A third party entity, published testing results of a Pure Hemp Botanicals 750 mg Full Spectrum Tincture on their website, and subsequently released a “Media Alert” regarding the testing results they obtained. Remedy Review states:
“Pure Hemp Botanicals’ 750 mg Pure CBD Oil Full Spectrum Tincture did not pass the Remedy Review standard by exceeding limits for the pesticide synergist piperonyl butoxide. Piperonyl butoxide is approved for use by the Colorado Department of Agriculture for organic growth of industrial hemp but prohibited by the USDA National Organic Program-highlighting the confusing and irregular standards across the ‘organic’ space….”
Pure Hemp Botanicals is a company that believes in transparency and quality products which are produced to the standards of the Colorado Department of Agriculture, Colorado Department of Public Health and Environment (CDPHE), Denver Environmental Health (DEH), and even the Federal Drug Administration (FDA) standards for food and dietary supplements. Our products are produced at our facility. We organically grow our own hemp, process it into high quality CBD rich distillate and isolate, formulate these concentrated products with qualified raw materials, and package the final formulation. We perform multiple testing points to confirm product quality, potency and absence of contaminants regulated by the state of Colorado.
Pure Hemp Botanicals has implemented FDA 21 CFR 111 compliant quality and production systems to give a level of assurance to our customers that products are produced to the same level as any other food or dietary supplement you would purchase in your neighborhood store.
As soon as Remedy Review communicated the testing results, Advanced Extraction, the manufacturer of the Pure Hemp Botanicals brand, began an investigation according to internal standards, which are consistent with implemented quality systems outlined in FDA 21 CFR 111. We contacted the laboratory and asked an extensive list of technical questions to aid in determination of subsequent investigation steps. The investigation also included analysis at multiple laboratories to evaluate the original testing results. Advanced Extraction concurrently performed a traceability analysis to determine materials used in the production of the batch of 750 mg full spectrum tincture, and began root cause investigation utilizing review of documentation and additional testing.
This test report indicates the presence of piperonyl butoxide (PBO) in the finished product analyzed. The originally provided testing report had to be revised twice by the contract laboratory which initially performed the testing due to incorrect levels of THC being reported, and due to incorrect specification limits (as provided by the state of California) being reported as compared to the analytical results.
Piperonyl Butoxide is an ingredient in a product used often in agricultural applications. Additionally, this compound is not identified as a pesticide or a compound of interest by the Colorado MED, and is not included in any regulatory testing panel specified by the Colorado MED. Since Pure Hemp Botanicals is produced in a completely vertically integrated company entirely in Colorado, the Colorado MED specifications for infused products, in conjunction with requirements set forth by the Colorado Department of Public Health and Environment (CDPHE) and Denver Environmental Health (DEH) was used as a reference to set product specifications for Pure Hemp Botanicals products.
Piperonyl Butoxide is a compound known as a pesticide synergist. A pesticide synergist is defined as “A Chemical that, while not possessing inherent pesticidal activity, nonetheless promote or enhance the effectiveness of other pesticides when combined.” This differs in the definition of a pesticide, which is defined as “A substance used for destroying insects or other organisms harmful to cultivated plants or to animals.” PBO is an organic compound used in many pesticide formulations, and enhances the effectiveness of pesticidal active ingredients in the formulation. PBO does not in itself have any pesticidal activity, meaning it cannot eliminate bugs on its own.
As previously stated, the ingredient Piperonyl butoxide commonly used in agricultural applications. After completion of the traceability study, it was determined that use of piperonyl butoxide was likely on the harvest crop used in the production of the batch of 750 mg tincture in question.
Piperonyl Butoxide is believed to be relatively non-toxic for humans. (http://npic.orst.edu/ingred/pbo.html). The Finished Product Specifications developed for Pure Hemp Botanicals are consistent with similar products regulated by the Colorado MED, a state governing and regulatory body. This compound has not been identified in any MED contaminant panel (pesticides or residual solvents). Products which meet the specifications set forth by the MED are considered safe for public consumption. We are continually evaluating regulations across the country, and evaluation of additional state regulation drives our process for continuous improvement, which includes the evaluation of changes related to growth and processing of industrial hemp, and their corresponding CBD products produced under the Pure Hemp Botanicals brand.
The evaluation of hemp and cannabis products produced in other states has resulted in an initiative to comply with the stricter standards set forth by regulatory bodies outside the state of Colorado. Additional testing is being conducted to validate the initiative to update specifications to levels published by the State of California for cannabis based products. Advanced Extraction has eliminated use of the pesticide synergist Piperonyl Butoxide and all other compounds listed in the California code related to manufacture of cannabis products.