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FDA reaffirms that CBD products can’t be marketed as dietary supplements The US Food and Drug Administration (FDA) has objected to New Dietary Ingredient (NDI) notifications submitted by two 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. As more states legalize cannabis, the push to "deschedule" it from the Controlled Substances Act is gaining momentum. At the same time, the Food and Drug Administration (FDA) recently approved the first conventional drug containing a cannabinoid derived from cannabis—cannabidiol (CBD) for two rare s …

FDA reaffirms that CBD products can’t be marketed as dietary supplements

The US Food and Drug Administration (FDA) has objected to New Dietary Ingredient (NDI) notifications submitted by two developers of full-spectrum hemp extract products, telling the companies an earlier decision by the agency to consider cannabidiol (CBD) as a drug means it won’t consider their applications to sell the products as dietary supplements.

Writing to Irwin Naturals, FDA said the company’s product, NDI 1199, contains CBD, which is an active ingredient in Epidiolex, a drug approved by FDA for the treatment of seizures in patients with Lennox-Gastaut syndrome and Dravet syndrome. Because CBD was not marketed as a dietary supplement before it became an active ingredient in an approved drug product, it is not excluded from the definition of a dietary supplement under the Federal Food, Drug, and Cosmetic Act (FD&C Act). (RELATED: FDA approves first marijuana-derived drug, Regulatory Focus 25 June 2018)

FDA sent a similar letter to Charlotte’s Web, Inc., a company with a similar full-spectrum hemp extract product, NDI 1202, that was intended to be marketed as a dietary supplement. Both NDI 1199 and NDI 1202 are “subject to the exclusion from the definition of dietary supplement,” the agency said, and “may not be marketed as or in a dietary supplement.”

While FDA has shown an interest in developing a product approval pathway for cannabis and cannabis-derived products, the agency doesn’t appear to have changed its stance on approving CBD products as food or dietary supplements.

In 2019, then-FDA Commissioner Scott Gottlieb stated it is illegal for companies to put CBD in food or market it as a dietary supplement because it is an active ingredient in an FDA-approved drug product. “[T]he only path that the FD&C Act allows for such substances to be added to foods or marketed as dietary supplements is if the FDA first issues a regulation, through notice-and-comment rulemaking, allowing such use,” Gottlieb said. (RELATED: FDA Begins Plotting Pathway for Cannabis Product Approvals, Regulatory Focus 02 April 2019)

However, FDA’s Q&A document on how it regulates cannabis and cannabis-derived products like CBD indicates it might reverse its position if presented with evidence of benefit. “FDA is not aware of any evidence that would call into question its current conclusions that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act,” FDA wrote in the Q&A. “Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not caused us to change our conclusions.” (RELATED: Update on the Regulatory Status of Cannabidiol in Food and Dietary Supplements and Future Prospects, Regulatory Focus 12 June 2019)

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‘Significant concerns’ about safety

Apart from the issue of CBD products being marketed as dietary supplements, FDA also raised concerns about safety of NDI 1199 and NDI 1202. In its letter to Irwin Naturals, FDA said the company “failed to show that the NDI will reasonably be expected to be safe,” citing vague evidence and inadequate descriptions of how it prepares cannabis, serving levels, frequency and duration of use. The letter noted some evidence provided by Irwin Naturals was for phytocannabinoid mixtures that couldn’t be compared to the product. FDA also said reports of hepatotoxicity and reproductive toxicity for CBD were not adequately addressed in the company’s notification.

“For these reasons, the information in your submission indicates that, even if NDI 1199 were not excluded from the definition of a dietary supplement, your notification does not provide an adequate basis to conclude that a dietary supplement containing the ingredient, when used under the conditions recommended or suggested in the labeling of your product, would reasonably be expected to be safe,” FDA wrote.

In its letter to Charlotte’s Web, FDA said the submission of 2 years of marketing for NDI 1202 was “insufficient to establish the safety of your ingredient when used under the proposed conditions of use.” The company also failed to provide underlying data for a study cited as evidence for proposing NDI 1202 as having no-observed adverse effect level. “In addition, none of the clinical and pre-clinical studies that you provided adequately address certain reported toxicity endpoints of CBD such as hepatotoxicity and reproductive toxicity,” the agency wrote.

Charlotte’s Web posted a response to FDA’s letter on their website, noting that the agency’s letter is inaccurate and “the conclusions drawn by the FDA do not appear to be based on the data provided in our NDI application.” The company also called on Congress to pass legislation that would regulate CBD as a dietary supplement.

“Both the House of Representatives and the Senate introduced bills that would legislate hemp CBD as a dietary supplement. We believe this legislation is a critical step to protect consumers and to establish guidance for manufacturers, and Charlotte’s Web intends to stay at the forefront of these efforts,” they wrote.

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.

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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.

“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.

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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.

The Surprising Reach of FDA Regulation of Cannabis, Even After Descheduling

As more states legalize cannabis, the push to “deschedule” it from the Controlled Substances Act is gaining momentum. At the same time, the Food and Drug Administration (FDA) recently approved the first conventional drug containing a cannabinoid derived from cannabis—cannabidiol (CBD) for two rare seizure disorders. This would all seem to bode well for proponents of full federal legalization of medical cannabis. But some traditional providers are wary of drug companies pulling medical cannabis into the regular small molecule drug development system. The FDA’s focus on precise analytical characterization and on individual active and inactive ingredients may be fundamentally inconsistent with the “entourage effects” theory of medical cannabis. Traditional providers may believe that descheduling cannabis would free them to promote and distribute their products free of federal intervention, both locally and nationally. Other producers appear to assume that descheduling would facilitate a robust market in cannabis-based edibles and dietary supplements. In fact, neither of these things is true. If cannabis were descheduled, the FDA’s complex and comprehensive regulatory framework governing foods, drugs, and dietary supplements would preclude much of this anticipated commerce. For example, any medical claims about cannabis would require the seller to complete the rigorous new drug approval process, the cost of which will be prohibitive for most current traditional providers. Likely also unexpected to some, there is no pathway forward for conventional foods containing cannabis constituents, with the (probably exclusive) exception of certain hemp seed ingredients, if those foods cross state lines. And it will certainly come as a shock to many that federal law already prohibits the sale of dietary supplements containing CBD–including those already on the market as well as those made from “hemp,” which has recently been descheduled under the 2018 Farm Bill. This Article describes in detail the surprising reach of the FDA and then outlines three modest, but legal, pathways forward for cannabis-based products in a world where cannabis has been descheduled.

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