Food And Drug Administration Standards Research Articles

Are cosmetics based on alpha hydroxy acids safe to use when purchased over the internet?

Alpha hydroxy acids (AHAs) are used in dermatology for topical treatment of skin disorders. Some regulatory bodies, including Food and Drug Administration (FDA), recommended labeling cosmetic products with sunburn alerts and proposed limitations regarding concentrations of AHAs in cosmetic products. In addition, The Cosmetic Ingredient Review (CIR) Expert Panel recommended 10% of AHAs in products as the maximal safe concentration. With a rapidly increasing trend of online purchasing of cosmetic products, it is important that their labels convey the necessary warnings and that they be harmonized with regulatory bodies regarding the recommended concentrations of AHAs. The aim of this report was to investigate whether or not the sunburn alert, as well as AHA recommendations mostly used for exfoliating cosmetic products, was visible to consumers during the online purchasing. The compliance with FDA and CIR Expert Panel standards was analyzed in the first 50 cosmetic products obtained after the conducted investigation on the Amazon.com e-commerce company website using the search term "AHA anti-aging." It was found that exfoliating cosmetic products contained AHAs in a broad range of concentrations, from 2.5 up to 70%. Nineteen out of 50 products contained a concentration of AHAs greater than recommended. Twelve products did not contain any data at all regarding the concentration of AHAs. Sunburn alerts were present in 16 out of 50 analyzed product pages. In conclusion, more efforts should be made in providing users with information and the necessity of protection from potential complications after topical AHAs product treatments.

The State of Patient-Reported Outcome Measures for Pediatric Patients with Inherited Retinal Disease.

Patient-reported outcome measures (PROMs) are questionnaires that assess health outcomes meaningful to the patient. PROMs have multiple applications, such as supporting clinicians’ decision-making for patient care, understanding the impact of disease on patient functioning, and evaluating the efficacy of therapeutics. Though PROMs were developed for various eye conditions, no PROM was tailored to pediatric patients with inherited retinal disease (IRD). Hence, a literature search was conducted using MEDLINE and Embase to identify PROMs potentially relevant to this patient population. This review evaluated selected pediatric PROMs against the US Food and Drug Administration (FDA) guidelines and found restricted use in the context of IRD. As there is a need for PROMs tailored to pediatric patients with IRD, we provide a perspective on applying the International Society for Pharmacoeconomics and Outcomes Research and FDA standards on the development of PROMs specific to IRD.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40123-022-00514-x.

Highlights on the Labels of Packaged Foods Sold in Jordanian Market from A Cross-Sectional Study

Jordan has adapted a strategy to prevent chronic diseases. Accordingly, Ministry of Health is looking for controlling food labeling particularly food fat, trans-fat, and caloric content. This study aimed to screen the food label of products that are sold in Jordanian market in terms of serving size, energy, macronutrient, fiber, total and added sugars, saturated and trans fat, cholesterol, dietary fiber, and micronutrient contents. A cross-sectional study was performed to screen the food label for the food products based on the standards of The United States Food and Drug Administration (FDA) regulations of 2016 and Jordan Food and Drug Administration (JFDA). Generally, food labels were not clear. The screened products were compliant with JFDA standards and not in compliance with some FDA standards. In addition, many products were found to be sources of added sugars, Na, and saturated fats. Stakeholders and legislators are called to focus on developing new laws, regulations, and polices for developing food label. Food manufacturers are needed to work hardly on developing informative, clear, easy-to-understand, and attractive food labels. The legislators of food label policies are called to look for ways to indicate the presence of high amounts of dietary risk factors such as sugars, added sugars, Na, saturated, and trans fats in packaged foods.

A REVIEW ON PHARMACEUTICAL VALIDATION AND ITS IMPLICATIONS

Quality is an essential aim of all manufacturing industries and their goods. The present interest in the pharmaceutical sector is in the several viewpoints on attaining such quality and has indeed been maintained by validation. Validation is among the key processes in attaining and preserving the ultimate product quality. Validation of processes stresses components of process design and maintenance of process control throughout marketing. The validation research must demonstrate and record the precision, sensitivity, characteristics and repeatability of the test techniques used by companies. Validation is therefore a crucial component of quality assurance. This study is intended to offer an understanding of the process validation of pharmaceutical products having a particular focus to the US Food and Drug Administration standards (FDA).

Multicenter Clinical Evaluation of ETEST Plazomicin (PLZ) for Susceptibility Testing of Enterobacterales.

ABSTRACTPlazomicin (PLZ), brand name ZEMDRI (Cipla Therapeutics), is a novel aminoglycoside antibiotic approved by the U.S. Food and Drug Administration (FDA) for treatment of complicated urinary tract infections including pyelonephritis. ETEST® is a gradient diffusion method that represents an alternative to the more laborious broth micro-dilution (BMD) method for performing antimicrobial susceptibility testing (AST). A multi-center evaluation of the performance of the new ETEST PLZ (bioMérieux) was conducted in comparison with BMD following FDA and International Standards Organization (ISO) recommendations using FDA-defined breakpoints. Clinical isolates of Enterobacterales (n = 598) were included. Fifty-three isolates were resistant to PLZ according to BMD. Overall, the ETEST PLZ demonstrated 99.0% essential agreement (EA), 92.8% category agreement (CA), 1.9% very major errors (VME), 0% major errors (ME), and 7.0% minor errors (mE) with both clinical and challenge isolates of Enterobacterales. The VME was found for a single Serratia marcescens strain. Individual species demonstrated EA rates ≥ 90%. In conclusion, we report that ETEST PLZ represents an accurate tool for performing PLZ AST of Enterobacterales.

Manganese Intake in Babies: Drinking Water plus Formula Can Cause High Exposures.

Manganese Intake in Babies: Drinking Water plus Formula Can Cause High Exposures.

Characteristics of Oil Mixed Red Palm Oil with Catfish Oil (Pangasius hypothalmus)

Riau Province is the region that has the largest plantation area in Indonesia with 2.4 million hectares of land in 2017 and production contributes 6 million tons per year and contributes 28.2 percent of Indonesia’s total CPO exports. On the other hand, the Kampar and Pelalawan districts are centers for the production of special freshwater fish for catfish (Pangasius hypoptalmus), where from year to year they have increased rapidly. This study aimed to charaterized oil mixed of red palm oil and catfish oil byproduct of catfish fillet. This research was conducted using a one-factor factorial experimental method, namely the difference in the ratio of the mixture between red palm oil and catfish oil. Red palm oil and catfish are stirred in a ratio of 70: 30 (B1), 60: 40 (B2), and 50:50 (B3). A serial of organoleptic and chemical test (saponification rate, iodine number, number acid, and fatty acid profile) were carried out. The results showed saponification rate was - 295.36, iodine concentration was 80.33 and acid number was 0.05. Furthermore, the fat content of each ratio B1 (14.28%, B2 (16.21% and B3 (17.11%), while the types of fatty acids obtained are saturated fatty acids (SAFA), unsaturated fatty acids single (MUFA) and polyunsaturated fatty acids (PUFA). The quality of the mixture of red oil and catfish oil produced in this study meets the FDA (Food and Drug Administration) standards, in which the best one was B3 (50: 50). It can be interpreted that the mixture can be used as a source of fatty acids needed by the body which contains omega-9 fatty acids, omega-6 and omega-3.

Irradiated Tree Nut Flours for Use in Oral Immunotherapy

Tree nut allergies affect an estimated 1% of the US population and is lifelong in 90% of allergic individuals. Oral immunotherapy (OIT) for food allergies is an effective method to induce desensitization in a majority of participants in trials of peanut, egg, and milk OIT. Limited trials using tree nut OIT have been reported, possibly due to the lack of standardized drug products. Food products used in OIT are considered drugs by the Food and Drug Administration (FDA) because they are intended to modulate the individuals' immune responses to the food allergens. As such, OIT drug products must meet FDA standards for acceptable levels of microbes and undergo testing for allergenic proteins. We aimed to determine the suitability of walnut, cashew, hazelnut, and almond flours for use in OIT trials. We employed gamma irradiation on commercially available walnut, cashew, hazelnut, and almond flours and tested their levels of microbial contamination, total protein, and allergen content, along with stability of these parameters over time. Our results demonstrate that irradiation of tree nut flours greatly diminishes the levels of total aerobic bacteria, mold, yeast, Escherichia coli, and Salmonella, whereas there are no substantial changes in total protein or allergen content. Importantly, the microbial levels, protein, and allergen content remained stable over a 24-month period. Irradiation of tree nut flours is a safe and effective method of processing to allow tree nut products to meet the FDA standards for OIT drug products.

Real-world evidence for U.S. Food and Drug Administration-approved oncology products, 2015 to 2020.

280 Background: Since the 21st Century Cures Act, there has been growing interest in using real-world evidence (RWE) to support regulatory filings for new drugs and indications. The goal of this study was to provide a comprehensive source of RWE use cases of U.S. Food and Drug Administration (FDA) approvals for oncology products. Methods: A systematic review of FDA new drug applications (NDAs) and biologics license applications (BLAs) from 1/2015-2/2020 for approved oncology products was performed. Data on the RWE study were extracted (data source, study design, statistical methods, results), and corresponding FDA comments were synthesized to identify patterns of the FDA’s review. Results: We identified 102 NDAs and BLAs, 8 (8%) of which included RWE, all post-Cures Act (see Table). RWE supporting avelumab, axicabtagene ciloleucel, and avapritinib were received positively and used by the FDA in their approval decision. RWE results were used to provide contextualization to the pivotal trial, rather than statistical comparison. Common data sources included Flatiron (38%) and chart reviews (38%). FDA critiques included lack of a priori study protocol, incomparability with the pivotal trial population and endpoints, and uncontrolled confounding. Conclusions: There have been few examples of RWE in oncology submissions, and most served to complement clinical trial results. To meet FDA standards, RWE studies should be clearly designed and discussed with the FDA and include robust methods to minimize bias. [Table: see text]

Zwitterionic carboxybetaine polymers extend the shelf-life of human platelets

The shelf-life of human platelets preserved in vitro for therapeutic transfusion is limited because of bacterial contamination and platelet storage lesion (PSL). The PSL is the predominant factor and limiting unfavorable interactions between the platelets and the non-biocompatible storage bag surfaces is the key to alleviate PSL. Here we describe a surface modification method for biocompatible platelet storage bags that dramatically extends platelet shelf-life beyond the current US Food and Drug Administration (FDA) standards of 5 days. The surface coating of the bags can be achieved through a simple yet effective dip-coating and light-irradiation method using a biocompatible polymer. The biocompatible polymers with tunable functional groups can be routinely fabricated at any scale and impart super-hydrophilicity and non-fouling capability on commercial hydrophobic platelet storage bags. As critical parameters reflecting the platelets quality, the activation level and binding affinity with von Willebrand factor (VWF) of the platelets stored in the biocompatible platelet bags at 8 days are comparable with those in the commercial bags at 5 days. This technique also demonstrates promise for a wide range of medical and engineering applications requiring biocompatible surfaces. Statement of significanceCurrent standard platelet preservation techniques agitate platelets at room temperature (20–24 °C) inside a hydrophobic (e.g., polyvinyl chloride (PVC)) storage bag, thereby allowing preservation of platelets only for 5 days. A key factor leading to quality loss is the unfavorable interaction between the platelets and the non-biocompatible storage bag surfaces.Here, a surface modification method for biocompatible platelet storage bags has been created to dramatically extend platelet shelf-life beyond the current FDA standards of 5 days. The surface coating of the bags can be achieved via a simple yet effective dip-coating and light-irradiation method using a carboxybetaine polymer. This technique is also applicable to many other applications requiring biocompatible surfaces.

Evaluation of lead and cadmium concentrations in lipstick and eye pencil cosmetics

Background: The aim of this study was to determine the concentrations of lead (Pb) and cadmium (Cd) in lipstick and eye pencil cosmetics of different grades in the markets of Iran. Methods: This descriptive study was conducted in Ahvaz city in 2018. Sixty different samples of lipstick and eye pencil of three common brands were selected and analyzed using the Inductively Coupled Plasma Atomic Emission Spectroscopy (ICP-OES) and the results were compared with standard values recommended by the Food and Drug Administration (FDA). The analysis of lipsticks was based on producer country and colors and producer country only for eye pencil. Results: The mean concentrations of Pb and Cd were 41.86 and 53.42 µg/g, respectively. Concentrations of lead were higher than those of Cd in lipsticks, while for eye pencil, Cd showed higher concentrations. The overall results indicated that in all brands and colors of lipsticks, only 33% of the samples had Pb content less than the FDA limit, and among lipstick samples, 44% had Cd concentration less than the FDA limit of 3 μg/g, however, in 100% of the eye pencil samples, the concentration of Cd was higher than the recommended value of 3 μg/g. Conclusion: Given the health risks of exposure to heavy metals and in order to increase community awareness about the harmful effects of cosmetics, it is necessary to monitor the concentration of these toxic elements in these products and encourage the manufactures to meet the FDA standards.

U.S. sweeteners: Combating excess consumption with an excise tax?

AbstractObesity is a public health problem in the United States that has been linked to excess sweetener consumption. The American Heart Association (AHA) recommends no more than 6–9 teaspoons/capita/day, while the U.S. Food and Drug Administration (FDA) recommends 200 calories/capita/day of caloric sweetener consumption. Both recommendations are well below the reported 2016 sweetener consumption levels. We quantify the input tax rates needed to reduce the current excess sweetener consumption level to the AHA and FDA recommended standards. We calculate the joint tax in the United States on two major sweeteners, sugar and High Fructose Corn Syrup (HFCS), to be 31 and 24 cents per pound, respectively, based on the AHA standard, and 19 and 17 cents per pound, respectively, using the FDA standard. These taxes would be roughly the magnitude of the existing sugar and HFCS prices. In both cases, the tax incidence on producers is much smaller than on consumers. Our focus is very different from past studies in that it deals with the effect of taxes on inputs to meet the recommended target rather than a selective tax (sugar‐sweetened beverage tax). If a sweetener tax were implemented, U.S. sugar and HFCS producers would lose US$398–US$489 and US$683–US$844 million per year, respectively.

Do drug package inserts meet the rules and regulations of Iran's Food and Drug Administration in terms of informing patients?

Background: Drug package inserts (PIs) are the most accessible source of information for users and are designed to aid the safe use of medicines and avert adverse events. This study measured the conformity of PIs with the health communications standards of Iran’s Food and drug Administration (FDA). Methods: This descriptive cross-sectional study evaluated 92 PIs related to 22 best-selling neurological and psychiatric drugs in Iran based on criteria approved by Iran’s FDA. Six categories of criteria were considered in evaluating the extent of conformity: I) writing and formatting, II) references, III) drug description, IV) warnings and precautions, V) interactions, and VI) side effects. Each PI was scored based on observation of standards; data was analyzed using Microsoft Excel pivot tables. Results: In total, 2929 items from 92 PIs were evaluated, of which 37 (40.2%) were related to antidepressants, 31 (33.7%) to sedatives and hypnotics, and 24 (26%) to anticonvulsant drugs. The PI content was insufficient in various aspects of conformity with standards in each category. Among the six categories, the best match was found in warnings and precautions with 667items (72.5%), followed by writing and formatting with 663 (69.1%). The lowest conformity was found in the reference category with 194 (26.4%) items. Conclusion: The PIs of Iranian neurological drugs do not fully meet Iran’s FDA standards. It is strongly recommended that smart PIs be developed using mobile apps to overcome this problem.

Contamination and Prevalence of Histamine in Canned Tuna from Iran: A Systematic Review, Meta-Analysis, and Health Risk Assessment

Histamine is one of the most important health issues associated with consumption of canned tuna because of possible allergic and anaphylactic reactions in consumers. Although the concentrations of histamine in tuna in Iran have been investigated in several studies, definitive conclusions are elusive. This study was undertaken as a systematic review and meta-analysis of the concentration and prevalence of histamine in Iranian canned tuna, and the related health risk was assessed. An extensive search of articles in the databases Scopus, PubMed, and Scientific Information Database resulted in 11 articles and a total of 693 samples for inclusion in this review. The minimum and maximum concentrations of histamine were determined as 8.59 ± 14.24 and 160.52 ± 87.59 mg kg−1, respectively. The mean concentration was calculated as 77.86 mg kg−1 (95% confidence interval [CI], 47.51 to 108.21 mg kg−1), which was lower than the 200 mg kg−1 recommended limit by the U.S. Food and Drug Administration (FDA). The mean prevalence of histamine was 9.19% (95%; CI, 6.88 to 11.5%). The 95% value of the target hazard quotient for adult consumers was calculated as 0.10. In all studies performed in Iran, the concentration of histamine in canned tuna was lower than FDA standard. Health risk assessment indicated low histamine risk (target hazard quotient < 1) for adults in Iran from consumption of canned tuna.

Fully validated SRM-MS-based method for absolute quantification of PIVKA-II in human serum: Clinical applications for patients with HCC

Protein induced by vitamin K absence or antagonist-II (PIVKA-II), an abnormal form of prothrombin, is used as a serological biomarker that aids in the diagnosis of hepatocellular carcinoma (HCC). PIVKA-II is typically measured by liquid binding assay (LiBA). However, without an internal standard, it is difficult to obtain accurate results. Thus, we aimed to develop a selected reaction monitoring-mass spectrometry (SRM-MS)-based assay to quantify PIVKA-II in serum. Our SRM-MS assay entailed the addition of a protein analog as an internal standard, the enrichment of PIVKA-II using a monoclonal antibody, chymotrypsin digestion, online desalting, and SRM-MS analysis. The performance of the SRM-MS assay was compared with that of LiBA in 400 human serum samples (100 chronic hepatitis, 100 liver cirrhosis, and 200 HCC). Integrated multinational guidelines were followed to validate the assay for clinical implementation. The linearity ranged from 1.28 to 100,000 ng/mL, and the use of a labeled protein analog as an internal standard allowed the error from the sample preparation to be corrected, improving the precision and accuracy. The SRM-MS assay was validated to meet all of the criteria of the compliance with guidelines per the US Food and Drug Administration (FDA), European medicines agency (EMA), Korea FDA (KFDA), and Clinical & Laboratory Standards Institute (CLSI). We have developed and validated a robust and reproducible SRM-MS assay that is superior to the conventional method of distinguishing HCC from noncancer patients, based on PIVKA-II levels, and satisfies clinical standards. This method has potential applications in quantifying other protein biomarkers.

Theranos Experience Exposes Weaknesses in FDA Regulatory Discretion.

Theranos Experience Exposes Weaknesses in FDA Regulatory Discretion.

Timely Hospital Glucose Measurement: Here Today, Gone Tomorrow?

From the Diabetes Research Institute, Mills-Peninsula Health Services, San Mateo, CA (D.C.K.); Walter Reed National Military Medical Center, Bethesda, MD (R.A.V.); Vanderbilt University School of Medicine, Nashville, TN (J.H.N.); and University of Florida College of Medicine, Gainesville (M.J.R.). B lood glucose meters (BGMs), first introduced in the US market in the 1970s, have revolutionized the care of patients with diabetes. Improved glucose control, enabled by frequent measurement, has greatly reduced long-term cardiovascular, renal, and ophthalmic complications. Although these devices were originally designed for and approved by the Food and Drug Administration (FDA) for “OTC self-monitoring by laypersons,” they have ubiquitously migrated into the hospital environment in which they have become the mainstay for inpatient glucose testing. Approximately 500 million of these tests are performed per year in US hospitals. The increase in hospital point-of-care (POC) testing is the result of 4 major phenomena: (1) the move toward tight glycemic control (TGC); (2) the emergence of rapid, easy-to-use, and inexpensive BGMs that require a small finger-stickederived sample of whole blood; (3) the progressive improvement in the accuracy of these devices; and (4) the increased prevalence of patients with diabetes. Point-of-care BGMs for hospitalized critically ill patients are now at risk because of new enforcement policies proposed by the Centers for Medicare & Medicaid Services (CMS) prohibiting the off-label use of these devices. As the CMS attempts to protect patients from this technology, which has not been appropriately tested to FDA standards, such enforcement will eliminate this important tool and no adequate replacement technology currently exists. The result will be a CMSmandated significant decline in the quality of care for diabetes patients in the United States. Here, we describe why POC BGMs are used in critically ill patients, how they have been regulated, how they are about to be regulated, and what can be done to safely transition from inadequate documentation to proper documentation of the performance of this tool.

Critical drug shortages: implications for emergency medicine.

Prescription drug shortages have become increasingly common and more severe over the past decade. In addition, reported shortages are longer in duration and have had a greater effect on patient care. Some of the causes of current drug shortages are multifactorial, including the consolidation of drug manufacturers, quality problems at production plants that restrict the supply of drugs, and a lack of financial incentives for manufacturers to produce certain products, particularly generic medications. Generic injectable medications are most commonly affected by shortages because the production process is complex and costly for these drugs, and profit margins are often smaller than for branded medications. Many commonly used emergency department (ED) generic injectables have been affected by shortages, including multiple resuscitation and critical care drugs. Several reports have shown that shortages can potentially have major effects on the quality of medical care, including medication errors, treatment delays, adverse outcomes, and increased health care costs. Currently, no published data exist outside of case reports that directly link ED-based drug shortages to overall patient safety events; however, there are several examples in the ED where first-line therapies for life-saving medications have been in short supply, and alternatives have higher rates of adverse events, narrower therapeutic indexes, or both. Aside from increasing notification about shortages, the U.S. Food and Drug Administration has little power to coerce manufacturers to produce medications during a shortage. Therefore, ED providers must learn to mitigate the effects of shortages locally, through active communication with pharmacy staff to identify safe and effective alternatives for commonly used medications when possible. Particularly given the effect on critical care medications, therapeutic alternatives should be clearly communicated to all staff so that providers have easy access to this information during resuscitations. This review focuses on the etiology of drug shortages, their effect on the ED, and potential solutions and mitigation strategies.

Evaluating eating behavior treatments by FDA standards

Behavioral treatments for obesity are not evaluated by the same criteria as pharmaceutical drugs, even though treatments such as low-calorie dieting are widely prescribed, require patients’ time and investment, and may have risks. The Food and Drug Administration (FDA) has a procedure for evaluating drugs, in which drugmakers must answer the following questions: (1) Is the treatment safe? (2) How dangerous is the condition the intervention is treating? (3) Is the treatment effective? (4) Is the treatment safe and effective for large numbers of people? We argue that using this framework to evaluate behavioral interventions could help identify unanswered research questions on their efficacy and effectiveness, and we use the example of low-calorie dieting to illustrate how FDA criteria might be applied in the context of behavioral medicine.

An evaluation of lead concentrations in imported hot sauces

In the last decade, the U.S. Food and Drug Administration (FDA) has issued several warnings and recalls for food products that exceed FDA standards for lead. Products containing chili peppers and salt were often suspected as sources of lead contamination, and included items such as candy that are routinely investigated. However, products such as hot sauces that contain similar ingredients have not been the focus of evaluations. This study quantified lead concentrations in imported hot sauces, evaluated product compliance to existing United States standards, and calculated potential dietary lead exposure for children using the Integrated Exposure Uptake Biokinetic Model. Finally, recommendations for reducing the risk of lead exposure from hot sauces are provided. Twenty-five (25) bottles of imported hot sauces manufactured in Mexico and South America were purchased in Clark County, Nevada. All hot sauces were analyzed for lead concentrations, pH, and leaded packaging. Hot sauces were analyzed by inductively coupled plasma mass spectrometry and packaging was analyzed using x-ray fluorescence technology. Four brands of hot sauces (16%) exceeded 0.1 ppm lead, the current FDA action level for lead in candy. Hot sauces with lead concentrations >0.1 ppm lead contained salt and were manufactured in Mexico. Subsequent analysis of additional lots of hot sauces exceeding 0.1 ppm lead revealed inconsistent lead concentrations between and within manufacturer lots. The lead concentrations of the plastic hot sauce lids ranged from below the limit of detection to 2,028 ppm lead. There was no association between lead concentrations in hot sauces and pepper type. These results indicate the need for more rigorous screening protocols for products imported from Mexico, the establishment of an applicable standard for hot sauce, and resources to allow for the enforcement of existing food safety policies. The data reported herein represent the first known investigation of lead concentrations in hot sauces.