Labeling Rules Research Articles

Muslim Food Consumer Protection Through The Regulation Of Halal Labels In Indonesia

The label is a tool to convey information about the products listed on the packaging. In addition to providing information about the product name, the label also provides information on the list of ingredients contained in the product, net weight, durability, value or usefulness of the product as well as information about halal. Objection is the main parameter in the product selection process. This provision makes limitations on food products to enter the Muslim market. This study aims to find out how is the form of legal protection for Muslim food consumers according to the applicable law in Indonesia and Muslim food consumer legal remedies if they feel disadvantaged due to violations of the halal label rules in Indonesia. This research is a Normative Law research through library research. Meanwhile, the normative juridical approach is used. Methods of approach through legislation (Statute Approach) and data sources through the technique of documentation and data analysis through qualitative descriptive. This article concludes that the form of legal protection for Muslim consumers was regulated through the Consumer Protection Act (UUPK) and other laws. Legal efforts by consumers through dispute resolution outside the court and within the court and through the Consumer Dispute Resolution Agency (BPSK).

Alcohol labelling rules in free trade agreements: Advancing the industry's interests at the expense of the public's health.

The Trans-Pacific Partnership Agreement (TPP) included novel rules for wine and spirits requiring parties to allow wine and spirits importers to display information required by the importing country on a supplementary label rather than on the standard label. Since the TPP negotiations concluded, alcohol-specific supplementary labelling rules have begun to appear in other trade agreements. The aim of this paper was to map the new instruments containing these rules and examine developments in the rules with implications for health information on alcohol containers. Trade agreements signed after the TPP negotiations concluded were retrieved and searched for alcohol-specific labelling provisions. A legal analysis of these provisions and related exceptions was undertaken. Supplementary labelling rules similar or identical to those in the TPP have been included in five subsequent trade agreements. The United States-Mexico-Canada Agreement also includes several additional provisions about alcohol labelling. Exceptions in the agreements provide some space for governments to defend labelling measure that might otherwise breach the rules, in the event of a dispute. By securing these rules, the alcohol industry is better positioned to claim the space on the standard label as industry 'real estate' and to oppose mandatory health information incorporated into the standard labelling. These risks can be mitigated by stemming the adoption of supplementary labelling rules in further trade agreements; clarifying the text of agreements and ensuring that regulators understand that the rules do not prevent the use of 'best-practice' warning labels.

Clinicians' Perspective of the New Pregnancy and Lactation Labeling Rule (PLLR): Results from an AAAAI/FDA Survey

On June 30, 2015, the US Food and Drug Administration (FDA) began implementation of the Pregnancy and Lactation Labeling Rule (PLLR), which replaced the pregnancy letter category system (A, B, C, D, and X) with integrated narrative summaries of the risks of using a drug or biological product during pregnancy and lactation. The letter category system, first established in 1979, was regarded as overly simplistic and misinterpreted as a grading system. The PLLR labeling format was created to improve the presentation of available data on use of the drug during pregnancy and/or lactation. To survey clinician awareness, assessment, and use of this new labeling format. In January 2018, an online survey, developed in collaboration between the American Academy of Allergy, Asthma & Immunology and the FDA, was sent to a random sample of the US membership of the American Academy of Allergy, Asthma & Immunology. The survey content consisted of questions addressing the following: demographic characteristics, awareness and use of the PLLR, and value and understanding of the PLLR format on the basis of an example of the "Pregnancy" subsection of labeling. Of the 1500 members who received the survey via an email, 184 (12%) completed the survey. Respondents had a mean age of 56 years and treated on average 2 pregnant women per month. Less than half (46%) of the respondents were aware that the pregnancy letter category system was replaced with a narrative summary. After reading the example, most of the respondents (68%) did not feel that the narrative summary was concise. However, 71% of the respondents found the background risk and disease-associated risk information helpful. Most of the respondents (95%) continued to use the pregnancy letter category system to make prescribing decisions. These survey results suggest that the PLLR format was not known by most prescribers and that the pregnancy letter category format is continuing to be used despite significant flaws in the old system. However, the survey did not address why prescribers were continuing to rely on the pregnancy letter category system. Whether this is due to the PLLR format itself or the lack of quality data to inform the safe use of medications in pregnancy cannot be determined from these survey results. The FDA will use these survey results to refine the communication of pregnancy safety information in labeling and will expand outreach efforts to educate health care providers in the new labeling system.

On the Design of Near-Optimal Sparse Code Multiple Access Codebooks

Sparse code multiple access (SCMA) is one of the competitive non-orthogonal multiple access (NOMA) techniques for the next generation of communication systems. In this paper, a systematic construction procedure for the design of SCMA codebooks under various channel environments is proposed in order to achieve near-optimal designs, especially for cases which consider small-scale SCMA parameters. The procedure includes the rotation angle design, the construction of multi-dimensional codebooks, and the design of labelling rules. The detailed design criteria and the related properties are derived and investigated. A low-complexity construction algorithm is further proposed for the cases of fading channels. Numerical results show that the designed SCMA codebooks provide improvements in error performance for all of the considered channel conditions, when compared to the codebooks presented in the prior literature.

Robust and automatic data cleansing method for short-term load forecasting of distribution feeders

Distribution networks are undergoing fundamental changes at medium voltage level. To support growing planning and control decision-making, the need for large numbers of short-term load forecasts has emerged. Data-driven modelling of medium voltage feeders can be affected by (1) data quality issues, namely, large gross errors and missing observations (2) the presence of structural breaks in the data due to occasional network reconfiguration and load transfers. The present work investigates and reports on the effects of advanced data cleansing techniques on forecast accuracy. A hybrid framework to detect and remove outliers in large datasets is proposed; this automatic procedure combines the Tukey labelling rule and the binary segmentation algorithm to cleanse data more efficiently, it is fast and easy to implement. Various approaches for missing value imputation are investigated, including unconditional mean, Hot Deck via k-nearest neighbour and Kalman smoothing. A combination of the automatic detection/removal of outliers and the imputation methods mentioned above are implemented to cleanse time series of 342 medium-voltage feeders. A nested rolling-origin-validation technique is used to evaluate the feed-forward deep neural network models. The proposed data cleansing framework efficiently removes outliers from the data, and the accuracy of forecasts is improved. It is found that Hot Deck (k-NN) imputation performs best in balancing the bias-variance trade-off for short-term forecasting.

Acute and Chronic Toxicity to Daphnia magna of Diuron and Capsaicin Used in Antifouling Paints

Diuron is a biocidal active substance commonly and typically used in antifouling paints, and capsaicin is a new-type of natural products used for antifouling paints. To evaluate acute and chronic toxicity of diuron and capsaicin on aquatic organism, Daphnia magna was selected as a model test organism. Based on the toxicity effects on fatality, time of the first reproduction, number of brood per female, body length, number of total offspring in acute and chronic test, a dose-response relationship was established and the most sensitive biological indices were proposed. The acute toxicity test showed that the 48 h-EC50 of diuron to Daphnia magna was 17.1 mg·L-1, the 48 h-EC50 of capsaicin to Daphnia magna was 12.4 mg·L-1. The chronic toxicity test showed that there were signifi-cant effects on all observed biological indices. The sensitive biological indices for diuron from strong to weak were number of total offspring > time of the first reproduction > body length > number of brood per female, and the sensitive biological indices for capsaicin from strong to weak were number of total offspring > body length > number of brood per female > time of the first reproduction. Based on the number of total offspring, the 21 d-EC10 of diuron was calculated to be 0.830 mg·L-1, the 21d-EC10 of capsaicin was 1.63 mg·L-1. Capsaicin was readily biodegradable and its EC10 of reproduction to Daphnia magna was greater than 1 mg·L-1. According to the Rules for Classification and Labeling of Chemicals-Part 28:Hazardous to the Aquatic Environment (GB 30000.28-2013), capsaicin can be considered to have low chronic risk for aquatic environment and an environment-friendly potential.

Self-Supervised Animation Synthesis Through Adversarial Training

In this paper, we propose a novel deep generative model for image animation synthesis. Based on self-supervised learning and adversarial training, the model can find labeling rules and mark them without origin sample labels. In addition, our model can generate continuous changing images based on the automatically labels learning. The labels learning model can be implemented on a large number of out-of-order samples to generate two types of pseudo-labels, discrete labels and continuous labels. The discrete labels can generate different animation clips, and the continuous labels can generate different frames in the same clip. Embedding pseudo-labels with latent variables into latent space, our model discovers regularities and features from latent space. Animation features are fully characterized by the pseudo-labels learned from the self-supervised module. Using upgraded adversarial training steps, the model learns to map animation features to pseudo-labels from the latent space and then organizes pseudo-labels embedding into latent variables to generate animation features. By adapting dimensions of pseudo-labels, we match fine features with latent variables. Such as using the two types of pseudo-labels, our model can also generate different styles of videos from the same dataset. The specific implementation tricks depend on the different pseudo-label dimensions and the number of pseudo-label dimensions. Comparing the results of our model with other state-of-the-art approaches, the model does not use complicated components, such as 3D convolution layers and recurrent neural networks. Our experimental results show that an appropriate number of the pseudo-label dimensions can better characterize animation features. In this case, an animation which reached human-level perception can be synthesized. The performance of animation synthesis has reached relatively superior results on several challenging datasets.

660: The impact of the pregnancy and lactation labeling rule

660: The impact of the pregnancy and lactation labeling rule

Automated training sample definition for seasonal burned area mapping

Monitoring of environmental change can benefit from the increasing availability of multitemporal satellite imagery, and efficient and effective analysis tools are needed to generate relevant spatio-temporal land cover datasets. We present a data driven approach for automatic training sample selection to support supervised spatio-temporal mapping of seasonally burned areas in the semi-arid savannas of Southern Africa. Our approach leveraged the distinctive spectral-temporal trajectories associated with areas on the landscape burned at different times or areas remaining unburned over time. Using fuzzy c-means clustering, we extracted distinctive trajectories from the multitemporal mid-infrared burn index (MIRBI) data derived from Landsat data and characterized them based on empirically developed labeling rules. The selected training trajectories captured both the burn condition (burned or unburned) and if burned, the timeframe of the burn event. We assessed the approach by training a Random Forests model using over 2500 automatically selected training data and validated the model against ground truth for years 2009 and 2014. Based on over 1000 validation points in each year, we obtained overall accuracies above 90% showing reliable and consistent training data were supplied by our automatic training sample selection approach. The method provides a data driven and automatic approach which can reduce the time-consuming and expensive training task, enabling quicker generation of relevant burned area information that can support fire monitoring programs and climate change research.

Allergens – food service responsibilities

Allergens – food service responsibilities

Exploring Large-scale Public Medical Image Datasets

Medical artificial intelligence systems are dependent on well characterized large-scale datasets. Recently released public datasets have been of great interest to the field, but pose specific challenges due to the disconnect they cause between data generation and data usage, potentially limiting the utility of these datasets. We visually explore two large public datasets, to determine how accurate the provided labels are and whether other subtle problems exist. The ChestXray14 dataset contains 112,120 frontal chest films, and the Musculoskeletal Radiology (MURA) dataset contains 40,561 upper limb radiographs. A subset of around 700 images from both datasets was reviewed by a board-certified radiologist, and the quality of the original labels was determined. The ChestXray14 labels did not accurately reflect the visual content of the images, with positive predictive values mostly between 10% and 30% lower than the values presented in the original documentation. There were other significant problems, with examples of hidden stratification and label disambiguation failure. The MURA labels were more accurate, but the original normal/abnormal labels were inaccurate for the subset of cases with degenerative joint disease, with a sensitivity of 60% and a specificity of 82%. Visual inspection of images is a necessary component of understanding large image datasets. We recommend that teams producing public datasets should perform this important quality control procedure and include a thorough description of their findings, along with an explanation of the data generating procedures and labeling rules, in the documentation for their datasets.

Wave linked partitions and 312-avoiding permutations with primacy being 1

In this paper, we mainly study connected non-crossing linked partitions, which are vividly called wave linked partitions, and their relation to 312-avoiding permutations with primacy being 1. Let W(n) be the set of wave linked partitions of {1,2,…,n} and let w(n, k) be the number of wave linked partitions of {1,2,…,n} with wave of length k. We obtain that the enumeration of W(n+1) is counted by the well-known nth Catalan number Cn and we present the recurrence relation of w(n, k). Let P1(n) be the set of 312-avoiding permutations of {1,2,…,n} with primacy being 1. As a main result, we construct an interesting bijection between W(n) and P1(n) by introducing a labeling rule on wave linked partitions. The labeling rule implies that the major index of such kind of permutations can be easily obtained from the labels of certain vertices in the corresponding wave linked partitions.

The Influence of Colorants, Flavorants and Product Identity on Perceptions of Naturalness.

Natural foods are important to consumers, yet frustrating to producers due to the lack of a formal definition of “natural”. Previous work has studied how consumers define naturalness and how they rate the naturalness of various products, but there is a gap in knowledge relating to how color and flavor additives impact perceptions. The objective of this study was to understand how colorants and flavorants on ingredient statements affect perceptions of naturalness. An online survey was launched in the United States, United Kingdom, and Australia to determine how consumers perceive products with ingredient statements containing different combinations of artificial and natural colors and flavors when shown with and without the product identity. Results showed that consumers look at the whole product primarily to make decisions about naturalness, but also consider other factors. Products derived from plants and products with natural colors and flavors were perceived to be the most natural. Artificial flavors may be more acceptable than artificial colors due to negative health perceptions and labeling rules associated with colors. Additionally, factors like ingredient familiarity and processing likely influence consumers when making decisions about product naturalness. Males, Millennials, and educated participants have higher naturalness scores than other participants in their respective demographics.

P101 Incidence of peri-pregnancy flares among patients with Crohn's disease

BACKGROUND: Evidence informing providers and payers regarding the appropriate management of women with reproductive potential continues to grow and was primarily stimulated by the FDA's Pregnancy and Lactation Labeling Rule. The objective of this analysis was to examine the unmet clinical needs of patients with Crohn's disease (CD) during pregnancy. METHODS: CD patients with pregnancies resulting in live births were identified in the MarketScan® database (1/2010-9/2016) using ICD-CM/CPT/MS-DRG codes. The estimated conception date (index date) was calculated based on the gestational age indicated by the diagnosis or procedure code for delivery. Continuous enrollment from the baseline (BL) period (6-months pre-index) through the postpartum period (6-months post-delivery) was required. Clinical proxies were developed to assess flares during the study period: (1) At least 2 ICD-CM codes for CD-related symptoms: abdominal pain, blood in stool, diarrhea, fatigue, fever, loss of appetite, weight loss, rashes; (2) ICD-CM code for CD-related complication: abscess, anal fissure, arthritis, bowel obstruction/stricture, fissure, fistula, gallstone, inflammation of the eye/mouth, kidney stone, liver disease, ulcers; (3) CD-related hospitalization/ER visit; (4) 60% increase in CD-related outpatient visits from BL; (5) addition or potency increase of oral corticosteroid from BL; (6) addition or dose increase in biologic therapy from BL; and (7) addition of other CD indicated therapies from BL. An assumption was made that only a single flare could occur within 30 days. RESULTS: 1,726 successful pregnancies among CD patients were identified. The mean age was 30.3 years, mean (SD) Deyo-Charlson comorbidity index was 0.1 (0.4), most patients had commercial PPO coverage (63.4%), and the most prevalent comorbid condition was infection (42.5%). There were no significant differences in BL characteristics between pregnancies with and without flares. Among the 1,726 pregnancies, there were a total of 5,074 flares (1,268 flares [25.0%] during the BL period, 2,227 flares [43.9%] during the pregnancy period, and 1,579 flares [31.1%] during the post-partum period). To account for differences in the duration of each peri-pregnancy period (baseline [6.0 months], pregnancy [9.2 months], postpartum [6 months]), average monthly flare rates were calculated. The rates were 211.3, 241.7, and 263.2 flares/month, respectively, for the BL, pregnancy and post-partum periods. The most frequent clinical proxies for flares during the BL period were an increase in CD-related outpatient visits from BL (23.7%) and CD-related symptoms (23.0%). The most frequent clinical proxies for flares during both the pregnancy and postpartum periods were the addition or increase in dose of CD-indicated therapies (45.6% pregnancy period, 35.8% postpartum period) and CD-related complications (25.0% pregnancy period, 35.4% postpartum period). CONCLUSION(S): The consistently high risk of flares during the peri-pregnancy period demonstrates the need for optimizing the management of CD. While sole reliance on claims data is a limitation in assessing poor CD control, the use of clinical proxies to explore national trends in CD disease control might help uncover unmet needs. Healthcare professionals should aim for disease control prior to pregnancy and have a treatment plan during and after pregnancy to optimize clinical outcomes and minimize CD-related complications for women.

Performance Analysis of Bit-Interleaved Polar Coded Modulation

Polar codes have been applied to the construction of bit-interleaved polar coded modulation schemes in recent years. Bit-interleaved polar coded modulation schemes consist of the concatenation of multi-order modulation and polar codes. The structure of polar codes has some similar features to bit-interleaved coded modulation schemes. This similar features motivate us to transform the concatenated transmission schemes into a universal equivalent channel model, which consists of independent parallel channels, through considering polar coding and modulation synthetically in practical applications. We also propose a general polar codes constructing algorithm to design the constituent polar codes for the equivalent channel model. Then we employ a bijective mapper to accomplish the modulation i.e., binary address mapping, from coded bits to signals in constellation with Gray labeling or set partition labeling rule in different order modulations. We analyze and compare the performance of the equivalent channel model with different order modulations under different decoding algorithms. Simulation results show that the performance of our proposed schemes outperforms that of low-density parity-check codes in WiMAX standard and Turbo codes.

New changes in pregnancy and lactation labelling: Review of dermatologic drugs.

BackgroundThe U.S. Food and Drug Administration has published new pregnancy and lactation labelling rules that set standards on the presentation of information with regard to drug usage during pregnancy and breastfeeding, as well as the effects on fertility. These guidelines became effective June 30, 2015, and classified the risks of using prescription drugs during pregnancy in three detailed subsections: Pregnancy, Lactation, and Females and Males of Reproductive Potential. These sections describe the risks within a real-world context of caring for these patients.ObjectiveIn this study, we reclassified and categorized drugs and treatments commonly used in dermatology according to these new guidelines.MethodsWe performed a search of the medical literature about the use of relevant prescription drugs during pregnancy and breastfeeding and their effect on fertility. The search included prospective and retrospective studies, review articles from PubMed-indexed journals (from inception to November 2018), U.S. Food and Drug Administration records, pregnancy exposure registries, relevant information and studies provided in drug labeling by companies, and updated pharmacologic texts and guidelines up to 2018.ResultsTopical immunomodulators, systemic immunomodulators (including biologics), systemic antipruritic agents, antimicrobials, as well as acne, hair, and cosmetic agents were included. We have made best attempts to review and consolidate existing and new data and include them in our guide.ConclusionThis new narrative format facilitates prescribing by considering a variety of factors. One previously overlooked aspect was the impact on the reproductive potential of both male and female patients. Rather than depending on overly simplistic letter risk categories, dermatologists will now need to make prescribing decisions based on each patient and the information provided, which will allow for better decision making and patient care.

PACKAGING AND LABELING REQUIREMENTS OF PHARMACEUTICALS IN REGULATED MARKETS LIKE U.S.A. AND INDIA

In pharmaceutical industry packaging and labeling plays a very important role. This article provides an overview of regulatory requirements and tests for Quality control and suitability of packaging and labeling of prescription and Over-The-Counter (OTC) Products in USA and India. The study has been informative to understand the need and importance of the labeling requirements of pharmaceuticals to protect the consumers by providing the suitable instructions for the use of the drug product at suitable place and suitable format.
 KEYWORDS: Innovator, Generics, PLR (Physician Labeling Rule), OTC, FPL (Final Printed Labeling), Testing of packages, ANDA, Regulatory requirements, USA, India Market.

(292) Lumbar Radiculopathy in the Pregnant Patient

Lumbar radiculopathy is a common cause of low back and leg pain in many patients. While there are multiple interventions both medical and surgical for the treatment of lumbar radiculopathy, the options become limited in the pregnant patient. We present the case of a 35-year-old female at 25-week gestational age with new onset severe low back and right leg pain. The patient had a history of prior lumbar laminectomy and discectomy for similar symptoms. She presented after failed conservative management with gabapentin and acetaminophen and the pain began to interfere with her daily activities. On presentation to the clinic the patient had severe lumbosacral radiculopathy consistent with Magnetic Resonance Imaging (MRI) findings of a new large disc extrusion on the right. After a discussion of the possible interventions the decision was made to treat the lumbar radiculopathy with caudal epidural steroid injection (ESI) performed under ultrasound guidance. Though there is no set maximum radiation dose deemed safe for the fetus by the American College of Obstetricians and Gynecologists (ACOG), the consensus is to limit the radiation dose to 50mGy before 15-week gestational age and 250mGy thereafter. Ultrasound guided caudal ESI was decided to be the safest course of action to decrease the amount of radiation to the fetus and minimize the risk of dural puncture given her previous laminectomy. Success was confirmed with easy passing of an epidural catheter and a decreased pain score after the procedure. Additionally, during the management of this patient we noted the new classification system from the Food and Drug Administration (FDA) regarding medications in pregnancy. Despite most medication black box warnings maintaining the old category system of A, B, C, D and X; the new FDA system emphasizes the Pregnancy and Lactations Labeling Rule (PLLR) to guide patient discussions and medical management.

Symbol Mapping Design for Bit-Interleaved Polar-Coded Modulation With Iterative Decoding

In this letter, we design a bit-interleaved polar-coded modulation system with iterative decoding subject to constraints on complexity, error floor, and waterfall region performance. We show that the hill-like trajectory of polar code extrinsic information transfer curves allows us to predict the gap of the bottleneck region that a polar code achieves at a given received signal-to-noise ratio for a given labeling rule. Using the gap, we propose a 3-D linear objective function to optimize for error floor, waterfall region performance, and complexity. The objective function requires Monte Carlo simulations for only three points on the extrinsic information transfer curve of the demapper for a given labeling rule. Our simulations show that the proposed method designs labeling rule and polar code duos that trade off error-floor and waterfall region performance with complexity and latency.

Value and protection of geographical indications by the Japanese Wine Law

Recently, Japanese wine law has changed dramatically. In October 2015, the definition of “Japan wine” and the labelling rules were introduced, and the registration guidelines for the geographical indication (GI) were formulated. Up to now, the Commissioner of the National Tax Agency has designated two wine GIs: “Yamanashi” and “Hokkaido”. However, it is not easy for Japanese consumers to understand the value and the role of GI. The National Tax Agency, prefectures, municipal authorities and winery associations organise from time to time promotional events of GI wines to spread the notion of GI. Even though the majority of “Japan wine”, including GI wine, is consumed in the internal market, it is necessary to protect the Japanese GIs in foreign countries. Due to the EU-Japan EPA that ensures the mutual protection of GIs, it is quite probable that the GI will play an important role in the export of Japanese wine, liquor and agricultural products.