Dear California Department of Public Health,
Cannabis Edibles are one of the most common ways for patients to consume their medical cannabis without having to smoke or vaporize it. Patients can easily incorporate medicated edibles into their daily routine; this allows patients to “forget” they are suffering from or treating an ailment, and allows them to actually go about their normal daily lives. It is important to keep allowing edible products that are appropriate to the patients that consume them; made from ingredients with a medicinal or nutritional value; packaged in a sensible way that gives ample warning on the contents; doesn’t perpetuate a negative stigma of doing something “bad”; adds undue financial burden; and creates extra waste.
The Cannabis industry currently presents an oxymoron when it comes to “Medical Edibles”; the vast majority of edibles found in an average dispensary (estimated at over 90%) are either heavily processed, contain refined sugars, corn syrup, food coloring, preservatives, or other ingredients that possess no medicinal or nutritional value, and yet they are used as a vessel to deliver cannabis as medicine to patients.
This is fueled by some edible manufacturers in the industry that are trying to make a quick buck, prioritizing profit over patient care. Rather than catering to patients’ health, this business model has created an environment that allows the philosophy of “Just crush up some corn-flakes, add marshmallow and cannabis oil, and you have a money making machine” to prevail.
This philosophy creates an ironic situation where for example, a patient who suffers from type two diabetes is faced with the choice of consuming a product that contains the medicine (Cannabis) as well as the potential cause for their health issues (refined sugars).
Most of the “Health Conscious” minimally processed edible products are produced by small / craft manufacturers, with a passion for cannabis and for creating products with the patients in mind, rather than being driven strictly by their bottom line. These manufacturers often use small batches (under 500 units per day) when hand-crafting their product, to ensure the highest standards of quality and freshness.
The proposed regulations promote large scale mass production over small batch craft productions by requiring costly testing procedures with each batch. They favor using ingredients with a longer shelf life (like refined sugar, carbohydrates, and preservatives) combined in an assembly line fashion, over hand crafted quality and nutritional value. In most cases, it would be impossible to offer a product that could be considered medicinal due to excessive testing and ingredient restrictions.
The proposed regulations pose an unsurmountable barrier to entry for most of the existing edibles manufacturers, who are struggling to turn a profit even in the current market. Taking away the ability to share a kitchen and the ability to safely and responsibly promote products via events and giveaways, would prevent the majority of the smaller manufacturers from obtaining a license and operating within the law, and would likely drive them to the illicit market.
The cultivation regulations seem to take into account the cottage industry, and the manufacturing regulations should make similar exceptions.
Application and License Fees (40150)
A combined fee of $3,000 for a small manufacturer is too high. With all of the proposed requirements, it will be impossible to turn a profit and pay state and local licensing fees.
We believe a fee similar to the Cottage cultivation fee would be more appropriate, and would allow a smaller manufacturer to get a license rather than operate in the illicit market
The jump in fee between a business grossing under 100k ($2,000) and a little over 100k ($7,500) is quite steep and disproportionate; it creates an unfair burden on a small manufacturer who is trying to grow their business.
A fee of $3,000-$4,000 for gross income over 100k and under 300k seems more proportionate
License Constraints (40175) & Definitions (40100)
The Prohibition of co-location/premises sharing in the proposed regulations (which are also present in the proposed MCRSA regulations) poses a threshold hardship to small makers and operators that would most likely be fatal to their businesses.
Many Businesses Do Not Require Full-time Facilities
Many very small, cottage and even small edibles and tincture manufacturers do not require a full-time manufacturing facility. They may need a facility as little as one day a month in order to make the products that they provide to dispensaries. As a result, most currently rent time in or share the cost of commercial kitchens or small manufacturing spaces with other makers of cannabis products. Or, they have had their own kitchens certified so that they can make their products at home. These spaces provide all the needs of a small maker, but at a cost that allows them to stay in business and support their families. This is a longstanding and important small-business approach, one that has enabled people to make a living for generations, and that allows people of limited means and without access to large amount of capital to launch and stay in business
Finding Affordable Manufacturing Space is Extremely Difficult, And the Cost of Build-Out Prohibitive for Many Existing Cottage Manufacturers
Compare the difficulty and costs of complying with the proposed regulation, which prohibits shared premises. The licensee would have to find a manufacturing location properly zoned for their county. In some locales, this is virtually impossible because the county has limited manufacturing to industrial zones, which means very limited space and fierce competition, and thus higher than normal prices per square foot. Moreover, because most “industrial” or even “commercial” spaces tend to be large, an operator may only be able to rent a space of 2,000 square feet or more - far greater than needed and prohibitively costly.
If the maker is lucky enough to find a landlord who has broken up their building into smaller units, they will have to pay the higher cost of rent (due to competition), and also the full cost of a build-out of a commercial kitchen or manufacturing facility. All without the option of subletting to others and thus sharing costs.
Forcing this constraint on the thousands of small manufacturers in order to get a license and stay in business will simply be impossible for the many who cannot secure a lease due to competition, and cost-prohibitive for the large majority of small cannabis manufacturers who have been supporting the significant local cash economies of so many regions in California.
Requiring Separate Premises for Every Small Cottage Manufacturer is Wasteful
Nor does prohibiting premises-sharing make sense from a business, environmental or land use perspective. Requiring every small manufacturer to reinvent the wheel would be incredibly wasteful of resources, land, and money that is currently being put to use by these makers support the families, send their kids to school, buy health insurance, and hire employees to help them in their business.
Premises-Sharing Means Money Goes to Employees, Not Landlords or Large Licensed Manufacturers
Rather than transferring so much of the capital in this industry to the commercial landowners and equipment manufacturers, would it not be much more beneficial to allow the cannabis manufacturers to use that same money to hire employees and build their companies, thus increasing the possibility for financial self-sufficiency for themselves and the California residents they employ?
A further concern is the dramatic transformation of the structure of the cannabis economy that could result. In addition to forcing many small companies to shut their doors entirely, overall it could easily lead to consolidation of the manufacturing process so that larger manufacturers will begin to make products for many smaller companies - at least those who can stay in business under this model.
Premises Sharing Will Further the Policy of Protecting the Existing Small Manufacturers Without Any Loss of Health or Safety.
In the end this is excessively burdensome, unfair and untenable for most small makers, and clearly biases the industry in favor of large, well-funded companies. I do not think this is the intent of these regulations, but it will be the result. This is precisely the opposite of the grassroots local maker market we've had and have supposedly wanted to protect as the industry becomes regulated.
The vast majority of edible manufacturers, especially those operated by minorities and lower income residents, have no access to capital or loans to acquire their own kitchen workspace or equipment, and they deserve the chance to enter the industry as a Cottage manufacturer, just as those who are well-funded can enter as a larger manufacturer. Sharing workspace and kitchen costs will help ease that burden and allow entry into this market, while maintaining all the health and safety measures.
License Constraints (40175 B and C)
Article B - There are several cases where a combination of medicated and non-medicated products in the same package would be useful. The most notable one is creating a non-medicated version of a product, both for testing / development, and to offer as samples to dispensaries, distributors, or event patients.
Without the ability to manufacture non-medicated products, how would manufacturers be able to get their product noticed?
Article C - Banning manufacturers (especially small ones) from sharing a kitchen space condemns them to failure and drives them back into the illicit market.
The vast majority of edible manufacturers, especially those operated by minorities and lower income residents, have no access to capital or loans to acquire their own kitchen workspace, and they deserve the same chance to enter the industry as a Cottage manufacturer. Sharing workspace and kitchen costs will help ease that burden and allow entry into this market, while maintaining all the health and safety measures.
Master Manufacturing Protocol (40262)
Creating a protocol detailing the exact formula of a product or manufacturing technique may risk the exposure of a proprietary “secret recipe”.
There's nothing stopping an employee from photocopying such a protocol, and selling it to a competitor or using it to start their own brand.
These details should only be shared with staff that’s directly responsible for that step in the production process.
The protocol should only contain steps once cannabis has been introduced, as this will reduce the chance of an employee stealing recipes, reduce the total cost and simplify the paperwork for producing a product. If a manufacturer is creating an ingredient (peanut butter, for example), that at a later stage is combined with cannabis oil to create the final product, there is no logical reason to include the peanut butter in the same Master Manufacturing Protocol, as it does not affect the medicine.
Requirement of Two Employees During Manual Operations
This section requires a minimum of two makers/employees even for the simplest and smallest of manufacturers who are making the product manually. Requiring a second person to do not much more other than verify and sign off on both the measurement and addition of any component is overly costly, burdensome and, as with some of the other proposed regulations, would eliminate any individual cottage manufacturers, unless they have a large enough business and/or the extra capital to hire an employee to monitor them.
It would also be fatal to a large number of existing medicinal cannabis product manufacturers that simply cannot afford to hire an employee to do nothing more than with all due respect: babysit the batch-maker.
Simpler and Far Less Burdensome Solutions Exist
A decrease in mis-measuring can be achieved without having to employ an additional employee simply to verify measurements. For example:
Requiring the two measurements be made using different scales; or
Requiring that the person measuring be a certified weighmaster.
Any Problems Would be Caught Before the Final Product Leaves the Manufacturer
In any event of a mistake, the manufacturer will inevitably catch and resolve the error at the following stages:
During the steps following measuring/adding: an experienced maker will notice differences in texture, volume, etc.. in the following manufacturing steps
During testing. Any risk to health and safety due to occasional mis-measurement will in any event be caught at the testing phase.
If a batch is not to standard, the manufacturer would be required to make adjustments and test again to make sure the product meets the standard.
These steps in the manufacturing process completely mitigate the risk that a sub-standard batch will reach the marketplace.
Batch Production Record (40264)
Many smaller or craft manufacturers produce products in smaller batches that can be under 100 units.
Following the full batch production record for only 100 products is not going to be financially possible, as the time and money spent would be too high (transportation, employee manpower and lab testing can easily surpass $500 per batch)
A more logical and affordable approach would be to test the initial oil only once, and periodically test final product as well for QA. If a manufacturer has been producing the same product with consistent results (which is the goal for every edible maker), they should be able to only test the oil once, and be able to produce different types of edibles from the same “Oil Batch”
Is a batch defined by the oil/butter used for the infusion (one oil batch creating making products), or by the production (everytime 100 cookies are baked, even if the batter / oil are the same, they are considered a different batch)
Does a batch have to be completed in one work day?
Can the medicated component (filling or batter) be considered a single batch, even if it’s being used in production multiple days in a row (i.e., make enough cookie batter for 1,000 cookies, and bake 300+ each day for three days)
Can different products that are infused with the same oil be considered the same batch (For example, four different cookie flavors sold in a single box).
Requiring more than 1 person to perform the entire edible production from start to end goes directly against the very same issues the Cottage industry was meant to address.
It will encourage small / Cottage cannabis entrepreneurs to turn to the illicit market if they do not get an opportunity to operate within the legal cannabis industry.
Prohibited Products (40300)
Many of the proposed prohibited ingredients / products have been used in the California Cannabis industry for the past 20 years. Patients have gotten used to getting their medicine through these products. Denying patients access to products that have been helping them for years will likely cause them to turn to the illicit market, or to try and create them at home, which will lead to less accurate dosing.
In addition, all the ingredients below are already available for purchase in supermarkets and have their own food and safety procedures in place. There is no evidence that shows combining them with cannabis would cause any danger, and the history of cannabis use in CA for the last 20 years has not shown any adverse effects to the prohibited ingredients.
Caffeine - A product that many people already consume in their day to day life, with known health benefits (shown to reduce risk of several types of cancer, risk of stroke, and alleviate migraines) . An infused coffee, and specifically a single pod “self-brew” product can offer patients an ease of use, accurate dosing, and a way to incorporate their medicine in their normal day routine.
Potentially hazardous food (stored under 41 degrees) - Preventing the manufacturing of products such as frozen meals does a huge disservice for patients. Using fresh ingredients that are frozen right after manufacturing helps maintain their nutritional value, and offering frozen meals to patients can be especially beneficial to those who cannot cook for themselves, or maintain fresh food in their kitchen, but still want the benefits of eating whole foods and whole nutrition. Creating a frozen meal delivery service, similar to others in the non-cannabis industry, would allow patients that cannot cook for themselves, or do not have the knowledge,time, or access to effectively and economically incorporate their medicine to their existing daily routine.
Potentially hazardous food (Juice / Fruits / Vegetables) - As products that are safely available in any supermarket or corner store, and are high in calcium, fiber, iron, magnesium, potassium and many more nutrients, it would do a disservice to patients to prevent them from access to these infused products, while allowing artificial drinks with highly processed alternative flavoring. Fruit preserves or jam products are also readily available everywhere, and have not shown to be the cause of health concerns.
Potentially hazardous food (Perishable baked goods) - Products that are commonly used by many in their day to day life, from muffins to cookies and brownies, and while they traditionally have a high amount of sugar, health conscious alternatives do exist. While it may be that a smaller micro-business would be better equipped to offer perishable “made to order” products, prohibiting the use of these ingredients would do a disservice to patients, and would likely drive them to purchase the medicine they have been used to in the illicit market.
Potentially hazardous food (Dairy) - There are many types of medicine (such as probiotics or vaccines) that need to be stored and handled in a way similar to dairy. Prohibiting an ingredient that is used in the creation process of many baked good, and is the main ingredient in many commonly used products (such as ice-create, milk chocolate, or cheese) would be a disservice to patients by preventing them access to these high protein products.
Potentially hazardous food (Meats) - From smoked meat to pre-cooked meat (i.e., frozen meals), meat is a vital source of protein in a healthy diet, and a source of many essential nutrients. Using meats as part of a frozen meal, or better yet, as part of a fresh hot meal delivered directly to a patient’s home, can provide more nutrition, and contribute to better physical and mental health compared to using “candy” as a means for taking their medication.
Potentially hazardous food (Butter) - Prohibiting a licensee from manufacturing butter is an unfair financial burden on the licensee. It discourages artisanal small batch creation of a product, in favor of large mass production. It forces the licensee to start a separate business to create “commercially available” butter before infusing it, should they want to create a hand-crafted product from scratch.
Serving Size / THC Limit (40305 / 40306)
Patients in California consume high dose edibles, as directed by their healthcare provider, in order to treat their varied medical condition(s). Some products currently contain as much as 1,000mg-2,000mg of THC per package, or even per dose (such as a large brownie). While these doses are extremely high for many people, there are patients who need to consume 200-300mg of THC/day or more to treat their ailment or condition (specifically cancer patients with severe pain & those suffering from PTSD). So, it is clear that there is a need for high-dosed edibles in order for patients to continue to consume their cannabis medication.
Creating a low limit on edibles will do a huge disservice to California by placing an undue financial and nutritional burden on patients and create more environmental waste for the state. Under the proposed regulations, some patients would be forced to eat/consume an exorbitant amount of calories in order to get their prescribed dose of medicine. For example, a single dose would be only 10mg, which on average will equal about 75 calories, that means 750 calories per pack, and 2,250 calories for a patient who needs 300mg. That is more than the US recommended calorie intake for an entire day. This will undoubtedly come at a higher cost to patients, since they have to buy medicine at a lower dose and therefore higher quantity. Buying 3 packs instead of one can be 2-3 times more expensive (judging by current market prices). Placing dosing and packaging limits on THC will also create more packaging waste; the demand for THC will not change, so patients purchasing edibles in a higher quantity in order to make up for the lower doses offered, will have more wrapping, plastic, cardboard, etc. to throw away.
Prohibiting these higher dose products will certainly drive patients who choose to consume their medicine through edibles to obtain them from the illicit market, or attempt to create edibles at home, which could prove very difficult to properly dose.
10mg Dose Limit - This is a dangerous, misleading, arbitrary and capricious number. First time patients who have never tried cannabis before, as well as longtime patients with a slow metabolism (and other conditions that could be the cause of THC sensitivity that have not been studied as much), could have a bad reaction to 10mg, feeling overwhelmed, nauseous, or experience other adverse reactions.
Providing any indication that 10mg is a “safe” dose to consume even for first time patients will be misleading, and could lead to unsafe experiences.
A better solution to dosage limits is education: we recommend requiring a dosage guide based on the patient’s frequency of use and tolerance level. Dosage guides would stress starting with a low THC dose, and going higher slowly only as needed, until finding the right dose. While this might require more responsibility on the patient’s part, cannabis is not a “one-size fits all” medication, and what might be too much for one patient could be not enough for another.
100mg/Pack Limit - Again an arbitrary number that will create an unnecessary financial and health burden on patients, as well as encourage illicit market activities.
A patient who needs to consume 300mg of THC (again, a common dose for patients with severe pain), is now faced with purchasing three separate products, rather than one, which will undoubtedly increase the price of consuming 300mg of THC.
Consuming 30 edible doses of 10mg each will translate to an extremely high calorie intake. Even with an extremely safe estimate of 30 calories per dose, patients would look at 900 calories when consuming their medicine.
Patients faced with the dilemma of consuming a high amount of calories, or turning to a source that can supply a single high dose edible, are more than likely to go with the latter, which would only fuel the illicit market, and expose patients to untested and unregulated products.
An unreasonable financial burden is placed on patients who will have to purchase several smaller items rather than a single larger item to get their required dosage of Cannabis.
Uniform Distribution (40307)
Uniform distribution is unrealistic for many product types, from infused nut butters (which would need a good stir), to drinks, or even soup. In a perfect world where patients can have prepared infused meals delivered to them, the specific distribution of the THC would not matter, as long as the entire product is consumed.
A more flexible and sensible approach would be to require a label that states uniform or non-uniform distribution of the medicine.
Release to Distributor as Finished Product (40401)
This will be especially burdensome on small manufacturers who produce in smaller batches and would like to offer a single package containing multiple single dose products, that are clearly labeled, but are in a plain package. For example, it will prohibit a package for am/pm designations with some sativa based, and some indica based products (similar to a Dayquil/Nyquil multi-pack), or high THC / High CBD options, unless everything inside was produced in the same batch, which may be overly costly or impractical in many cases.
Having the ability to manufacture individual products in separate batches, would add more flexibility, especially for microbusiness / cottage manufacturing, a manufacturing dispensary, or if a manufacturer is also a distributor.
Every responsible cannabis manufacturer and consumer would agree that keeping cannabis out of the reach of children is a top priority. However, specifically targeting cannabis with more scrutinized rules and regulations than other products / industries, only perpetuates the cannabis stigma, and can make patients feel like they are still doing something wrong or illegal.
There are many products that are prohibited for kids, such as alcohol or cigarettes, yet do not have any child-proof requirements. You can even purchase a box of chocolates that are infused with alcohol (enough to require showing ID) at a local supermarket, and yet there are no child-proof requirements.
Another obvious example is firearms, which have no child-proof requirements at all, and yet they cause many more deaths and injury at the hands of children than accidental cannabis ingestion.
These packaging requirements are not based on any particular research, but rather driven by mass public hysteria, primarily caused by some of Colorado's shortfalls in packaging and consumer education requirements early on after legalizing recreational cannabis.
Cannabis edible packaging has come a long way from a saran wrapped brownie; take a look at some high-end cannabis products and the style, design, and creativity parallels that of the kind of product found in exclusive boutiques and department stores, while still providing obvious warning and dosing information. These types of products can help patients feel more “normal”, by incorporating their medicine in their normal daily routine, as well as elevate the cannabis industry and bring it out of the shadows of the illicit market, but the proposed regulations strip away that evolutionary opportunity.
Education should be the first step, and perhaps requiring a single child-proof “safe bag” where all the cannabis products are kept would be the more reasonable choice (similar to a gun “lockbox”)
A childproof requirement without exceptions (for example, a producing dispensary or microbusiness), will prevent many opportunities to serve real ingredients and real food to patients. For example: Home delivered meals (to those who are bed/home ridden), a fresh cannabis juice bar, a restaurant that wishes to offer medicated meals, and any manufacturer that wishes to offer a nutritional product.
The following individuals support this letter.
Tomer Grassiany (Los Angeles, CA), Founder of The Art Of Edibles, member of LA Cannabis Taskforce and board member of the Southern California Coalition.
Elise McDonough (Sierra Madre, CA).
Jeff Haas (West Hollywood, CA) Anakatrina’s Edibles
Anakatrina Waltz (Long Beach, CA) Anakatrina’s Edibles
Janice Hardoon (Los Angeles, CA) Koreatown Collective
Lucy Bussell (Los Angeles, CA) Lucy Goosey Edibles
Catherine Goldberg (Los Angeles, CA) Weedbar
Dan Braunstein (Los Angeles, CA) Grassfed
Liz Rudner (San Francisco, CA) Moonman’s Mistress
Jamel Ramiro (San Francisco, CA) Moonman’s Mistress
Chris Sayegh (Los Angeles, CA) The Herbal Chef
Victoria Chamberlain (North Hollywood, CA) The Weed Show
Angela Viesti (Los Angeles, CA) Pura Vida