Rep. Jerry McNerney (D-Calif.), in partnership with the Natural Products Association, has reportedly filed an amendment to the House Agriculture appropriations bill that would give the U.S. Food and Drug Administration (FDA) funding to undertake the process to identify a safe daily intake level of cannabidiol (CBD). “Since the passage of the 2018 Farm Act – which eliminated hemp from the definition of marijuana under the Controlled Substances Act – we’ve seen a significant increase in the production and sales of CBD products,” said McNerney in a June 18, 2019, press release. “With more and more CBD appearing on supermarket shelves across the country, it’s time for American consumers to have accurate information on CBD and for producers to be properly regulated to make the marketplace safe and reliable.” FDA has also announced the extension of the comment period for the public hearing intended to "obtain scientific data and information…
Tag Archives cannabis
On May 31, 2019, the U.S. Food and Drug Administration (FDA) held a widely anticipated public hearing with stakeholders on cannabis and cannabis-derived compounds to gain insights on product safety and a potential regulatory framework for products containing such substances. The hearing focused on cannabidiol (CBD)—a popular but controversial compound that has been added to products ranging from tinctures and lotions to sodas and ice cream. Interest in the product was spurred by the passage of the 2018 Farm Bill, which removed hemp (cannabis plants with less than 0.3% THC content) from the Controlled Substances Act. The Farm Bill also complicated FDA’s role in regulating CBD because although the substance was de-scheduled by Congress, the Agency still regulates it as a drug—meaning that any consumer product with CBD is technically a misbranded drug in violation of FDA rules. While the Agency has taken limited actions against companies using CBD as…
The Association of American Feed Control Officials (AAFCO) has issued guidelines on the 2018 Farm Bill and its removal of hemp from the list of controlled substances. "As of April 2019, hemp and hemp products may not be used in animal feed or pet food in the United States," the guidelines state. "In 2015 AAFCO asked the hemp industry to come forward and present information for the scientific review to establish definitions for animal foods made from the industrial hemp plant. We expected information on hemp seed oil, hemp seed meal, and whole hemp seeds. Although there are private companies and organizations working on applications, to date, the industry has not submitted any data showing that ingredients derived from the hemp plant are safe and useful in animal food. AAFCO is encouraging the industry to submit their data promptly." The guidelines also advise that feed with cannabidiol (CBD) is not…
The U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB) has issued an industry circular stating that it "will return for correction any applications for formulas containing 'hemp' ingredients (other than ingredients derived from hemp seeds or hemp seed oil)" until the U.S. Food and Drug Administration (FDA) indicates that the ingredients' use would not violate the Federal Food, Drug, and Cosmetic Act. The circular, addressed to wineries, breweries, distilleries and importers, states that TTB consults with FDA on ingredients' safety and notes that, despite the change in the definition for "marijuana" in the 2018 Farm Bill, "FDA stressed that food companies that wish to use cannabis or cannabis-derived ingredients in their foods are subject to the relevant laws and regulations that govern all food products, including those that relate to the requirements for food additive approval and substantiation of evidence for Generally Recognized as Safe (GRAS) status."
The U.S. Food and Drug Administration (FDA) has announced that it will take a number of steps to advance its consideration for the potential regulatory framework for cannabis and cannabidiol (CBD) products. Specifically, this includes a public hearing, an agency working group, question-and-answer updates and the possibility of enforcement actions. A public hearing on May 31, 2019, aims to obtain “scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.” Electronic or written comments will be accepted until July 2, 2019. FDA is seeking comments, data and information related to (i) what levels of cannabis cause safety concerns; (ii) how the mode of delivery (e.g., ingestion, absorption, inhalation) affects the safety of, and exposure to, cannabis; (iii) how cannabis interacts with other substances; and (iv) standardized definitions for cannabis-related ingredients, supply chain quality control, effective marketing and labeling of…
Tapatio Foods has filed a trademark infringement lawsuit alleging that Tiowaxy Hot Sauce is sold with a similarly designed label, confusing consumers and causing brand tarnishment to Tapatio's hot sauce. Tapatio Foods v. Alfarh, No. 19-0335 (E.D. Cal., filed March 11, 2019). Tapatio alleges that Tiowaxy's label infringes because it also features a man in a sombrero with the brand name above the image. Further, Tiowaxy contains THC—which is derived from cannabis—and Tapatio alleges that "the association of the Infringing Marks with marijuana," "a Schedule 1 controlled substance," has tarnished Tapatio's reputation. Tapatio seeks an injunction, corrective advertising, disgorgement and damages for alleged Lanham Act and California consumer-protection statute violations.
The U.S. Department of Agriculture (USDA) has announced an online listening session to hear public input about "a new program to regulate hemp production." The agency's Agricultural Marketing Service (AMS) will host the webinar on March 13, 2019, with registration required by March 11 to speak during the session. "The Secretary of Agriculture and the respective USDA agencies, including AMS, are working to implement the provisions of the 2018 Farm Bill as expeditiously as possible to meet the needs of producers and other stakeholders," the announcement states. "To allow for public input and ensure transparency, it is important to hear from stakeholders regarding their priorities, concerns, and requests."
Class action litigation, the legal landscape for cannabis and the evolving implementation of the Food Safety Modernization Act (FSMA) were trending topics at the 2019 Grocery Manufacturers Association (GMA) Legal Conference. Numerous panels at the conference focused on emerging issues affecting the industry and anticipated trends moving forward, including implications of whole genome sequencing; how courts view the confluence of First Amendment rights and mandated advertising content; and standards-of-identity issues related to non-dairy milks, non-animal meats and cell-grown meats. Shook Partners Katie Gates Calderon, Phil Goldberg and Jim Muehlberger presented with Courtney Ozer, Assistant General Counsel – Litigation for Unilever United States, and Suzanne Werner, Litigation Counsel – The Coca-Cola Company, on strategies for avoiding and defending against claims involving product testing. The panel discussed (i) assembling a crisis-management team, which should include key company stakeholders, inside counsel, public-relations and governmental-relations personnel; (ii) understanding the pending lawsuit, which involves robustly…
U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb reportedly said in a February 27, 2019, hearing before the House Appropriations Committee that the agency will hold public hearings on cannabidiol (CBD) in April 2019. Gottlieb reportedly told the committee that FDA is assembling a working group of senior officials to create rules that would govern CBD in food and other uses. According to CNBC, "Gottlieb floated what a possible framework might look like. He suggested high concentrations might be regulated as a drug that has more stringent oversight while lower concentrations could be categorized as food products that come with an easier review process." Meanwhile, a New York City crackdown on CBD in food products has reportedly been postponed. Beginning in October 2019, CBS reports, violators selling CBD food may be subject to fines of $200 and risk lower public health letter grades.
New York City's health department has reportedly ordered restaurants to stop serving products that contain cannabidiol (CBD) on the grounds that the compound has not been approved as safe for use in food by the U.S. Food and Drug Administration. City inspectors have apparently marked CBD products as embargoed during routine inspections but have not confiscated the products from the restaurants. Maine's state health authorities reportedly began a similar crackdown on edible products containing CBD in late January, informing retailers that the compound is an unapproved food additive. The health departments' actions do not affect CBD sold in non-food products such as in oil or lotion, according to Eater. Industrial hemp, CBD's source, has faced similar regulatory confusion following the passage of the 2018 Farm Bill, which permitted the cultivation of industrial hemp as an agricultural product. An Idaho federal court has determined that when hemp can be transported between…
