Labeling requirements manufacturing guidelines

FDA reviewed the scientific evidence and recommendations of various scientific bodies, including the Institute of Medicine, National Academies of Science, an expert panel for the National Cholesterol Education Program, and the Advisory Committee on the Dietary Guidelines for Americans 2000. On July 9, 2003, the FDA issued a regulation requiring manufacturers to list trans fatty acids on the Nutrition Facts panel of the labels of foods and some dietary supplements. The new requirement will mean that manufacturers of most conventional foods and some dietary supplements will have to list in the Nutrition Facts panel the trans fat content of the product, in addition to the information about its overall fat content and saturated fat content. Dietary supplement manufacturers will need to list trans fat, as well as saturated fat and cholesterol, on the Supplement Facts panel when their products contain more than trace amounts (0.5 g) of trans fat. Examples of dietary supplements that may contain trans fat are energy and nutrition bars. 

The basic structure of the ICH GMP guideline for API production is shown in Table 15. It consists of 19 chapters, which cover the requirements for quahty management, personnel, premises, equipment, documentation, materials, production and process controls, packaging and labeling, storage and distribution, laboratory controls, validation, change control, complaints, recalls, contract services, cooperators, APIs manufactured by cell culture/fermentation, and APIs used in clinical trials [52]. 

Some of the information required may be in the form of bar codes. This has stimulated the European Pressure Sensitive Manufacturers Association (EPMSA) in line with the Article Numbering Association (ANA) EAN guidelines, to produce a standard for bar code overprinting on pressure sensitive labels. EAN bar codes can now be successfully printed onto labels using flexographies, or thermal transfer printing. 

The information required for a notification is the chemical identity, amount manufactured or imported, use, physico-chemical properties, ecotoxicity studies, available mutagenicity studies and animal toxicity, indir t long-term effects on humans and recommendations for disposal and labelling. The data requirements for the notification of new substances are based on the OECD MPD and arc very similar to those in the EC. The minimum information required is listed in Table 34.1. There are no official reduced data requirements for notification of substances to be supplied only in low amounts, although FOEFL will negotiate on a case-by-case basis for certain of the standard tests to be omitted, especially if the substance is to be used in special applications or has special disposal methods which minimise environmental contamination. Studies are to be conducted in compliance with GLP to OECD guidelines or their equivalent. 

Following the joint advisory committee meeting on LABAs, the FDA issued LABA use guidelines (see Section 16.5) and requested LABA manufacturers to include additional statements in the product labels. For pediatric and adolescent patients who require LABA in addition to inhaled corticosteroid, the use guidelines state that these patients should use a combination product containing both an inhaled corticosteroid and a LABA to ensure adherence with both medications. 

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