CBD/Hemp

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A federal district court recently issued summary judgment in favor of a retail defendant in a trade secret misappropriation case involving the alleged misappropriation of a CBD cream formula. On September 3, 2020, Healthcare Resources Management Group, LLC (“HRMG”) filed suit in the Southern District of Florida against several parties, including hemp products retailer Medterra CBD, LLC (“Medterra”), alleging that…
Continue Reading Federal Court Issues Summary Judgment in Favor of Retail Defendant in Alleged Trade Secret Misappropriation of a CBD Cream Formula

On January 15, the U.S. Department of Agriculture (USDA) published its final rule that provides regulations for the production of hemp in the United States. The final rule incorporates modifications to the interim final rule that has been in place since October 31, 2019, however, much of the regulatory paradigm remains unchanged. Below are some highlights from the final rule:…
Continue Reading USDA Issues Final Rule Regulating Hemp Production

On Thursday, December 17th, the Federal Trade Commission (FTC) announced that it was taking action against six companies selling CBD-based products.  These companies faced administrative actions by the FTC for “making a wide range of scientifically unsupported claims about their ability to treat serious health conditions,” such as cancer, Alzheimer’s disease, and pain relief.  The six actions have been resolved…
Continue Reading Operation CBDeceit Marks Beginning of FTC Crackdown on Deceptive CBD Medical Claims While FDA Continues to Issue Warning Letters

CBD continues to flourish in the markets despite lack of federal regulations, and we’ve identified some significant events that indicate there’s no sign it’s stopping.

Topical CBD Pain-Relief Receives FDA Product Listing Certification

Elixicure, an over-the-counter (OTC) CBD-infused topical pain-relief cream marketed for treating inflammation, aches, and pains, has received product listing certification from the Food & Drug Administration (FDA). …
Continue Reading Seyfarth on CBD – February 2020 Update

In its largest mass enforcement action involving cannabidiol (CBD) yet, the U.S. Food & Drug Administration (FDA) announced on November 25 the issuance of 15 warning letters to various companies for illegally selling products containing CBD.  In addition to the letters, the FDA published a revised Consumer Update detailing safety concerns about CBD products more broadly.  Notably, the FDA commented that it “plans to provide an update on its progress regarding the agency’s approach to these [CBD] products in the coming weeks.”  Previously, the FDA had indicated it would generate a report by this Fall.  Finally, the FDA reiterated that “[i]t is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.”  Unlike hemp derivatives– hulled hemp seed, hemp seed protein powder, and hemp seed oil–which were added to the FDA’s Generally Recognized as Safe (GRAS) inventory, the FDA also confirmed that, at this time, CBD is not generally recognized as safe for use in human or animal food.
Continue Reading FDA Stresses CBD Safety Concerns in 15 Warning Letters and Revised Consumer Update

Businesses should take note of recent developments in the CBD space. Consumer protection regulatory agencies issued another joint warning to a company selling CBD products making allegedly unsubstantiated claims. And, the FDA continues to stick to its public position that it is working toward both understanding the impact of CBD on users and crafting an effective regulatory framework. Despite this activity, Congressional leaders are still nipping at the heels of the FDA. Senator Chuck Schumer called on the FDA to issue and implement its CBD regulatory framework as soon as possible, and to report back to his office on its progress to date. In the interim, businesses will be left wondering what the rules of the road are.
Continue Reading FDA and FTC Issue Joint Warning Letter For CBD Products and Senator Schumer Applies Pressure on FDA to Regulate CBD

Through a reintroduced House bill, Congress is taking strides to push for cosmetic regulation reform and, separately, through the SAFE Act, it is seeking to establish a safe harbor for financial institutions to support the burgeoning cannabis industry. Plus, the USDA just issued an interim rule for hemp production.
Continue Reading Cosmetics, Hemp, and CBD: Legislative and Regulatory Update

On September 10, 2019, the Federal Trade Commission (FTC) sent warning letters to three companies that sold cannabidiol (CBD) products marketed with misleading claims that they could treat serious diseases. The FTC aims to “protect consumers from unfair and deceptive practices in the marketplace,” and accordingly has the responsibility of jointly overseeing marketing and advertising of products that fall under the U.S. Food & Drug Administration’s control.  (In 2019, the FDA issued four warning letters, and publicly disclosed the names of the companies in question. We previously discussed these letters in an earlier article.) According to its press release, the FTC warned three companies that it is illegal to market cures or preventative features of a product without supporting “competent and reliable scientific evidence.” The FTC has not publicly identified the recipients of the letters.
Continue Reading FTC Issues Additional Three Warning Letters to CBD Companies

Following last year’s passage of the 2018 Farm Bill, the National Credit Union Administration (NCUA) issued a regulatory update in August of 2019 to federally insured credit unions.  Citing growth in hemp-related commerce, the NCUA emphasized the need for credit unions to understand the gamut of regulation across jurisdictions in order to lend lawfully to hemp-related businesses.  Within its memorandum to members, the NCUA provided: 1) a summary of repercussions generated by the 2018 Farm Bill, 2) specific compliance program concerns with regard to the Bank Secrecy Act (BSA) and Anti-Money Laundering Act (AML), and 3) considerations under existing NCUA regulations for lending.

Continue Reading National Credit Union Administration Issues Statement About Serving Hemp Businesses

CBD is “thriving” in the current regulatory environment, but is it doing so illegally?

As former U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb opined last  week, “the CBD craze is getting out of hand. The FDA needs to act.”  Since the passage of the Farm Bill in December of 2018, there has been a marked uptick in interest in the cannabidiol (CBD) space from businesses and users alike.  Congress explicitly preserved the FDA’s authority to regulate CBD-containing products to ensure that they are safe and that their claims are valid.  Current federal law expressly allows for the distribution of hemp-derived CBD products that contain 0.3% tetrahydrocannabidiol (THC) or less to be sold, with certain caveats.  The FDA has provided clarity that hulled hemp seed, hemp protein powder, and hemp seed oil can be legally used in foods.  Other CBD products, however, are still subject to various state law regulations as well as the U.S. Food, Drug, and Cosmetic Act (FD&C Act), which requires FDA pre-market approval for drug products.  Currently, the FDA treats CBD products aimed at human or animal consumption as drugs and therefore they cannot be distributed without prior approval or a rulemaking exception (more on this below).  The following is a brief update on recent developments within the federal regulatory regime of CBD products. 
Continue Reading CBD is Everywhere – But Where Does the FDA Stand?