FDA has issued a new batch of CBD warning letters, this time to 15 CBD companies the agency said are “illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act.” So far in 2019, FDA has issued 22 warning letters over CBD.
Simultaneously alongside FDA's announcement yesterday of the 15 new warning letters, the agency also published a consumer update alerting the public to potential hazards related to CBD products.
The 15 companies who were sent warning letters on November 22 are: Koi CBD LLC, Pink Collections Inc., Noli Oil, Natural Native LLC, Whole Leaf Organics LLC, Infinite Product Company LLLP, Apex Hemp Oil LLC, Bella Rose Labs, Sunflora Inc., Healthy Hemp Strategies LLC/Curapure, Private I Salon LLC, Organics Industries Inc. (Plant Organix), Red Pill Medical Inc., Sabai Ventures Ltd, and Daddy Burt LLC.
Products cited include oils, gummies, pet products, and skincare products.
In its warning letters, FDA cites these firms for selling CBD products as dietary supplements despite the fact that FDA has not authorized CBD as a legal ingredient for dietary supplements or food. The products containing CBD are illegal dietary supplements and considered unapproved new drugs, the agency said. FDA also cited some of the companies for making illegal disease-treatment claims.
Some of the products cited included products marketed as pet supplements, with those warning letters co-signed by the FDA Center for Veterinary Medicine.
The FDA Consumer Update published on November 25 is titled “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-Derived Compounds, Including CBD.” It discusses warnings about some of FDA’s concerns about CBD products currently on the market.
FDA pointed to concerns over potential liver injury, drug interactions, male reproductive toxicity, and side effects. The agency’s update also highlighted potential negative behaviors by some companies marketing CBD products, including circulating of “misleading, unproven, and false product claims” and, in the case of manufacturing, a potential “lack of appropriate processing controls and practices [that] can put consumers at additional risks.”
Said FDA: “For example, the agency has tested the chemical content of cannabinoid compounds in some of the products, and many were found to not contain the levels of CBD they claimed.”
Specifically regarding pets, FDA said: “The FDA has not approved CBD for any use in animals, and the concerns regarding CBD products with unproven medical claims and of unknown quality equally apply to CBD products marketed for animals.”
FDA stated: “The FDA is concerned that people may mistakenly believe that trying CBD ‘can’t hurt.’ The agency wants to be clear that we have seen only limited data about CBD’s safety and these data point to real risks that need to be considered.”
FDA also said as it has before that the agency continues to evaluate any adverse health risks concerning CBD, stating in the Consumer Update: “The FDA is actively working to learn more about the safety of CBD and CBD products…” The agency noted its efforts so far to gather information about CBD, including the FDA an open meeting held on May 31 of this year and comments it recently collected via public docket. It also stated that it continues to “evaluate the regulatory framework” for cannabis and cannabis-derived compounds.
One CBD company, CV Sciences (San Diego), applauded FDA’s recent set of warning letters.
“CV Sciences supports FDA’s recent enforcement actions against bad actors who make unsubstantiated claims that CBD-containing products can treat cancer, Alzheimer’s disease, opioid withdrawal, etc.,” said Duffy MacKay, ND, senior vice president of scientific and regulatory affairs for CV Sciences, in a press release. “These companies put consumers at risk, while giving responsible companies within the industry a black eye.”
However, CV Sciences and some other industry representatives are concerned by the “alarmist tone” of FDA’s Consumer Update.
Said MacKay: “CV Sciences is disappointed that FDA’s consumer update, released simultaneously with the warning letters, used an inappropriately alarmist tone. CV Sciences is concerned that FDA is creating a narrative that questions the safety of CBD to try to address the significant number of fly-by-night companies entering the CBD industry. There are more direct ways for FDA to address bad actors, while still working with responsible companies to establish the appropriate scope of hemp-derived ingredients for supplements based on sound research. However, CV Sciences continues to be optimistic that FDA has a similar goal to create a clear, regulatory path for science-based, hemp-derived CBD ingredients that provide an appropriate and safe level of CBD.”
The Natural Products Association (NPA; Washington, DC) distributed a press statement saying that the need for FDA to establish a safe level for daily CBD use is what should be of utmost concern. “New CBD warning letters and a consumer update from the Food and Drug Administration (FDA) does not go far enough to protect consumers from a looming public health crisis,” NPA said. The association has urged Congress to pass legislation to fund a CBD health-hazard evaluation by FDA.
Daniel Fabricant, PhD, president and CEO of NPA, said in the association’s press release: “Consumers and America's burgeoning hemp industry are the biggest losers here because this so-called action only invites another vaping crisis where illicit and potentially lethal imported substances posing as CBD can and will proliferate. CBD is as common as bottled water in the U.S., and letters to a handful of companies and bureaucratic head-scratching helps no one. It is well past time to bring science into the equation as federal rules require and as the U.S. House of Representatives directed. Safety and consumer protection must come first.”