Label Claim Research Articles

Non-destructive quantitative analysis of pharmaceutical ointment by transmission Raman spectroscopy

Transmission Raman spectroscopy was used to develop a non-destructive quantitative analytical model for the assay of a crystal dispersion-type ointment containing acyclovir as a model drug with a concentration of 3% w/w. The obtained Raman spectra were pre-processed by applying multiplicative scatter correction, standard normal variate, and first or second derivative by the Savitzky-Golay method to optimize the partial least squares (PLS) regression model. The optimized PLS model showed good prediction performance for 85%, 100%, and 115% label claims, with average recovery values of 100.7%, 99.3%, and 99.8%, respectively. Although the material properties and manufacturing method of acyclovir and white petrolatum were expected to be different from those of the calibration set, the mean recovery value of the commercial product was 104.2%. These results indicate that transmission Raman spectroscopy is a useful process analytical technology tool for product development and quality control of a crystal dispersion-type ointment with low drug concentration.

Pesticides Use Pattern in Okra

A survey on the pesticide usage pattern in okra conducted among 100 farmers in Tapi District of Gujarat during 2017-18, revealed a clear trend in greater use of newer molecules followed by organophosphorous insecticides. Changing trend in awareness among farmers on the use of stick for mixing, and of measuring cup, and not reusing the pesticide containers for household purpose was observed. However, farmer’s knowledge on recommended pesticide, dosage, safe harvest interval, label claim, personnel protection as well as spraying, proper disposal of pesticide container was lacking, but their knowledge was fair enough on time of application and storage, proper mixing and measuring of pesticides. To produce pesticide residue free okra fruit, it is essential to educate the farmers about proper preharvest interval, use of recommended pesticides, increased awareness about restricted and banned ones, and health hazards caused by misuse of pesticides.

Clean vs dirty labels: Transparency and authenticity of the labels of Ceylon cinnamon.

Ceylon cinnamon, which was regarded as a luxury spice during ancient times, has been consumed for its medicinal properties and health benefits for thousands of years. For centuries, Arabian traders controlled the European cinnamon trade through limited supplies from a country which they did not reveal. Content marketing analysis and chemical profiling of value-added products of Ceylon cinnamon in the global marketplace are proposed to investigate the clean status of the product labels. In the present study, a mixed-method approach was employed to investigate the labels of 6 types of value-added forms of cinnamon; i.e. quills, powder, tea, breakfast cereals, confectionery and bakery and nutraceuticals which are used in USA, UK, Mexico, Japan and products of Sri Lankan cinnamon exporters. Two hundred and seventy-six labels were analyzed to find out the aspects of clean status, transparency and authenticity. Key label claims of the cinnamon products lie within the bounds of cleaner, healthy, nutritional and sustainable attributes. Consumer perception lies within ingredients, nutritional value, country of origin and claim on safety and quality standards and certification. The value chain transparency, ethical rules (species mislabeling), and chemical profile of the pharmaceutical, confectionery and fragrance industry inputs were ignored. The best claim and competitive advantage of the Ceylon cinnamon; an ultra-low level (<0.01 mg/g Dry Weight) of Coumarin, were rarely indicated in labels. Lack of clean labels and traceability lagged Ceylon cinnamon in the 40 international markets while Cassia cinnamon (Coumarin content 2.23 mg/g DW), a major competitor of Ceylon cinnamon appears in the market with dirty labels. Millennials and upper-middle-class female consumers in their active ages, place a high demand on Ceylon cinnamon. Today's tech-savvy global consumers of Ceylon cinnamon use market intelligence frequently for identifying product authenticity. Well equipped clean labels were found to be demanded by the modern cinnamon consumers.

IN VITRO ASSESSMENT OF PHYSICOCHEMICAL PARAMETERS OF FIVE GENERICS AMLODIPINE BESYLATE TABLETS MARKETED IN YEMEN

Objective: The present paper aims to evaluate the quality of five different brands (local and imported) of oral film-coated tablets of generic Amlodipine besylate 5 mg marketed in Sana`a-Yemen, through physiochemical parameters. Methods: Different physicochemical parameters, including the uniformity of tablet weight, hardness, thickness, disintegration time, and an assay of active ingredients, were conducted to validate the quality of generics Amlodipine Besylate 5 mg according to USP specification. Results: From the obtained results, it was observed that all the brands of Amlodipine Besylate 5 mg have passed the tests and met the specifications of USP. Results of weight variation, hardness, thickness, and disintegration time were ranged from-3.8 % to+5.13 % to-1.25 % to+3.25 %, 5.06±0.31 to 13.21±1.5, 2.682±0.04 to 3.676±0.01 and 25 s to 2 min: 30 s, respectively. The dissolution test and the assay results of all the brands are also ranged within the acceptable label claim 93.7±2.24 to 98.4±0.85 and 93.22±0.38 to 100.15±0.33, respectively. However, there is no relation was found between the disintegration time and the dissolution test. Conclusion: According to the finding, all the selected Amlodipine Besylate 5 mg brands are met pharmacopeia standards and USP specifications. Therefore, the local and imported Amlodipine Besylate 5 mg can be used safely to get the desired therapeutic efficiency.

Development of symptom-focused outcome measures for advanced and indolent systemic mastocytosis: the AdvSM-SAF and ISM-SAF\xa9

BackgroundAdvanced systemic mastocytosis (AdvSM), indolent systemic mastocytosis (ISM), and smoldering systemic mastocytosis (SSM) are rare diseases characterized by neoplastic mast cell infiltration of more than one organ. A content-valid patient-reported outcome (PRO) questionnaire that assesses relevant signs and symptoms that are important and understandable to individuals with a condition is critical for assessing new treatment benefit as well as supporting product labeling claims. Notably, no such PRO questionnaire has been developed in accordance with regulatory and scientific guidelines for use in AdvSM, ISM, and SSM patient populations. To fill that gap, this study documents the development and content validity of instruments evaluating signs and symptoms of systemic mastocytosis.MethodsA review of peer-reviewed literature, advice meetings with clinical therapeutic area experts, patient concept elicitation interviews, concept selection and questionnaire construction meetings, and patient cognitive debriefing interviews were conducted, and regulatory feedback was incorporated.ResultsFor AdvSM, 26 sign- and symptom-level concepts were identified in literature, 39 by clinicians, and 33 by patients. For ISM/SSM, 38 sign- and symptom-level concepts were identified in the literature, 39 by clinicians, and 57 by patients. Two patient-reported instruments, the Advanced Systemic Mastocytosis Symptom Assessment Form (AdvSM-SAF) and Indolent Systemic Mastocytosis Symptom Assessment Form (ISM-SAF)(©Blueprint Medicines Corporation), were developed based on consolidated findings. Cognitive debriefing interviews with AdvSM and ISM patients showed the AdvSM-SAF and ISM-SAF were understood and interpreted as intended by the majority of patients.ConclusionThe AdvSM-SAF and ISM-SAF are content-valid tools measuring symptoms from AdvSM and ISM patients’ perspective.

Living well with kidney disease by patient and care-partner empowerment

Living with chronic kidney disease is associated with hardships for patients and their care-partners. Empowering patients and their care-partners, including family members or friends involved in their care, may help minimize the burden and consequences of chronic kidney disease-related symptoms to enable life participation. There is a need to broaden the focus on living well with kidney disease and re-engagement in life, including an emphasis on patients being in control. The World Kidney Day Joint Steering Committee has declared 2021 the year of ‘Living Well with Kidney Disease’ in an effort to increase education and awareness on the important goal of patient empowerment and life participation. This calls for the development and implementation of validated patient-reported outcome measures to assess and address areas of life participation in routine care. It could be supported by regulatory agencies as a metric for quality care or to support labeling claims for medicines and devices. Funding agencies could establish targeted calls for research studies that address the priorities of patients. Patients with kidney disease and their care-partners should feel supported to live well through concerted efforts by kidney care communities including during pandemics. In the overall wellness program for patients with kidney disease, the need for prevention should be reiterated. Early detection with a prolonged course of wellness despite kidney disease, after effective secondary and tertiary prevention programs, should be promoted. World Kidney Day 2021 continues to call for increased awareness of the importance of preventive measures throughout populations, professionals, and policy makers, applicable to both developed and developing countries.

Living Well with Kidney Disease by Patient and Care-Partner Empowerment

Living with chronic kidney disease (CKD) is associated with hardships for patients and their care-partners. Empowering patients and their care-partners, including family members or friends involved in their care, may help minimize the burden and consequences of CKD-related symptoms to enable life participation. There is a need to broaden the focus on living well with kidney disease and re-engagement in life, including an emphasis on patients being in control. The World Kidney Day (WKD) Joint Steering Committee has declared 2021 the year of “Living Well with Kidney Disease” in an effort to increase education and awareness on the important goal of patient empowerment and life participation. This calls for the development and implementation of validated patient-reported outcome measures to assess and address areas of life participation in routine care. It could be supported by regulatory agencies as a metric for quality care or to support labelling claims for medicines and devices. Funding agencies could establish targeted calls for research that address the priorities of patients. Patients with kidney disease and their care-partners should feel supported to live well through concerted efforts by kidney care communities including during pandemics. In the overall wellness program for kidney disease patients, the need for prevention should be reiterated. Early detection with a prolonged course of wellness despite kidney disease, after effective secondary and tertiary prevention programs, should be promoted. WKD 2021 continues to call for increased awareness of the importance of preventive measures throughout populations, professionals, and policy-makers, applicable to both developed and developing countries.

Consumer perception of dried dairy ingredients: Healthy, natural, and sustainable?

Conscious consumerism is growing, along with consumer demand for socially conscious dairy products or dairy alternatives. To successfully position dairy products (especially conventional dairy) in this changing marketplace, dairy producers and processors must understand how to strategically use both on- and off-package messaging aligned with consumer perceptions. However, consumer perception of attributes such as sustainable, natural, and healthy is complex, and varies between product categories as well as among products within a category. The objective of this study was to characterize consumer definitions of the terms "sustainable," "natural," and "healthy" as they pertain to dried dairy ingredients. To meet this objective, we conducted an online survey with 3 maximum difference scaling exercises to determine the importance of 63 label claims to consumer definitions of the terms sustainable, natural, and healthy. The role of priming with dried ingredient processing information on consumer perception of these terms was also explored. Within the dried dairy ingredients category, there is extensive cognitive overlap between the terms sustainable, natural, and healthy. Priming did not affect consumer definitions of any of these terms. Certification-related claims were considered among the least important claims for consumer definitions of sustainable, natural, and healthy, whereas claims that were simple to read and visualize were considered among the most important. Claims related to animal welfare and happiness or simple, minimal ingredients and processing were considered by consumers to be important for all 3 terms. For each of these terms, there was a cluster of consumers who defined the term primarily by simple ingredients and minimal processing, and another cluster who defined the term primarily by happy cows and conscious farming practices. The terms sustainable and healthy each had a third, unique consumer cluster. This third definition cluster defined sustainability primarily by environmental effects, whereas this cluster defined healthy primarily in fitness and nutrition terms. Age and to a lesser extent, gender, affected importance placed on these 3 terms and also affected definition of the term. Understanding these consumer definitions provides insight on how to formulate marketing and educational messaging to speak to each consumer segment.

Analyses of consumers' preferences and of the correspondence between direct and indirect label claims and the fatty acid profile of milk in large retail chains in northern Italy

Combined results from 2 survey studies were used to obtain information useful for the industries and retailers involved in the milk production and selling chain in North Italy. The first survey identified different clusters of fluid milk purchasers by examining their preferences and attitudes toward 12 intrinsic-extrinsic and credence milk attributes, by applying best-worst scaling methodology, whereas the second survey characterized the fatty acid (FA) profiles of commercial milk sold by large-scale retailers to verify the correspondence between the actual FA profile and the direct and indirect claims on the labels. To summarize information about the FA profile of milk, which may be considered an advanced attribute of milk quality, the milk FA index (MFAI) was calculated for each milk sample. A total of 130 milk samples (around 85% of the labels in northern Italy) and a total of 502 participants who answered a face-to-face questionnaire were considered in the 2 surveys. The milk samples were 13.1% organic, 9.2% certified as being of mountain origin, and over 50% noncertified but linked to cow grazing or to a mountain environment on their labels. The FA profiles showed a wide range of variation, with saturated FA ranging from 63.4 to 71.8, and polyunsaturated FA from 2.76 to 5.85. The FA profile and MFAI index of certified milk (organic or mountain-derived) were significantly different from the profiles of noncertified milk, whereas no correspondence was observed between the retail price and milk quality. When ranked on the basis of MFAI, which proved to be a good discriminating tool, the certified milks presented a bimodal distribution, indicating that certification does not always guarantee a real difference. The consumers chose milk considering the origin of the product, brand, expiration date, and process certification as the most important attributes, whereas they rated price and organic certification as the least important attributes. The study showed that about 20% of the consumers had a high propensity to buy milk on the basis of its quality. However, this attribute is often incorrectly indicated or not indicated at all on the milk label, with misleading images or claims that do not correspond to the actual FA quality of the milk. Having a clear index that offers information about the FA profile could thus be an interesting tool to improve the awareness of buyers and to valorize and differentiate milk products.

Association of partial systemic exposure and abuse potential for opioid analgesics with abuse deterrence labeling claims supporting product-specific guidance.

BackgroundOver the past decade, U.S. FDA has approved 10 opioid analgesics in abuse-deterrent formulations (ADFs). ADFs are intended to reduce abuse of a prescription opioid through manipulation of the product to use one or more routes of abuse. Although it is critically needed for evaluation of the abuse deterrent properties of an opioid product, the relationship between systemic exposure and likelihood of abuse of the opioid has not been fully characterized. To fill the current knowledge gap, we have evaluated the association of subjective measures predictive of abuse potential (e.g., scores of “drug liking,” “take drug again”), which are referred to as ‘pharmacodynamic (PD)’ responses for measuring abuse potential, with systemic exposure of the opioid using the data from all the clinical abuse potential trials submitted to FDA in support of the approval of innovator ADFs.MethodsExtensive pharmacokinetic (PK) and subjective response data from 11 clinical abuse potential trials in recreational opioid users following oral and nasal administration of intact and manipulated oxycodone, hydrocodone and morphine products from the FDA internal database were utilized for the present analysis. This retrospective study used data collected from January 11th, 2010 until March 25th, 2015. The potential relationship between PK metrics, especially those for early exposure measures, and the subjective measures of drug liking and take drug again as PD metrics of abuse potential were explored using linear and logistic regression analyses. Heterogeneity analysis was conducted to assess study-to-study variation and multi-level logistic regression analysis was used to affirm the identified PK-PD relationship based on pooled data.FindingsFollowing oral and nasal administration of intact and manipulated opioids, the maximum visual analogue scale (VAS) for Drug Liking was generally achieved no later than the time to peak plasma drug concentration. Both heterogeneity analysis and multi-level logistic regression indicated insignificant inter study variability for the evaluated PK-PD relationships. Duration of Drug Liking response (i.e., VAS ≥ 65) lasted for 2 to 4 h after drug administration. The early portion of the systemic area under the plasma concentration-time curve (AUC), e.g., partial AUCs in the first 3 h and 4 h were found to be associated with abuse potential measures including maximum Drug Liking VAS and maximum Taking Drug Again VAS. Neither a formulation factor (e.g., immediate-release vs. extended-release, intact vs. manipulated) nor a route of administration was identified as a significant factor together with early partial AUCs to predict the probability of maximum Drug Liking or maximum Take Drug Again responses being greater than or equal to 65.InterpretationOur assessment indicates that the measure of early systemic drug exposure of opioids is the best predictor of the abuse potential response in recreational opioid users following oral or nasal administration of a single dose of an intact or manipulated abuse deterrent opioids. Our findings support FDA's recommendation of comparative PK studies with early partial AUCs as a supportive PK metric for the assessment of abuse deterrent properties of generic opioid drug products in the general and product-specific guidance's of ADFs.FundingThe study was partially funded by Fiscal Year 2017 Critical Path of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration.

Claims of Reduced Odor on Tobacco Packs in Low- and Middle-Income Countries.

IntroductionCigarettes designed to have less smoke smell were developed by the tobacco industry to supposedly reduce negative qualities. Cigarettes with marketing claims communicating these designs have been sold in high-income countries and marketing of “less smoke smell” terms on cigarette packaging can promote cigarette use. It is unclear to what extent they have been marketed in low- and middle-income countries (LMICs).Aims and MethodsThe Tobacco Pack Surveillance System (TPackSS) systemically collected tobacco packs available in 14 LMICs with high tobacco use between 2013 and 2017. We coded 4354 packs for marketing appeals, including claims related to smoke smell. We describe “less smoke smell” and similar claims found on these packs and compare across country and tobacco manufacturers.ResultsPhrases communicating less smoke smell were present on packs purchased in nine of 14 LMICs, including Bangladesh, Brazil, China, India, Mexico, Philippines, Russia, Ukraine, and Vietnam. The most commonly (74.1%) used terminology was “less smoke smell,” “LSS,” or a combination of the two. Packs from Russia had the most prevalent use (11.8%) of such claims. Companies using these terms across 21 brands included Japan Tobacco International (JTI), British American Tobacco (BAT), Philip Morris International (PMI), and other smaller companies. JTI accounted for 70.9% of packs with such terms.ConclusionsSome of the world’s largest tobacco companies are communicating less smoke smell on packs in LMICs. Less smoke smell and similar phrases on packaging should be prohibited because they can enhance the appeal of cigarettes.ImplicationsTobacco companies are using “less smoke smell” and similar phrases on cigarette packs in LMICs. These claims have the potential to increase the appeal of smoking and promote cigarette use. Countries should consider policies to restrict attractive labeling claims, in accordance with the WHO Framework Convention on Tobacco Control (FCTC) Article 13 guidelines, which recommends restrictions on attractive design elements on tobacco packaging.

Analytical strategies to determine the labelling accuracy and economically-motivated adulteration of “natural” dietary supplements in the marketplace: Turmeric case study

Turmeric has faced authenticity issues as instances of economic-adulterations to reduce the cost. We used carbon-14 and HPLC analyses as complementary methods to verify “all-natural” label claims of commercial dietary supplements containing turmeric ingredients. A high percentage of curcumin-to-curcuminoids value was used as an indicator to imply the presence of synthetic curcumin. However, using the HPLC method alone did not provide direct evidence of curcuminoids’ natural origin, whereas using only the carbon-14 method cannot test for potency label claims and determine which constituent(s) contain 14C radiocarbon. By analyzing results from both methods, a significant correlation between the percentage of curcumin-to-curcuminoids and % biobased carbon (Pearson’s r = −0.875, p < 0.001) indicated that synthetic curcumin was greatly attributed to determined synthetic ingredients. Only four out of the 14 samples analyzed supported authentic label claims. This orthogonal testing strategy showed its potential for the quality control of turmeric products.

In vitro Comparison of Pancreatic Enzyme Preparations Available in the Indian Market

PurposePancreatic enzyme replacement therapy (PERT) involves exogenous enzyme supplementation and is used in the treatment of pancreatic exocrine insufficiency. Clinical efficacy of PERT preparations is a function of physical properties and release kinetics that vary between commercially available products. In this study, we evaluated the physical properties, in vitro dissolution, and release kinetics of commercially available pancreatic enzyme preparations available in the Indian market.MethodsPhysical properties such as particle size distribution and water content of the capsules were measured by dynamic light scattering and Karl–Fischer titration method, respectively. An analytical procedure based on the European pharmacopoeia (EP) method was used to determine lipase activity, and a modified United States pharmacopoeia (USP)–based method was used for dissolution studies. Enzyme release was ascertained under gastroduodenal conditions in buffered media.ResultsConsiderable variations in physical properties such as particle size and water content were observed between pancreatic enzyme preparations. Some preparations failed to meet the labeled lipase content as per USP standards (>90% label claim) and showed inconsistent release behavior (>5% relative standard deviation).ConclusionDifferences exist between pancreatic enzyme preparations in terms of physical properties, dissolution, and release behavior that can affect their clinical efficacy. The present study suggests, therefore, that these preparations should not be used interchangeably.

Living Well With Kidney Disease by Patient and Care-Partner Empowerment: Kidney Health for Everyone Everywhere

Living with chronic kidney disease (CKD) is associated with hardships for patients and their care-partners. Empowering patients and their care-partners, including family members or friends involved in their care, may help minimize the burden and consequences of CKD-related symptoms to enable life participation. There is a need to broaden the focus on living well with kidney disease and re-engagement in life, including an emphasis on patients being in control. The World Kidney Day (WKD) Joint Steering Committee has declared 2021 the year of “Living Well with Kidney Disease” in an effort to increase education and awareness on the important goal of patient empowerment and life participation. This calls for the development and implementation of validated patient-reported outcome measures to assess and address areas of life participation in routine care. It could be supported by regulatory agencies as a metric for quality care or to support labeling claims for medicines and devices. Funding agencies could establish targeted calls for research that address the priorities of patients. Patients with kidney disease and their care-partners should feel supported to live well through concerted efforts by kidney care communities including during pandemics. In the overall wellness program for kidney disease patients, the need for prevention should be reiterated. Early detection with a prolonged course of wellness despite kidney disease, after effective secondary and tertiary prevention programs, should be promoted. WKD 2021 continues to call for increased awareness of the importance of preventive measures throughout populations, professionals and policy makers, applicable to both developed and developing countries. World J Nephrol Urol. 2021;10(1):1-6 doi: https://doi.org/10.14740/wjnu420

CBD oils on the Belgian market: A validated MRM GC-MS/MS method for routine quality control using QuEChERS sample clean up

Quality control of CBD oils on the Belgium market showed that the CBD content not always corresponds to the label claim. There is a pressing need to develop new analytical methods specifically developed to the assay of such oily samples. Analytical issues are, however, encountered for routine analyses due to the matrix complexity, high cost of cannabinoid standards and low Δ9-THC concentrations. An oily matrix could cause technical damages to analytical instruments and reduce the lifetime of the chromatographic columns. This paper proposes a procedure combining a sample cleanup by QuEChERS, removing the oily matrix, followed by a validated MRM GC-MS/MS method for the routine analysis of CBD oil samples. Eighteen CBD samples were selected on the Belgium market for analysis. This method allows the quantification of CBD, the legality check for the Δ9-THC content by a CBN standard and the screening of seven other cannabinoids namely CBN, CBDV, CBT, CBC, Δ8-THC, THCV and CBG. The method was validated at three concentration levels (0.5–1–2% (w/v)) for CBD and (0.05–0.1–0.2% (w/v)) for CBN. The detection limits for CBT, CBD, CBC, Δ8-THC, CBN and for the other cannabinoids of interest, were 10 and 14 ng/mL respectively. The accuracy profile values for CBD and CBN showed that the β-expectation tolerance intervals did not exceed the acceptance limits of ± 20%, meaning that 90% of future measurements will be included within this error range.

Fluorescence spectroscopy method for estimation of Ivabradine in bulk and the tablet dosage form

A simple and sensitive spectrofluorimetric method has been developed for the estimation of Ivabradine HCl in bulk and the tablet dosage form. Ivabradine HCl in methanol produces fluorescence at 325 nm (λem) with excitation at 287 nm (λex). The linearity range was found to be 100–500 ng/ml with a correlation coefficient of 0.999. The limit of detection (LOD) and limit of quantitation (LOQ) for the developed method were found to be 8.38 and 25.39 ng/ml, respectively. The developed method was found to be specific, sensitive, accurate, and precise. It was successfully used for the estimation of Ivabradine HCl in its tablet dosage form. The content of Ivabradine HCl in marketed formulations was found to be 101.25 ± 1.16 % of label claims.

To Estimate the Label claim of tablet in their combination by simultaneous estimation using UV-Visible Spectrophotometric method

Objective: The main objective of the work was to check the label claim of tablet in combination by Simultaneous estimation by UV method. Method: Spectrophotometric method development and validation are plays important role in the development and manufacture of pharmaceuticals. This Spectrophotometric method was a simple and reproducible for the quantitative determination of Paracetamol and Caffeine in tablet formulation was developed and validated in the present work. The various parameters like specificity, linearity, precision, accuracy, robustness and ruggedness were studied according to ICH guidelines. The wavelength 273nm was selected for the estimation of Caffeine using distilled water as a solvent and the wavelength 243nm selected for the estimation of Paracetamol using distilled water as solvent the drug obeyed Beer’s-Lambert’s law over the concentration range 20-120µg/ml. Recovery study was performed to confirm the accuracy of the method. The method was successfully applied for routine analysis of this drug in formulation the method were validated as pr ICH guidelines. Conclusion: A simple UV spectrophotometric method was developed for the Simultaneous determination of Paracetamol and Caffeine in tablet formulation without any interference from the excipients. The present method succeeded in adopting a simple sample preparation that achieve satisfactory extraction recovery and facilitated its application in co formulated formulation.

Microbial Variability of Commercial Equine Probiotics

Probiotics are defined as live microorganisms that confer a health benefit to the host when administered in adequate amounts, therefore the presence of viable microorganisms is essential. Previous studies reported inconsistencies when comparing contents of probiotics marketed for use in animals with label claims. However, to the author's knowledge the variability of the same product between different lots has yet to be evaluated. The objective of this observational study was to evaluate the content and inter-lot variability of commercial equine probiotic products using culture dependent and independent techniques. Eleven probiotics marketed for use in horses were evaluated for microbial content using culture-dependent and independent techniques. The content was then compared to microorganisms listed and quantities on the label of the probiotic. Statistical analyses were performed using a Kruskal-Wallis test. None of the 11 probiotics met their label claim. Nine of the 11 did not have statistically significant inter-lot variability. Several products lacked microorganisms listed on the label based on both culture and polymerase chain reaction (PCR) analyses.

Comparative analysis of the fatty acid composition of commercially available fish oil supplements in Turkey: Public health risks and benefits

Fish oil supplements have gained popularity in recent years due to their many health benefits, leading to a rapid increase in the number of fish oil supplements available to consumers during the COVID-19 pandemic. In this study, the fatty acid composition (FA) of 15 commercial fish oil supplements including syrups (SYR) and capsules (CAP) from the Turkish marketplace was analyzed and some quality indices were evaluated. In addition, EPA and DHA content of FA was compared with their label claims. Fish oil supplements were analyzed using gas chromatography-mass spectrometry (GC–MS) to determine their fatty acid composition and content. In fish oil supplements, the content of EPA ranged from 3.51 % to 20.51 %, and the contents of DHA ranged from 3.28%–52.42%. The label claims for EPA presented a reasonable accuracy for products examined, but it was observed that the DHA levels of some supplements showed a considerable difference with the labels. EPA and DHA levels of fish oil capsules on the Turkish retail market were more consistent with their claimed label content compared to fish oil syrups. The n3/n6 and PUFA/SFA ratios in the supplements were greater than those recommended by the FAO/WHO. The atherogenicity index (AI) and thrombogenicity index (TI) were below the maximum recommended limit value (1) in terms of coronary heart disease risk. Moreover, most of the supplements had higher lipid quality indices, including fish lipid quality (FLQ), hypocholesterolemic/Hypercholesterolemic (h/H) ratio, health-promoting index (HPI), polyene index (PI), and unsaturation index (UI).

Digging up the dirt on "clean" dietary labels: Public health considerations and opportunities for increased Federal oversight.

"Clean" dietary labels are often viewed by consumers as referencing products that are minimally processed, without additives, preservatives, artificial colors, or ingredients, but may also be interpreted as vegan, gluten-free, dairy-free, "real," or "natural." Although the "clean" diet trend continues to grow in popularity, there is a lack of consensus regarding the definition and use of this terminology with a corresponding lack of regulation for such labels in the United States. This multidisciplinary scoping review examines the public health implications of the "clean" label trend and the legal and policy landscape for regulation. We report on findings from case law and legal research generated through the Westlaw database and from the U.S. Food and Drug Administration (FDA) enforcement actions and website documents to discuss options for federal- and state-level intervention to mitigate harm. One feasible avenue for change is for the FDA to provide industry guidance, disseminate public statements to debunk myths, and enforce labeling statutes to police deceptive "clean" labeling claims. We also suggest consumer-protection litigation and state-level litigation via attorneys general as alternative actions to combat the abundant misinformation associated with "clean" diets and labels. Although the FDA has taken some enforcement actions, these efforts are insufficient given the proliferation of "clean" label products in the marketplace and the potential for adverse impacts on public health including increased risk for disordered eating. The current unregulated, undefined landscape for "clean" dietary labels thus requires urgent action by federal authorities and state attorneys general.