The Impact of Qualified Health Claims on Advertising Evaluations: The Cases of POM Wonderful and Minute Maid

Sambucus nigra L. (S. nigra) is a shrub widespread in Europe and western Asia, traditionally used in medicine, that has become popular in recent years as a potential source of a wide range of interesting bioactive compounds. The aim of the present work was to develop a topical S. nigra extract formulation based on ethosomes and thus to support its health claims with scientific evidence. S. nigra extract was prepared by an ultrasound-assisted method and then included in ethosomes. The ethosomes were analyzed in terms of their size, stability over time, morphology, entrapment capacity (EC), extract release profile, stability over time and several biological activities. The prepared ethosomes were indicated to be well defined, presenting sizes around 600 nm. The extract entrapment capacity in ethosomes was 73.9 ± 24.8%, with an interesting slow extract release profile over 24 h. The extract-loaded ethosomes presented collagenase inhibition activity and a very good skin compatibility after human application. This study demonstrates the potential use of S. nigra extract incorporated in ethosomes as a potential cosmeceutical ingredient and on further studies should be performed to better understand the impact of S. nigra compounds on skin care over the time.

Download Full-text

Governance of differential stakeholder interests in supply chains and networks

Journal on Chain and Network Science ◽

10.3920/jcns2013.1001 ◽

2013 ◽

Vol 13 (2) ◽

pp. 99-105 ◽

Cited By ~ 1

Author(s):

E.F.M. Wubben ◽

H.J. Bremmers ◽

P.T.M. Ingenbleek ◽

A.E.J. Wals

Keyword(s):

Social Sciences ◽

Business Models ◽

Production Systems ◽

Stakeholder Management ◽

Data Gathering ◽

Health Claims ◽

Stakeholder Dialogue ◽

Stakeholder Interests ◽

Multi Stakeholder ◽

The Impact

Competing frames and interests regarding food provision and resource allocation, adding to the increased global interdependencies, necessitate agri-food companies and institutions to engage themselves in very diverse multi-stakeholder settings. To develop new forms of interaction, and governance, researchers with very different backgrounds in social sciences try to align, or at least share, research trajectories. This first paper in a special issue on governance of differential stakeholder interests discusses, first, different usages of stakeholder categories, second, the related intersubjectivity in sciences, third, an rough sketch of the use of stakeholder management in different social sciences. Social science researchers study a wide variety of topics, such as individual stakeholder impact on new business models, stakeholder group responses to health claims, firm characteristics explaining multi-stakeholder dialogue, and the impact of multi-stakeholder dialogue on promoting production systems, and on environmental innovations. Interestingly, researchers use very different methods for data gathering and data analysis.

Download Full-text

What Is the Impact of Prior Authorization on the Incidence of Pediatric Tonsillectomy?

Otolaryngology ◽

10.1177/0194599820969631 ◽

2020 ◽

pp. 019459982096963

Author(s):

Vanessa F. Torrecillas ◽

Kaden Neuberger ◽

Alexander Ramirez ◽

Paul Krakovitz ◽

Jeremy D. Meier

Keyword(s):

Elective Surgery ◽

Lag Time ◽

Cross Sectional Study ◽

Health Claims ◽

Third Party ◽

Prior Authorization ◽

Cross Sectional ◽

Before And After ◽

The Mean ◽

The Impact

Objective Third-party payers advocate for prior authorization (PA) to reduce overutilization of health care resources. The impact of PA in elective surgery is understudied, especially in cases where evidence-based clinical practice guidelines define operative candidacy. The objective of this study is to investigate the impact of PA on the incidence of pediatric tonsillectomy. Study Design Cross-sectional study. Setting Health claims database from a third-party payer. Methods Any pediatric patient who had evaluation for tonsillectomy from 2016 to 2019 was eligible for inclusion. A time series analysis was used to evaluate the change in incidence of tonsillectomy before and after PA. Lag time from consultation to surgery before and after PA was compared with segmented regression. Results A total of 10,047 tonsillectomy claims met inclusion and exclusion criteria. Female patients made up 51% of claims, and the mean age was 7.9 years. Just 1.5% of claims were denied after PA implementation. There was no change in the incidence of tonsillectomy for all plan types ( P = .1). Increased lag time from consultation to surgery was noted immediately after PA implementation by 2.38 days (95% CI, 0.23-4.54; P = .030); otherwise, there was no significant change over time ( P = .98). Conclusion A modest number of tonsillectomy claims were denied approval after implementation of PA. The value of PA for pediatric tonsillectomy is questionable, as it did not result in decreased incidence of tonsillectomy in this cohort.

Download Full-text

Considerations for the design and conduct of human gut microbiota intervention studies relating to foods

European Journal of Nutrition ◽

10.1007/s00394-020-02232-1 ◽

2020 ◽

Vol 59 (8) ◽

pp. 3347-3368

Author(s):

J. R. Swann ◽

M. Rajilic-Stojanovic ◽

A. Salonen ◽

O. Sakwinska ◽

C. Gill ◽

...

Keyword(s):

Gut Microbiota ◽

Intestinal Microbiota ◽

Intervention Studies ◽

Health Claims ◽

Host Responses ◽

Human Gut ◽

Eligibility Criteria ◽

Functional Changes ◽

Human Gut Microbiota ◽

The Impact

AbstractWith the growing appreciation for the influence of the intestinal microbiota on human health, there is increasing motivation to design and refine interventions to promote favorable shifts in the microbiota and their interactions with the host. Technological advances have improved our understanding and ability to measure this indigenous population and the impact of such interventions. However, the rapid growth and evolution of the field, as well as the diversity of methods used, parameters measured and populations studied, make it difficult to interpret the significance of the findings and translate their outcomes to the wider population. This can prevent comparisons across studies and hinder the drawing of appropriate conclusions. This review outlines considerations to facilitate the design, implementation and interpretation of human gut microbiota intervention studies relating to foods based upon our current understanding of the intestinal microbiota, its functionality and interactions with the human host. This includes parameters associated with study design, eligibility criteria, statistical considerations, characterization of products and the measurement of compliance. Methodologies and markers to assess compositional and functional changes in the microbiota, following interventions are discussed in addition to approaches to assess changes in microbiota–host interactions and host responses. Last, EU legislative aspects in relation to foods and health claims are presented. While it is appreciated that the field of gastrointestinal microbiology is rapidly evolving, such guidance will assist in the design and interpretation of human gut microbiota interventional studies relating to foods.

Download Full-text

Modelling the dietary impact of health-related claims on food labels in the UK

Proceedings of The Nutrition Society ◽

10.1017/s0029665120002748 ◽

2020 ◽

Vol 79 (OCE2) ◽

Author(s):

Asha Kaur ◽

Peter Scarborough ◽

Mike Rayner

Keyword(s):

Nutritional Quality ◽

Meta Analysis ◽

Saturated Fat ◽

Nutritional Composition ◽

Health Claims ◽

Baseline Scenario ◽

Health Related ◽

Mathematical Equations ◽

The Impact

AbstractHealth-related claims (HRCs) are statements found on food packets that convey the nutritional quality of a food (nutrition claims) and/or its impact on a health outcome (health claims). Foods carrying HRCs have a slightly improved nutritional profile than foods without HRCs, however, it's unclear whether this translates into dietary improvements. We conducted a modelling study to measure the effect of HRCs on diet. As HRCs are already present on foods it is assumed that any impact that they have upon diet are already in effect. We modelled the impact on food purchases of removing HRCs, by assuming that the sales boost they receive is neutralised. These results can be inverted to estimate the current dietary impact of HRCs. Using the Living Costs Food (LCF) survey data, we calculate the average purchases and nutrient intake per person, per day. The LCF data is divided into sales of products with HRCs and sales of products without HRCs through solving mathematical equations combining LCF sales data with odds ratios from a meta-analysis examining the impact of HRCs on choices and data from a survey of foods examining the prevalence of HRCs and the nutritional quality of foods that carry them so that the sum of the sales of products with HRCs and without HRCs is equal to the total sales of products. Similarly, mathematical equations are solved that combine nutritional composition data with the sales of foods carrying and not carrying HRCs. In the baseline scenario foods carrying HRCs made-up 37% of the total purchases, and contributed 29% (559kcal) of the total kcals purchased (1907kcal). When HRCs are removed from foods there is an average increase of 18kcal/d (95% Uncertainty Intervals [UI] -15, 52), + 2g/d increase in total fat (95% UI -1, 4) and saturated fat (95% UI 1, 3), smaller changes are seen for protein (+ 0.5g/d, 95% UI -1, 2), total sugar (+ 0.5g/d, 95% UI -4, 7) and carbohydrate (-0.5g/d, 95% UI -5, 7). There is reduction in the amount of fruit (-11g/d, 95% UI -34, 26) but an increase in vegetables (+ 6g/d, 95% UI -6, 19). These results should be interpreted with caution due to the large uncertainty intervals. When HRCs are removed, we see a small deterioration in the quality of the average diet. If we invert these findings we can assume HRCs currently have a positive, albeit small, impact on diet.

Download Full-text

Impact of Chiropractic Care on Use of Prescription Opioids in Patients with Spinal Pain

Pain Medicine ◽

10.1093/pm/pnaa014 ◽

2020 ◽

Vol 21 (12) ◽

pp. 3567-3573 ◽

Cited By ~ 3

Author(s):

James M Whedon ◽

Andrew W J Toler ◽

Louis A Kazal ◽

Serena Bezdjian ◽

Justin M Goehl ◽

...

Keyword(s):

Primary Care ◽

Spinal Pain ◽

Chiropractic Care ◽

Care Physician ◽

Health Claims ◽

Prescription Opioids ◽

Office Visits ◽

Opioid Prescription ◽

Health Claims Data ◽

The Impact

Abstract Objective Utilization of nonpharmacological pain management may prevent unnecessary use of opioids. Our objective was to evaluate the impact of chiropractic utilization upon use of prescription opioids among patients with spinal pain. Design and Setting We employed a retrospective cohort design for analysis of health claims data from three contiguous states for the years 2012–2017. Subjects We included adults aged 18–84 years enrolled in a health plan and with office visits to a primary care physician or chiropractor for spinal pain. We identified two cohorts of subjects: Recipients received both primary care and chiropractic care, and nonrecipients received primary care but not chiropractic care. Methods We performed adjusted time-to-event analyses to compare recipients and nonrecipients with regard to the risk of filling an opioid prescription. We stratified the recipient populations as: acute (first chiropractic encounter within 30 days of diagnosis) and nonacute (all other patients). Results The total number of subjects was 101,221. Overall, between 1.55 and 2.03 times more nonrecipients filled an opioid prescription, as compared with recipients (in Connecticut: hazard ratio [HR] = 1.55, 95% confidence interval [CI] = 1.11–2.17, P = 0.010; in New Hampshire: HR = 2.03, 95% CI = 1.92–2.14, P < 0.0001). Similar differences were observed for the acute groups. Conclusions Patients with spinal pain who saw a chiropractor had half the risk of filling an opioid prescription. Among those who saw a chiropractor within 30 days of diagnosis, the reduction in risk was greater as compared with those with their first visit after the acute phase.

Download Full-text

Global review of heart health claims for oat beta-glucan products

Nutrition Reviews ◽

10.1093/nutrit/nuz069 ◽

2020 ◽

Vol 78 (Supplement_1) ◽

pp. 78-97

Author(s):

Rebecca Mathews ◽

Alison Kamil ◽

YiFang Chu

Keyword(s):

Drug Administration ◽

Food And Drug Administration ◽

Health Claims ◽

Soluble Fiber ◽

Beta Glucan ◽

Oat Bran ◽

The Us ◽

Cereal Fiber ◽

The Impact ◽

The Relationship

Abstract Coronary heart disease (CHD) is the leading cause of death globally. Consumption of whole grains and cereal fiber, as part of a healthy diet, can lower the risk of CHD. Health claims on food products are effective in helping consumers select healthful diets. The US Food and Drug Administration was the first to approve a health claim, in 1997, between beta-glucan soluble fiber from whole oats, oat bran, and whole oat flour and reduced risk of CHD. Only a few countries have approved similar claims. Since 1997, a significant amount of additional evidence has been published on the relationship between oat beta-glucan and CHD. To assist other jurisdictions in potentially utilizing this claim, the full extent of data that supports this claim (ie, the evidence utilized by the US Food and Drug Administration to substantiate the claim, as well as the results of 49 clinical trials published since 1997) are reviewed here. The complexities involved in authoring evidence-based health claims, including the impact of processing on beta-glucan cholesterol-lowering efficacy in approving eligible beta-glucan products, are also discussed.

Download Full-text