use as drugs. Currently, about 20% of the U.S. population takes herbal supplements, mostly to treat or manage an illness. 67 But herbal products aren’t regulated as drugs. Instead they are regulated as supplements under the larger umbrella of “food.”

The FDA isn’t generally in the business of approving plants as medicine, even though numerous pharmaceuticals are based on compounds found in medicinal herbs throughout the world. 68 While many of these drugs are available only through a physician’s prescription, the whole plant varietals from which drugs are derived often remain available as herbal supplements. In 2015, for example, a Chinese pharmacist was awarded the Nobel Prize for her contribution to the discovery of the antimalarial drug artemisinin, an extract refined from wormwood. Her research was based on analyzing ancient medical texts, wherein the use of wormwood to treat malaria was referenced repeatedly. 69 Wormwood is still a widely used therapeutic herb.

There is precedent for approving a “botanical drug” within the FDA, though only two products have been accorded this status by the powers-that-be. Both contain highly purified and standardized extracts from botanical sources. Isolated extracts of CBD and THC from cannabis have already been approved as pharmaceuticals and, therefore, according to FDA policy, the botanical drug designation cannot apply to these single-molecule plant compounds.

Up until this point, the FDA has regulated CBD and THC just like any other pharmaceutical. But this might not be possible for much longer. We are now at a crossroads, and the FDA is faced with the unprecedented challenge of regulating hemp-derived CBD for general consumption as supplements, food additives, beverages, vape oil concentrates, artisanal extracts, tinctures, and raw herb. And not only CBD. Cannabis expresses incredibly complex biochemical diversity in which THC and CBD play major, but not all-encompassing, roles.7071

Classifying CBD as a single-molecule drug is too narrow a designation. Nor should CBD products be relegated by default to the poorly regulated supplement sector with its grab-bag of vitamins, minerals, essential oils, plant-based tinctures, nutraceuticals, and replicates of endogenous neurotransmitters – anything that’s not pharma.

Even if federal officials were to make a sincere effort to strengthen DSHEA’s enforcement capabilities, cannabis deserves recognition for its unique therapeutic attributes as an herbal adaptogen. Cannabis has a long and well-documented history as an herbal remedy in many countries, including the United States. The first evidence of its therapeutic use dates back nearly five thousand years to ancient China, and its continued use as a medicine over millennia is a testament to the plant’s safety, efficacy, and enduring popularity. 727374

Other Regulatory Models

How do other countries around the world regulate herbal products? What criteria are used to define a “traditional” herbal medicine and how does this vary in different cultures? 75 Could these examples help to inform U.S. regulatory policy that governs not only CBD, but whole plant cannabis and other herbal medicines, as well?

The World Health Organization has published extensively on the subject of regulating herbal medicines, 76777879 as has the American Herbal Products Association. 8081

The 2019 WHO report “WHO Global Report on Traditional and Complementary Medicine” outlines how 179 countries around the world regulate traditional and herbal medicines. Ninety-one have established national policies related to herbal medicines. Many countries (Indonesia, China, Australia, Korea, India, and Thailand, to name a few) have registered hundreds if not thousands of herbal medicines with an official regulatory agency. 82

The European Union (EU) has established a Committee on Herbal Medicinal Products and Food Supplements Directive with consumer protection in mind. But the process to place a product on the “positive list” – the approved list of supplements that can be marketed in the EU – is prohibitively expensive. It’s estimated to cost €100,000-400,000 to conduct the tests necessary to be considered for inclusion on the list.83 The high price point favors large processors and all but prohibits smaller companies from participation.

In Australia, herbal medicines are regulated as complementary medicines under the Therapeutic Goods Administration (TGA) in line with the Australian Regulatory Guidelines for Complementary Medicines. Herbal products are considered non-prescription medicines and are required to state their status as traditional medicines on the label. The fees associated with selling these products are significantly less than those in the EU. 84 Australia and the EU both require pre-market lab testing by a state lab. Recently, however, the quality of herbal products available in the Australian marketplace and the permitted list of health claims have been criticized by scientists and doctors. Proof of efficacy is not required by the TGA and some of the claims are very general and have little support in scientific, clinical, or cultural literature. 85

Most countries don’t have one single category under which all botanical products are regulated. Instead they are regulated under a number of different categories depending on the herb. Botanical products are most often regulated as over-the-counter drugs, but they also may be regulated as prescription drugs, health foods, supplements, self-medications, and functional foods, or they can be placed in their own separate category. 86 Given the complex chemical makeup of herbs, and the wide range of safety profiles and therapeutic effects, it makes sense to build flexibility into how a botanical product is regulated.

Tiered Systems

A useful metric for establishing the appropriate regulatory category for a particular herb could be based on an assessment of both the safety profile and hypothetical use cases for a product. This assessment would take into account historical evidence, scientific evidence, reported adverse effects, and pharmacological data, as well as traditional uses and folklore. Does an herbal product make explicit health claims? How strong is its safety profile? For how long has it been used therapeutically and by whom?

Some countries create tiers of products based on a number of factors. Australia, for example, has a two-tier system based on risk. Higher risk medicines must be evaluated for safety and efficacy and registered by the Australia Register of Therapeutic Goods. Lower risk medicines must contain pre-approved, low-risk ingredients, can only make limited claims, and may or may not be listed in the Register. The difference between ‘registered’ and ‘listed’ is key – they have separate requirements and imply different levels of regulatory rigor.

Korea has enacted a four-tiered labeling system for Health/Functional Foods (HFFs), which include supplements and other processed foods. The system is intriguing and worthy of consideration as a model for how it evaluates the safety and veracity of claims made about specific HHFs. Korea requires labels to reflect the quality of evidence supporting the therapeutic use of a product. There are four levels, each with a permitted statement that must be included on the label. Korea’s decision-tree of questions for determining product quality, safety and efficacy – which recognizes the validity of various kinds of data – might be a useful tool for crafting CBD and cannabis regulations in the United States [see Figure 22.1 in citation]. 87

One of the strengths of this four-tiered system of regulation is that it embodies a more nuanced and realistic view of botanical medicine than the FDA’s all-or-nothing approach to sanctifying medical claims. CBD isn’t a medicine unless the FDA says it is, according to the FDA, and because whole plant CBD-rich cannabis, unlike pharmaceutical CBD, is not an FDA-approved remedy, artisanal CBD-rich product-makers run afoul of the law if they make health claims about their formulations. This puts cannabis companies and CBD start-ups in an odd position – they have to market their products without saying what they’re good for.

Course Correction

Since its inception in 1973, the FDA has served as a handmaiden for cannabis prohibition, a dishonest, ignominious policy that has undermined medical science and thwarted medical advances. The FDA has been on the wrong side of history on this issue. Now the FDA has a chance to make a significant course correction by restoring cannabis to its rightful place in the pantheon of therapeutic herbs.

Toward this end, Project CBD recommends the formation of a Committee on Traditional Herbal Medicinal Products to advise the FDA and oversee implementation of a tiered regulatory program. This committee would set separate standards for different kinds of traditional herbal medicines, while validating CBD product safety and quality, which sensible regulations and realistic enforcement policies can ensure without engaging in expensive, drawn-out clinical trials.

The need for better oversight of cannabis products and other herbal supplements is inarguable.

The overriding objective should always be easy public access to diverse and affordable product options that are subject to rigorous manufacturing and compliance oversight.

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