Cannabis Food Safety - FDA/GMP Compliance in Manufacturing, Dispensaries and Growers

With the increase in therapies and other consumer products derived from cannabis and its components, including cannabidiol (CBD), various federal, state and county agencies are beginning to regulate the industry for compliance. The Food and Drug Administration (FDA) sets high standards for food and pharmaceutical industries to ensure the safety of the consumer. CBD-based food products fall under existing food safety regulations - namely the Food Safety Modernization Act (FSMA) . Those products include cannabis-infused beverages (water, tea, coffee, juice, and beer), salves, oils, balms, vapes, edibles (cookies and gummies), and even dog treats. Cosmetics, supplements, and nootropics fall under the existing Federal Food, Drug and Cosmetic Act (FD&C) which prohibits the introduction or delivery into interstate commerce of cosmetics that are adulterated or misbranded (Sec. 301). Cannabis manufacturers, dispensaries and growers need to follow Good Manufacturing Practices (GMPs) to stay compliant with those regulations. Below, we outline some of the food safety risks to cannabis manufacturers, as well as good practices to follow to stay complaint.

Food Safety Risks to Cannabis Producers

Foodborne illnesses affect 1 in 6 Americans and lead to 3,000 deaths each year. The estimated cost in the US is $15.6B each year. These illnesses are caused by bacteria, viruses, parasites, environmental contaminates (plastic/metal), and toxins (bleach, other chemicals). Children under 5, pregnant mothers, adults over 65, and individuals that are immune-compromised are most susceptible. The top 5 risk factors responsible for food borne illnesses include:

1. Improper hot/cold holding temperatures (i.e., cannabis oil)
2. Improper cooking temperatures of food
3. Dirty and/or contaminated utensils/equipment (e.g., cross contamination due to using the same utensil in two batches)
4. Poor employee health/hygiene
5. Unsafe sources for ingredients

The highest percentage of cannabis users are older, therefore, bacterial diseases like salmonella could be lethal to them.

Contamination to your products can come in many forms including:

• Bacterial diseases such as C. Bot, Listeria, E. Coli, and Salmonella
• Viral dangers including Noro Virus and Hepatitis A (your sick policy prevents this)
• Molds/Mycotoxins (especially in cannabis plants)
• Pesticides (mitigated by proper testing/recalls/disposal)
• Heavy metals such as Chromium, Mercury, Arsenic, and Lead pulled out of soil and into plant
• Solvents such as Butane, Ethanol, and Pentane

Most Common Violations

The most common food safety violations to cannabis producers are actually very simple to mitigate. They center around hand washing and personal hygiene, including:

1. Using Sinks for Hand Washing ONLY (not used for food prep, etc.)
Water should reach 100°F within 30 seconds of activation. Employees should use soap and paper towels or an air drying device (not multi-use towels).
2. Wash Hands at Appropriate Time
• Entering food prep areas
• Before putting on clean, single-use gloves or between glove changes
• Before engaging in food prep (edibles or oils)
• When changing tasks or switching between raw foods and RTE foods
• After handling soiled dishes, equipment, utensils, etc.
• After touching bare human body part (e.g., arms)
• After using towels
• After coughing, sneezing, blowing nose, using tobacco, eating/drinking
• After caring for service animals or aquatic animals

Good Manufacturing Practices (GMPs)

GMPs are required by FSMA to assure your food product is wholesome, suitable for consumption and unadulterated. The FSMA guidelines provide plenty of documentation online. You are required to provide documentation of compliance if you are audited. A few areas of attention are worth noting to potential cannabis manufacturers:

1. Personnel Hygiene
Your staff need to practice good hygiene including using hair/beard nets, wearing their hair back, avoiding jewelry that could fall into the products, and wearing close-toed shoes. Hand washing is a must. Growers should be expected to wear Tyvek suit/scrubs if touching the plants. Dispensaries should always use single-use gloves, tongs or deli tissues when handling the product. Bare hand contact is prohibited. Personal items (mobile phone, purse, jacket) need to be stored outside the production areas. Employees should not be consuming food/beverages or using tobacco/vape in production areas. Your facility should have designated areas for this activity. Any food/beverages should be in clean and spill-proof containers.

2. Facility Build Out
   Your facility (floors, walls, ceiling, sinks) and grounds must be satisfactory, sanitary and maintained. For example, you must demonstrate that you have adequate water supply, temperature / pressure (e.g., hot water provided to your sinks), drainage/waste treatment, and pest control to prevent cross-contamination.
3. Equipment and Utensils
Your equipment and utensils/tools must be fabricated with safe materials, be of commercial design, and certified for sanitation by ANSI accredited certification programs (e.g., NSF). Consider equipment that is corrosion resistant, non-toxic and designed to withstand harsh chemicals/cleaners. They should have smooth seams to avoid accumulation of bacteria.

4. Sanitation Practices
Food contact surfaces and utensils must be cleaned. Non-food contact surfaces (e.g., floors, ducts, pipes, tanks) must be cleaned. Portable utensils and equipment must be cleaned, sanitized and properly stored to minimize contamination risk and allergen cross-contact. EPA-approved sanitizer solutions (e.g., chlorine/bleach or quaternary ammonium) should be readily available at all times and easy for employees to use. It should be the proper concentration (use test strips to measure every 4 hours). The solution should be changed every four hours if using buckets and every morning if using spray bottles. Ware washing should be done via a dishwasher with high/low temps. Most regulations require a 3 compartment sink for wash/rinse/sanitize) in case the dishwasher breaks down. Chemicals have to be labeled, stored away from food contact surfaces and used per manufacturer’s instructions. Emergency procedures should be documented in case of fire, flood, or sewer issues or an imminent health hazard (e.g., spraying chemicals on crop, salmonella outbreak, etc.).

5. Warehouse and Distribution
You must use proper storage, temperature controls, and processes to prevent damage/deterioration of equipment and food products. All food products and raw materials should be stored in clean, covered containers. Avoid warm or moist conditions where bacteria can be allowed to grow.

6. Potentially Hazardous Foods (PHF)
Foods such as meat, cheese, and dairy should be refrigerated. Cannabis oil needs to be refrigerated before putting into food products to keep toxins like Clostridium Botulinum (usually found in soil; thrives in oxygen) from forming. Some states/counties will check the heat step of your oil to test shelf stability.

7. Temperature Control
   The recommended holding temperatures are 41°F or below for cold foods/135°F or above for hot foods. Facilities should regularly calibrate their thermometers and keep logs for holding and cooking temperatures as well as heat step.
8. Extraction Concerns
Use food grade stainless steel for all CO2 extraction equipment so it doesn’t contaminate with rust particles. Clean/sanitize your extraction equipment daily. Refrigerate your cannabis oil if going into edible products. The heat step should kill C. bot spores. Ensure you are using food grade solvents (e.g. butane, CO2, etc.). Ensure you are testing for arsenic, mercury and aflatoxins and that your testing via regulations in your state/county.

9. Processes and Controls
You should keep adequate documentation/logs to support that you have proper quality control, employee training, standard operating procedures (SOPs) and HACCP compliance. All documentation should be stored onsite for 1 year and 7 years offsite. It is important that your ingredients or raw materials (e.g., food grade essential oils, flavors, etc.) are sourced properly from a licensed/FDA-regulated sources. Your sources should provide documentation on their GMP certification, licenses, shelf stability, pesticide use, and product testing.

How Union Jack Helps With Compliance

Cannabis manufacturers, growers, and dispensaries should consider hygienic cleaning and handling tools / containers to maintain compliance with HACCP food safety programs and Good Manufacturing Practices (GMPs). Union Jack can really help with the Equipment / Utensils and Sanitation sections of the FSMA GMPs. We're a leading supplier of cleaning and handling tools for craft food and beverage. We provide a number of FDA and NSF-compliant, color-coded products that are purpose-built for food safety including:

• Stainless-steel pharma scoops
• Stainless steel sinks
• Color-coded hygienic plastic scoops
• Food hoes, rakes and shovels
• Reusable bulk storage containers for transport or storage of food product or ingredients
• Ultra-hygienic floor/bench squeegees
• Tank/tube/hand brushes (great for extraction equipment or surface cleaning)
• Wall brackets to store your tools securely and off the floor
• Wall and floor scrubbing pads/brooms to assist with sanitizing your facility and equipment
• Metal detectable pens, clipboards, and scrapers

If you are company that produces cannabis-based products, click here to check out our large selection or give us a call to discuss your needs!

Seek Professional Guidance

We strongly encourage manufacturers, growers and dispensaries to speak with a professional that’s familiar with the regulations in their state or county. They can help with conducting employee training, compliance inspections, license sign offs, running pesticide investigations, writing press releases, conducting recalls, conducting shelf stability and CBD source approvals. Allay Cannabis Consulting out of Denver, Colorado is one such firm. They are a wealth of information.

Union Jack 

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