Once again, the Golden State finds itself at the forefront of new cannabis legislation and policy. Recently, California made a major break with the Food and Drug Administration regarding CBD and hemp products. Earlier this month, California’s governor Gavin Newsom signed Assembly Bill 45 (AB 45) into law, creating the first-ever regulatory framework overseeing the sale of hemp-derived CBD.
While Hemp and CBD have technically been legal for a few years now, federal hemp regulations have been hazy, inconsistent, and at times downright incoherent. California’s monumental decision to circumvent the federal government and create these regulations independently could set a precedent influencing other states in the future, creating a domino effect similar to what we saw following California’s decision to legalize medical marijuana back in ‘96.
Keep reading to learn more about AB 45 and what it means for the hemp industry going forward.
The Food And Drug Administration’s Stance On Hemp And CBD
In 2018, congress passed the most recent iteration of the Farm Bill, which made hemp federally legal in the United States for the first time in nearly a century. The bill also formally defined hemp as cannabis that contains less than 0.3% delta 9 THC per dry weight.
As a result of the bill’s passing, CBD products derived from hemp became federally legal as well, and the nation saw a massive influx of these kinds of products as many existing farmers transitioned into hemp cultivation specifically to grow plants with high CBD content.
While the Farm Bill officially legalized hemp and CBD, it preserved the FDA’s authority to regulate the cannabinoid. Instead of creating a robust regulatory framework, the FDA has simply refused to approve any CBD products for sale, except for Epidiolex, essentially ignoring the proliferation of hemp-derived CBD into the market and leaving these products in a nebulous legal gray zone.
However, with the exception of a few sternly worded warning letters, the agency hasn’t taken any action to prevent the sale of CBD and has seemingly made little effort to enact any sort of regulatory policy.
Any CBD product used in food or marketed as medicinal or therapeutic in any way are technically out of compliance with the FDA’s requirements and therefore unregulated. Since this is virtually every CBD product, the entire industry has been unregulated.
What Is AB 45?
This brings us to California’s AB 45. The bill creates new hemp regulations for cultivators, as well as CBD manufacturers and sellers across the state. Now manufacturers of hemp products will be required to register with the Department of Public Health the same way any other manufacturer of food, cosmetics, or dietary supplements already does.
Hemp and CBD products will formally be required to undergo laboratory testing to ensure THC percentages are below 0.3% and are absent of any potential contaminants like pesticides, mycotoxins, or heavy metals. The new bill also bans any marketing of these products that includes untrue or unsubstantiated health claims.
New CBD packaging requirements will also go into effect. These new hemp labels will require very explicit specifications outlined below.
Hemp Product Labeling Requirements
According to AB 45, CBD labels and hemp flower packaging must include the following:
A label, scannable barcode, internet website, or quick response (QR) code linked to the certificate of analysis of the final form product batch by an independent testing laboratory that provides all of the following information:
The product name.
The name of the product’s manufacturer, packer, or distributor, and their address and telephone number.
The batch number, which matches the batch number on the product.
The concentration of cannabinoids present in the product batch, including, at minimum, total THC and any marketed cannabinoids or ingredient, as required by the department in regulation.
The levels within the product batch of contaminants, as required in subdivision (c) of Section 111925.2.
The product expiration or best by date, if applicable.
A statement indicating that children or those who are pregnant or breastfeeding should avoid using the product prior to consulting with a healthcare professional about its safety.
A statement that products containing cannabinoids should be kept out of reach of children.
The following statement, “THE FDA HAS NOT EVALUATED THIS PRODUCT FOR SAFETY OR EFFICACY.”
The requirements of this section shall apply to products manufactured 90 days or more after the enactment of this section.
The Future Of CBD Regulations
While the industry will have to adjust to the new California hemp regulations, consumers will likely benefit from the more standardized products. It’s likely that other states and the federal government will adopt similar policies in the near future, but only time will tell.