Chemical Solvent Residue: USP Chapter <467> Residual Solvents. The solvents are classified as class 1 (solvents that known to cause unacceptable toxicities, should be avoided in the production), class 2 (solvents associated with less severe toxicity should be limited), class 3 (less toxic, should be used where practical).

CoA: Certificate of Analysis. The formal report of the testing results of the product. The CoA should contain product name, Brand, lot/batch number, Brand/expiry/retest date, test, specifications for each test and the actual test results. A signature of the Quality Unit certifies the validity of the certificate. CoA typically includes tests for identity, impurities and potency.

Dietary Supplement cGMP: The requirements include provisions related to: the design and construction of physical plants, cleaning, proper manufacturing operations, quality control procedures, testing final product or incoming materials and in-process materials, handling consumer complaints, and maintaining records.

Economic adulteration: Product is adulterated if it omits a valuable constituent or substitutes another substance, in whole or in part, for a valuable constituent (for instance, tea tree oil diluted with olive oil, or pomegranate spiked with Ellagic acid).

FDA: US Food and Drug Administration. The FDA published the final rules for current Good Manufacturing Practices (cGMP) of Dietary Supplements in May 2007 are published in Title 21 of the Code of Federal Regulations, Part 111 (21 CFR 111). The FDA has the authority to audit the dietary supplement companies and take actions against any unsafe dietary supplement products.

Food cGMP: Current food Good Manufacturing Practices (GMP) are published in Title 21 of the Code of Federal Regulations, Part 110 (21 CFR 110). GMPs describe the methods, equipment, facilities, and controls for producing processed food (buildings and facilities, equipment, production and process control, defect action level).

Heavy Metals: typically includes Lead, Arsenic, Cadmium, and Mercury.

Herbicides/pesticides: Herbicides and pesticides apply to any substances or mixture of substances intended to prevent, destroy, or control any unwanted species of plants or animals causing harm during or otherwise interfering with the production, processing, storage, transport, or marketing of pure articles. The designation includes growth regulators, defoliants, or desiccants, and any substances applied to crops before or after harvest to protect the product from deterioration.

Identity testing: test the authenticity of the ingredients. USP provides monograph chapters for some ingredients which include appropriate identity testing methods. Other identity methods are developed by Brands and these methods must be verified.

In House or qualified quality control lab: According to cGMP, a qualified lab is located in the finished product owner’s facility, and/or finished product manufacturing facility, and/or independent testing laboratory who is in cGMP compliance and provides testing service for Brands.

Microbiological: Major sources of microbial contamination are associated with human or animal feces used as plant manure, contaminated irrigation water and/or process water, and poor worker hygiene and sanitation practices during harvesting, sorting, processing, packaging, and transportation. Good Manufacturing Practices (GMPs) are employed and adequate microbiological specifications are established for non-sterile dietary supplements.

NPA: Natural Products Association. NPA was the first organization to offer a third-party GMP certification program specific to the manufacturing of dietary supplements and dietary ingredients. The NPA GMP Standard includes all of the current FDA GMP requirements and certain requirements from the NPA GMP standard.

NSF: NSF International, The Public Health and Safety Company™, is a not-for-profit, non-governmental organization. The NSF Good Manufacturing Practices (GMP) Registration for Brands of dietary supplement enables the company become certified as complying with current FDA GMP requirements.

Pharmaceutical cGMP: FDA cGMP regulations on prescription and OTC drug manufacturing processes.

TGA: Australian Government, Department of Health and Ageing, Therapeutic Goods Administration. TGA regulates: Medical devices, Complementary medicines, OTC medicines, Prescription medicines, Blood & tissues, IVDs & other therapeutic goods. The TGA carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard.

USP: United States Pharmacopeia, an official public standards–setting authority. USP sets standards for food ingredients and dietary supplements and also conducts voluntary verification programs for Brand of dietary ingredients and dietary supplements. The onsite audit by USP ascertains information about the participating company’s quality systems and critical manufacturing information.