FDA Workshop Tackles Candy-Like Nonprescription Drugs

In the 1990s, the Food and Drug Administration (FDA) approved oral transmucosal lozenge formulations of the strong opioid drug fentanyl (also known as fentanyl “lollipops”),[1] stirring a backlash because of the formulation’s increased potential for abuse.[2]

Since then, drug formulations that look or taste like candy — such as flavored chewable gels (also called gummies), lozenges or tablets — have become a common delivery system for dietary supplements (including multivitamins, probiotics and melatonin [MIDNITE and others]) and many nonprescription (over-the-counter) drugs. For example, there are candy-like formulations of certain antacids (such as calcium carbonate [TUMS and others]), fever and pain medicines (such as acetaminophen [CHILDREN’S TYLENOL and others]) and laxatives (such as magnesium hydroxide [DULCOLAX and others]).

The advantages of candy-like drugs are that they are appealing and easy to swallow, especially for children. However, these formulations have been implicated in an increased risk of accidental overdose and poisoning in children, who may confuse them with candy. For instance, a recent study by Centers for Disease Control and Prevention (CDC) researchers demonstrated that from 2019 to 2022, more than one-half of U.S. emergency department visits due to unsupervised melatonin ingestions among infants and young children involved gummies or chewable formulations of this supplement.[3]

In October 2023, the FDA convened its first public workshop of experts to discuss the use of solid, oral, candy-like nonprescription drug products and supplements.[4] These experts included physicians, pharmacists and pediatric nurses as well as chemists and poison control scientists, researchers and others.

Important takeaways from the FDA workshop[5]

Neither the CDC nor the FDA has a formal definition of candy-like drugs. Although the experts at the FDA workshop did not come up with a formal definition, they generally agreed that any drug that has the coating, feel, look, shape, smell, texture or packaging of an existing candy can be considered a candy-like drug.

An important concern about candy-like drugs is that, unlike tablets and capsules, these products may have unstable amounts of certain ingredients due to changes in their properties during their shelf life. For example, pantothenic acid (commonly known as vitamin B5) completely degrades in chewable gel multivitamins. Therefore, the United States Pharmacopeia (USP) recommends against delivering this vitamin in chewable gels. Another unstable ingredient is folic acid, which is a very important ingredient in dietary supplements. Although manufacturers may increase the extra (overage) amounts of folic acid in chewable gels to compensate for any decline in the level of this nutrient during the lifespan of the candy-like product, the USP cautions that these amounts should not exceed the tolerable upper intake level of folic acid. Another concern for gel-containing drugs is that their coating may impair the release of certain nutrients, such as vitamin A.

A general shortcoming of candy-like supplements is that their nutrient overage amounts, if any, are not reported on their labeling, which can mislead consumers about the actual amount of each nutrient they may consume. This is a particular problem for products that contain calcium, iron and certain fat-soluble vitamins (mainly vitamins A, D and K) because they can accumulate in the body, potentially reaching unsafe levels in the blood.

Another concern is that candy-like products tend to contain significant amounts of sugar. On average, a gummy drug contains 1-3.5 grams of sugar. Because the dose of these products usually is more than one gummy and they are taken daily, as in the case of multivitamins, the added sugar can add up to about 10% of the recommended daily sugar allowance, increasing the risk of dental caries or cavities, among other problems.

At the workshop, some experts challenged the FDA for permitting the proliferation of candy-like nonprescription drugs because, in their view, the danger to children outweighs the benefits. In lieu of these drugs, the experts called for the development of solid dosage forms of oral drugs that children can swallow easily, such as mini-tablets or mini-capsules. Others suggested improving the taste and texture of oral drugs as well as training children to swallow conventional tablets and capsules. Studies show that even four-year-old children can be trained effectively to swallow tablets of varying sizes up to 10 millimeters.

Realizing that “the horse has already left the barn” for the rise of candy-like drugs in the U.S. market, participants suggested ways to reduce the risks of candy-like drugs among children. For instance, a CDC poison control expert emphasized the importance of using child-resistant containers and not removing medications from these containers as a means to prevent accidental ingestion of medications. Other experts highlighted the need for requiring flow restrictors (devices that decrease the flow of medications) or single-dose packaging for certain drugs to limit the quantity of medications that children could access on their own. Recommendations for minimizing the appeal of candy-like drugs to children included not providing them in ring, animal and similar shapes and not displaying cartoon or iconic characters on their packaging.

At the workshop, the FDA did not discuss future steps regarding regulations of candy-like drugs, leaving the onus on consumers to protect children from the risks of these products.

What You Can Do

To protect children from the risk of drug overdosing or poisoning, always keep all drugs, including candy-like ones, in their original containers and store them in a safe place that is out of a child’s reach and sight.[6] Ask family members and visitors to do the same around children.

Do not tell young children that drugs are “candy,” even if they do not like to take their medications. Teach children to always ask first before eating or drinking anything and that no one should ever consume another person’s medication.

Call 911 immediately if your child (or another person) has collapsed or is unconscious after ingesting extra amounts of any medication or any potentially poisonous substance. It also is important to show the container to emergency responders and try to estimate the amount of the drug or substance consumed before they arrive, if possible.

If a child has no specific symptoms after a suspected overdose or poisoning, call the Poison Control helpline at 800-222-1222. The helpline staff can help you determine whether the situation is serious and tell you what more should be done.

Report all serious adverse events related to all drug types to MedWatch, the FDA’s drug-safety reporting program, by visiting http://www.fda.gov/MedWatch or by calling 800-FDA-1088.
 

References

[1] Stanley TH. The fentanyl story. J Pain. 2014;15(12):1215-1226.

[2] Public Citizen. Letter to the FDA regarding fentanyl (ORALET) narcotic lollipop. January 25, 1994. https://www.citizen.org/wp-content/uploads/1319.pdf. Accessed April 3, 2024.

[3] Freeman DI, Lind JN, Weidle NJ, et al. Notes from the field: Emergency department visits for unsupervised pediatric melatonin ingestion — United States, 2019-2022. MMWR Morb Mortal Wkly Rep. 2024;73(9):215-217.

[4] Food and Drug Administration. Defining 'candy-like' nonprescription drug products. Agenda. October 30, 2023. https://www.fda.gov/media/172272/download?attachment. Accessed April 3, 2024.

[5] Food and Drug Administration. Defining 'candy-like' nonprescription drug products. Workshop transcript. October 30, 2023. https://www.fda.gov/media/174469/download?attachment. Accessed April 3, 2024.

[6] Centers for Disease Control and Prevention. Adverse drug events in children. Updated February 23, 2023. https://www.cdc.gov/medicationsafety/parents_childrenadversedrugevents.html. Accessed April 3, 2024.