FDA and FTC Issue Joint Warning Letter for Delta-8 THC Products Imitating Children's Snacks
In July 2024, FDA and FTC jointly issued a warning letter to Earthly Hemps for marketing Delta-8 THC-infused food products that imitate popular children's snacks including Slushers fruit snacks, Doritos chips, and Flamin' Hot Cheetos. The joint federal action represents coordinated enforcement addressing both food safety violations (FDA) and deceptive marketing practices (FTC) in a single warning letter—a rare but increasingly common approach for cannabinoid products that pose risks to children.
What Happened
Earthly Hemps marketed three Delta-8 THC-infused products through its website (earthlyhemps.com):
Dr. Blaze THC Delta-8 Slushers: Packaging resembling conventional fruit snacks with brightly colored liquid streams commonly used for children's products
Doweedos Delta-8 Chips: Featuring a cartoon anthropomorphized orange tortilla chip, directly mimicking Frito-Lay's Doritos branding and marketing style
Delta-8 Weedos: Using identical font, color scheme, and graphical style as Frito-Lay's Flamin' Hot Cheetos, with product appearance indistinguishable from actual Cheetos
FDA and FTC conducted joint review of the company's website and products in November 2023, January 2024, March 2024, and June 2024, ultimately determining the products violated both the Federal Food, Drug, and Cosmetic Act (FDA jurisdiction) and the Federal Trade Commission Act (FTC jurisdiction).
FDA Violations: Adulterated Food
FDA determined the products are adulterated under Section 402(a)(2)(C)(i) of the FD&C Act (21 U.S.C. § 342(a)(2)(C)(i)) because they contain Delta-8 THC, an unsafe food additive.
Delta-8 THC is Not GRAS: FDA analyzed Delta-8 THC under Generally Recognized as Safe (GRAS) criteria in 21 CFR 170.30 and concluded it does not meet GRAS requirements because:
No scientific consensus exists on safety for use in food
Available data raise serious health concerns including risks to central nervous system and cardiopulmonary systems
Animal studies suggest gestational exposure interferes with neurodevelopment
Not used in food before January 1, 1958 (the date for establishing GRAS through common use)
Over 300 adverse event reports submitted to FDA (2021-2023), with nearly 50% involving hospitalization
No Food Additive Approval: Delta-8 THC has no FDA food additive regulation authorizing its use in conventional food. Under Section 409 of the FD&C Act (21 U.S.C. § 348), any substance added to food that is not GRAS and lacks an approved food additive petition is deemed an unsafe food additive.
Consequence: Foods containing unsafe food additives are adulterated, and introducing adulterated food into interstate commerce is prohibited under Section 301(a) of the FD&C Act (21 U.S.C. § 331(a)).
FTC Violations: Deceptive and Unfair Marketing
FTC found violations of Section 5 of the FTC Act (15 U.S.C. § 45), which prohibits unfair or deceptive acts or practices in commerce.
Deceptive Marketing: The packaging creates a false impression that THC-infused products are conventional snacks. FTC Policy Statement on Deception (103 F.T.C. 174, 176 n.9 (1984)) explains that the appearance and intended use of a product can create consumer impressions, and it is deceptive if this impression is false and not corrected by the seller. Key deceptive elements:
Visual similarity to children's snacks makes products easily confused with traditional food
Children focus on appearance and may not read or comprehend warning labels
Cartoon characters and bright colors specifically appeal to children
Brand mimicry (Cheetos look-alike) deliberately creates consumer confusion
Unfair Practice - Unwarranted Health Risk: FTC determined that marketing edible THC products to look like children's snacks presents an unwarranted risk to health and safety. Commission Policy Statement on Unfairness (104 F.T.C. 1070, 1071 (1984)) establishes that practices presenting unwarranted health or safety risks violate Section 5. FTC emphasized:
Children are particularly at risk for mistakenly ingesting THC edibles
Packaging actively increases likelihood of accidental consumption
Known adverse health effects in children who consume THC
Preventing risks to children is an FTC enforcement priority (FTC Strategic Plan 2022-2026)
Public Health Data
From January 1, 2021 through December 31, 2023, FDA received over 300 adverse event reports for Delta-8 THC products:
Nearly 50% involved hospitalization or emergency department visits
Approximately two-thirds described adverse events after consuming edible products (candy, brownies, chips)
Both children and adults affected, but children face higher risks
Many cases involved unintentional consumption due to product appearance
FDA specifically warned consumers about accidental THC ingestion by children in June 2022, yet Earthly Hemps continued marketing products in packaging resembling children's snacks.
FDA's Sweeping Statement on ALL Cannabinoids
The warning letter includes a critical statement with broad implications for the entire cannabinoid industry:
"We know of no basis to conclude that any use in food of a cannabinoid, plant derived or otherwise, would be safe and lawful."
This language means:
Delta-8 THC: Expressly illegal (available data show harm)
Delta-9 THC: Illegal in food (controlled substance + safety concerns)
CBD: No lawful pathway for use in conventional food despite 2018 Farm Bill
Other cannabinoids (CBN, CBG, CBC): Presumed unlawful absent GRAS determination or approval
Hemp-derived cannabinoids: Source doesn't matter—still illegal in food under federal law
FDA reiterated that CBD is excluded from the dietary supplement definition under Section 201(ff)(3)(B) of the FD&C Act (21 U.S.C. § 321(ff)(3)(B)) because it was the subject of substantial drug investigations (Epidiolex approval) before being marketed in food or supplements.
State Laws Don't Override Federal Law
Many cannabinoid companies mistakenly believe state cannabis legalization authorizes marketing cannabinoid food products. This is incorrect. Federal food safety laws apply nationwide regardless of state cannabis laws. The FD&C Act and FTC Act are federal statutes with federal jurisdiction. State legalization of cannabis:
Does NOT make cannabinoids lawful food additives under federal law
Does NOT exempt companies from FDA food safety requirements
Does NOT prevent FDA or FTC enforcement actions
Does NOT create a defense in federal enforcement proceedings
What This Means for Cannabinoid Brands
If you manufacture, distribute, or sell cannabinoid products:
Cease marketing edible cannabinoid products immediately: Delta-8 THC, CBD, and other cannabinoids cannot lawfully be used in conventional food under current federal law.
Eliminate packaging that appeals to children: Avoid cartoon characters, bright colors, brand mimicry, or packaging resembling conventional snacks. This applies to ALL products, not just cannabinoid products.
Don't rely on state legalization: State cannabis laws do not create federal food safety exemptions. FDA and FTC have nationwide jurisdiction.
Review ALL product lines: The warning letter's statement about cannabinoids applies broadly. Reformulating from Delta-8 to CBD or other cannabinoids does not solve the legal problem.
Understand enforcement priorities: Products marketed to or accessible by children receive heightened federal scrutiny and aggressive enforcement.
Enforcement Escalation Options
Both agencies have significant enforcement tools available:
FDA Options:
Seizure of adulterated products in commerce
Injunctions prohibiting future violations
Import alerts causing automatic detention
Criminal prosecution for prohibited acts
Consent decrees requiring court-supervised compliance
FTC Options:
Federal court actions for injunctions and civil penalties
Civil penalties up to $46,517 per violation per day
Asset freezes to prevent dissipation pending litigation
Consumer redress requirements
Consent orders with ongoing compliance monitoring
Recent FTC cases involving deceptive marketing to children have resulted in multi-million dollar settlements and permanent injunctions.
Recommended Actions
If you currently sell cannabinoid edibles:
Immediately cease all sales of Delta-8 THC, CBD, and other cannabinoid food products
Remove products from website, e-commerce platforms, and retail locations
Issue stop-shipment notices to distributors and retailers
Consult FDA/FTC regulatory counsel (not general business attorneys)
Plan product recalls if products are already in distribution
Review other product lines for similar compliance issues
Do NOT:
Continue selling "while supplies last"
Rebrand with different packaging and resume sales
Reformulate with different cannabinoid (still illegal)
Argue state law permits sales (irrelevant to federal enforcement)
Ignore either FDA or FTC portions of joint letters
Get the Full Enforcement Breakdown
Compliance Vault subscribers receive comprehensive analysis of every major FDA and FTC enforcement action, including:
✓ Complete legal analysis of food additive law and GRAS requirements
✓ FTC deceptive marketing standards with case law and policy statements
✓ FDA's position on ALL cannabinoids including CBD, Delta-9 THC, CBN, CBG, and synthetic cannabinoids
✓ Product packaging guidelines showing what triggers FTC child safety concerns
✓ State vs. federal law analysis explaining why state cannabis legalization doesn't help
✓ Response strategies for joint FDA/FTC warning letters
✓ Enforcement escalation scenarios including seizures, injunctions, and civil penalties
The full Earthly Hemps enforcement breakdown includes detailed analysis of the 2018 Farm Bill, CBD exclusion clause, GRAS eligibility criteria, FTC unfairness doctrine, and comprehensive prevention checklists for cannabinoid and snack food brands.
Related Topics: FDA Warning Letters, FTC Enforcement, Delta-8 THC, CBD, Cannabinoids, Hemp, Deceptive Marketing, Children's Products, Food Additives, GRAS
Legal Citations:
FDA Violations:
FD&C Act § 201(s), 21 U.S.C. § 321(s) - Definition of "food additive"
FD&C Act § 301(a), 21 U.S.C. § 331(a) - Prohibited act (introducing adulterated food)
FD&C Act § 402(a)(2)(C)(i), 21 U.S.C. § 342(a)(2)(C)(i) - Adulteration (unsafe food additive)
FD&C Act § 409, 21 U.S.C. § 348 - Food additive approval requirement
21 CFR 170.30 - GRAS eligibility criteria
FD&C Act § 201(ff)(3)(B), 21 U.S.C. § 321(ff)(3)(B) - Dietary supplement exclusions
FTC Violations:
FTC Act § 5, 15 U.S.C. § 45 - Unfair or deceptive acts or practices
FTC Act § 12, 15 U.S.C. §§ 52, 55(a)(1) - False advertisements for foods
FTC Policy Statement on Deception, 103 F.T.C. 174 (1984)
Commission Policy Statement on Unfairness, 104 F.T.C. 1070 (1984)
Warning Letter Reference: CMS # 674916, July 2024
Company: Earthly Hemps, Cape Coral, FL
Issuing Offices: FDA Center for Food Safety and Applied Nutrition + FTC Division of Advertising Practices
Products Affected: Dr. Blaze THC Delta-8 Slushers, Doweedos Delta-8 Chips, Delta-8 Weedos