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All suppliers of hemp materials used to manufacture hemp dietary supplements must be carefully qualified and tested to ensure compliance with current regulations. It is critical that the source is a natural product from hemp and that CBD is not synthesized or isolated. The minimum requirements for hemp materials follow:
- Verify that the source is from the hemp plant, also known as Cannabis sativa
- Verify by testing that the content of delta-9 tetrahydrocannabinol (THC) is below 0.3 percent.
- Verify by testing the content of cannabidiol (CBD) as necessary to ensure the achievement of any product label claims for CBD content.
- Verify by testing the presence of cannabinoids other than CBD are present to ensure that the source is not an isolate and to meet product label claims of Full Spectrum and/or Broad Spectrum as applicable.
- Verify that the purity of the product for residual solvents, heavy metals, and pesticides. A vendor qualification program supports this verification process.
Hemp Extract with CBD may act as a suitable supplement and/or be a possible health benefit for:
About Herb Supplement Manufacturing: CBD Manufacturing & CBD Supplement Manufacturing
CBD increases the body’s own endocannabinoids that help regulate the immune system and the nervous system. Research indicates that CBD interacts with the serotonin receptors which may have a positive impact on anxiety. It also interacts with the pain receptors which may result in decreased pain and soreness. CBD oil is currently popular among athletes and celebrities for its pain-relieving effects. A number of studies have shown how CBD may assist with pain.
Ion Labs provides a number of types of CBD ingestibles and CBD topicals, which includes CBD oils and CBD lotions. This includes the creation of CBD oil and CBD liquid capsules.
Agriculture Improvement Act of 2018 (better known as the 2018 Farm Bill)
Effective on December 20th, 2018, President Donald Trump signed the Agriculture Improvement Act of 2018 (better known as the Farm Bill) into law which in-turn removed hemp from the Controlled Substances Act and amended the definition of marijuana by removing hemp and all parts of the plant and all derivatives from the definition. Section 297A now clearly defines hemp as the plant cannabis sativa L, or any part of that plant (whether growing or not) including all seeds, salts, salts of isomers, acids, cannabinoids, derivatives, and extracts, with a delta-9 tetrahydrocannabinol (THC) concentration of no more than 0.3 percent on a dry weight basis. Section 7125 also allows the development of industrial hemp and the development of new and emerging commercial products derived from hemp.
The Hemp Farming Act, which passed as a provision in the Agriculture Improvement Act of 2018, removed from the list of controlled substances the hemp plant, also known as Cannabis sativa L. While the hemp plant is no longer a controlled substance, it is still unclear how FDA will regulate the use of hemp in food products and dietary supplements. Authors of the Hemp Farming Act, Ron Wyden and Jeffery A Merkley, dispatched a letter to FDA January 15, 2019 urging the FDA to update federal regulations governing the use of certain hemp-derived ingredients in food, beverages or dietary supplements.
Hemp being a gold mine for agriculture innovation provides a huge market in the health and wellness industry. One of the more promising components of Hemp is CDB. CBD (cannabidiol) is currently one of the major emerging products in the U.S. dietary supplement market. According to Hemp Business Journal, the CBD market is estimated to grow by 700 percent by 2020 and become a $2.1 billion industry.
Ion Labs has announced that they will now begin Hemp & CBD manufacturing in 2019 and plan to incorporate a large range of these products into their operation. Ion Labs plans to focus on manufacturing Hemp and CBD ingestibles and topical products.
Regulation of Hemp Extract CBD Manufacturing
As stated by the FDA, “CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC). On June 25th, 2018, the U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome, and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.” [More FDA info here] [Information cited from FDA approves the first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy PRESS RELEASE]
The 2018 Farm Bill expanded on details stated in the 2014 version of the annual bill which would lead to the creation of Hemp Pilot Programs that would ultimately help lead the legal cultivation by states without requiring a permit from the DEA.
The 2018 Farm Bill will allow hemp to be regulated by the USDA, which includes now labeling of American-grown hemp as certified organic. Starting now interstate hemp commerce will be considered legalized. The definition of hemp will be altered to make it a non-drug commodity in 2019. With the legalization of hemp, CBD will now be researched and documented more, as well as regulated to begin understanding the medical efficacy of the product.
Processes Involved in CBD Manufacturing
Manufacturing CBD from the hemp plant is a complex process comprising of a number of stages, each with a different set of equipment. From growing hemp to extracting, refining and delivering the final product, CBD manufacturing may take several months. As with any product derived from an herbal source, high-quality CBD products come only from a well-organized, reliable supply chain to ensure consistency batch after batch. Here are the major steps involved in CBD manufacturing:
1. Testing the Raw Material
The first step after receiving the raw material, hemp, is to test the purity of the plant. In addition to the plant itself, this testing is carried out on all the materials involved in manufacturing and packaging the final product.
2. Extracting Oil from the Hemp Plant
Hemp flowers are crushed and ground to increase the surface area. They are then fed to the extraction machine which uses a solvent like ethanol or CO2 to dissolve only the required extracts. This is done at high pressures; at normal pressure, the solvent sublimates to yield active ingredients ready for the next stage.
3. Dewaxing and Filtration
The impure oil is dissolved once again in a food grade solvent. Freezing the solution precipitates waxes and other impurities which are filtered to yield a more potent oil. A processing technician decides the type of filtration suitable for the solution. The processing technician may choose from vacuum filtration, wintered filtration, gravity filtration or pour-through filtration.
This step may be repeated several times until the desired level of purity is achieved.
To remove the remaining impurities and extract purest possible CBD and other cannabinoids, the process of distillation is crucial. This step requires the most care and caution. In the absence of an experienced processing technician, precious terpenes and cannabinoids can be destroyed. Proper temperature, circulation, and vacuum manipulation are critical for extraction of various cannabis extracts.
5. CBD Isolation
Isolating CBD to a 99.5% or more pure form requires specialized equipment and trained staff. A combination of chromatography and distillation through a complex mixture of solvents can yield CBD of 99.5% or more purity. This step is repeated over and over until desired purity is achieved.
6. Various Formulations
CBD extracts are then mixed into various food-grade carriers. Different types of formulation options for CBD are:
- Cream (CBD Skin Care Manufacturing)
- Soft Gels
- Dropper bottles
- And many more.
Potency tests are carried out to ensure that CBD has not lost its potency during formulation.
7. Testing the Final Product
The final product is then carefully tested for microbes, heavy metals, pesticides and other contaminants. These tests ensure that the product has the required level of potency and is fit for retail.
The final product is packaged and labeled according to formulation type and the client’s requirements if it is a custom formulation. Private label CBD would be standard to whatever the in-house formula may be. Materials used are all food grade and ensure that the product does not lose its efficacy. The labels are placed carefully to make sure that no unsubstantiated claims are made. Proper cGMP operations will have an in-house label control department that focuses on this exact process.
9. Warehousing and Delivery
The product is then stored and delivered with extreme care and modified climatic conditions to ensure that it does not lose its effectiveness or get contaminated during storage or transit.
In-House CBD Manufacturing, Product Testing, & Stability Testing
Each stage of our Private Label CBD Manufacturing process is performed in accordance with the Master Batch Record and is documented on associated Batch Production Records for every batch produced. Our process control system and finished product testing ensure that our Private Label CBD is of the highest quality, identity, purity, strength, and composition throughout the entire manufacturing process. Stability testing is performed in intervals of 6, 12, 18, and 24 months.
Custom CBD Manufacturing Inquires & Private Label CBD Manufacturing Inquiries
To purchase private label CBD in orders of 1,000 or more unlabeled or unlabeled units, please click here to view stock products. If you are inquiring about high-volume custom CBD formulations and/or custom CBD supplements, please use the form below or call (727) 527-1072.
Disclaimer for Ion Labs Private Label Hemp Extract CBD Manufacturing
Please note: Ion Labs does not manufacture cannabidiol supplements. CBD is not a dietary supplement, it is a chemical compound that is naturally present in hemp.
* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. Effects may vary between individuals. If you have existing medical conditions please consult your doctor prior to use.
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