In 2015 and 2016, USP launched a series of “roundtable” events designed to engage industry in discussion of issues that present particular scientific challenges. The roundtables are a precursor to the standards setting process and are intended to help inform USP’s work so that we can better address our customers’ unmet needs. Topics have included probiotics, medical cannabis and, most recently, gummy dietary supplements.
Like probiotics, the popularity and availability of gummy dietary supplements in the marketplace continues to grow. According to recent reports, gummy dietary supplements now account for 9.8% of all dietary supplements (ranking third behind pills and softgels) and sales are forecasted to grow from $625 million to $1 billion by 2017. Their soft texture and flavorings make them an appealing choice for consumers, especially those who have difficulty swallowing pills or digesting other supplement forms, such as children or older adults. However, given their unique manufacturing process, gummy dietary supplements can present some particular challenges in terms of quality.
In its continuous effort to benefit public health by supporting quality in the marketplace, USP’s roundtable discussion gathered industry leaders to get their input on developing quality standards for gummy dietary supplements. About 40 stakeholders representing major gummy manufacturers, ingredient manufacturers, contract laboratories, and trade associations were invited to participate in the event held March 3, 2016 in Rockville, MD.
Discussion of Technical and Quality Challenges and Considerations
Participants shared their views on technical and quality challenges in manufacturing as well as scientific and public health considerations related to the future development of USP quality standards for gummy dietary supplements. Key discussion topics included:
• Raw Materials and Manufacturing: Participants provided insight into the challenges they face related to sourcing compendial-grade raw materials and harmonization of raw material qualities among gummy ingredient suppliers. Concerns were raised that too stringent quality specifications may inhibit product innovation. Some noted that at the beginning that USP may need to develop standards for the most common type of gummy in the US market—starch molded gummies with gelatin. In addition, challenges in variations in weight and ingredient overages in the manufacturing process were also discussed.
• Quality Parameters in Product Specification: To help USP determine suitable quality parameters (i.e., analytical methods and acceptance criteria for identification, strength, performance, specific tests, and limits for contaminants) to consider for future monograph development, participants shared the quality parameters and acceptance criteria currently practiced in industry. These include weight variation, appearance, organoleptic test, water activity, titratable acidity, moisture, loss on drying, Brix, and/or pH, and microbial testing. The discussion also addressed the applicability of dissolution and disintegration performance testing to gummy dietary supplements and current expiration dating practices.
• Testing Procedures: Dietary supplement cGMP mandates that manufacturers use scientifically-valid methods for process and quality control in the manufacturing process. USP encouraged manufacturers to share their testing methods to help inform future USP standards development activity relating to gummy dietary supplements. Participants shared various techniques for extracting ingredients for sample preparation (e.g., freezing, melting, grinding and slicing) and a variety of analytical methods for testing ingredient strength, including , high-performance liquid chromatography (HPLC), ultra-high performance liquid, inductively coupled plasma-optical emission spectroscopy (OES), and mass spectrometry (MS). In addition, USP provided an update on the development of testing procedures that it has conducted for gummy dietary supplements with oil soluble vitamins, water soluble vitamins, and minerals.
• Shipping, Handling and Labeling: Participants shared industry-wide challenges related to shipping at the manufacturer level as well as storing and handling at the retail level. These challenges may affect the quality, integrity and the shelf life of gummy dietary supplements and may impact subsequent standardization of such products.
They also provided their opinion regarding the labeling of gummy dietary supplement products. This included industry feedback as well as an update from USP on proposing alternative compendial nomenclature to use in lieu of “gummy,” a term that FDA has noted may pose a safety concern as it can be confused with candy and food connotations in pharmaceuticals. USP noted that they may form a working group to discuss the issue and determine the best solution.
Learn More and Get Involved in the Development of USP Standards for Gummy Dietary Supplements
A full summary of this roundtable discussion with additional details and outcomes can be found in “USP Collaborates with Industry to Develop Quality Standards of Gummy Supplements” from the March 2016 USP Dietary Supplements E-Newsletter. Building on knowledge gained from the roundtable, USP continues to ask for industry input regarding gummy dietary supplements. Priority needs include information on the following:
• Ingredient overages,
• Piece weight variation, and
• Validated testing procedures.
If you are interested in contributing to this effort, please contact Seong Jae Yoo, Ph.D., USP Scientific Liaison, Dietary Supplements and Herbal Medicines, at firstname.lastname@example.org. To stay informed of USP dietary supplement news and activities, subscribe to the quarterly newsletter.