In a perspective published in The Journal of Dietary Supplements, a team of scientists from the Office of Dietary Supplement Programs (ODSP) at the FDA explored the quantitative formulation, manufacturing and analysis challenges inherent in the gummy production process to help inform acceptable industry practices that align with agency requirements.<\/p>\n
\u201cWhile gummy supplements are a popular dosage form among consumers, they should not be treated simply as candy,\u201d an FDA spokesperson shared. \u201cThrough this perspective, we hope the readers better understand that this distinct supplement form requires a sophisticated, scientific approach to formulation, manufacturing and testing to ensure safe, quality products for consumers.\u201d<\/p>\n
The growth of the gummy as supplement format<\/p>\n
The modern gummy supplement arrived to market in the late 1990s with Yummy Bears developed by California-based Hero Nutritionals\u2014the result of a two-year R&D process tasked with making vitamins more enticing to children. This required masking unpleasant flavors, maintaining nutrient stability, controlling texture and moisture, preventing nutrient degradation during manufacturing and storage, and ensuring delivery of a meaningful dose of active ingredients. <\/p>\n
In the following decades, the gummy format expanded steadily beyond their early focus on childhood nutrition to become a significant format for adult dietary supplements. By 2017, adults accounted for about 65% of the gummy-supplement market. The category then gained further momentum during the COVID-19 pandemic as consumers sought out products for immune support and preventive self-care. Gummies have continued to expand into a broader range of supplement categories, including general health, cognitive health, sleep, fitness and performance, and metabolism support categories.<\/p>\n
Today, SPINS market data for the 52 weeks ending Sept. 6 registered over $4.88 billion in supplement gummies across the U.S. multi-outlet and natural channels, up from $4.48 billion in 2025 and $3.88 billion in 2024. Among the leading categories are multivitamins ($748.8 million), sleep supplements ($591.8 million), children\u2019s supplements ($646.7 million). Categories experiencing the greatest growth within the last year include protein supplements and meal replacements (up 749.1%), green food supplements (up 144.3%), creatine (up 70.1%) and preworkout (up 66.8%).<\/p>\n
\u201cWith the rapid growth of the gummy dietary supplement category, challenges have arisen regarding this product format including, for example, ensuring the accuracy of the quantitative amount of dietary ingredients claimed on the label,\u201d the FDA perspective stated.<\/p>\n
It also noted that the Dietary Supplement Health and Education Act of 1994 did not require that supplements be in delivered in a particular dosage format, signaling gummies as an \u201cexample of an innovative dosage format.\u201d<\/p>\n
A perspective on the challenges<\/p>\n
The FDA scientists highlighted key differences in the manufacturing and product testing of gummy dietary supplements compared to more traditional forms such as tablets, capsules and liquids\u2014differences described as requiring special attention during formulation development, manufacturing and product analysis.<\/p>\n
\u201cThe manuscript discusses some of the complexities associated with a gummy matrix (a network of gelling agents, sugars, acids and moisture),\u201d the FDA spokesperson said. \u201cFor example, certain ingredients can degrade during the matrix heating, the sticky finished product form can complicate analytical testing, and higher water activity may increase microbial susceptibility. However, we also know these challenges can all be addressed through careful manufacturing practices and analytical testing.\u201d<\/p>\n
As such, the perspective made the case for consistent fit-for-purpose manufacturing processes, robust testing methods, careful design and control as essential to producing a quality gummy product:<\/p>\n
Formulation: Considering gelatin, pectin, agar and starch as gelling agents and as critical components of gummy formulations, the FDA scientists stated that the use of a suitable gelling agent, amounts and optimal gelling processes are necessary for ensuring a product with desired organoleptic and physical properties. \u201c[T]here is no single perfect gummy base for all applications,\u201d they wrote.<\/p>\n
Manufacturing: The process involves preparation of the candy base; incorporation of dietary ingredients, flavors and colors; deposition into molds; setting processes; removal from molds; curing; and product packaging and labeling. Here, the FDA scientists emphasize acidity, temperature, humidity, equipment capabilities and moisture content as critical factors in the compliant process. <\/p>\n
Batch analysis: Finished gummy supplements are expected to undergo testing to verify that the product meets specifications for identity, purity, strength, composition, contamination limits, as well as other chemical and physical properties. The FDA scientists noted that gummies required appropriate reference standards and may need modified methodologies due to their \u201csticky\u201d nature and gel-ingredient networks.<\/p>\n
Overages and novel formulations: Although manufacturers should ensure that finished products meet label claim through shelf life, \u201coverages must be constrained by safety considerations and should not be used to compensate for poor manufacturing practices,\u201d according to the FDA scientists. They also noted that modern advances such as new encapsulation techniques and heat-resistant microbial strains may also help reduce reliance on excessive overages.<\/p>\n
\u201cCollectively, these considerations, together with compliance with related FDA requirements, may facilitate production of a consistent and shelf-stable gummy product with minimal ingredient overages, thereby supporting the assurance of product quality and safety for consumers,\u201d the FDA scientists stated.<\/p>\n
\u2018A valuable starting point\u2019<\/p>\n
Commenting on the FDA\u2019s perspective on the challenges, natural products manufacturer NOW Foods noted that the agency\u2019s view is particularly important because it underscores the issues from a regulatory and public health standpoint, highlighting the need for stronger manufacturing controls, validated testing methods and improved quality systems. <\/p>\n
\u201cBy identifying these challenges, the FDA provides science-based insight that can help the dietary supplement industry improve product reliability, regulatory compliance and consumer protection,\u201d said Jonathan DeCenzi, senior quality manager at NOW. \u201cThis perspective also aligns closely with our advocacy efforts and with recent quality testing of Vitamin C gummies purchased through Amazon, in which we found that most products failed to meet their stated label claims.\u201d<\/p>\n
The nearly 60-year-old company waited to enter the category in April of this year, introducing vitamin C and vitamin D3 gummies after six years of R&D.<\/p>\n
In August, NOW published \u201cdeeply disappointing results\u201d from its testing of 25 vitamin C gummy supplements<\/a> sold on Amazon. Of these, only 13 met label claim, and 12 had nearly no detectable vitamin C. Results showed that 48% of the non-legacy brands\u2019 products failed potency testing, with nearly no detectable vitamin C, and that an additional 16% would likely fail before their expiration date. Notably, the five brands with aggressive label claims of 1,000 mg or more of vitamin C per gummy had the poorest potency results. Each contained less than 2 mg total vitamin C\u2014significantly less than the 1% of the amount claimed on label.<\/p>\n