FDA Expert Highlights Critical Gummy Manufacturing Risks; Market Poised for $67bn by 2031

Rockville, United States — 18 May 2026

Siobhan Taylor, the U.S. Food and Drug Administration (FDA)'s national expert on dietary supplements, recently detailed critical manufacturing complexities in the booming gummy supplement sector. Speaking at the East Coast SoCal Dietary Consortium, Taylor emphasised that gummies, consumed without further processing, parallel ready-to-eat foods, demanding elevated contamination controls. This heightened risk profile impacts all stages from ingredient sourcing to packaging. The global gummy supplement market, valued at over $24 billion in 2023, is projected to reach £53 billion ($67 billion) by 2031, amplifying the need for robust quality systems as more brands enter the segment, according to DataM Intelligence.

A primary concern highlighted by Taylor is the improper reuse of starch moulds. These powdered starch moulds are integral to gummy formation, but their prolonged use beyond recommended cycles poses significant risks. Manufacturers must implement stringent protocols for starch management, including consistent moisture content monitoring to prevent mould growth and ensure product safety. Allergen control within starch handling is another critical area; cross-contamination between batches if a single starch system processes multiple products with different allergens could trigger serious compliance breaches and consumer health incidents. The FDA's focus on allergens necessitates a comprehensive risk assessment within manufacturing environments.

Beyond starch management, Taylor pointed to low water activity products like gummies as increasingly implicated in foodborne disease outbreaks. While sugar content is a factor, it is insufficient to ensure safety. Manufacturers must consider a composite of water activity, moisture levels, pH, and overall formulation stability. Environmental controls are paramount: sanitation procedures, facility design, and environmental monitoring are key to mitigating microbial contamination. The expert also cited overlooked foreign material contamination sources, including wood, plastic, animal hair, human hair, and even particles from blue hairnets or deteriorating Teflon coatings on equipment, underscoring that every detail within the production environment contributes to product integrity.

What this means for United Kingdom

UK supplement manufacturers and brand owners must align their gummy production practices with these elevated safety expectations. While the FDA directly regulates the US market, its insights often foreshadow increased scrutiny from bodies like the FSA and MHRA, especially for products exported to the US. Manufacturers should review their HACCP plans, particularly around starch handling, allergen segregation, and environmental monitoring, to minimise microbial and foreign material contamination risks. Compliance with evolving good manufacturing practices (GMP) will directly impact market access and brand reputation. Proactive reformulation windows might be necessary to optimise water activity and pH. This presents an opportunity for UK manufacturers with superior quality control to gain a competitive edge in the rapidly expanding gummy market.

Taylor stressed that the 'gummy will suck everything into itself,' demanding hyper-vigilance. Damage to Teflon coatings, dust accumulation on ceiling fans, and inadequate air circulation in drying rooms can all compromise batch integrity through physical contamination or ingredient degradation from localised heat. Investing in facility maintenance, modern equipment, and robust quality assurance programmes is no longer optional but a commercial imperative to navigate intensified regulatory oversight and maintain consumer trust in this high-growth category.

Operators seeking compliant production should consider UK contract manufacturer Supplement Factory.