On Friday, May 31, 2019, the U.S. Food and Drug Administration (FDA) held a public hearing to discuss scientific data and information about products containing cannabis or cannabis-derived compounds. Acting Commissioner Sharpless made no new announcements about FDA’s current thinking about how it will regulate products containing cannabis or cannabis-derived compounds. However, it was clear from the FDA panel’s questions to the various academic, industry, and other stakeholders that FDA is looking for as much data from as many sources as possible. In particular, FDA’s questions focused on age and youth restrictions, dose and route of administration and how they affect the safety of the products, adverse event reporting, and interactions between cannabis/cannabis-derived products and other drugs. In addition, FDA continued to inquire about whether deregulating cannabis and cannabis-derived products would affect the incentive for research on these products.
Industry stakeholders asked for a prompt, expedited, clear, and transparent regulatory framework for products containing cannabis and cannabis-derived products. Specifically, industry sought clear definitions for terms like “full spectrum,” “broad spectrum,” “isolate,” and “THC-free.” Further, industry requested regulations on labeling, testing, good manufacturing practices, and track and trace for products. Many industry stakeholders asked FDA to look to the dietary supplement and food regulations already in place as a guideline for regulations on cannabis.
Continue reading FDA Holds Public Hearing on Cannabis
The public’s desire for organic products continues to grow. This is equally true for cannabis and hemp-derived products, especially where they are being used for medicinal purposes. The U.S. Department of Agriculture (USDA) has issued regulations setting out standards setting out specific requirements that must be met for an agricultural product to be labeled “organic”. In order to be able to include the USDA’s organic certified seal on a product’s packaging, a USDA-accredited certifying agency must verify that the product meets USDA’s regulations. This USDA certification provides many benefits, including, for example, premium prices for products. So why haven’t we seen many certifications for hemp products?
Back in 2016, the USDA, in conjunction with the U.S. Drug Enforcement Administration and the U.S. Food and Drug Administration, issued a Statement of Principles on Industrial Hemp concerning the applicability of Federal law to industrial hemp programs after the 2014 Farm Bill, but the ability to gain organic certification for hemp products was unclear. The USDA also issued Instruction: Organic Certification of Industrial Hemp Production (updated in September 2018), which stated that industrial hemp produced in accordance with the 2014 Farm Bill could be certified if it met all of the requirements of USDA’s organic regulations. The problem was that under the 2014 Farm Bill only certain parts of the hemp plant (e.g., the stalk and non-viable seeds) were permitted to seek organic certification. And, actually, some hemp seed products have received USDA organic certification.
Continue reading Big News for the Organic Certification of Hemp
Last year was a record year for cannabis. Canada passed the Cannabis Act, making adult-use cannabis legal there. The FDA approved a cannabidiol-based medicine, Epidiolex. And the President signed the Agriculture Improvement Act of 2018, aka the 2018 Farm Bill, into law on December 20, 2018.
While the 2018 Farm Bill granted the U.S. Department of Agriculture the ability to regulate hemp, it also preserved the right for the U.S. Food and Drug Administration (FDA) to regulate products containing cannabis or cannabis-derived compounds. The FDA regulates products such as human and animal drugs, biological products, cosmetics, food and animal feed, among other things. So any inclusion of cannabis or cannabis-derived compounds, like CBD, in any of those types of products would be regulated by the FDA. The FDA has stated that this is true regardless of the source of the cannabis substance, be it hemp or marijuana.
Read the full Duane Morris alert.
Most analysts are predicting no longer whether, but when, cannabis will become federally legal for adult use in the United States, as it has in Canada, Uruguay and a few other countries, with others such as Mexico expected to soon follow. It may come in the form of the government itself removing cannabis as a scheduled drug under the Controlled Substances Act (CSA). It may come in the form of the current STATES Act pending in Congress, which would remove state-legal compliance from being subject to the CSA, or through other Congressional action. It may come through court action, such as the current constitutional challenge to the CSA as it applies to cannabis, whose initial dismissal was recently argued on appeal.
To read the full text of this article by Duane Morris partner David Feldman, please visit the Green Entrepreneur website.
The US Senate, by an overwhelming 86-11 vote, last week approved the sweeping Farm Bill containing language which fully legalizes industrial hemp. As we know, hemp, which is derived from cannabis plants, is used to make products from rope to clothing and does not contain THC, the psychoactive part of the plant. In colonial days hemp was so crucial that farmers, like George Washington, were legally required to grow it.
Most believe the House will follow suit. Hemp has not been legal on a federal level since federal criminalization of cannabis in the 1930s. Many believe that occurred in part because of fears of hemp competing with powerful timber interests and DuPont’s then new patent on nylon. After the 1930s bill was declared unconstitutional in 1968, the Nixon Administration helped orchestrate passing the Controlled Substances Act. That law, still in force, declared all parts of the cannabis plant as Schedule I drugs, as dangerous as heroin and LSD. A top Nixon aide later admitted, “Did we know we were lying about the drugs? Of course we did.” Constitutional challenges thus far have been unsuccessful.
Legalization of hemp could yield a variety of products that previously could only be produced with imported hemp. These could include food, building materials, paper products and many others. Currently, it it believed that China is the largest producer of hemp, since it is legal to do so in a number of Chinese provinces. They started farming it during the Vietnam War to make more breathable uniforms for their soldiers in the intense heat. This Senate vote is indeed a significant step towards relaxation of federal cannabis regulation.
A video replay of the webinar Cannabis 101: Update on the Federal Enforcement & State Regulatory Environment is available to view.
The webinar covers the topics:
- Attorney General Jeff Sessions’ Memo Rescinding the Cole Memo—What Has Changed?
- How Federal Enforcement Works from the Perspective of a Former Federal Prosecutor
- Federal Legislative Update—Congressional Attempts to Protect the Cannabis Industry
- State Regulatory Actions and How Courts Are Interpreting Cannabis Regulations
Watch above in the embedded viewer, or go to the event page to watch the replay.
Patents are an important tool for businesses to secure a competitive advantage, particularly for companies in an emerging industry such as the cannabis industry. Contrary to popular belief, cannabis and cannabis-related inventions are not only are patentable, but the number of patents and applications being filed in this area is growing steadily. The evolving legal and regulatory framework and the development of new technologies as the industry matures and consolidates means that those businesses that have taken steps to patent protect their technologies early on are likely to be at a competitive advantage.
How do patents fit into the current state and federal cannabis regulations?
As of this writing, twenty-nine U.S. states and the District of Columbia have legalized medical marijuana. and eight states permit recreational use. Under federal law, cannabis remains a Schedule I controlled substance under the Controlled Substances Act. However, the United States Patent and Trademark Office (USPTO), an agency of the United States Department of Commerce, has issued, and continues to issue patents to cannabis and cannabis-related inventions. The USPTO has traditionally taken a hands-off approach to barring particular kinds of inventions from patentability. Congress has determined that two kinds of inventions are categorically not patentable: those encompassing human organisms (The Leahy-Smith America Invents Act (AIA) (Public Law 112-29, sec. 33(a), 125 Stat. 284), and those having as their sole purpose use in atomic weapons (The Atomic Energy Act of 1954, See 42 U.S.C. 2181(a)). Otherwise, assuming that a patent application covering cannabis or cannabis-related products meets the legal standards for patentability, the USPTO is presently granting such patents.
To read the full text of this article by Duane Morris attorney Gretchen L. Temeles, Ph.D., please visit the Cannabis Law Report website.