Processing aids used during manufacturing dietary supplements can help improve product quality, enhance appearance and shelf life, aid with packing and transportation, and much more. 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 soft gels, gummies, powders, capsules and tablets.
The 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 improving product quality, consistency and manufacturability, enhancing a product’s appearance and shelf life, and 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 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.
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 some cases, it often helps explain the exact functionality and/or 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 forgotten anytime soon; however, continuous improvements in processing practices and equipment may make some of them obsolete. Processing aids are important to the production of quality dietary supplement products. They perform valuable functions making them imperative in many applications. A product compliance database like HawkScanner can be detrimental while processing aids in making sure what’s being produced is FDA compliant. Sign up for a free account today and stay be alerted with any changes in your products.