Medical decisions should not be made based on advertising. Consult a physician on the benefits and risks of particular hemp-derived products.

What is RSM, and why is it important? There are several definitions for regulatory starting material (RSM). In broad terms, it encompasses the chemicals used in the extraction of compounds from organic sources, but it may also include the compounds themselves as they are used to make other products, such as pharmaceuticals. RSMs play an important role in the cannabis industry, which uses them for extracting cannabinoids such as THC and CBD. It provides the extracts with consistent, standardized concentrations of phytocannabinoids. 

What is Regulatory Starting Material?

The main issue in the discussion about RSMs surrounds their use as starting materials in compendial processes to manufacture drugs or active pharmaceutical ingredients (APIs). These materials are often derived from natural sources or organisms that have not been fully characterized or tested for purity or potency. For example, plant material or animal tissue may be used as an RSM because these substances are easily obtainable from nature and can be converted into pure drug substances through extraction and processing methods. However, these substances may also contain contaminants that could affect product quality if they were not removed before use as an RSM.

The choice of regulatory starting materials is a crucial step in determining where the drug substance manufacturing process begins. Choosing the right RSMs can be difficult, and there is frequently heated discussion about it among cannabis manufacturing companies and among regulatory agencies that examine commercial marketing applications.

Proprietary Natural Product Extraction Methods

The cannabis plant contains a variety of chemicals that are extracted with organic solvents. These include terpenes and cannabinoids, which are used to make medical marijuana.

The process of producing medicinal cannabis is based on two main stages: drying and extraction. The first stage involves drying the plant material to a moisture level that allows for safe transport and storage, while the second stage involves extracting the active ingredients from the plant material using organic solvents such as ethanol, carbon dioxide, or butane.

Product development and extraction techniques have taken center stage as the cannabis business moves from an illegal market to a legal one. There have been tens of thousands of chemical components identified within the cannabis plant, each with unique chemical characteristics and requirements for preservation during drying and extraction.

In the past, when cannabis was illegal, many companies could not afford to invest in developing proprietary methods of drying and extraction. As a result, they were forced to use simple, inexpensive methods (with some success) that were available from third parties.

The most practical way to extract medicinal cannabis is with organic solvents, which include regulatory starting materials.

The Need for Regulatory Starting Material Standards

Two key criteria interact to determine how many stages there are between the introduction of an RSM and the end of the production method. The first concerns the active pharmaceutical ingredient’s (API’s) physical characteristics, which are established at the final crystallization stage and any ensuing size reduction procedures. The second issue has to do with how impurities originate, are dealt with, and are eliminated. When compared to contaminants produced later in the manufacturing process, those introduced or formed early in the process often have a lot more potential to be removed during subsequent downstream purifying activities. As a result, it is more likely that late-forming contaminants will make it into the finished API.

When these two factors are considered together with other considerations such as safety and efficacy, it is easy to see why regulatory agencies want to know what goes into their drugs from start to finish. This is where starting material standards come in handy: they allow regulators to ensure that every step of an API’s production has been carried out reliably and consistently over time by multiple manufacturers around the world.

Cannabis derivative products need a consistent starting point to be effective. At Abundant Labs, our experienced cannabis professionals employ extraction and production methods paired with analytical tools that test the material at every stage of the process to ensure that we stay within our parameters and produce the purest cannabis extracts.

Medical decisions should not be made based on advertising. Consult a physician on the benefits and risks of particular hemp-derived products.

Abundant Labs has always been at the forefront of the hemp extraction industry, but now we’re expanding our repertoire. Our R&D team is still working hard to bring you the best hemp and cannabis extracts on the market, but now they’re broadening their scope to include a variety of biological materials. We have always been committed to developing new techniques and methods for extracting all kinds of biological materials and we’ll continue this tradition as we expand into new fields.

Why Choose Abundant Labs 

Abundant Labs is a biorefinery that specializes in the extraction of a wide range of biological materials, including cannabis.

Our expert analytics team is part of our quality-assurance guarantee, so you can trust that we will produce consistent products no matter what material we’re extracting. Our mission is to make sure that every customer has access to high-quality products without having to worry about consistency or safety. We have built a reputation for doing this by focusing on innovation and quality-control measures that go above and beyond what’s required by law.

When you work with Abundant Labs, you can expect professionalism, advanced data, and consistency.

We believe that customers should be treated like clients, not like numbers. That’s why we make sure that every member of our team is well-versed in the needs of all types of clients—from small businesses to large corporations—and are ready to help you reach your production goals.

And as always, we make sure that every product we create is consistent. That means no matter when you order your products you’ll always know exactly what you’re getting. 

Learn more about our equipment and our team by visiting our website. Please feel free to reach out to us with any questions or to inquire about ordering. 

“Medical decisions should not be made based on advertising. Consult a physician on the benefits and risks of particular hemp-derived products.”

Interest in creating therapeutic options that are made from either natural phytochemicals or synthetic cannabis derivatives has increased as knowledge of the endocannabinoid system has grown. A myriad of components makes up the endocannabinoid system, many of which are found in the majority of the body’s cell types.

API Synthesis 

The U.S. Food & Drug Administration (FDA) defines an active pharmaceutical ingredient (API) as any chemical or combination of substances intended to be employed as the active component in the production of a medicinal product. Such chemicals are designed to provide pharmacological action or other direct effects in the diagnosis, treatment, mitigation, or prevention of disease, as well as to alter the structure or function of the body. API can be found in the form of liquids, powders, crystals, and extracts that are produced through chemical synthesis, plant extraction, or biotechnology.

Clinical application of the product requires processing the API into a pharmaceutical formulation. A variety of raw materials with various physical and chemical properties are used in the synthesis of APIs, which is typically a challenging and multi-step process requiring several chemical transformations and operations. To perform API synthesis, specialized knowledge is required.

Difference Between Synthesis and Extraction

Depending on the company, the production of specific cannabis-based or cannabis-derived products and drugs and their specific strategies heavily influence whether chemical synthesis or extraction of phytochemicals is preferred. There are two or more stereoisomers of various cannabinoids. Despite having the same formula, these compounds’ atoms are arranged differently, which allows the molecules to have various pharmacological actions.

As a result, the extracted and synthesized products may have distinct chemical profiles due to the variations in the stereochemistry of plant-derived and synthetic forms of the same target cannabinoids. The strategy for producing various candidates may thus be determined by the desired end result.

API Uses

Cannabis businesses can employ API synthesis to create cannabis products that are standardized, highly effective, and/or targeted. Abundant Labs is able to produce strains with consistent concentrations of different types of Cannabinoids and terpenes using a combination of stable plant genetics and automated, high-tech manufacturing procedures.

We believe that employing API production methods at Abundant Labs provides our customers with products that are not only of the absolute highest quality but also give us the ability to have complete control over the entire process. This practice helps us achieve our main goal, which is to provide consistent and safe products for our customers. Abundant Labs will continue to develop new means for providing high-quality products in a safe way to all consumers.

If you’re interested in learning about newer methods for obtaining CBD isolates and other products, take a look at our website and blog to learn more. And if you want to know more about Abundant Labs or the high-quality hemp products we make, don’t hesitate to reach out!

The cannabis industry is a bit of a Wild West. Its existence as a Schedule 1 substance has made research into the medical benefits nearly impossible to undertake until recently and there are next to no uniform standards for the production of hemp and hemp-derived products. The FDA has purposefully neglected to impose regulations, preferring to delegate to the DEA, and this has caused numerous issues in the industry, most notably with quality control and consistency. 

Federal vs State Regulations

More than ever before, Americans are supportive of legalizing marijuana and reforming cannabis laws. Due to cannabis’ legal status, there is no industry-specific regulation at the federal level; however, government organizations are involved in ensuring that safe products reach consumers. States that have authorized the sale of marijuana for medical or recreational purposes have established state-based regulatory frameworks.

This lack of framework at the federal level has created a bit of a mess for hemp producers and labs that operate in one state but sell nationwide. 

Since the Agricultural Improvement Act of 2018 was passed, the subspecies of cannabis known as hemp has been recognized by federal law as a lawful agricultural product (the 2018 Farm Bill). The 2018 Farm Bill specifies that the federal definition of industrial hemp requires it to have a concentration of delta-9 tetrahydrocannabinol (delta-9 THC) of no more than 0.3 percent on a dry weight basis.

If these criteria are satisfied, Section 280E of the U.S. Internal Revenue Code, which prohibits companies that traffic in illicit drugs from deducting regular business expenses other than the cost of items sold, is no longer applicable to hemp-related firms. Additionally, potential money-laundering accusations are no longer a concern for funding sources like federally chartered banks.

Despite the fact that these loosened regulations have a considerable impact on hemp cultivation, marijuana, which is frequently used as a psychotropic drug, is nevertheless classified by federal law as a Schedule 1 substance, along with heroin and LSD. As a result, even in jurisdictions where marijuana usage for recreational purposes is legal, cannabis-related enterprises may have legal challenges when financing, producing, transporting, and selling cannabis products.

State-level regulations of marijuana have become more lenient in comparison to federal marijuana restrictions. In many states, having a small amount of marijuana in your possession or using it recreationally is no longer a crime.

Financial institutions that assist marijuana companies, however, run the risk of violating the Controlled Substances Act as well as being deemed money launderers under the Bank Secrecy Act (BSA) of 1970. Given this risk, brokers and banks will often refuse to work with cannabis companies, making it difficult to secure R&D funding to improve production processes. 

The lack of federal regulation also opens up different operations to unique risks. Cannabis that may be considered “safe and ingestible” in Washington State, for example, may not be sellable in Alaska. 

Barriers in Research 

Due to the lack of federal regulation, the amount of research conducted in the United States on the health impacts of cannabis and cannabinoid use has been constrained, depriving patients, medical professionals, and policymakers of the data they require to make informed choices about the use of cannabis and cannabinoids. There is a risk to the public’s health because there is a paucity of data supporting claims about how cannabis and cannabinoids affect health.

The obstacles to such studies must first be recognized and removed in order to encourage research on cannabis and cannabinoids. An NCIH committee noted a number of impediments to conducting basic, clinical, and population health research on cannabis and cannabinoids. This includes funding constraints, laws and regulations that restrict access to cannabis products used by an increasing number of consumers and patients in state-regulated markets, and policies that prohibit the use of cannabis products.

Complicating matters, a number of different organizations may be involved in the review process for a study involving cannabis or cannabinoids, including the National Institute on Drug Abuse (NIDA), the U.S. Food and Drug Administration (FDA), the U.S. Drug Enforcement Administration (DEA), institutional review boards, state offices or departments, state boards of medical examiners, the researcher’s home institution, and potential funders.

In some states, in order to conduct clinical trials or any other activity involving Schedule 1 substances, researchers conducting clinical research on cannabis or cannabinoid products must also apply for and receive a controlled substance certificate from a state board of medical examiners or a controlled substance registration from a department of the state government.

It takes a number of approvals from various federal, state, or local agencies, institutions, or organizations for basic and clinical researchers to obtain cannabis or cannabinoids from NIDA for research purposes, including initiatives to assess the value of cannabis or cannabinoids for treating a medical condition or fulfilling a therapeutic end need. Researchers may find this approach intimidating. Numerous cannabis researchers have reportedly been deterred from conducting further studies or asking for grant money due to the significant layers of bureaucracy that result from cannabis’ Schedule 1 classification.

The data is clear: cannabis can be a useful medicine, and it has the potential to become a major part of the American economy. But right now, the industry is operating in a legal gray area.

The FDA’s role in this field is crucial—they need to step up and clarify their position on marketing regulations for cannabis products so that patients and companies can have confidence in what they’re doing. They also need to create uniform federal regulations for research so that innovation can continue at its best pace.

We believe that Abundant Labs is taking the right approach, focusing on science-driven research with a focus on data collection. For more information on our labs, equipment, and analytics, visit our website. 

Disclaimer: Medical decisions should not be made based on advertising. Consult a physician on the benefits and risks of particular hemp-derived products.

When purchasing hemp-derived products, you may find yourself confused about the inclusion of other ingredients. Topicals, edibles, and oils can all contain a variety of different ingredients, each with their own purpose. It’s important to do your research and talk to your doctor before using hemp products, and ensure you are purchasing quality products.

What Can Be Found In Distillate? 

Hemp distillate and hemp-derived products can contain numerous different additives. You will commonly find additional oils in your hemp-derived products. Ingredients can be added with the intention of introducing additional medicinal benefits as well.

Carrier Oils 

A carrier oil, as the name suggests, transports the active compound’s contents. Because essential oils or concentrates can be too potent on their own, carrier oils are used to dilute them. Carrier oils are used to help dissolve CBD molecules to increase bioavailability. Typically,  a medium-chain triglyceride (MCT oil) is used, and this is often made from coconut oil, though nut or other plant-based carrier oils can be used as well.

Knowing the type of carrier oil in your hemp-derived product is important if you want to avoid potential exposure to allergens or irritants. Sometimes, though, carrier oils can bring their own health benefits! Avocado oil, for example, is rich in healthy fats and antioxidants, helps reduce cholesterol, and can even improve skin texture.

Carrier oils improve the bioavailability of everything they come into contact with, including essential oils. This is why distillates often include essential oils.

Essential oils

Essential oils are plant compounds, or terpenes, extracted from plants. They carry unique benefits like anti-inflammatory and anti-fungal properties, and when absorbed into the bloodstream can improve digestion and immunity, and even be used to treat nausea.

When combined with the amazing medicinal properties of hemp, scientists have been able to create incredibly effective topicals that can improve a wide variety of conditions.

When done with purpose and research, oils and plant extracts can be combined with hemp to create more effective, better-absorbing treatments for numerous ailments, and that’s exactly what we do at Abundant Labs.  If you’re looking for a high-quality, effective hemp oil or plant extract, you’ve come to the right place. At Abundant Labs, we combine our proprietary distillation methods and experience in producing industrial hemp products to create the best products on the market.

Our production team consists of experienced science professionals with many years of experience producing industrial hemp products and in lab management. They use proprietary distillation methods in production that allow us to create our products in a manner that is more efficient than other producers, which also allows us to ensure quality products throughout the process. To learn more about our products, equipment, and data, visit our website.