Seems that companies are popping up everywhere to produce CBD extracts, oils and isolates.
Currently, regulations on marijuana- or hemp-related products are established by individual states, generally through their departments of agriculture. Companies involved in the growing, handling, processing, holding, marketing or distribution of these products would be wise to acquire and study their state’s requirements thoroughly.
Only one drug related to cannabis has been approved, directed for the treatment of epilepsy. FDA is actively looking into what cannabis and CBD products do, and what they are used for, according to its website. Although hidden marketing claims cover a remarkable number of conditions that CBD can be used for, openly making such claims constitutes the product as a drug. And, in the eyes of FDA, that would make it an unapproved drug and illegal to sell or distribute in the U.S.
More companies are getting into the cannabis/CBD processing and marketing business. They are involved in everything from growing to harvesting, processing and marketing their products. Federal regulations remain a big concern. FDA may take two paths. Because so many companies are involved in the cannabis/CBD industry, FDA might determine these products qualify as GRAS and can be marketed as a dietary supplement without specific drug claims. Or, FDA may decide to classify cannabis/CBD products as a drug, which would require the filing of new drug applications (NDAs) or abbreviated new drug applications (ANDAs), and drug establishment registrations along with the required drug listings. The latter would squash smaller companies that are jumping on board in this growing industry.
To prepare for the hemp and CBD challenges ahead, companies should establish a production and process control system as required by the GMPs (good manufacturing practices) for dietary supplements and for finished drug products. These regulations are found in the Code of Federal Regulations, Title 21, Parts 111, 210 and 211. The required production and process control system becomes their company’s operating system. That is, the standard operating procedures (SOPs) and documents required by these regulations must be created as an integrated system, each relying on other SOPs or documents in order to establish complete control over all operations and the quality control (QC) unit. The system must establish specifications for each material used in processing, for each in-process phase of production, and for each finished product, including the finished packaged product. The QC unit must ensure that all specifications are met throughout the entire process.
Additionally, it would be wise collect additional data, including full chemical analysis, clinical trials and testing, stability, etc., on each of the products being produced. This data will help a company remain at the forefront if and when FDA decides to enforce its stance that these products are drugs. A company may not be able to afford filing for an NDA, but if a large pharmaceutical company does, a smaller company that has done the work might find ways to marry in with the larger company and file an ANDA.
Some dietary supplement regulations are stricter than the drug GMPs, likely due to the lack of confidence FDA had in the dietary supplement industry.
Regardless, it makes sense to prepare for what may come.
Hopefully, those who are involved in the cannabis/CBD industry are doing their best to keep the industry at the forefront of quality and compliance.
To read related content, check out the “Hemp/CBD: Market evolution” digital magazine.
Gary Callahan is owner/CEO of GMP Consulting. He has more than 40 years of hands-on and management experience in the pharmaceutical and dietary supplement manufacturing industry. Throughout his career, he has implemented many GMP and SOP programs in several different companies to meet compliance standards set by FDA