Label Claim Research Articles

Development and validation of UV spectroscopic method for the quantification of bempedoic acid in bulk and marketed product

Simple, rapid and precise UV spectroscopic method using two solvent blends such as Methanol: Distilled water 3:1 (DW) and Acetonitrile: Distilled water 3:2 (DW) were developed for the estimation of Bempedoic acid in bulk and marketed tablets as per ICH guidelines. The two proposed solvent blends validated for linearity, accuracy, precision, robustness, ruggedness and solution stability. The percent recoveries in the marketed tablet formulations were found to be good agreement with the label claim. The UV method validated statistically and the results suggest proposed solvent blends can employed for the routine analysis of Bempedoic acid in bulk and marketed tablet formulations.

Quantification of ivermectin in veterinary products consumed off-label as a treatment for COVID-19.

The COVID-19 pandemic caused global pandemonium, and due to an unprecedented global response, the popularity and use of (veterinary) ivermectin, amongst many other conceivable 'treatments', experienced a meteoric rise. Ivermectin is a macrocyclic lactone compound belonging to the avermectin drug class and is a registered medicine in many countries, although the most common use is as veterinary medicine. In this study, a fast HPLC method was developed and validated for the quantification of ivermectin in veterinary products that were used off-label by a substantial number of people during COVID-19. Locally used veterinary products were collected as well as commercial products acquired and were tested using the newly developed method. The ivermectin content was compared to the products' label claims and it was found that all products tested contained ivermectin within acceptable limits. However, the use of veterinary products is strongly discouraged due to high dosages and administration regimens that were tested in animals and can lead to serious adverse events in humans. The presence of untested excipients and secondary actives, such as clorsulon, which can cause unknown (long-term) health impacts in humans, further adds credence to this warning.

Regulatory Compliance of Health Claims on Omega-3 Fatty Acid Food Supplements.

Unlike the mandatory information that must be provided on a food supplement label, health claims are voluntary. This study assesses the regulatory compliance of omega-3 fatty acid (ω-3-FA) supplement label claims. Of the 97 supplements, 76 (78.4%) carried verbal claims referring to active substance, of which 68 (89.5%) were claims specific to ω-3-FA. According to the European Union Health Claims Registry, 107 claims listed on 59 supplements were authorized, as opposed to nine unauthorized claims on nine supplements. The degree to which claims aligned with regulatory standards, expressed in terms of scores scaled from 0 to 1, was the highest for supplements intended for pregnant women (1), while, in the case of adults, the mean score was 0.76 ± 0.35, and, in case of children, was 0.85 ± 0.27. Statistical analysis revealed a minor tendency for higher health claim scores to be associated with lower product prices. Furthermore, differences in compliance levels across groups of supplements formed according to the country of origin/sources of ω-3-FA/target populations were explored. The main differences were associated with products from Sweden and Italy/fish oil/supplements for pregnant women. A comparison of the daily intake of ω-3-FA provided by the supplement (based on labeled information) with the intake requirements for supplements with claims referring to ω-3-FA, supported 91 claims, five were unsubstantiated, and 11 were missing required data. Supplements also contained mineral- (19 approved) and vitamin-related claims (73, of which 9 were unauthorized). This study's findings reveal the extent of misuse of labelled information in markets that require pre-market supplement registration. Importantly, the non-compliance of health claims can significantly undermine consumer trust.

Label Accuracy and Quality of Select Weight-Loss Dietary Supplements Sold on or near US Military Bases.

Background/Objectives: Sixty-eight percent of service members are living with overweight or obesity, some who may not consult a healthcare provider when they decide to lose weight. Instead, they often turn to weight-loss dietary supplements for self-care solutions. The purpose of this case series study was to examine the label accuracy and quality of select weight-loss dietary supplements sold on or near US military bases across the country. Methods: Weight-loss dietary supplements (n = 44) were selected and purchased in GNCs, Exchanges, and Shoppettes across 12 military installations from March 2023 to January 2024. Liquid chromatography-mass spectrometry was used to verify the label accuracy according to the Supplement Facts listed ingredients and whether they contained any ingredients prohibited for use in the military. Product label claims were analyzed using the Operation Supplement Safety (OPSS) Risk Assessment Scorecard. Results: Thirty-six products (82%) had inaccurate labels. Twenty-seven (61%) had ingredients listed on the label not detected through analysis. Sixteen products (36%) contained hidden ingredients. The four products purchased within one mile from the base listed multiple prohibited ingredients on the labels, with all detected. Forty (91%) products scored a "no-go" according to the OPSS Scorecard and none contained a third-party certification seal on the label. Multiple stimulants were included in products such that the product safety was unknown. Conclusions: The majority of weight-loss dietary supplements analyzed in this case series study had inaccurate labels and were considered a "no-go" according to the Scorecard. Service members should only have access to safe, high-quality dietary supplement products. OPSS is collaborating with the Department of Defense stakeholders to determine the most effective ways for service members to have access to third-party certified products on all military establishments.

Antibiotic Residues in Cattle Reported to Be Raised Without Antibiotics.

In 2019, the U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) provided revised guidance for labeling claims of "raised without antibiotics" (RWA) and similar terms for meat and poultry produced in the US. In 2022, Price et al. published a study reporting that 15% of RWA-labeled cattle contained antibiotic residues in urine samples. In 2023, the USDA embarked on the project reported herein to independently determine the extent of antibiotic drug residues present in kidney and liver tissues from slaughtered cattle purported to be RWA. In this study, FSIS inspectors randomly collected kidney and liver tissues from 189 RWA animals in 79 slaughter establishments across the US. The samples were monitored for 185 veterinary drugs multiple times by different means, including liquid-chromatography coupled with tandem mass spectrometry (LC-MS/MS) and quadrupole high-resolution MS with an orbital ion trap instrument (LC-Q/orbitrap). Samples from 37 animals (20%) met the analytical identification criteria for at least one antibiotic confirmed in at least two analyses. Multiple antibiotics were determined in 11 RWA animals. Macrolides (tulathromycin, tildipirosin, tilmicosin, and gamithromycin) were confirmed in 20 (11%) of the RWA animals. The ionophore, monensin, was also confirmed in tissues from 11 samples, with unconfirmed/partial identifications in 8 others. Tetracyclines were confirmed in samples from 12 animals, several of which were found to contain multiple antibiotic residues. One animal each was also found to be positive for sulfamethazine (a sulfonamide antibiotic) and metabolites of penicillin G (a β-lactam antibiotic). Although they are not antibiotics, two anthelmintics (fenbendazole and eprinomectin) were confirmed in tissues from 3 RWA animals. FSIS has informed the slaughter establishments with positive results and advised them to conduct a root cause analysis and implement corrective actions.

The Quantitation of EPA and DHA in Fish Oil Dietary Supplements Sold in the United States

The dietary supplement industry is expanding, but it still remains far less regulated than the pharmaceutical industry, resulting in inconsistent quality control. Limited research has been performed in the U.S., particularly regarding the quantification of omega-3 fatty acids like eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). The aim of this study was to quantify the omega-3 fatty acid content in fish oil capsules and liquids purchased from major stores and a grocery chain and compare the results to their label claims. A total of 6 out of 15 were found to have EPA levels ±20% and 10 out of 15 were ±20% outside of the label claim for DHA. One product did not have a label claim for EPA and DHA, but did have a claim for total omega-3 content. These discrepancies indicate that consumers may unwittingly be consuming higher or lower quantities of omega-3 fatty acids than expected, potentially affecting their health outcomes.

Consumer willingness to pay for fair and sustainable foods: who profits in the agri-food chain?

Going through an era where sustainability and definitions of fairness have been extended and integrated into the agri-food chain, there is a need to understand, on a multi-dimensional and multinational level, the structure of agri-food value chain revenues and consumers’ intentions regarding necessity foods. The study analyzed 1,020 questionnaires from Algeria, Germany, Greece, Italy, and Tunisia revealing that taste prioritizes brand and packaging. Social networks, including family and friends, significantly influence the purchase of fair products. Furthermore, a choice experiment revealed the consumer preferences around attributes of the olive oil case as local, traditional, or organic, from a family or farmer association, in a glass bottle, purchased in small local shops/markets, typical and/or extensive nutritional labeling and health claims, non-relevant branding, and finally a fair price reflecting the reasonable quality of the olive oil product. Regarding the agri-food value chain, the results highlight the revenue distribution among stakeholders as unequal and unfair from consumer perceptions, with an imperative need for transparency. The study investigates in-depth the multifaceted dimensions of the fairness concept in the food market from a consumer’s perception, showing their willingness to pay for necessities based on fair pricing and sustainable practices.

PCR69 10 Years on From the FDA’s Women’s Health Research Roadmap: A Landscape Review of Female-Specific Clinical Outcome Assessments (COA), Health Agency Recommendations and Drug Label Claims With COA Related to Women’s Health

PCR69 10 Years on From the FDA’s Women’s Health Research Roadmap: A Landscape Review of Female-Specific Clinical Outcome Assessments (COA), Health Agency Recommendations and Drug Label Claims With COA Related to Women’s Health

Clinical and Physiologically Based Pharmacokinetic Model Evaluations of Adagrasib Drug-Drug Interactions.

Adagrasib is a potent, highly selective, orally available, small molecule, covalent inhibitor of G12C mutated KRAS. As both a substrate and strong inhibitor of cytochrome P450 (CYP) 3A4, adagrasib inhibits its own CYP3A4-mediated metabolism following multiple dosing, resulting in time-dependent drug-drug interaction (DDI) liabilities. A physiologically-based pharmacokinetic (PBPK) model was developed and verified using a combination of physicochemical, in vitro and clinical pharmacokinetic (PK) data from healthy volunteers and cancer patients. The PBPK model well-described the single and multiple-dose adagrasib PK data as well as DDI data with itraconazole, rifampin, midazolam, warfarin, dextromethorphan, and digoxin, with model predictions within 1.5-fold of the observed clinical data. The PBPK model was used to predict untested scenarios including the clinical victim and perpetrator DDI liabilities at the approved dosing regimen of 600 mg twice daily (b.i.d.) in cancer patients. Strong, moderate, and weak inhibitors of CYP3A4 are predicted to have a negligible effect on the steady-state exposure of adagrasib 600 mg b.i.d. resulting from the significant inactivation of CYP3A4 by adagrasib. Additionally, strong and moderate inducers of CYP3A4 are predicted to decrease adagrasib exposure by 68% and 22%, respectively. As a perpetrator, adagrasib 600 mg b.i.d. is predicted to be a strong inhibitor of CYP3A4, a moderate inhibitor of CYP2C9 and CYP2D6, and an inhibitor of P-glycoprotein (P-gp). These results successfully supported regulatory interactions with the United States Food and Drug Administration regarding dosing recommendations for when adagrasib is used concomitantly with other medications, supporting a range of label claims in lieu of clinical trials.

Application of continuous wavelet transforms for simultaneous estimation of domperidone and lansoprazole in capsule formulations

UV–Vis spectroscopy remains essential in pharmaceutical research and quality control due to its accessibility, simplicity, and effectiveness. However, overlapping spectra resulting from multicomponent drug formulations present challenges. Here, we describe a signal processing strategy using continuous wavelet transform (CWT) to resolve overlapping spectra of domperidone (DMP) and lansoprazole (LSP) for simultaneous quantification. Three different wavelet functions (Symlets 3, Coiflets 1, Daubechies 10), were found to be suitable for this purpose. Linear calibration curves were constructed using the CWT zero-crossing technique and the methods were validated by analyzing a set of synthetic mixtures, intra-and inter-day samples, and standard addition samples. The assay results of commercial capsule samples were compared with those obtained by derivative spectroscopy, and no significant statistical difference was observed. The proposed CWT methods demonstrated good compliance with the label claims and proved to be reliable, versatile, fast, and cost-efficient analytical methods without the need for preliminary separation procedures.

Development and Validation of a Headspace GC-MS Method for Simultaneous Quantification of Antimicrobial Preservatives in Biopharmaceutical Peptide Formulations.

The four most used antimicrobial preservatives in biopharmaceutical parenteral formulations are phenol, meta-cresol, chlorobutanol, and benzyl alcohol. Preservatives are included in various combinations in biopharmaceuticals highlighting the importance of an analytical method to quantify the four preservatives simultaneously. A headspace GC-MS method was developed to quantify phenol, chlorobutanol, meta-cresol, and benzyl alcohol. The method was validated according to USP <1225>. System suitability <USP 621> was conducted daily for retention time (%RSD < 2.0%), peak area (%RSD < 5.0%), USP tailing factor (< 2.0 and %RSD < 10.0%), and peak resolution (> 2.0). Analytical ranges were 1.5-90 μg/mL for phenol and meta-cresol, 30-240 μg/mL for benzyl alcohol, and 30-300 μg/mL for chlorobutanol. Method accuracy ranged from 94% to 108% and precision from 4% to 15 %RSD for all the tested preservatives. The method was applied to three marketed teriparatide drug products selected as a model. Preservative concentrations of the biopharmaceutical marketed products were determined and were found to be comparable with the labeled concentrations, except for an expired product with 2.5% of the label claim. The developed headspace GC-MS method can be used to evaluate the drug quality of the parenteral formulations and to support the assessment of biopharmaceutical peptide drug products.

Sustainable Spectrophotometric Quantification of Lansoprazole Through Mixed Hydrotropy Approach

Solubility is the property of a substance to dissolve in or form a homogeneous mixture with another substance. One of the most common problems associated with making a solution is poor solubility. There are many drugs that are sparingly soluble or insoluble in water, and lansoprazole is one of them. Aqueous solubility of lansoprazole is 0.05 mg/ml at room temperature. The current study aims to improve lansoprazole solubility using a mixed hydrotropy method. The purpose of the mixed hydrotropic solubilization approach is to increase the solubility of weakly water-soluble drugs in hydrotropic agent blends. To avoid the use of organic solvents, the mixed hydrotropy idea may be a good option. In this current research attempt, a novel method for spectrophotometric estimation of lansoprazole using a mixed solvent blend (containing 10% SC and 20% SB) as the solvent was developed. By observing the absorbances of the drug&amp;apos;s standard solutions, the calibration curve for lansoprazole was drawn. The absorbances were measured at 275 nm compared to the corresponding reagent blanks. The percent label claims were found to be very near to 100, showing that the proposed approach is accurate. The suggested method estimates percent recoveries to be near 100 with significantly low percentage deviation and standard error values. As a result, the proposed process is simple, safe, and precise, and it does not require the use of harmful chemical solvents.

Content-Related Quality Control of Water- and Fat-Soluble Vitamins in Fortified Non-Alcoholic Beverages.

Vitamin-fortified non-alcoholic beverages (VFNABs) are rising in popularity and availability. However, owing to their regulation as foods, there are also growing quality and safety concerns. Therefore, we aimed to provide an overview of the content-related quality of VFNABs on the Slovenian market. Vitamin contents in 50 VFNABs (29 waters, 5 juices, 12 energy drinks, and 4 instant drinks) were determined using validated methods based on liquid chromatography. The results revealed several quality issues, which were determined in all four VFNAB types. These included an indication of at least one vitamin, present in a lower-than-significant amount, on the nutrition declaration in 64% of the tested VFNABs and vitamin contents outside the tolerance interval (65-150% of the label claim) in almost half of the cases (48.4%, n = 244). Since the disclosed quality issues are not only a reason for the misleading of consumers but may also pose safety risks for both individuals and public health, we further performed an overall assessment of the VFNABs as vitamin sources. The results revealed that the tested VFNABs not only fully cover but in several cases considerably exceed daily vitamin needs (up to 616% of the reference values), an effect which is further accentuated in children. The performed content-related quality control study undoubtedly highlight the need for stricter quality control and regulation and can be utilized as a foundation and recommendation for the manufacturers in terms of committing to and pursuing the production of VFNABs.

Extrinsic attributes that drive consumer purchase of block mozzarella

Consumer demand for cheese continues to increase with mozzarella being one of the primary cheeses in the US The objective of this study was to understand the impact of extrinsic attributes on consumer desires for block mozzarella cheese. An online survey was conducted with mozzarella consumers (n = 437). Adaptive Choice-Based Conjoint (ACBC) and Kano modeling were utilized to determine the importance of attributes applicable to block mozzarella. Maximum Difference (MXD) scaling was applied to further quantify the appeal of 23 label claims/messages. Subsequently, 2.5-h immersive qualitative focus groups were conducted (n = 28 consumers) that included mozzarella usage occasion discussion, naming identification, block mozzarella sorting, label discussion, and group tasting. Survey data were evaluated by univariate and multivariate statistics. The ideal block mozzarella for consumers was made from whole milk, had a firm texture/shreds well, block/bar shape, with a resealable package and farmer owned labeling. Milkfat amount and label claims were the most important attributes (P < 0.05) across all consumers from conjoint analysis. Consumers found "produced without added hormones," "made with milk from our pasture-raised cows," and "made locally" to be the most appealing label claims. Consumer segmentation identified a Natural Cluster (n = 243) which assigned high utility to claims such as "all natural" and "organic" while the Flavor Cluster (n = 194) assigned high utility to "established business for more than 75 years" and "#1 in Italy." Melt was a must-have attribute for mozzarella consumers while easy to shred and slice was a performance attribute. Block mozzarella is generally a price-driven product, except for special occasions where consumers seek out block mozzarella that they perceive to be of higher quality.

A New Validated Method for Rapid Determination of OLEU Concentration in Dietary Supplements: Comparison with Total Phenol Content and Antioxidant Activity

The market for olive leaf dietary supplements is expanding rapidly and is valued at $437.15 million today. However, information on the control of these products is sketchy and the origin and variety of olives are rarely stated. The aim of this research was to validate a simple and rapid screening method for oleuropein determination in olive leaf dietary supplements. A matrix blank was prepared by removal of oleuropein from a mixture of dietary supplements and the matrix was then spiked with known concentrations to create a spiked matrix calibration curve in the range 5 - 40% oleuropein. Five replicate extractions and analyses of the matrix standards were carried out over 10 days. Precision was less than 6% RSD and linearity was demonstrated by the Fischer test. Extraction recovery was > 90% and there was a strong linear relationship between authentic and matrix standards. All tested products conformed to the label claim which was strongly correlated with total polyphenols measured by the Folin-Ciocalteau method. Antioxidant activity was measured by the DPPH assay and was found to be strongly correlated with total phenol content and oleuropein concentration.

Regulatory compliance of taurine containing food products marketed in India using a validated method: A pilot study

Taurine is an important functional food ingredient found in infant food, nutritional supplements and energy drinks. Concerns about the safety and quality of these products have prompted enhanced regulatory interest and enforcement. This study aimed to investigate regulatory compliance of taurine, in selected food products available in the Indian market. To assess compliance, a liquid chromatography method based on post-column derivatization with ninhydrin for the determination of taurine was validated for selectivity, accuracy, precision, linearity range, limit of detection, recovery and analysis of certified reference material. Excellent sensitivity, reproducibility and selectivity were achieved. The limit of detection and limit of quantification for the method was 0.0014 mg/100 mL and 0.0044 mg/100 mL, respectively. The overall percentage recoveries ranged from 95 % to 98 %. A total of 26 different products were analysed for their taurine content and compared with the label claim. Box-plots revealed wide variation in the taurine content. The determined concentrations of taurine ranged from 21.69 to 36.80 mg/100 g for infant foods with 7 out of the 9 samples analysed in the permitted tolerance limit of 20 % of the stated claim. Taurine content varied from 195.7 to 445.8 mg/100 mL for energy drinks with the percentage difference between obtained and declared values ranging from 4.15 to 11.46. All the 9 dietary supplements analyzed were found to contain taurine (20.48–68.62 mg/100 g), even though it was not listed as an ingredient. Our results confirm the efficacy of the proposed method in ensuring compliance with taurine in food products, underlining its importance for risk assessors and regulators.

Impact of Manufacturing Process and Compounding on Properties and Quality of Follow-On GLP-1 Polypeptide Drugs.

The prevalence of follow-on and compounded products of glucagon-like peptide-1 analogs is increasing. We assessed glucagon-like peptide-1 analogs semaglutide and liraglutide for purity, potential immunogenicity, and expected stability, by comparing a representative selection of commercially available follow-on drug substances (DSs) and drug products (DPs) with their corresponding originators. Tests included several chromatography methods coupled with ultraviolet and mass spectrometry detectors, inductively coupled plasma optical emission spectroscopy, inductively coupled plasma mass spectrometry, nuclear magnetic resonance, dissolution analyses, in silico peptide/major histocompatibility complex II-binding prediction, and fibrillation assays. Overall, 16 injectable semaglutide, 8 oral semaglutide, and 2 injectable liraglutide follow-on products were analyzed alongside originator products. Compared with originator, follow-on injectable semaglutide DSs and DPs had new impurities and impurity patterns, including high molecular weight proteins, trace metals, anions, counterions, and residual solvents. Analyses showed that several commercialized follow-on oral semaglutide DPs had a markedly lower quantity of semaglutide than the label claim, while dissolution tests indicated different semaglutide and sodium N-(8-[2-hydroxybenzoyl] amino)caprylate (SNAC) release profiles, which may reduce bioavailability. Neoepitopes were identified in DS and DP semaglutide follow-ons, indicating potential immunogenicity. Fibrillation assays showed increased fibrillation tendency and reduced physical stability in liraglutide follow-on DP samples compared with originator. This study highlights that differences in the manufacturing processes of follow-on semaglutide and liraglutide (vs those used for originators) can result in several changes to the DSs and DPs. The impact of these changes on efficacy and safety outcomes remains unknown and should be investigated by clinical studies.

A Clinicians Guide to Recommending Common Cholesterol-Lowering Dietary Supplements.

The US dietary supplement (DS) market has expanded exponentially since 1994, with an estimated 50,000-80,000 individual products currently available. Many DS claim cholesterol or cardiovascular benefits. Overall, well-designed randomized controlled trials (RCTs) with DS are lacking, while studies with favorable results are commonly performed outside of the USA, resulting in inconsistent findings. The expansion of the DS market has limited the ability of the Food and Drug Administration to regulate and prevent substandard products. Eicosapentaenoic acid and docosahexaenoic acid are components of DS fish oil. Recent RCTs utilizing prescription fish oil have provided mixed findings and small but significant safety concerns. Hence, the role of DS fish oil is limited and no longer recommended by major cardiovascular guidelines. Concerns have also been observed from RCTs utilizing prescription niacin, resulting in a negligible role for DS niacin in lipid management. Red yeast rice has demonstrated significant low-density lipoprotein cholesterol (LDL-C) reductions in studies performed worldwide, including the USA. However, quality concerns and inconsistent study results have been reported on multiple occasions. Other common DS have produced modest reductions in LDL-C and may provide other cardiometabolic benefits, including garlic, phytosterols, psyllium, and berberine. Yet inconsistent study results and quality concerns continue to be reported for most. Nonetheless, there is a need for alternative therapies that can safely and effectively reduce cardiovascular risk. However, until DS routinely match label claims and are free of contaminants, the agents have a limited role in clinical practice.

Nutrient Analysis of Raw United States Beef Offal Items.

Nutrient composition of beef offal was evaluated to expand availability of nutrient data for the following beef items: beef heart, liver, kidney, tongue, honeycomb tripe, oxtail, marrow bones, testicles, and blood. These items are consumed both domestically and internationally, with significant regional variations that can be contributed to unique cultural meals and dietary patterns. Standardized procedures were used to dissect and homogenize beef offal samples. Nutrient analysis occurred at United States Department of Agriculture Agricultural Research Service-approved laboratories using validated methods and standards. Each of the offal items in the study qualified for at least one "Good Source" or "Excellent Source" nutrient labeling claim as defined by the United States Food and Drug Administration, based on composition of the separable lean component. This study provides analytically derived nutrient information for U.S. beef offal items. The results reflect that these products could be beneficial in providing essential nutrients as a component of a healthy diet.

Nutrient Analysis of Raw and Cooked USDA Prime Beef Cuts.

Nutrient composition data that accurately represent available beef products are critical to understanding beef's role in healthy dietary patterns. The quality of beef products has changed over the past several decades, and updated nutrient data are warranted as USDA Prime beef cuts become more available. In an effort to provide a complete nutrient profile for frequently purchased USDA Prime beef cuts, five USDA Prime cuts; strip loin steak, tenderloin steak, ribeye steak, top sirloin steak, and rib roast were collected from retail stores in six geographical locations over three collections for macro- and micronutrient analysis in both the raw and cooked state. The separable lean portion of all analyzed USDA Prime cuts qualified as a good or excellent source, providing 10-19% or at least 20% of the daily value, respectively, for protein, niacin, vitamin B12, selenium, phosphorus, and zinc per FDA labeling claim standards. There was not a significant difference in cholesterol content between any of the cuts, raw or cooked (p ≥ 0.44 and 0.34, respectively). The percent lipid in raw, separable lean portions of the rib roast and strip loin steak was significantly greater than the lipid portion in tenderloin and top sirloin steaks (p ≤ 0.01). Per USDA standards, the separable lean portions of tenderloin steak and top sirloin steak qualify as lean beef, containing less than 10 g total fat, less than 4.5 g saturated fat, and less than or equal to 95 mg cholesterol. The current study provides the most up-to-date nutrient analysis for USDA Prime beef cuts, helping consumers and health professionals better identify the role of high-quality beef cuts in healthy dietary patterns.