Sibyl Swift, Ph.D.

The number of Individuals that use dietary supplements and herbal medicine products are continuous to increase in many countries. The context of usage of a dietary supplement varies widely from country-to-country; in some countries supplement use is just limited to general health and well-being while others permit use for medicinal purposes. To date, there is little consensus from country to country on the scope, requirements, definition, or even the terminology in which dietary supplement and… Show more

The number of Individuals that use dietary supplements and herbal medicine products are continuous to increase in many countries. The context of usage of a dietary supplement varies widely from country-to-country; in some countries supplement use is just limited to general health and well-being while others permit use for medicinal purposes. To date, there is little consensus from country to country on the scope, requirements, definition, or even the terminology in which dietary supplement and herbal medicines categories could be classified. Transparent science-based quality standards for the ingredients across these regulatory frameworks/definitions becomes even more important given the international supply chain. Meanwhile, there has been a rapid advancement in emerging technologies and data science applied to the field. This review was conceived at the Global Summit on Regulatory Sciences that took place in Beijing on September 2018 (GSRS2018) which is organized by Global Coalition for Regulatory Science Research (GCRSR) that consists of the global regulatory agencies from over ten countries including the European Union. This review summarizes a significant portion of discussions relating to a longitudinal comparison of the status for dietary supplements and herbal medicines among the different national jurisdictions and to the extent of how new tools and methodologies can improve the regulatory application. Show less

The toxicity of parenterally administered vitamin E isomers, delta-tocotrienol (DT3) and gamma-tocotrienol (GT3), was evaluated in male and female CD2F1 mice. In an acute toxicity study, a single dose of DT3 or GT3 was administered subcutaneously in a dose range of 200 to 800 mg/kg. A mild to moderately severe dermatitis was observed clinically and microscopically in animals at the injection site at doses above 200 mg/kg. The severity of the reaction was reduced when the drug concentration was… Show more

The toxicity of parenterally administered vitamin E isomers, delta-tocotrienol (DT3) and gamma-tocotrienol (GT3), was evaluated in male and female CD2F1 mice. In an acute toxicity study, a single dose of DT3 or GT3 was administered subcutaneously in a dose range of 200 to 800 mg/kg. A mild to moderately severe dermatitis was observed clinically and microscopically in animals at the injection site at doses above 200 mg/kg. The severity of the reaction was reduced when the drug concentration was lowered. Neither drug produced detectable toxic effects in any other tissue at the doses tested. Based on histopathological analysis for both DT3 and GT3, and macroscopic observations of inflammation at the injection site, a dose of 300 mg/kg was selected as the lowest toxic dose in a 30-day toxicity study performed in male mice. At this dose, a mild skin irritation occurred at the injection site that recovered completely by the end of the experimental period. At a dose of 300 mg/kg of DT3 or GT3, no adverse effects were observed in any tissues or organs. Show less

estrogen receptor-α (er-α) is an important mediator of the bone response to mechanical loading. we sought to determine whether restricting dietary energy intake by 40% limits the bone formation rate (bfr) response to mechanical loading (load) by downregulating er-α-expressing osteocytes, or osteoblasts, or both. female rats (n = 48, 7 mo old) were randomized to adlib-sham and adlib-load groups fed ain-93m purified diet ad libitum or to er40-sham and er40-load groups fed modified ain-93m with… Show more

estrogen receptor-α (er-α) is an important mediator of the bone response to mechanical loading. we sought to determine whether restricting dietary energy intake by 40% limits the bone formation rate (bfr) response to mechanical loading (load) by downregulating er-α-expressing osteocytes, or osteoblasts, or both. female rats (n = 48, 7 mo old) were randomized to adlib-sham and adlib-load groups fed ain-93m purified diet ad libitum or to er40-sham and er40-load groups fed modified ain-93m with 40% less energy (100% of all other nutrients). after 12 wk, load rats were subjected to a muscle contraction protocol three times every third day. er40 produced lower proximal tibia bone volume (-22%), trabecular thickness (-14%), and higher trabecular separation (+127%) in sham but not load rats. er40 rats exhibited reductions in mineral apposition rate, but not percent mineralizing surface or bfr. load induced similar relative increases in these kinetic measures of osteoblast activity/recruitment in both diet groups., but absolute values for er40 load rats were lower vs. adlib-load. there were fourfold and eightfold increases in proportion of estrogen receptor-α protein-positive osteoblast and osteocytes, respectively, in load vs. sham rats, with no effect of er40. these data suggest that a brief period of mechanical loading significantly affects estrogen receptor-α in cancellous bone osteoblasts and osteocytes. chronic energy restriction does result in lower absolute values in indices of osteoblast activity after mechanical loading, but not by a smaller increment relative to unloaded bones; this change is not explained by an associated downregulation of er-α in osteoblasts or osteocytes. Show less