Vicente Sederberg LLP Hemp Update: October 2021
Oct 19, 2021
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“Self-GRAS” Framework Confirmed by Federal Court
Last week, U.S. Hemp Roundtable reported that the legality of the self-affirmed GRAS (Generally Recognized As Safe) framework (self-GRAS) was confirmed by a federal court. Self-GRAS allows companies that have self-determined the safety of their food ingredients to be exempt from pre-market review by FDA, based on reviews by independent, qualified expert panels. When used in the food supply, these ingredients also qualify for exemption from the New Dietary Ingredient notification (NDIN) requirements for dietary supplements.
Problems with a mandatory NDIN-only approach were brought to light recently when two comprehensive and science-driven NDINs for hemp extract ingredients were rejected by the FDA. This decision is great news for CBD companies that have already invested resources to establish the safety of products through self-GRAS. If you’re interested in the process and legal considerations for self-GRAS for your products, contact a member of our hemp team.
USDA Launches Hemp eManagement Platform (HeMP)
The U.S. Department of Agriculture (USDA) recently launched the Hemp eManagement Platform (HeMP), an online system for USDA producers, states, tribes, testing laboratories, and sampling agents that will be used to manage and submit hemp information and reporting to USDA. HeMP makes recordkeeping for you and your business easier, allowing your staff members to apply for licensing, update contact information and track supporting documents on demand.
USDA Pilot Hemp Insurance Program Available in Select Counties
A pilot hemp insurance program available in select counties through Multi-Peril Crop Insurance provides coverage against loss of yield because of insurable causes of loss for hemp grown for fiber, grain, or CBD oil. Revenue protection for hemp is offered nationwide under the Whole-Farm Revenue Protection plan of insurance. Also, hemp is insurable under the Nursery crop insurance program and the Nursery Value Select pilot crop insurance program, if grown in containers and in accordance with federal regulations, any applicable state or tribal laws, and terms of the crop insurance policy. For more information, see www.farmers.gov/manage/hemp.
USDA Grants $20 Million for Hemp Research Focused on Sustainability, Diversity and Equity
Oregon State University’s Global Hemp Innovation Center received a $10 million grant to define economic opportunities for hemp in the Western U.S. In addition, Central State University, a Black-administered institution based in Wilberforce, Ohio, received $10 million to research the viability of using hemp as an aquaculture or fish-farming feed ingredient to address food-safety concerns about consuming seafood raised with feed additives. Read more here.
AAFCO Updates Position on Hemp Products in Animal Food
The Association of American Feed Control Officials (AAFCO) recently issued a position paper and call to action on hemp and hemp byproducts in livestock feed and companion animal pet food. AAFCO believes that further research is needed to demonstrate that it is not only safe to feed hemp products target animals, but that it is also safe to consume the resultant human food produced from such animals. AAFCO encourages the hemp and feed industries to continue researching the proposed products’ (whole hemp plants, hemp seed oil, CBD, other cannabinoids) safety and efficacy and submit applications to AAFCO and the FDA for review and approval on a national level.
Guide for Shipping Hemp and Hemp-Derived CBD Products
Under the 2014 and 2018 USDA Farm Bills, certain hemp and hemp-derived CBD products can be shipped via USPS, FedEx and UPS— but only if certain conditions are met. Click here for a newly updated summary from our hemp team.
NIHC States Position that Raising the THC Limit of Hemp Would Help Assure Delta-8 Products Are Safe
National Industrial Hemp Council (NIHC) has called for raising the THC limit for industrial hemp from 0.3% to 1% as part of the solution to assuring the safety of delta-8 THC products. “The clearest pathway to protect consumer safety and create a hemp economy that works for everyone is to revise the federal definition of hemp to include all tetrahydrocannabinol,” NIHC said. Read more here.
NASDA Calls for USDA to Expand Access to Federal Grant Programs for Hemp
The National Association of State Departments of Agriculture (NASDA) is urging the USDA to give hemp two different classifications depending on its intended use (specialty crop or agronomic commodity) in order to expand access to federal grant programs. The request would make it so hemp farmers could have greater access to grants that stakeholders say would provide them with valuable resources as the industry continues to evolve.
State-by-State Hemp & Cannabinoid Compliance Guide
VS’s hemp team is excited to announce the public release of our State-by-State Hemp & Cannabinoid Compliance Guide — an affordable, easy-to-use compliance solution to help your business navigate the ever-changing regulatory environment of hemp-derived CBD products. Take the guesswork out of ensuring compliance with all aspects of selling hemp-CBD products in different states — from packaging and labeling, to testing, distribution, and more.
Request a complimentary consultation with an attorney to discuss a customized package that best fits your needs.
SB 292: On October 4, Gov. Newsom signed SB 292, a measure that will conform California statutes regulating the reporting and testing of industrial hemp to the new requirements established under the USDA interim and final rule, including provisions to align the California Food and Agricultural Code, California Department of Food and Agriculture regulations and the State Plan with the federal requirements. Specifically, the law will:
Require registered established agricultural research institutions, registered growers of industrial hemp, and registered hemp breeders to report to the Farm Service Agency of the USDA information regarding their hemp production in the state including the location, acreage, and license or registration number associated with each location where hemp will be produced.
Require that laboratory test reports of hemp allow for a measurement of uncertainty associated with the test results.
Require laboratories to use appropriate, validated methods and procedures for all testing activities, including when estimating the measurement of uncertainty.
Sunsets sections of the California Food and Agriculture Code that will become inoperative upon the sunset of the 2014 federal Farm Bill and makes technical changes to other sections that need updating due to changes in the Industrial Hemp Program.
Allows for “despoil” of non-compliant “hot hemp” in addition to “destruction.”
AB 45: On October 6, Gov. Newsom signed AB 45 into law, finally legalizing the sale of food, beverages, dietary supplements, pet products, and cosmetics containing hemp-derived ingredients, including CBD. Further rulemaking is forthcoming. Read this VS Insights article from Andrea Golan and David Kramer for a high-level summary of AB-45’s key provisions.
Guidance issued on October 4 by the Dept. of Agricultural Resources gave Massachusetts licensed hemp farmers and processors permission to sell hemp flower, hemp biomass, and other hemp ingredients (i.e. CBD isolate) to adult-use cannabis manufacturers and dispensaries. Among other requirements, hemp products sold in dispensaries must carry labels that include (1) manufacturer name and address; (2) THC and CBD concentrations; and (3) a warning that the product “has not been tested, analyzed, or approved by the Massachusetts Department of Agricultural Resources or the FDA.”
Effective October 11, all THC products derived from the cannabis plant (including delta-8 THC and THC-O-acetate) are covered by Michigan state law and regulated by the state’s Marijuana Regulatory Agency. These products—which were previously available for sale to individuals of all ages by businesses that cannot currently sell licensed marijuana products—will only be made available after appropriate approvals, rigorous testing, and commercial standards that currently protect consumer safety in the legal marijuana marketplace. Read more here.
Oklahoma regulators issued an advisory about medical cannabis products that contain THC analogs, including THC-O-acetate.
Texas Department of State Health Services updated its website guidance to confirm the state's position that delta-8 THC is a schedule 1 controlled substance. “Texas Health and Safety Code Chapter 443 (HSC 443), established by House Bill 1325 (86th Legislature), allows Consumable Hemp Products in Texas that do not exceed 0.3% Delta-9 tetrahydrocannabinol (THC). All other forms of THC, including Delta-8 in any concentration and Delta-9 exceeding 0.3%, are considered Schedule I controlled substances.”
CWCB Expo New York | November 4–6, 2021
Michelle Bodian and Brandon Kurtzman will take the podium on Friday, November 5, 2021 at 3 p.m. to present “Opportunities at the Intersection of Hemp and Marijuana” at the Cannabis World Congress and Business Exposition in New York. Attend their session for a timely update on the intersection of hemp and marijuana across the U.S., including which states allow the manufacture and sale of hemp ingredients and products by marijuana operators. Learn more and register here!
NIHC 2021 Hemp Business Summit | November 14–16, 2021
Planning on attending the National Industrial Hemp Council’s 2021 Hemp Business Summit in Washington, DC? VS hemp attorney Shawn Hauser will be there! Get in touch to schedule a meet up during the conference. Learn more about the conference and register here!
Contact our hemp team with any questions!