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The FDA has just posted a new alert for consumers, warning that several companies selling CBD products have violated federal regulations. The FDA issued warning letters to five companies for selling products labeled as containing delta-8 THC in ways that violate the FD&C Act. This action is the first time the FDA has issued warning letters for products containing delta-8 THC. Today, the U.S. Food and Drug Administration issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act.

If You Use CBD, the FDA Has an Urgent New Warning for You

The agency has recently clamped down on certain companies selling CBD products.

The medical use of cannabis has been a divisive topic of conversation for decades now, but in recent years, more and more people have been pushing for its acceptance. Derived from the cannabis plant, there are a plethora of cannabis products available for consumption, but most are made from the two most prominent cannabinoids found in the plant: cannabidiol (CBD), which is often revered for its health benefits, and tetrahydrocannabinol (THC), which is what produces the psychological effects that make people feel high. Despite the rising public acceptance of these products, however, there is still plenty of concern from federal regulators. In fact, the U.S. Food and Drug Administration (FDA) just released an urgent new warning targeted at CBD users. Read on to find out what the agency is alerting consumers about now.

Following the 2012 legalization of marijuana in Colorado, 17 other states and Washington, D.C., have since made it legal for people to use and sell various cannabis products. But recreational marijuana has not been federally legalized, and only one cannabis product has been federally approved by the FDA. In 2018, the agency approved Epidiolex, which contains CBD, for the treatment of certain seizures—making it the first and only FDA-approved drug that “contains a purified drug substance derived from marijuana.” This is only available through a prescription as well.

In a recent crackdown against unapproved cannabis products, the FDA issued an alert on May 4, notifying consumers that it has sent warning letters to five different companies illegally selling delta-8 products in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). According to the FDA, delta-8 THC is a cannabinoid that is not naturally “found in significant amounts” in the cannabis plant, so concentrated amounts of this substance are typically synthetically manufactured from other cannabinoids like CBD through the use of additional—and potentially harmful—chemicals. ae0fcc31ae342fd3a1346ebb1f342fcb

“This action is the first time the FDA has issued warning letters for products containing delta-8 THC,” the agency noted.

The warning letters were issued to the following companies: ATLRx Inc., BioMD Plus LLC, Delta & Hemp, Kingdom Harvest LLC, and M Six Labs Inc. According to the agency, the citations address these companies selling products as “unapproved treatments for various medical conditions or for other therapeutic uses,” as well as several violations related to drug misbranding and the addition of delta-8 THC in foods.

“The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide. These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea and anxiety,” FDA Principal Deputy Commissioner Janet Woodcock, MD, said in a statement.

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The FDA noted that several of the companies were also warned about additional violations of the FD&C Act, particularly concerning CBD products. The violations included “marketing CBD products claiming to treat medical conditions in humans and animals, promoting CBD products as dietary supplements, and adding CBD to human and animal foods.”

“It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement,” the agency explained. “The FDA has seen only limited data about CBD safety and these data point to real risks that need to be considered before taking CBD for any reason.”

One of the companies has also been marketing CBD products for food-producing animals, according to the FDA. The agency warned that this could also impact consumers, as there are “potential safety concerns related to human food products” such as meat, milk, and eggs produced from animals that are given CBD, “as there is a lack of data on safe CBD residue levels.”

This isn’t the first time the FDA has had to send warning letters in regards to CBD products. Over the past several years, a number of companies have been cited by the agency for “illegally selling unapproved CBD products that claimed to diagnose, cure, mitigate, treat or prevent various diseases.”

The FDA has been sending warning letters since at least 2015, and 12 companies—including the five just issued—have been cited in the first five months of 2022 alone. Alongside the warnings, the agency has also tested the chemical content of cannabinoid compounds in some of the products sold by these companies and “many were found to not contain the levels of CBD” they were claiming to when marketing to buyers.

“Consumers should beware purchasing and using any such products,” the FDA advises.

FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta-8 THC Products

Violations Include Marketing Unapproved New Drugs, Misbranding, Adding Delta-8 THC to Food Products

Today, the U.S. Food and Drug Administration issued warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). This action is the first time the FDA has issued warning letters for products containing delta-8 THC. Delta-8 THC has psychoactive and intoxicating effects and may be dangerous to consumers. The FDA has received reports of adverse events experienced by patients who have consumed these products.

There are no FDA-approved drugs containing delta-8 THC. Any delta-8 THC product claiming to diagnose, cure, mitigate, treat, or prevent diseases is considered an unapproved new drug. The FDA has not evaluated whether these unapproved drug products are effective for the uses manufacturers claim, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products, or whether they have dangerous side effects or other safety concerns.

Delta-8 THC is one of over 100 cannabinoids produced in the Cannabis sativa L. plant but is not found naturally in significant amounts. Concentrated amounts of delta-8 THC are typically manufactured from hemp-derived cannabidiol (CBD) and have psychoactive and intoxicating effects. Products containing delta-8-THC are available in varying forms, including but not limited to candy, cookies, breakfast cereal, chocolate, gummies, vape cartridges (carts), dabs, shatter, smokable hemp sprayed with delta-8-THC extract, distillate, tinctures, and infused beverages.

The warning letters address the illegal marketing of unapproved delta-8 THC products by companies as unapproved treatments for various medical conditions or for other therapeutic uses. The letters also cite violations related to drug misbranding (e.g., the products lack adequate directions for use) and the addition of delta-8 THC in foods, such as gummies, chocolate, caramels, chewing gum, and peanut brittle.

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“The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide. These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea and anxiety,” said FDA Principal Deputy Commissioner Janet Woodcock, M.D. “It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children. We will continue to safeguard Americans’ health and safety by monitoring the marketplace and taking action when companies illegally sell products that pose a risk to public health.”

The FDA recently published a consumer update expressing serious concerns about the potential health effects of delta-8 THC products. The FDA has received adverse event reports involving products containing delta-8 THC from consumers, healthcare practitioners, and law enforcement, some of which resulted in the need for hospitalization or emergency room treatment. The agency is also aware of an increasing number of exposure cases involving products containing delta-8 THC received by national poison control centers and alerts issued by state poison control centers describing safety concerns and adverse events with products containing delta-8 THC.

In addition to the violations related to FDA-regulated products containing delta-8 THC, several of the warning letters outline additional violations of the FD&C Act, including marketing CBD products claiming to treat medical conditions in humans and animals, promoting CBD products as dietary supplements, and adding CBD to human and animal foods. CBD and delta-8 THC are unapproved food additives for use in any human or animal food product, as the FDA is not aware of any basis to conclude that the substances are generally recognized as safe (GRAS) or otherwise exempt from food additive requirements. One of the letters expresses concerns regarding CBD products marketed for food-producing animals, and the potential safety concerns related to human food products (e.g., meat, milk, eggs) from animals that consume CBD, as there is a lack of data on safe CBD residue levels.

The FDA issued warning letters to:

The FDA has previously sent warning letters to other companies illegally selling unapproved CBD products that claimed to diagnose, cure, mitigate, treat or prevent various diseases, in violation of the FD&C Act. In some cases, there were further violations because CBD was added to food products. The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy.

The FDA has requested written responses from the companies within 15 working days stating how they will address these violations and prevent their recurrence. Failure to promptly address the violations may result in legal action, including product seizure and/or injunction.

FDA Warns Companies Illegally Selling Over-the-Counter CBD Products for Pain Relief

Products Listing CBD as Inactive Ingredient Cited for Unapproved Drug and Misbranding Violations

The U.S. Food and Drug Administration has issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the warning letters address the illegal marketing of unapproved drugs labeled as containing CBD. The FDA has not approved any over-the-counter (OTC) drugs containing CBD, and none of these products meet the requirements to be legally marketed without an approved new drug application. The letters explain that, as CBD has known pharmacological effects on humans, with demonstrated risks, it cannot be legally marketed as an inactive ingredient in OTC drug products that are not reviewed and approved by the FDA. Additionally, the letters cite substandard manufacturing practices, including failure to comply with current good manufacturing practices.

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“The FDA continues to alert the public to potential safety and efficacy concerns with unapproved CBD products sold online and in stores across the country,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “It’s important that consumers understand that the FDA has only approved one drug containing CBD as an ingredient. These other, unapproved, CBD products may have dangerous health impacts and side effects. We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety. Meanwhile, we will continue to monitor and take action, as needed, against companies that unlawfully market their products — prioritizing those that pose a risk to public health.”

The FDA issued warning letters to:

The products that are the subject of the warning letters issued today have not gone through the FDA drug approval process and are considered unapproved new drugs. There has been no FDA evaluation of whether these unapproved drug products are effective for the uses manufacturers claim, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products or whether they have dangerous side effects or other safety concerns.

The FDA has previously sent warning letters to other companies illegally selling unapproved CBD products that claimed to prevent, diagnose, mitigate, treat or cure various diseases, in violation of the FD&C Act.

Under the FD&C Act, any product intended to diagnose, cure, mitigate, treat or prevent a disease, and any product (other than a food) that is intended to affect the structure or function of the body of humans, is a drug. OTC drugs must be approved by the FDA or meet the requirements for marketing without an approved new drug application under federal law, including drug products containing CBD, regardless of whether CBD is represented on the labeling as an active ingredient or an inactive ingredient.

The FDA has not approved any CBD-containing drug products other than one prescription drug for the treatment of seizures associated with tuberous sclerosis complex, Lennox-Gastaut syndrome and Dravet syndrome in human patients.

The FDA has requested written responses from these companies within 15 working days stating how they will address these violations or providing their reasoning and supporting information as to why they believe these products are not in violation of the law. Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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