Food fortification is likely to have played an important role in the current nutritional health and well-being of populations in industrialized countries. Starting in the early part of the 20th century, fortification was used to target specific health conditions: goitre with iodized salt; rickets with vitamin D-fortified milk; beriberi, pellagra and anaemia with B-vitamins and Fe-enriched cereals; more recently, in the USA, risk of pregnancy affected by neural-tube defects with folic acid-fortified cereals. A relative lack of appropriate centrally-processed food vehicles, less-developed commercial markets and relatively low consumer awareness and demand, means it has taken about another 50 years for fortification to be seen as a viable option for the less-developed countries. The present paper reviews selected fortification initiatives in developing countries to identify different factors that contributed to their successful implementation, as well as the challenges that continually threaten the future of the se programmes. Ultimately, the long-term sustainability of fortification programmes is ensured when consumers are willing and able to bear the additional cost of fortified foods. There has been an enormous increase in fortification programmes over the last couple of decades in developing countries. Considerable progress has been made in reducing vitamin A and I deficiencies, although less so with Fe, even as Zn and folic acid deficiencies are emerging as important public health problems. Food fortification based on sound principles and supported by clear policies and regulations can play an increasingly large role in this progress towards prevention and control of micronutrient malnutrition.

Many children in developing countries survive on a nutritionally inadequate diet. Dietary inadequacies during the complementary feeding period can be prevented by using complementary food supplements (CFSs) such as water dispersible or crushable micronutrient tablets, micronutrient sprinkles added to food just before feeding, or fortified spreads added to food just before feeding or fed as a snacks. A meeting was convened to discuss technical and operational issues related to the development of these new approaches and to identify knowledge gaps. The technical issues covered: what micronutrients to include, tolerable upper intake limits, bioavailability, micronutrient and macronutrient stability, package systems and amounts, encapsulation technologies, methods to limit or eliminate allergens, bacterial and chemical contamination, interactions between CFSs and complementary foods, and flavoring agents. Operational issues included: identifying the market positioning of CFSs, cost positioning of CFSs, regulatory requirements, CFS production and technology transfer, quality assurance, and public-private sector partnership and coordination. Intervention trials are needed to determine the efficacy of CFSs in preventing micronutrient deficiencies. Other important knowledge gaps relate to technical and operational issues. Sprinkles and tablets are produced using well-known technologies, but further research is needed to modify them for use as CFSs. Spread development is not as advanced as sprinkle and tablet development, and further research is needed to improve the technology. Although none of the products is ready for widespread use, enough information is available to set research priorities and accelerate product development and implementation.

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The use of flour fortified with 66 mg/kg of electrolytic or reduced iron to reduce the prevalence of anemia was determined in a two-year, double-blind, controlled trial. The trial was conducted in Sri Lanka among preschoolers between 9 and 71 months old, primary schoolers 6 to 11 years old, and nonpregnant women. At baseline, 18.4% of the preschoolers had low hemoglobin (Hb) concentrations. Neither electrolytic nor reduced iron had an effect on Hb concentration among preschoolers. Only 7% of the primary schoolers were anemic at the start of the trial and, again, fortification had no effect on Hb concentration. Twenty-nine percent of women had a low Hb at outset and there was no evidence that fortification had an effect on Hb in this group. The findings from this study suggest that fortification of flour with electrolytic iron or reduced iron was not beneficial in reducing anemia in this population. This was probably due to the low prevalence of anemia and low bioavailability of the fortificant iron. Fortification with either iron fortificant was acceptable.

At the Product Quality Research Institute (PQRI) Workshop held last January 14-15, 2014, participants from academia, industry, and governmental agencies involved in the development and regulation of nanomedicines discussed the current state of characterization, formulation development, manufacturing, and nonclinical safety evaluation of nanomaterial-containing drug products for human use. The workshop discussions identified areas where additional understanding of material attributes, absorption, biodistribution, cellular and tissue uptake, and disposition of nanosized particles would continue to inform their safe use in drug products. Analytical techniques and methods used for in vitro characterization and stability testing of formulations containing nanomaterials were discussed, along with their advantages and limitations. Areas where additional regulatory guidance and material characterization standards would help in the development and approval of nanomedicines were explored. Representatives from the US Food and Drug Administration (USFDA), Health Canada, and European Medicines Agency (EMA) presented information about the diversity of nanomaterials in approved and newly developed drug products. USFDA, Health Canada, and EMA regulators discussed the applicability of current regulatory policies in presentations and open discussion. Information contained in several of the recent EMA reflection papers was discussed in detail, along with their scope and intent to enhance scientific understanding about disposition, efficacy, and safety of nanomaterials introduced in vivo and regulatory requirements for testing and market authorization. Opportunities for interaction with regulatory agencies during the lifecycle of nanomedicines were also addressed at the meeting. This is a summary of the workshop presentations and discussions, including considerations for future regulatory guidance on drug products containing nanomaterials.