Food Insecurity and NSAP Use Among Sexual Minority People: Analysis of a Population-Based Sample From National Health Interview Survey, 2017

Background Food insecurity is a pressing public health problem. Lesbian, gay, and bisexual (LGB) people are at risk for food insecurity, yet this issue remains grossly understudied among this population. The purpose of this study was to add to the existing literature surrounding food insecurity and the use of Federal food assistance programs (SNAP) among LGB people. Methods This study used publicly available, de-identified data from the 2017 National Health Interview Survey (NHIS). Primary variables were sexual orientation, food security status, and receipt of SNAP. Food security was assessed using the 10-item USDA Family Food Security measure. Results In our sample, people who identified as bisexual had the highest rates of food insecurity (23.8%, n = 76). Female sexual minorities were 52% more likely to experience food insecurity (aOR = 1.518, 95% CI 1.105–2.087, p = .01) and 44% more likely to report household SNAP assistance than their heterosexual counterparts (aOR = 1.441, 95% CI 1.025-2.028, p = .03). SNAP partially mediated the association between sexual orientation and food insecurity for LGB females. Conclusions Our findings add to the growing empirical evidence documenting food insecurities among sexual minority adults. Our results reiterate the need for sexual orientation to be included in nationally representative federal food security measures.

The nutriRECIPE-Index – development and validation of a nutrient-weighted index for the evaluation of recipes

Background Our objective was to develop a nutrient-based index for evaluating and improving menus in public catering. The nutriRECIPE-Index comprises 24 nutrients and nutrient groups. In developing the index, the following steps were included: setting the goals of the index, nutrient selection, target metrics and scaling, weighting, proof of concept and validation of the index. Furthermore, a unique database was created to integrate bioactive plant compounds in the assessment. An assessment of standard recipes and supposedly healthy recipes should show a significant difference in the results of the nutriRECIPE-Index. Finally, the nutriRECIPE-Index should generate similar or more specific results than existing indices such as the Nutri-Score and the Healthy Meal Index. Methods A whole meal cycle (comprising 6 weeks, 106 recipes and including different menu lines, partially with different side dishes) at a university canteen was analysed with the Federal Food Code (BLS) and the nutriRECIPE-Index. The Healthy Meal Index (comprising 3 nutritionally relevant items) and the Nutri-Score algorithm (comprising 7 items) were used to validate the nutrient composition and the results of the nutriRECIPE-Index. Results The resulting scores of the recipes and menu lines showed substantial differences, wherein the meals of a health-promoting menu line usually received higher scores than the standard recipes. A correlation between the nutriRECIPE-Index and the Healthy Meal Index (0.604) and the Nutri-Score (0.591) was observed. The nutriRECIPE-Index was better at identifying the worst menus and could better separate mediocre menus from good menus. Conclusion The nutriRECIPE-Index is a useful and comprehensive tool for evaluating the nutritional value of recipes and is the first to consider bioactive plant compounds. Further adjustments to different target populations, settings, and cultural backgrounds are possible.

Creating healthy food environments in family childcare settings

Background Considering nearly two-thirds of preschool children in the United States are in some form of child care, child care settings are an opportunity to improve the food environments and reduce the risk of obesity in young children. University of Minnesota Extension developed a culinary nutrition education training for family child care providers. This is relevant for other countries whose child care system includes caring for children in home or center settings that prepare food for children. Objectives Start Strong: Cooking, Feeding and More (SS), consists of four two-hour culinary nutrition education sessions for family providers. The overall goals of SS are to 1) increase providers' knowledge and skills to procure and prepare healthy foods for children and 2) increase providers' knowledge and understanding of Federal food assistance programs to share the information with food-insecure families. Each session includes a cooking skill, nutrition topic, and food assistance program. Results Twelve rural participants who self-identified as female, non-Hispanic White participated in the SS sessions and completed pre, post, and three-month follow-up surveys, to assess the impact of the program on providers' knowledge, confidence, and practice. Based on the paired samples t-tests between pre-to-post and pre-to-follow-up surveys, there were statistically significant increases in providers' confidence in preparing whole grains, using beans and low-cost protein sources, and cooking techniques to reduce. The increase in confidence using cooking techniques to reduce salt was still statistically significant three months after the training. The providers' awareness of Federal food programs between pre-post increased and three months later increased. Conclusions SS increased family child care providers' skills and confidence to prepare healthy foods for children in their care. This increases the likelihood children will make healthy choices now and in the future. Key messages Start Strong is a culinary nutrition education training for family child care providers. Start Strong improves providers’ knowledge and skills to prepare healthy foods for children in their care.

Abbreviated New Drug Application Process: A Gift for The Industry and The Patients

The United States Food and Drug Administration (USFDA) is one of the main regulated agencies wherein the submission and approval of the new drugs is done. This review is based on the process of submission to the ANDA as per FDA norms as described in paragraph IV submission in Federal Food, Drug, and Cosmetic Act (FD and C Act). No drug would exist in the market until it gets accepted by regulatory authorities. The ANDA submission is for those firms seeking to copy branded drugs before running out of patents to get profit on them. A generic applicant must provide in its application a "certification" that a patent submitted to FDA by the brand-name drug's sponsor and scheduled in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book). A Generic Product must meet the standards recognized by FDA in Reference listed drugs (RLD). This study concludes the process of ANDA submission to FDA and acts correlated to the submission in paragraph IV, the details of ANDA filling in the eCTD format and overview of the review process the checklist to the applicant.

Drug importation: limitations of current proposals and opportunities for improvement

Drug importation is a policy proposal to help alleviate rising pharmaceutical prices. Restrictions on drug importation stem from the Federal Food, Drug, and Cosmetic Act but authorization of importation can be made by the Health and Human Services (HHS) Secretary. During the Trump administration a number of states passed laws to develop a drug importation programs, however, none have been authorized by HHS. Limitations of these importation programs include sole reliance on Canada, exclusion of high-cost drugs like biologics, and persistent legal hazard of the Personal Importation Program. Potential revisions to current law include expansion of countries approved for importation, inclusion of biologics, and codifying protection for personal importation. Drug importation policies are not a panacea to address rising pharmaceutical prices but may blunt prices while more permanent solutions are pursued.

U.S. FDA and FTC: Opioid Addiction and Health Fraud

Opioid addiction is a serious health epidemic that affects millions of Americans. Opioids are a class of drugs that include: the illegal drug heroin, synthetic opioids (fentanyl), and pain relievers available legally by prescription, such as: oxycodone, hydrocodone, codeine, morphine and others. There are limited drugs approved by the U.S. Food and Drug Administration (FDA) for opioid addition treatment. However, some marketers and distributors are illegally marketing products with unproven claims about their ability to help in the treatment of opioid addiction and withdrawal. Selling unapproved products with claims that they can treat opioid addiction and withdrawal is a violation of the Federal Food, Drug, and Cosmetic Act (FD&C) Act, and making unsubstantiated therapeutic claims are also a violation of the Federal Trade Commission Act, which prohibits deceptive advertising.

The Dynamics of SARS-CoV-2 (RT-PCR) Testing

The COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is estimated to have affected 6.2 million people in the United States and 27.5 million people worldwide as of September 9, 2020. On February 2, 2020, the Secretary of the Department of Health and Human Services (HHS) determined that the public health emergency justified the development and emergency use of “in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19” by activating the Emergency Use Authorization (EUA) authority under section 564 of the Federal Food, Drug, and Cosmetic Act. Unfortunately, effective mitigation efforts were thwarted early in the outbreak resulting in an expansion of the initial EUA on February 29, 2020, to improve accessibility to in vitro diagnostic testing. Expectantly, the development and deployment of SARS-CoV-2 testing including RT-PCR expanded rapidly in the weeks following the EUA expansion. These newly developed and approved SARS-CoV-2 RT-PCR tests boast impressive positive and negative agreement rates nearing 100%. Despite the exceptionally high rates of agreement, caution is advised as the RT-PCR tests approved under the COVID-19 EUA are in vitro analyses developed with samples artificially doped with SARS-CoV-2 RNA. These tests therefore do not have clinically applicable sensitivity and specificity because they lack a “gold standard” for diagnosis. Here we present three challenging cases requiring cautious interpretation of the newest generation of RT-PCR molecular detection assays, highlighting the major challenges faced by providers treating patients potentially infected with SARS-CoV-2.

A pharmacist-driven Food and Drug Administration incident surveillance and response program for compounded drugs

Disclaimer In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose To provide an overview of compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, and to describe the pharmacist’s role within the US Food and Drug Administration’s (FDA’s) Compounding Incidents Program, whose efforts are aimed at protecting the public against poor-quality compounded drugs through surveillance, review and response to adverse events and complaints. Summary Compounded drugs may serve an important medical need for patients who cannot be treated with medications approved by FDA; however, compounded drugs are not approved by FDA and are not subject to premarket review for safety, efficacy, or manufacturing quality; thus, they may pose safety risks to patients. Prompt reporting of adverse events or complaints related to compounding is important in identifying these risks and implementing safeguards to protect the public. FDA’s Compounding Incidents Program consists of a team of pharmacists dedicated to the surveillance and review of adverse events and complaints and follow-up actions related to safety risks associated with compounded drugs. Pharmacists are a vital component of FDA’s Compounding Incidents Program, utilizing their clinical skill set and regulatory knowledge to review and act on safety issues that affect public health. Conclusion As FDA continues to expand the Compounding Incidents Program and its efforts to protect the public against poor-quality compounded drugs, we encourage the continued submission of adverse event reports by healthcare professionals and consumers to FDA’s MedWatch reporting system in addition to adverse event reporting compliance by outsourcing facilities.

Assessing sense of community at farmers markets: A systematic review

Farmers markets are valuable for reducing food insecurity and delivering healthy food options to populations living with low incomes. However, farmers markets have developed a reputation for being exclusive shopping spaces devoted to affluent, white shoppers. Sense of community (SOC), or a person’s feelings of belonging at farmers markets, could be an important, under-addressed asset or barrier to farmers markets patronage for people living with low incomes. To document and describe how SOC influences customer engagement with farmers markets, we conducted a systematic review of published, peer-reviewed literature following PRISMA guidelines. Systematic review protocol involved three stages: identifying peer-reviewed articles using key search terms, screening abstracts and articles for inclusion and exclusion, and analyzing articles for SOC at farmers markets. Of the 24 articles included in the systematic review, 10 addressed SOC in farmers markets shoppers living with low incomes, 6 addressed SOC in farmers markets shoppers living with middle to high incomes, and 8 did not indicate the shoppers’ income level. SOC served as both a barrier and facilitator to farmers markets patronage for all income levels. However, farmers markets shoppers who received federal food assistance reported a feeling of exclusion discouraging them from shopping at farmers markets. These negative experiences were more prominent among Black, Indigenous, and other People of Color (BIPOC) living with low incomes. SOC appears to be an important factor in determining who shops at farmers markets and the frequency with which they visit. Farmers markets managers should consider how to strengthen SOC to improve engagement with people living with low incomes, and more specifically, BIPOC living with low incomes.

Consumer Trust in Quality and Safety of Food Products in Western Siberia

Modern Russia faces difficulties in ensuring food quality and safety. The updated federal food security doctrine focuses on export opportunities and monitoring the ratio between domestic production and consumption. This agenda is determined by possible external threats: sanctions and trade wars, various conflicts, and economic and agricultural crises. The aim is to reveal the features of consumer behavior when interacting with food operators and to show the influence of socio-economic characteristics on individual practices. Empirical data are obtained from the authors’ mass survey and in-depth interviews. Results might signify that society came to a consensus on trust in quality and safety of food. Observed differences in outlet and product choices can be explained by income, settlement type, and age. Local producers are struggling to enter retail chains, as there are contradictions between consumer expectations and internal policies of sales operators. Experts argue that people poorly assess the real risks of economizing and favoring low-quality food.