The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) amends the Food, Drug and Cosmetic Act (FDCA), elevating the standard of proof of safety (better known as a \"safety standard\") for cosmetics to the standard of a \"reasonable certainty … [of] … safe.\"a standard equal to that of food ingredients. The standards of the proof of safety differ for various classes of FDA-regulated product categories e.g., cosmetics, dietary supplements, food ingredients and food itself. This manuscript describes the various standards of proof, the essential differences between the standards, key elements required to achieve a particular standard and, compares the standards to more familiar legal terms such as \"a preponderance of the evidence\" or \"beyond reasonable doubt.\" The standards of proof for these product categories are also ranked according to increasing threshold for achievement of \"safe\" status. Lastly, this manuscript suggests how the requirements for the high standard of a \"reasonable certainty of safe\" (or \"reasonable certainty of no harm\") might be met.

Liposomes have been considered promising and versatile drug vesicles. Compared with traditional drug delivery systems, liposomes exhibit better properties, including site-targeting, sustained or controlled release, protection of drugs from degradation and clearance, superior therapeutic effects, and lower toxic side effects. Given these merits, several liposomal drug products have been successfully approved and used in clinics over the last couple of decades. In this review, the liposomal drug products approved by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) are discussed. Based on the published approval package in the FDA and European public assessment report (EPAR) in EMA, the critical chemistry information and mature pharmaceutical technologies applied in the marketed liposomal products, including the lipid excipient, manufacturing methods, nanosizing technique, drug loading methods, as well as critical quality attributions (CQAs) of products, are introduced. Additionally, the current regulatory guidance and future perspectives related to liposomal products are summarized. This knowledge can be used for research and development of the liposomal drug candidates under various pipelines, including the laboratory bench, pilot plant, and commercial manufacturing.

After the approval of a new drug, the Food and Drug Administration (FDA) may issue postmarketing requirements (PMRs), studies that the law requires manufacturers to conduct for drugs approved under certain conditions, and postmarketing commitments (PMCs), studies that the FDA and manufacturers agree should be conducted as a condition of approval.
With regulators\' increasing reliance on gathering important evidence after initial product approval, we sought to assess the track record of PMRs and PMCs by synthesizing information about postmarketing study completion rates, timeliness, study types, and results reporting.
A systematic review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines was conducted. Studies published in academic journals or government reports that reported original data about the characteristics of PMRs or PMCs were included. Studies of post-approval trial mandates issued by regulators outside the USA were excluded, as were those that addressed post-approval research without mentioning either PMCs or PMRs or a specific approval pathway associated with statutorily required PMRs. Two investigators independently screened and extracted data from studies and reports. Data sources included the Federal Register from 2003 to 2020, FDA backlog reviews from 2008 to 2020, PubMed from January 2006 to April 2021, and the US Government Accountability Office (GAO) database for reports from January 2006 to April 2021. PMR/PMC characteristics (e.g., completion rates, timeliness, results reporting, outcomes) were not meta-analyzed due to the heterogeneity in study designs.
Twenty-seven peer-reviewed articles from PubMed, five GAO reports, 17 annual Federal Register notices, and 12 annual backlog reviews were included. Among the 27 studies, 13 reviewed PMRs and PMCs, one reviewed only PMCs, and 13 reviewed only PMRs. A majority of new drugs were approved with at least one PMR or PMC. PMCs were completed at higher rates than PMRs, although delays were common and neither was found to be completed more than two-thirds of the time. Over two-thirds of PMRs and PMCs reported their findings in publications and trial registries. Over half of PMCs and PMRs produced novel information for clinical practice or leading to regulatory action, such as confirmation of benefit or a labeling change.
PMRs and PMCs are common for new drugs and can lead to worthwhile outcomes, but are often delayed or incomplete. Greater attention is needed to timely completion, improving transparency of findings, and ensuring that PMRs and PMCs produce optimally useful information for prescribers and patients.

The aim of this observational review was to review trends in deficiencies in clinical pharmacology dossiers by analysing the frequency and characteristics of major objections (MOs) related to clinical pharmacokinetics and dose-exposure-response (DER) relationships in assessment reports for medicinal products submitted in centralised procedures to the European Medicines Agency (EMA). Initial Assessor (Day 120) assessment reports between 2013 and 2018 were reviewed MOs and characterised with regards to ATC code, orphan status, legal basis and type of molecule, major objection topic and if scientific advice had been sought during development. 23% of the 551 identified Day 120 assessments contained at least one major objection related to clinical pharmacology. Most common topics identified were related to the pharmacokinetics in the target populations, analytical methods, dose-exposure-response relationships, absorption, distribution, metabolism, excretion, comparative bioavailability, and bioequivalence issues. The importance of a robust clinical PK dossier in the assessment of marketing authorisation applications was highlighted by the high frequency of major objections. This review should provide valuable insights to ensure that aspects of bioanalytical methods, comparative bioavailability, PK in the target population and DER relationships are thoroughly addressed in future marketing authorisation applications.

Oily, low water activity (OL aw) products including tahini (sesame seed paste), halva (tahini halva), peanut butter, and chocolate, have been recently linked to numerous foodborne illness outbreaks and recalls. This review discusses the ingredients used and processing of OL aw products with a view to provide greater understanding of the routes of their contamination with foodborne pathogens and factors influencing pathogen persistence in these foods. Adequate heat treatment during processing may eliminate bacterial pathogens from OL aw foods; however, post-processing contamination commonly occurs. Once these products are contaminated, their high fat and sugar content can enhance pathogen survival for long periods. The physiological basis and survival mechanisms used by pathogens in these products are comprehensively discussed here. Foodborne outbreaks and recalls linked to OL aw foods are summarized and it was observed that serotypes of Salmonella enterica were the predominant pathogens causing illnesses. Further, intervention strategies available to control foodborne pathogens such as thermal inactivation, use of natural antimicrobials, irradiation and hydrostatic pressure are assessed for their usefulness to achieve pathogen control and enhance the safety of OL aw foods. Sanitation, hygienic design of manufacturing facilities, good hygienic practices, and environmental monitoring of OL aw food industries were also discussed.

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BACKGROUND: Skin-whitening products are in the high trend of demand for skin beautifying and lightening. Sources of ingredients for cosmetics could be natural, semi-synthetic, and synthetic that may affect the halal status of a product. The lack of scientific evidence on the safety and risks of such ingredients is a major concern to many consumers.
OBJECTIVE: This review paper aimed to shed light on the skin-whitening ingredients and their issues related to safety, health risk, and halal status.
METHODS: Based on the reviews scientific publications published from January 2015 to July 2020 using Web of Science and Scopus engines.
RESULTS: Based on the review, most of the common ingredients in the skin-whitening products are originated from plants, animals, microbes, and heavy metals. Health risk of the ingredients was evaluated based on the usage, chronic or acute adverse effect, frequency of incidence, and the hazardous chemical contents of a halal cosmetics. The halal status of the ingredients was investigated based on the sources of origin, safety evaluation, and associated health risk of the ingredients.
UNASSIGNED: This review shows that ingredients play a vital role in the halal status decision-making of a cosmetic product. Therefore, the categories of Halal-Safe, Haram-Prohibited, and Critical-Need further evaluation were suggested to integrate the sources of ingredients with safety.

Edible oils have economical and nutritional benefits. These oils offer nutrients that are essential to human health because they are the primary source of mono- and poly-unsaturated fats. Moreover, edible oils are used in home cooking and industrial food manufacturing. Therefore, edible oils have a considerable demand worldwide. However, some edible oils, such as olive oil, are more expensive than any other vegetable oils. Thus, oils such as olive oil are mixed with cheap edible oils as a result of the high price difference. Accordingly, adulteration in edible oils to obtain additional profit for the producer becomes a major issue of high concern for consumers. Moreover, adulteration in edible oils can cause several problems that affect consumer health. Therefore, the need for a sensitive, accurate and suitable method to detect the adulteration is highly considered. We provide a brief review of the different methods and techniques used to detect adulteration in edible oils, especially olive oil, with the aim of promoting consumer awareness of the authenticity of edible oils. © 2020 Society of Chemical Industry.

Goldenseal (Hydrastis canadensis L.) is a medicinal plant widely used in various traditional systems of medicine and as a food supplement. It has been traditionally used by Native Americans as a coloring agent and as medicinal remedy for common diseases and conditions like wounds, digestive disorders, ulcers, skin and eye ailments, and cancer. Over the years, goldenseal has become a popular food supplement in the USA and other regions. The rhizome of this plant has been used for the treatment of a variety of diseases including, gastrointestinal disorders, ulcers, muscular debility, nervous prostration, constipation, skin and eye infections, cancer, among others. Berberine is one of the most bioactive alkaloid that has been identified in different parts of goldenseal. The goldenseal extract containing berberine showed numerous therapeutic effects such as antimicrobial, anti-inflammatory, hypolipidemic, hypoglycemic, antioxidant, neuroprotective (anti-Alzheimer\'s disease), cardioprotective, and gastrointestinal protective. Various research finding suggest the health promoting effects of goldenseal components and their extracts. However, few studies have also suggested the possible neurotoxic, hepatotoxic and phototoxic activities of goldenseal extract and its alkaloids. Thus, large randomized, double-blind clinical studies need to be conducted on goldenseal supplements and their main alkaloids to provide more evidence on the mechanisms responsible for the pharmaceutical activity, clinical efficacy and safety of these products. Thus, it is very important to review the scientific information about goldenseal to understand about the current scenario.

Ascomycete Cordyceps fungi such as C. militaris, C. cicadae, and C. guangdongensis have been mass produced on artificial media either as food supplements or health additives while the byproducts of culture substrates are largely used as animal feed. The safety concerns associated with the daily consumption of Cordyceps fungi or related products are still being debated. On the one hand, the known compounds from these fungi such as adenosine analogs cordycepin and pentostatin have demonstrated different beneficial or pharmaceutical activities but also dose-dependent cytotoxicities, neurological toxicities and or toxicological effects in humans and animals. On the other hand, the possibility of mycotoxin production by Cordyceps fungi has not been completely ruled out. In contrast to a few metabolites identified, an array of biosynthetic gene clusters (BGCs) are encoded in each genome of these fungi with the potential to produce a plethora of as yet unknown secondary metabolites. Conservation analysis of BGCs suggests that mycotoxin analogs of PR-toxin and trichothecenes might be produced by Cordyceps fungi. Future elucidation of the compounds produced by these functionally unknown BGCs, and in-depth assessments of metabolite bioactivity and chemical safety, will not only facilitate the safe use of Cordyceps fungi as human food or alternative medicine, but will also benefit the use of mass production byproducts as animal feed. To corroborate the long record of use as a traditional medicine, future efforts will also benefit the exploration of Cordyceps fungi for pharmaceutical purposes.