In our previous post, we highlighted that the United Stated Department of Agriculture (“USDA”) published its final rule (the “Final Rule”) regulating the production of industrial hemp under the Agriculture Improvement Act of 2018 (the “2018 Farm Bill”). The Final Rule supersedes regulations set forth in the interim final rule published on October 31, 2019 (the “Interim Rule”).

The Final Rule was initially scheduled to take effect on March 22, 2021. However, a White House Memorandum issued by the Biden Administration on January 21, 2021 (the “Biden Memorandum”) effectively “froze” all regulations that had been published in the Federal Register but had not yet taken effect, including the Final Rule. The Biden Memorandum also granted agencies (such as the USDA) the authority to “consider opening a 30-day comment period.”

As part of the transition to the Biden Administrations, the USDA and many other agencies took this opportunity to review new and pending regulatory actions, including the Final Rule.
Continue Reading USDA Final Rule Takes Effect

Delta-8 has been the topic of many conversations over the last year in various cannabis circles. Is it legal?  How will hemp-derived Delta-8 THC impact the state-legal marijuana industry?  How is Delta-8 THC extracted from hemp and in what quantities?  Much of this was already covered in a recent webinar hosted by our firm a

The Federal Trade Commission (“FTC”) has joined the U.S. Food and Drug Administration (“the “FDA”) in enforcing laws related to marketing CBD products. The FDA has historically issued warning letters and pursued companies that illegally market CBD products with claims the products may treat medical conditions.  The FTC has joined the FDA is this pursuit and announced settlements with six different CBD companies involves fines ranging between $20,000-$85,000 in addition to notifications provided to consumers.  Pursuant to these settlement agreements the respondent companies are also prohibited from similar marketing efforts in the future, any health claims must have scientific evidence to support them.

Industry actors making any health or therapeutic claims are vulnerable to action by agencies such as the FDA and FTC, however, they may also be subject to civil suits based on enforcement by those agencies. In April of 2020 Charlotte’s Web Holdings, Inc. (“CWB”) was served with yet another (its second) class action lawsuit due to how their products are labeled. Benson v. Charlotte’s Web Holdings, Inc., No. 1:20-cv-00418 (N.D. Ill.)  The suit based a significant portion of the allegations on FDA guidance:

 “Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)]. Under that provision, if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a dietary supplement”

Companies facing enforcement actions by the FTC may similarly be subject to civil allegations.

WHAT DOES THIS MEAN FOR YOUR BUSINESS
Continue Reading CBD Companies Now Facing Monetary Penalties For Deceptive Marketing, Will Civil Liability Follow?

On January 15, 2021, the United States Department of Agriculture (“USDA”) published its final rule (the “Final Rule”) regulating the production of industrial hemp under the Agriculture Improvement Act of 2018 (the “2018 Farm Bill”). The Final Rule modifies regulations set forth in the interim final rule published on October 31, 2019 (the “Interim Rule”). The modifications are based on approximately 5,900 public comments submitted to the USDA over three public comment periods.

The Final Rule contains the following key provisions:
Continue Reading USDA Releases Final Rule Regulating Industrial Hemp

On August 20, 2020, the Drug Enforcement Administration (“DEA”) published an Interim Final Rule on industrial hemp and hemp derivatives (the “Interim Rule”), which immediately went into effect, to conform DEA regulations with the Agriculture Improvement Act of 2018 (the “2018 Farm Bill”).

As we previously discussed, the 2018 Farm Bill effectively removed industrial hemp from the definition of “marijuana” in the Controlled Substances Act (CSA). Additionally, tetrahydrocannabinols contained in industrial hemp, such as Cannabidiol (commonly known as CBD), were also removed from the purview of the CSA.


Continue Reading The DEA’s Interim Final Rule and its Impact on the Industrial Hemp Industry

The U.S. Food and Drug Administration (FDA) issued a press release on the evening of Monday, November 25 concerning its recent enforcement actions and a regulatory decision concerning products that contain cannabidiol (CBD).  The Warning Letters follow FDA’s trend of focusing its CBD product enforcement on unapproved drug claims.  The regulatory decision stated in the press release concerns FDA’s decision that CBD is not generally recognized as safe (GRAS) for use as a food additive.

The fifteen (15) Warning Letters, each dated November 22, 2019, were issued to companies for marketing various CBD products. The products identified in the Warning Letters spanned conventional foods, dietary supplements and animal products.  FDA made specific mention in several Warning Letters about statements regarding the use of CBD products in infants and children.
Continue Reading FDA States CBD Is Not GRAS for Use in Food, Issues More Warning Letters

Today, the United States Department of Agriculture (the “USDA”) released a draft interim final rule regarding the establishment of a domestic hemp production program. We expect the interim final rule to be published in the Federal Register in the next day or so, which will initiate the 60-day public comment period. This rule establishes rules to approve state and tribal plans to regulate the production of hemp pursuant to the Agriculture Improvement Act of 2018, or the 2018 Farm Bill.
Continue Reading USDA Interim Hemp Regulations

Trademark practitioners, hemp producers, and hemp-derived product manufacturers have long struggled with the clash of federal and state law regarding protection of trademarks with the United States Patent and Trademark Office (USPTO). Historically, the USPTO has refused registration of marks that include cannabis, hemp, CBD or derived products on the basis that these marks were unable to have lawful use in commerce under existing federal law. These waters became even murkier after the passage of the Agricultural Improvement Act of 2018 (known as the 2018 Farm Bill), which removed “hemp” from the list of controlled substances under the Controlled Substances Act (CSA). On May 2, 2019, the USPTO issued Examination Guide 1-19, outlining the USPTO’s policies with respect to trademarks including legal CBD and hemp-derived goods and services since passage of the 2018 Farm Bill. This appears to open the door for registration of marks that include legal CBD, hemp or hemp-derived products (such as hemp oil), or services such as the cultivation or production of hemp.

Continue Reading USPTO Issues Guidance on CBD and Hemp Trademarks After the 2018 Farm Bill