Safety considerations for dietary supplement manufacturers in the United States.

Due to significant dietary supplement use in the US, product manufacturers must understand the importance of implementing a robust approach to establishing safety for all ingredients, including dietary ingredients, components, and finished dietary supplement products. Different regulatory pathways exist by which the safety of dietary ingredients can be established, and thus allowed to be marketed in a dietary supplement. For individual dietary ingredients, safety information may come from a variety of sources including history of safe use, presence of the ingredient in foods, and/or non-clinical and clinical data. On occasion safety data gaps are identified for a specific ingredient, particularly those of botanical origin. Modern toxicological methods and models can prove helpful in satisfying data gaps and are presented in this review. For finished dietary supplement products, issues potentially impacting safety to consider include claims, product labeling, overages, contaminants, residual solvents, heavy metals, packaging, and product stability. In addition, a safety assessment does not end once a product is marketed. It is important that manufacturers actively monitor and record the occurrence of adverse events reported in association with the use of their products, in accordance with the law. Herein, we provide a comprehensive overview of considerations for assessing dietary supplement safety.

Registered dietitians' use of physical assessment parameters in professional practice.

OBJECTIVE: To examine how registered dietitians who have completed one of two physical assessment programs use the knowledge and skills learned in practice and whether method of instruction had an affect on use of skills in practice. SUBJECTS/SETTING: Surveys were mailed to 891 persons, all of whom completed a Dietitians in Nutrition Support dietetic practice group or University of Medicine and Dentistry of New Jersey continuing education program. Four hundred seventeen surveys were returned and 407 were usable. STATISTICAL ANALYSIS: chi(2) analysis and stepwise logistic regression was used to analyze the data. Statistical significance was P=.05. RESULTS: Sixty percent of respondents worked in a clinic setting. Four of the five most-used competencies were similar between the two programs. More registered dietitians are using physical assessment competency information in clinical assessment, but not performing the competencies independently. Respondents with the Certified Diabetic Educator credential (P=.007) and Certified Nutrition Support Dietitians credential (P=.215) were more likely to use select physical assessment competencies. Confidence was reported as enhancing use of physical assessment competencies (n=153, 45%) and time was a barrier to using physical assessment competencies (n=159, 52%). APPLICATIONS/CONCLUSIONS: There were no significant differences in use of physical assessment competencies between the University of Medicine and Dentistry of New Jersey program and the Dietitians in Nutrition Support program. Although not statistically significant, there appeared to be more use of physical assessment competencies by those who received additional training and those who completed the University of Medicine and Dentistry of New Jersey program. This study reveals that registered dietitians are using the values in clinical assessment, however they must move to actually performing physical assessment competencies in practice.