When choosing an analogy for the CBD oil industry, the words Wild Wild West come to mind. It is the same for any new industry which has to find its legs in the beginning. Take the auto business for example. It struggled initially due to a lack of suitable roads. Every new area has hurdles to overcome. Over a year has passed since the passage of the Farm Bill of 2018. This bill took hemp off the schedule 1 narcotics list and made it legal. At this point, many of the cowboys of the CBD industry are ready to put on a suit and tie. But there are challenges. Farmers and CBD products producers are adjusting to understanding and complying with the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) requirements for production and promotion of products. This includes figuring out what FDA category CBD products fall into. This can be kind of tricky with a product that is so versatile. Kind of like the bystander in Superman who called: “Is it a bird? Is it a plane? It’s Superman!” Except, in this case, it’s: “Is it a food? Is it a supplement? Is it a topical? It’s ALL of them!” FDA and FTC employees are also struggling to understand this new industry so they can properly regulate it for the public’s safety. For Fusion CBD the challenge has been welcome. “As the industry started to take shape we didn’t even know what we were navigating,” said Ed McCauley, co-founder of Fusion CBD. “We began developing products with an X-factor of the unknown regulations that would apply to CBD products.” Over the past year, McCauley has been attending FDA certification classes to get fully up to speed on FDA safety regulations. “Our goal is to be fully compliant with not just one, but all three of the non-pharmaceutical areas that the FDA monitors–food, supplement, and cosmetic.”
Fusion CBD on Being Compliant with current Good Manufacturing Practices (cGMP)
Fusion CBD Founders Ed McCauley and Adam Kurtz, along with other reputable CBD companies in the CBD product industry, have embraced the extra work that comes with being cGMP compliant. cGMP refers to the current Good Manufacturing Practice regulations enforced by the FDA. cGMPs ensure that manufacturers have systems with proper design, monitoring, and control of manufacturing processes and facilities. “Though it takes a tremendous amount of time and effort to get in all of the documentation needed to demonstrate compliance, it is really good for the industry,” said McCauley. “There are, unfortunately, a lot of fly-by-night CBD companies out there with mislabeled products. That is bad for consumers and all of us in the industry.” It is important for retailers and consumers of CBD products to be aware of cGMPs. Consumers and retailers should know whether or not the CBD companies they are buying from are in compliance or working towards compliance. McCauley said that they had not heard of any CBD companies receiving FDA inspections yet. He expects them to come soon, however. When they do, Fusion CBD will be ready. He predicts that failure of being FDA compliant will put a lot of companies out of the game.
The FDA Big Five – Key Elements of Quality
There are five key things that FDA inspectors look for when determining the safety and quality of a product. It is on these things that the cGMPs are based.
Purity – labeling with documentation
Limits for potential contaminant – third party testing
These items are reflected in product labeling and product descriptions. The FDA requires back up documentation for both of these. This documentation includes information from 3rd party testing as well as internal Standard Operating Procedure plans. And the plans that CBD companies and any company with supplements are numerous. A company in compliance will be able to show inspectors their Safety Plan, Sanitation Plan, Microbial Plan, Storage Plan among many others.
So What are Current Good Manufacturing Practices?
Having Standard Operating Procedures clearly outlined is an important part of cGMPs for CBD product manufacturers. Current Good Manufacturing Practices for nutritional supplement companies include many areas.
CBD product manufacturers must take measures to exclude from operation any personnel who are suffering from a health condition that could cause contamination. In other words, complaint companies will not have Sneezy Joe packaging up your CBD oil. Personnel must practice hygienic practices like wearing protective outer garments, hair nets, being clean and washing their hands thoroughly throughout the day. Additionally, personnel must remove any jewelry or objects that might fall into the product. There will be no wedding rings (or gum) in the CBD cream. CBD companies must have a qualified Quality Control person in place who will inspect and keep records. Records include how the company is following its Standard Operating Procedures and the training of the personnel involved. No records? No Good.
Not only do the personnel need to be clean and sanitary, so do the grounds and physical plant. FDA regulations and inspectors ensure that both are free of germs, toxins, and pests (can you say bugs and rats? Yuck!) The grounds and plant must also be protected from potentially contaminated neighbors. So if the CBD company is located next to 3-mile Island, that could be a problem. (For those of you on the young side, 3-Mile Island Pennsylvania was the site of a nuclear power plant disaster in 1979.)
Next up on the Current Good Manufacturing Practices hit parade is equipment and utensils. All equipment must be appropriate for use in the facility and not itself bring the risk of contamination. Equipment must also be installed, cleaned, and maintained per the operating manual. We don’t want any equipment leaking oil or gas into our products.
As part of being cGMP compliant, CBD producers need to ensure that their product contains a manufacturing code identifying their company. CBD products must also contain a batch number so that if any problems arise, the specific batch of products in question can be isolated quickly and easily for the sake of safety, correction, and recall if needed.
Being compliant with current Good Manufacturing Practices means that even the handling of returned products must be outlined in advance and documented. Quality Control personnel in the company must be involved to determine if the returned product can be salvaged. They also determine if the returned product perhaps implicates other products in the same batch that may have issues that need to be handled.
One of the top reasons that producers fail to be compliant is the lack of a written procedure for product complaints. As with returned products, complaints must be reviewed by qualified Quality Control personnel. Records must be kept which include the name and description of the supplement, the batch number, the date and nature of the complaint, the reply to the complaint and follow up actions taken as a result. If you have ever made a complaint about a product, did you have any idea that your complaint was so well documented? It was if the company was in compliance.
For companies that label their supplements with shelf life dates, records of the product must be kept for a year past the shelf life date. If no shelf life date is used in the labeling, records must be kept for 2 years beyond the distribution of the last batch of dietary supplements associated with those records. In other words, supplements, unlike wine, do not become better with age. They just become untraceable.
A Challenge of Naming – “To CBD or Not to CBD, That is the Question”
One of the things that makes it challenging is the fact that many CBD companies, like Fusion CBD, actually produce full-spectrum products. Full-spectrum CBD products contain much more than CBD. They actually contain all of the naturally occurring cannabinoids and terpenes found in the hemp plant. This issue is not talked about enough. It is important because CBD isolate, meaning CBD without the rest of the naturally occurring cannabinoids and terpenes, is one of the active ingredients in the FDA approved drug Epidiolex. This drug treats seizures and is currently the only FDA drug containing CBD isolate. Full-spectrum CBD products and isolate CBD products are not the same and should not be regarded as the same thing relative to regulation.
Trouble Areas – Where Companies Fail on cGMPs
With all of the details and nuances of FDA compliance, there are a few that frequently trip companies up. They are:
Not having master manufacturing records or missing significant requirements from the records;
Not having criteria for product safety and quality for finished products. Also, failure to test all finished batches or at least a subset of finished batches;
For significant dietary ingredients, e.g. those that make of the bulk of the product, not establishing specifications for incoming material or failure to conduct identity testing;
Not having quality control review procedures. The other mistake on this is having quality control review procedures but not implementing a significant part of them;
No batch records;
Having significant plant deficiencies.
CBD Products and the Future
With the increased attention and regulation of this industry, the public can expect good products to stay on the market and improve, and bad products to disappear. The clear winner in all of this is the consumer. The industry also wins because as consumer confidence in CBD products grows, so will the industry. Companies like Fusion CBD attend conferences on best practices and freely share knowledge with others in the industry.
Disclaimer: The statements made regarding these products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your health care professional about potential interactions or other possible complications before using any product. The Federal Food, Drug and Cosmetic Act requires this notice.