Siobhan Taylor, national expert on dietary supplements at the U.S. Food and Drug Administration, spoke about these difficulties last week at the East Coast SoCal Dietary Consortium event held in Rockville, MD.
“You have to think about every step along the way,” she said. “What you list on the label is what [the FDA] is going to hold you to, because that’s what you’re promising the consumer.”
Preference among consumers for supplements in a gummy format has increased in recent years. According to DataM Intelligence, the gummy supplements market was valued at over $24 billion in 2023 and is projected to reach nearly $67 billion by 2031.
As more companies offer gummies, the probability of contamination cases may also increase. Taylor likened gummies to ready-to-eat salad mixes.
“People are not going to cook [a gummy], heat it, process it, or do any other kill steps,” she said. “They’re just going to eat it right out of the bottle. So thinking about contaminants, is anything in my environment possibly going to be a risk?”
Old starch
One concern the FDA has with gummy production is the extended use of starch. Powdered starch serves as a mold, but some gummy production facilities may be using these molds longer than recommended.
Additionally, companies need to be aware of the allowable moisture content to prevent mold growth in the starch and checking this consistently. This may require a moisture test on the starch before manufacturing even begins.
Monitoring for allergen contamination is also a factor companies must consider, Taylor added.
“If you handle allergen ingredients, how are you ensuring in that starch that there’s not cross contamination from allergens, from one product to the next?” she said. “Allergens is a huge deal for the FDA… Your starch is going to touch multiple things. Your molds are going to touch multiple batches. You have to care about the allergens.”
Sugar and contamination
According to Taylor, low water activity foods and food ingredients, like gummies, chocolate and marshmallows, have been increasingly implicated in outbreaks of foodborne diseases. These include foods high in sugar.
Gummy manufacturers can control a product’s sugar content, but that is not the only factor that must be monitored.
“That’s not everything that you have to think about,” Taylor said. “You really have to go back to water activity, moisture, pH, formulation. All of that tells a cohesive story together. It’s not just one thing. How are you maintaining your production environment to reduce the risk of microbial contamination? What does your sanitation look like? Have you determined if you need environmental monitoring?”
Other forms of contamination
Gummy supplement manufacturers also need to consider a wide variety of other sources of contamination in the production process, including wood, plastic, animal rodent hair, human hair, fiberglass falling from ceilings and even particles from the blue hairnets worn by employees.
For example, damage to Teflon, such as scratches, can affect gummy batches. Sometimes that damage occurs not in the production process but when the molds are not in use. Often they are not stored appropriately.
Facilities also have ceiling fans.
”Do they have dust and debris gathering on them? How often are you cleaning them?" Taylor said. “How much from the fan is going to suck into the gummy itself? How do you keep the airflow in your drying curing rooms from doing the same thing?”
Through her presentation, she stressed the importance of remembering that the gummy is going to suck everything into itself and that being hyper vigilant in manufacturing means no detail goes unnoticed.
