FDA's Intergovernmental Affairs Staff would like to share with you an important update to the Agency's website regarding the accidental ingestion by children of food products containing tetrahydrocannabinol (THC), to include recent new data reported to FDA and national poison control centers. Accidental ingestion of these edible products (described below) may cause serious adverse events.
- Some edible products are designed to mimic the appearance of well-known branded foods by using similar brand names, logos, or pictures on their packaging. FDA is aware of reports of copycat products packaged to look like Cap’n Crunch, Cocoa Pebbles, Cocoa Puffs, Froot Loops, Fruity Pebbles, Nerds Ropes, Starbursts, Sour Patch Kids, and Trix, among others.
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From January 1 - May 31, 2022, FDA received over 125 adverse event reports related to children and adults who consumed edible products containing THC; some individuals who ate these edible products reportedly experienced adverse events such as hallucinations, increased heart rate and vomiting, and many required medical intervention or hospital admission.
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In addition, national poison control centers received 10,448 single substance exposure cases involving only edible products containing THC between January 1 and May 31, 2022. Of these cases, 77% involved patients 19 years of age or younger.
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FDA is actively working with federal and state partners to further address the concerns related to these products and monitoring the market for adverse events, product complaints, and other emerging cannabis-derived products of potential concern.
We hope this information is helpful to you. If you have any questions, please contact myself or FDA's Intergovernmental Affairs Team at iga@fda.hhs.gov.
Ruth G. Watson, J.D.
Intergovernmental Affairs Specialist (on detail)
Intergovernmental Affairs (IGA)
Office of the Commissioner/OPLIA U.S. Food and Drug Administration
Mobile: 301 219-4162
Office: 301-796-8927
Ruth.Watson@FDA.HHS.gov
June 16, 2022
What's New
This alert has been updated to include new data reported to the FDA and national poison control centers.
Audience
What is the problem?
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Edible products containing tetrahydrocannabinol (THC) can be easily mistaken for commonly consumed foods such as breakfast cereal, candy, and cookies, and accidentally ingested.
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Accidental ingestion of these products can lead to serious adverse events, especially in children.
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Some edible products are designed to mimic the appearance of well-known branded foods by using similar brand names, logos, or pictures on their packaging. These copycats are easily mistaken for popular, well-recognized foods that appeal to children.
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The FDA is aware of reports of copycat products packaged to look like Cap’n Crunch, Cocoa Pebbles, Cocoa Puffs, Froot Loops, Fruity Pebbles, Nerds Ropes, Starbursts, Sour Patch Kids, and Trix, among others.
Examples of Products
Who is at risk?
The FDA is advising consumers about the risk of accidental ingestion, especially by children, of edible products that contain THC. Accidental ingestion of these edible products may cause serious adverse events.
Summary of Problem and Scope
Some manufacturers are packaging and labeling edible products containing THC to look like popular brands of commonly consumed foods, such as breakfast cereal, candy, and cookies. These products appeal to children and may be easily mistaken for popular, well-recognized foods.
The FDA is aware of multiple media reports describing children and adults who accidentally consumed copycat edible products containing THC and experienced adverse events. Additionally, from January 1, 2021, through May 31, 2022, the FDA received over 125 adverse event reports related to children and adults who consumed edible products containing THC. Some individuals who ate these edible products reportedly experienced adverse events such as hallucinations, increased heart rate and vomiting, and many required medical intervention or hospital admission. Ten of the reports specifically mention the edible product to be a copycat of popular foods, such as Cocoa Pebbles, Gushers, Nerds Rope, Skittles, Sour Patch Kids, and Starburst.
In addition, national poison control centers received 10,448 single substance exposure cases involving only edible products containing THC between January 1, 2021, and May 31, 2022. Of these cases, 77% involved patients 19 years of age or younger. Of the total cases, 65% involved unintentional exposure to edible products containing THC and 91% of these unintentional exposures affected pediatric patients. Furthermore, 79% of the total cases required health care facility evaluation, of which 7% resulted in admission to a critical care unit; 83% of patients requiring health care facility evaluation were pediatric patients. One pediatric case was coded with a medical outcome of death following the ingestion of a suspected delta-8 THC edible.
FDA Actions
The FDA is actively working with federal and state partners to further address the concerns related to these products and monitoring the market for adverse events, product complaints, and other emerging cannabis-derived products of potential concern.
Recommendations for Consumers
- Call 9-1-1 or get emergency medical help right away if you or someone in your care has serious side effects from these products. Always keep these products in a safe place out of reach of children.
- Call the local poison control center (1-800-222-1222) if a child has consumed these products. Do not wait for symptoms to call.
- Contact your healthcare provider if you or someone in your care recently ingested these products and you have health concerns.
How to report complaints and adverse events:
Health care professionals, patients and consumers are encouraged to report complaints and cases of exposure and adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Visit www.fda.gov/fcic for additional consumer and industry assistance.
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