What Can We Learn from the FDA's Warning Letters for Hemp-Derived Products?

By Shawn Hauser, Angela George, Genevieve Meehan

Nov 24, 2025

Key Summary

The U.S. Food and Drug Administration (FDA) maintains that hemp-derived cannabinoids are not lawful food additives.
The FDA has targeted hemp products with unsubstantiated medical claims, unsafe forms, Delta-8 THC, and “copycats” due to potential consumer health risks.
These actions underscore the evolving regulatory landscape for hemp and cannabinoid products and the need for companies to maintain full compliance with federal and state laws.

A Brief History of FDA Warning Letters

The Food and Drug Administration (FDA) maintains that hemp-derived cannabinoids are not lawful food additives. Despite this, the agency has historically limited its enforcement to specific high-risk scenarios rather than targeting all hemp products broadly, and enforcement is largely limited to issuing warning letters. The agency has repeatedly issued warning letters to businesses marketing or selling hemp-derived products in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which provides the legal authority for agency enforcement.

Over the past decade, enforcement has focused on hemp-derived products that pose potential public health risks, largely including those making unsubstantiated health claims, but also encompassing certain Delta-8 THC products, unsafe product forms, and “copycat” products.

The FDA has historically enforced against hemp products that make certain medical or health claims, which directly violate the FD&C Act. Health-related drug claims often involve statements suggesting a product can affect the body’s structure or function, such as advertising potential treatments for conditions like COVID-19, cancer, or diabetes. Such claims elevate the agency’s concern because they mislead consumers and pose potential health risks. By contrast, the FDA has generally not pursued enforcement actions against hemp businesses whose products avoid these types of claims until more recent years.

2024 FDA Warning Letters

In May 2022, the FDA issued its first-ever warning letters for delta-8 THC products to five companies in various states, all for unsubstantiated health or therapeutic claims, among other violations. However, more recently, the agency has expanded enforcement to include other high-risk cannabinoid products that do not necessarily tout unverified health claims.

In 2024, the FDA most notably cracked down on so-called “copycat" delta-8 THC products in violation of the FD&C Act but continued to issue enforcement letters pertaining to unapproved new drugs and product forms.

FDA & FTC Crackdown on Delta-8 “Copycat” Products

"Copycat" products intentionally mimic the packaging, brand names, and designs of popular national snack products, raising both legal and public safety issues. These products raise serious concerns for the FDA, FTC and state regulators because their familiar packaging is misleading, possibly deceptive, and highly appealing to children, creating a real risk that kids could accidentally ingest edible hemp-derived products.

Regarding the advertising, labeling, and promotion of food and cosmetic products, the FDA and the Federal Trade Commission (FTC) share overlapping jurisdiction and often coordinate enforcement efforts.

On July 15, 2024, the two federal entities jointly issued five warning letters to the following companies selling “copycat” delta-8 THC consumable products: Hippy Mood (PA), Earthly Hemps (FL), Shamrockshrooms.com, Mary Janes Bakery Co. LLC (FL) and Life Leaf Medical CBD Center (SC). A similar letter was also issued to GrowGod LLC for identical violations solely by the FDA.

In addition to FD&C Act violations for adulterated human foods due to delta-8 THC content, the FTC also warned these companies for engaging in unfair and deceptive marketing practices in the sale of “copycat” delta-8 THC products.

The warned companies sold a variety of “copycat” food products that blatantly mimicked the packaging of well-known brands popular with children, including Froot Loops and Cap’n Crunch cereals, Flamin’ Hot Cheetos, Chips Ahoy cookies, and various candies such as Skittles, Sour Patch Kids, and Jolly Ranchers.

Additional Warning Letters

The FDA also sent three additional warning letters for various other violations of the FD&C Act. The following warning letters pertain to products that were not “copycat” products, but encompassed other health and safety risks:

White Label Leaf, LLC/Flying Monkey US, LLC, cited for adulterated human foods and unapproved new drugs containing delta-8 THC.
Root Bioscience Brands, LLC dba Naternal, cited for unapproved new human and animal drugs containing CBD, CBG, and CBN.
Anne’s Daye Ltd dba Tampon Innovations, cited for unapproved devices in the form of CBD-coated tampons.

2025 FDA Warning Letters

This year, the FDA issued warning letters to seven companies concerning unapproved hemp cannabinoid products intended for human and animal consumption that either made unsubstantiated health claims, contained delta-8 THC, and/or presented material safety risks due to their form (i.e., CBD eye drops, intravenous CBD).

To rectify these violations, the FDA required each company to submit a written response to the warning, including documentation of the steps taken to address the violations, within 15 business days of receiving the warning. Failure to properly address the claims could result in potential legal action, including seizure of the product and/or injunction.

Warning Letters Issued for Delta-8 & CBD Products

Two of these seven companies, Latro Inc. and TKO Distribution, received warnings for marketing human food products containing delta-8 THC. The FDA considers delta-8 THC to be an unauthorized and unsafe food additive. Accordingly, any food product containing an unapproved additive is deemed adulterated and its sale in interstate commerce is thus prohibited under the FD&C Act.

In August 2025, the FDA issued a warning to Trew Balance for marketing homeopathic CBD eye drops, emphasizing that purported homeopathic drugs remain subject to the same statutory requirements as other drugs. Earlier in the year, Pico IV Inc. received a warning for an intravenous form of CBD that does not qualify as a dietary supplement under the FD&C Act.

The FDA considers both of these CBD products unapproved new drugs and cited their high-risk administration methods as public health concerns, prohibiting their sale in interstate commerce.

Warning Letters Issued for Animal CBD Products

Notably, the majority of this year’s warning letters, sent to House of Alchemy LLC/Hamet & Love LLC, Holista LLC, and Bailey’s Wellness LLC, focused on CBD products intended for animal consumption.

The FDA issued warning letters to these three companies for the unauthorized sale of new animal drugs and the marketing of adulterated animal food products. Each company offers a variety of edible CBD products for animals, ranging from common household pets to livestock, such as horses, cows, and goats.

Like new drugs for human consumption, unapproved new animal drugs that make health claims that are unsubstantiated by the FDA are prohibited from interstate sale. Beyond potential safety concerns for the animals themselves, the FDA has consistently raised concerns about the consumption of cannabinoid products by food-producing animals and the resulting safety of human food products, such as meats, cheeses, and milk, derived from them.

Industry Takeaways and Compliance Implications

These enforcement actions reflect a decade-long consistent trend in the FDA’s approach to hemp-derived products, highlighting its strategy of directing its limited resources toward products that pose the greatest risks to public safety.

Although all hemp-derived products on the market are technically adulterated or misbranded, the FDA has historically refrained from acting where its enforcement priorities are not triggered. FDA’s approach with warning letters to date illustrates that the agency’s focus remains on high-risk products, suggesting that it will act only when products are deemed adulterated, unapproved, or misbranded; however, this does not imply that it will act against every hemp product on the market.

The FDA’s targeted, safety-driven enforcement approach underscores the critical need for a coordinated federal and state hemp regulation of hemp products, with consistent and stable oversight by food and drug regulators.

This growing concern has led to recent legislative efforts and the enactment of new laws to heavily regulate hemp product packaging and marketing in states like Florida, and even to efforts to outright ban the sale of hemp products in states like Texas and California.

As new actions emerge, the regulatory landscape for cannabis and hemp-derived products continues to evolve. This pattern of federal enforcement highlights the importance of staying compliant with state and federal laws, understanding enforcement priorities, and keeping pace with a rapidly evolving legal landscape, as falling behind is not an option in this space.

As the FDA continues to clarify its stance on consumable cannabinoids, regulatory compliance remains essential. To learn how your business can stay ahead of new enforcement trends, connect with Vicente LLP’s hemp and cannabinoid attorneys.