Safety & CBD
By John Carberry
A major concern of those using or thinking of using CBD is safety. This concern has risen to much higher awareness given the crisis in the vaping community. SNCE Laboratories (SL) offers CBD and Astaxanthin products with completely transparent vision for our customers into the “Farm to Fork” traceability, analysis and third-party certificates of analysis (COA) of our products. Here is how we do this:
Our quality plan has been in place from before our first sales and is based on the FDA’s models of the current Good Manufacturing Practices specifications. (cGMP). This document numbers about 300 pages and has in place all practices, protocols and SOPs for food safety and control of manufacturing processes.
Records for every production lot, for every bottle or container are controlled by lot number and all records from the beginning for every activity are maintained and are available for audit when required.
Our process begins with the procurement of raw materials from a farm. SL starts its “Lot Control” in our process at the farm. A “lot” of industrial hemp is identified, and the farmer certifies that the lot comes from one field and offers to us a state certified certificate of analysis certifying that the industrial hemp is safe and complaint with the law. This analysis includes a proof that the hemp contains less than 0.3% THC as required by low. It includes a heavy metal, biocide, pesticide, and chemical analysis demonstrating safety.
This lot is then processed in SL’s laboratories, which include the use of food grade ethanol, and food grade certified ingredients, such as coconut oils and other ingredients.
The processing comes to a resting point where the lot is consolidated when the oil extraction is completed from that lot is blended as a lot, and samples and sent out for analysis. This analysis is then performed from this sample by a certified third-party independent laboratory.
Our materials are stored in temperature-controlled coolers and freezers from which we record the temperatures 24/7 with thermometers connected to on line data loggers.
When the third-party independent analysis is complete by the lab, this is used to qualify the lot and is the basis of formulation where mixtures are designed to meet the content specification for each container. For instance if we want 12 ml of CBD and/or astaxanthin in half a ml, half a dropper, in a 30 ml bottle containing 600 mg of each, then our formulation scientists calculate the formulation mixtures and extracts the data and ratios from the analysis to complete an accurate analysis for that formulation.
There is a QR code and a bar code on each and every package of product SL sells and ships. This code links you to our web site where the analysis of
- That particular formulation for that bottle or container;
- Based on the third-party independent lab report for that stock oil lot;
- Linked to the certification for the lot of hemp;
- From a particular farm and field;
- To that farms state certified COA.
- Farm to Fork, 100% of the time.
In each case the level of THC is certified and listed for the actual formulation in that particular lot. In the case of Clear Serene, the level of THC is “not detectable”. Meaning there is no THC. In the case of Green Serene, the level is always less than 0.3% THC, and normally about one third that level.
What are the main dangers in buying CBD? Our cGMP plan and control aims to identify and eliminate these dangers. Here are some we identify and seek to control:
Industrial Hemp is famous for being a very efficient agent for removal of heavy metals. In fact, industrial hemp has been used to mitigate heavy metal soil contamination. So our analysis always includes, both for the raw material and the stock oil analysis, a very sensitive survey for heavy metals.
Industrial hemp is often grown on or near tobacco fields where pesticides are often used and these can blow over from one field to the other or be deposited long term in fields. So for this reason our analysis for both the stock oil and raw material is very sensitive to detect and measure pesticides.
It can be a danger if THC levels are too high. A lot per lot detailed analysis is necessary to assure safety.
CBDa is not effective, to be effective it must be “decarboxylated. If the decarboxylation is not performed nearly completely, the efficacy of the product will be diminished, even eliminated.
Decarboxylation should be done at a low temperature to avoid denaturing the broad-spectrum constituents, a temperature less than 60 degrees C is optimal. So, we need to see the amount of CBDa and CBD, and we need to understand the nature of the broad-spectrum constituents contained after decarboxylation.
Food grade ingredients must be certified and constituently used.
A safety seal must be used, and it must be applied immediately after the container is filled and sealed. There must not be a delay between sealing and applying the safety seal.
Solvents, metals, pesticides, biological agents, biocides, THC, many chemicals and compounds must be measured and certified to be within control and specifications for each and every drop, each and every bottle, each and every lot, each and every lot of industrial hemp from the farm. Farm to Fork.
If there is not complete transparency in these regards, if there is not a lot number linked to an on line analysis and certification for that bottle, then this should be seen as a safety warning flag.
One should only use products with this lot control listed on the actual bottle, and linked to an on line to certification and analysis for that lot of which that bottle is a part of the actual lot analyzed.
SL’s professional scientists and formulation specialists and quality specialists stand ready to address any and all questions or concerns that may be expressed by contacting us through our web site of giving us a call:
+1 865 262 0909