Two weeks after opening a comment period on an interim final rule on hemp farming, the U.S. Department of Agriculture (USDA) has received more than 600 comments. The rule set limits for the amount of tetrahydrocannabinol (THC) that can legally be produced by the crop, and farmers have reportedly told the agency that the limit is unmanageable. One issue is that the regulations do not acknowledge a difference between Delta-9 THC and THC-A, according to a former hemp farmer interviewed by Law360 who also reportedly said he had never seen a test result as low as the limit set by USDA. Another possible issue is that the crop must be tested by a laboratory registered with the Drug Enforcement Administration, which may reduce the number of qualified firms to a single laboratory. Comments on the interim final rule will be accepted until December 31.
Category Archives U.S. Government and Regulatory Agencies
The American Olive Oil Producers Association has filed a citizen petition urging the U.S. Food and Drug Administration (FDA) to "promulgate regulations for the standards of identity for olive oil and olive-pomace oil." The lack of standard of identity has led to "widespread mislabeling of grades, adulteration, consumer mistrust, and unfair and unethical industry business practices," the petition asserts, and the "continued absence of an enforceable standard is harming consumers. Off the shelf product testing demonstrates that U.S. consumers are frequently misled by mislabeling of grades and marketing tactics that leave them unable to differentiate between high quality extra virgin olive oil and low-quality, old or rancid oils, as well as cheap by-products that are chemically and mechanically refined and colored to resemble olive oil." The petition urges FDA to regulate "various grades of olive oil"—"extra virgin olive oil, virgin olive oil, olive oil composed refined oils"—to "promote honesty and…
The U.S. Department of Agriculture (USDA) has issued an interim final rule "specifying the rules and regulations to produce hemp." The rule outlines provisions for USDA "to approve plans submitted by States and Indian Tribes for the domestic production of hemp" and "establishes a Federal plan for producers in States or territories of Indian Tribes that do not have their own USDA-approved plan." Under the rule, hemp producers must obtain licenses, maintain "information on the land on which hemp is produced," comply with procedures for testing tetrahydrocannabinol concentration levels and dispose of non-compliant plants. The rule took effect October 31, 2019, and the agency will accept comments until December 30, 2019.
Reps. Roger Marshall (R-Kan.) and Anthony Brindisi (D-N.Y.) have introduced the Real Marketing Edible Artificials Truthfully (MEAT) Act, which would "codify the definition of beef for labeling purposes, reinforce existing misbranding provisions to eliminate consumer confusion, and enhance enforcement measures available to the [U.S. Department of Agriculture] if the [Food and Drug Administration] fails to take appropriate action," according to Marshall's press release. "The lack of any Federal definition of 'beef' or 'beef products' for the purposes of meat food product labeling has led some to begin marketing imitation products as meat or beef, creating the opportunity for marketplace confusion and consumer fraud that Congress originally charged the various Federal food regulatory agencies with the duty to prevent," the bill's text states. "Imitation products labeled as beef or as beef products create confusion in the marketplace. These products are in direct violation of the 'Congressional Findings and Declaration of Policy'…
The U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have announced a joint warning letter sent to Rooted Apothecary LLC focused on the potential benefits that the company claimed its cannabidiol (CBD) products could provide. "The Agency continues to be concerned about the proliferation of products asserting to contain CBD that are marketed for therapeutic or medical uses without having been reviewed for safety and effectiveness by the FDA as is required by law and to protect the public health," the letter states. "There are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD. Without this information, we are unable to ensure that these products will not cause harm to people who use them." The agencies warn that Rooted Apothecary is marketing unapproved drugs because it advertises its CBD-infused products as helping to diagnose, cure, mitigate, treat or prevent a number…
The U.S. Department of Agriculture (USDA) has published a set of changes to the National List of Allowed and Prohibited Substances, which documents the synthetic materials allowed or banned in the production and handling of organic agriculture. The amendments include the addition of "elemental sulfur for use as a molluscicide," the addition of "polyoxin D zinc salt to control fungal diseases" and the reclassification of magnesium chloride "from an allowed synthetic to an allowed nonsynthetic ingredient in organic handling." USDA also published a list of proposed changes and will accept comments on the proposal until December 17, 2019. The proposed rule would "add blood meal, made with sodium citrate, to the National List as a soil fertilizer," "add natamycin to the National List to prohibit its use" and "add tamarind seed gum as a non-organic agricultural substance for use in organic handling when organic forms of tamarind seed gum are…
The U.S. Food and Drug Administration has published a warning letter it sent in September 2019 to a company selling cannabidiol (CBD) oil as a dietary supplement. “This product is labeled as a dietary supplement; however, it cannot be a dietary supplement because it does not meet the definition of a dietary supplement,” the letter stated. “Under those provisions, if an article (such as CBD) is an active ingredient in a drug product that has been approved [], 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 outside the definition of a dietary supplement. There is an exception if the substance was ‘marketed as’ a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available…
The U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA) announced a number of developments in their work on organic food, poultry and food safety. FDA released an update on the implementation of the Food Safety Modernization Act (FSMA), announcing it will track outcomes for FSMA rules for inspections and recalls via the Food Safety Dashboard. One metric the agency will track is how quickly a company issues a public notice for a Class 1 recall for human and animal food. FDA has also released guidance on recall plans for its multipart guidance on “how to comply with the requirements for hazard analysis and risk-based preventive controls under our rule entitled ‘Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.’” USDA updated the National Poultry Improvement Plan (NPIP) Program Standards to incorporate proposed changes published in April 2019, including the amendment of the testing…
The U.S. House of Representatives has passed the SAFE Banking Act, which allows financial-service firms to work with "cannabis-related legitimate businesses and service providers," providing protection from federal prosecution for banks in states that have legalized cannabis. The bill, introduced by Rep. Ed Perlmutter (D-Colo.), has been sent to the Senate. In its press release praising the bill's passage, the National Cannabis Industry Association introduced a plan calling for "cannabis products, like other highly regulated consumables, to be regulated by the government agencies that currently regulate most food and drugs, primarily the Food and Drug Administration (FDA) and the Alcohol and Tobacco Tax and Trade Bureau (TTB) within the U.S. Department of the Treasury." Under the plan, "cannabis products would be divided into four categories, based on chemical components, safety, intended use, and consumption method. Each of these groups would be regulated through a separate regulatory 'lane' tailored to the…
The U.S. Food and Drug Administration has released guidance on the use of "medically important antimicrobials" in "food-producing animals." The guidance describes a voluntary process that "will help ensure new animal drugs containing antimicrobials of human importance are administered only under veterinary oversight and only for therapeutic uses." The agency will accept comments on the guidance until December 24, 2019.