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November 24, 2020
Processing aids are used in a variety of products, including softgels, gummies, powders, capsules and tablets.
Examples include antimicrobials, nitrogen gas, anti-foaming agents, pH regulators, anti-caking agents and more.
Process aids don’t have to be listed on the supplement label, even though trace amounts may remain in the product.
Processing aids are substances or additives of natural or synthetic origin used in the production of dietary supplement dosage forms. They are commonly used in a wide variety of products, dosage forms and applications, including softgels, gummies, powders, capsules and tablets.
FDA or USDA must approve processing aids prior to commercial use. They are considered extremely safe and used in small volumes; they do not materially alter the finished product.
The primary purpose of processing aids in dietary supplements is to facilitate the manufacturing of products, which includes but is not limited to:
a. Improving product quality, consistency and manufacturability
b. Enhancing a product’s appearance and shelf life
c. Aiding with packing and transportation
Processing aids used in dietary supplements can include:
Food contact lubricants (e.g., medium chain triglycerides [MCTs], polyethylene glycol [PEG], mineral oil) used on equipment in softgel or tablet manufacturing
Antimicrobials used in the final wash botanicals safety
Nitrogen gas used to reduce product oxidation both in process and finished products
Anti-foaming agents used to reduce foam in gummies and beverage manufacturing
pH regulators and anti-caking agents used in wide variety of dosage forms
In the U.S., processing aids are required to be GRAS (generally recognized as safe). This means the overwhelming evidence considered by industry, academia and independent experts agrees the processing aid is safe for consumers. Use level must be at the level required to obtain effect needed, though some chemicals may have specified max allowable levels. Trace levels of processing aids may be present in the final product.
Canada does not have a regulatory definition of a food-processing aid; however, food additives require pre-clearance by the Canadian minister of health.
In line with FDA’s requirements, process aids are not required to be listed on the supplement label, even though some trace amounts of the material may remain in the product. Most brands follow that guidance. In certain cases, and in some jurisdictions, process aids are being labeled due to either requirements or transparency initiatives. In these cases, it often helps explain the exact functionality/reason for use of process aids in a specific application with easy-to-understand consumer language.
Processing aids offer numerous advantages to product manufacturers, so they are not likely to be eliminated anytime soon; however, continuous improvements in processing methods and equipment may make some of them obsolete. Improvements in the formulation and application of processing aids also might make them more effective for their intended use. Finally, companies may opt to select more ethical processing aids or include them in their ingredient list.
Processing aids are important to the production of quality dietary supplement products. They perform valuable functions making them indispensable in many applications.
Edward Shneyvas is senior vice president of research and development (R&D), innovation and business development at Best Formulations, a full-scale contract manufacturer of nutraceuticals and dietary supplements including softgels, capsules, tablets, powders and teas.
Senior Vice President of R&D, Innovation, and Business Development, Best Formulations
Edward Shneyvas is Senior Vice President of R&D, Innovation, and Business Development at Best Formulations, a full scale contract manufacturer of nutraceuticals and dietary supplements including softgels, capsules, tablets, powders, and teas.
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