- The 2018 U.S. Farm Bill removed “hemp” from the definition of cannabis but did not allow for inclusion of cannabidiol (“CBD”) in food or supplements
- Regulations will remain in terms of labeling and serving size, and they will be determined by CDPH (California Department of Public Health)
- Green Hygienics exclusively works with industrial hemp and stands to benefit from the signing of AB45 in California
The Farm Bill of 2018 was a game-changer in the hemp industry. Signed into law in December 2018, the Farm Bill removed “hemp” (Cannabis sativa L) and its derivatives comprised of a low concentration (less than 0.3%) of the psychoactive 9-tetrahydrocannabinol (“THC”) compound from the Controlled Substances Act definition of cannabis. Within the bill, the FDA preserved authoritative rights over hemp products (https://ibn.fm/5Zy7w). Therefore, all hemp products must meet any applicable FDA requirements or standards – much like any other product sold legally on the market.
Assembly Bill 45 and Its Provisions
Recently, more than three years after this ruling, Assembly Bill 45 (AB45) was signed by Governor Gavin Newsome, allowing for hemp-derived cannabinoids, extracts, and derivatives, in food and dietary supplements. However, AB45 does not come without restrictions (https://ibn.fm/wQL1d). The legislation comes only weeks after the FDA denied two New Dietary Ingredient applications filed by well-known CBD brands. There is currently no guidance for the serving size, which CDPH will address. Key provisions of the bill include:
- The food, drink, supplement, etc., is not adulterated by including industrial hemp or its derived cannabinoids, derivatives, or extracts. Manufacturers must register with theCDPH, demonstrate the proper industrial hemp sourcing, and comply with good manufacturing practices. Industrial hemp may not be included in any product that contains alcohol, tobacco, or nicotine.
- The use of any cannabinoid known to exhibit intoxicating properties is prohibited. For example, under AB45, THC – including delta 9 and delta 8 derivatives – is strictly prohibited. The CDPH will have full discretion to include or exclude within the definition of any other cannabinoid (except CBD) that has been determined to cause intoxication.
- AB45 only focuses on the final extract, which cannot exceed 0.3% THC concentration – not acknowledging the Interim Final Rule of the Drug Enforcement Administration (“DEA”) to classify any hemp extraction that exceeds the 0.3% rule as a Schedule 1 controlled substance.
- Inhalable products within the state lines are prohibited until the new tax on inhalable products is authorized.
- Hemp manufacturers must undergo rigorous testing requirements – including that the hemp must be tested by an independent third-party testing laboratory in raw extract final form. Testing requirements for contamination levels will be the same as the ones used for cannabis.
- AB45 prohibits labeling, advertising, and marketing any hemp product using a “health-related statement.” The packaging and labeling must include:
- A label, barcode, and an internet website or QR code that links to the certificate of analysis containing the product name, contact information, batch number, the concentration of cannabinoids, and the contaminant levels
- An expiration or “best by” date, if applicable
- A statement that indicates the product should be avoided by children, pregnant, or breastfeeding mothers unless discussed with a medical professional
- A statement that all cannabinoid products should be kept out of the reach of children
- The statement: THE FDA HAS NOT EVALUATED THIS PRODUCT FOR SAFETY OR EFFICACY
Companies that only grow and produce industrial hemp stand to benefit from Governor Newsome signing AB45.
With a focus on the high standard cultivation and processing of industrial hemp, California-based Green Hygienics Holdings (OTCQB: GRYN) is one company expected to benefit from the new bill. The company grows its hemp in a controlled environment at its farm in California, which, with 824 acres and 392,000 square feet of greenhouse space, is the largest USDA Certified Organic hemp for CBD farm in North America.
The company will soon manufacture pharmaceutical-grade bioactive cannabinoids and other active ingredients that can be used for multiple applications in various sectors such as the pharmaceutical, nutraceutical and skincare industries. Green Hygienics is registered with the FDA and was granted USDA Organic Certification in 2020. Products available from the company are currently found in the US, and will be in international markets soon.
For more information, visit the company’s website at www.GreenHygienics.com.
NOTE TO INVESTORS: The latest news and updates relating to GRYN are available in the company’s newsroom at http://ibn.fm/GRYN
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