Issue link: https://www.e-digitaleditions.com/i/1101841
Tablets & Capsules April 2019 32C daily value of 50 grams. This change is particularly important for dietary supplements that have a serving size larger than a single tablet or capsule. The third major change is to the units of measure for vitamins A, D, and E. The agency updated the daily values and eliminated the use of international units (IUs). The conversion from IUs to micrograms or milli- grams represents a challenge, because many supplier and raw material specifications are still based on IUs. Without knowing the actual amount added as the dietary ingredient, converting from IUs to micrograms or milligrams is difficult. Vitamins A and C are no longer mandatory, so the mandatory nutrients in the vitamin and mineral category are now vitamin D, calcium, iron, and potassium. The dec- laration of folate has been changed so that the regulation now includes a defined potency for folic acid. Therefore, if folic acid is added as the source of folate, the amount of folic acid and folate must be declared. The percent daily value for folate is based on the calculated folate amount. One change that does not influence the declaration in the supplement facts panel is the requirement to keep records for added sugar, dietary fiber, vitamin E, and folate. Manufacturers must keep records in cases that use a mixture of both naturally occurring and added or syn- thetic ingredients but aren't required to keep records in cases that use only naturally occurring or only added or synthetic ingredients. Updates The updates to nutrition labeling requirements for dietary supplements mostly affect the new daily values for nutrients. Almost all daily values have changed, and there are now four codified subpopulations: the general population (persons 4 years and older), infants, toddlers, and pregnant and lactating women. While calculating the new daily value percentages for declaration involves a lot of workforce time and money, other changes to the nutri- tion labeling requirements present different challenges. The first major change is the new definition of dietary fiber. The FDA defined dietary fiber as certain naturally occurring fibers that are "intrinsic and intact" in plants and added isolated or synthetic non-digestible soluble and insoluble carbohydrates that the agency has determined have beneficial physiological effects on human health. For the past two years, industry has been held in suspense as the FDA reviewed numerous studies to confirm beneficial physiological effects of isolated or synthetic non-digest- ible carbohydrates. A recent guidance for industry finally acknowledged inulin, one of the predominantly used fibers, as a dietary fiber. The initial list of seven isolated fibers in the final rules has now increased to 15 acknowl- edged dietary fibers, including the large groups of mixed plant cell-wall fibers, inulin, and inulin-type fructans. The second major change is the requirement for decla- ration of added sugars and the establishment of a new Customized Fill Release in Gelatine Soft Capsules Revolutionary Release Fast release and reduced cross-linking Reliable Release Reduced cross-linking Standard Release Improved shelf-life and stability Release profile Enteric Release One-step-production of truly enteric capsules GELITA USA · Sioux City, IA · www.gelita.com · service.na@gelita.com