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Too Little, Too Late: Ineffective Regulation of Dietary Supplements in the United States
Millions of people in the United States consume dietary supplements hoping to maintain or improve their health; however, extensive research has failed to demonstrate the efficacy of numerous supplements in disease prevention. In addition, concerns about the safety of routine and high-dose supplementation have been raised.
The Food and Drug Administration regulates dietary supplement quality, safety, and labeling, and the Federal Trade Commission monitors advertisements and marketing; still, vast enforcement challenges remain, and optimal governmental oversight has not been achieved. If the composition and quality of ingredients cannot be reliably ensured, the validity of research on dietary supplements is questionable. Moreover, the health of the US public is put at risk.
Journal Article
Assessment of phthalates/phthalate alternatives in children’s toys and childcare articles: Review of the report including conclusions and recommendation of the Chronic Hazard Advisory Panel of the Consumer Product Safety Commission
The Consumer Product Safety Commission (CPSC) convened a Chronic Hazard Advisory Panel (CHAP) on Phthalates found in children’s toys, and childcare products, and in products used by women of childbearing age. The CHAP conducted a risk assessment on phthalates and phthalate substitutes, and made recommendations to either ban, impose an interim ban, or allow the continued use of phthalates and phthalate substitutes in the above products. After a review of the literature, the evaluation included toxic end points of primary concern, biomonitoring results, extant exposure reconstruction, and epidemiological results. The health end points chosen were associated with the rat phthalate syndrome, which is characterized by malformations of the epididymis, vas deferens, seminal vesicles, prostate, external genitalia (hypospadias), and by cryptorchidism (undescended testes), retention of nipples/areolae, and demasculinization (~incomplete masculinization) of the perineum, resulting in reduced anogenital distance. Risk assessment demonstrated that some phthalates should be permanently banned, removed from the banned list, or remain interim banned. Biomonitoring and toxicology data provided the strongest basis for a mixture risk assessment. In contrast, external exposure data were the weakest and need to be upgraded for epidemiological studies and risk assessments. Such studies would focus on routes and sources. The review presents recommendations and uncertainties.
Journal Article
Heavy metals in essential oils proposed for the modification of footwear lining leather—Quality management and product safety
Due to their antiseptic action, essential oils can be incorporated into leather in order to improve the hygienic properties of footwear by reducing microbial growth and multiplication in the interior. This paper presents the results of analyses of the contents of heavy metals, i.e., As, Cd, Cu, Ni and Pb in cinnamon, eucalyptus, oregano, manuka and thyme oils proposed for modification of lining leather. Experiments carried out using atomic absorption spectrometry were designed to evaluate the impact of the addition of these oils on the quality and safety of footwear considering the possible presence of toxic metals. In the context of the limits for metal contents in products set out in the European REACH Regulation, Oeko-Tex® Leather Standard by Oeko-Tex® Association, Restricted Substances List by AFIRM Group and List of Restricted Substances in Shoes by CADS Association, it was found that the oils tested were characterised by low levels of As (thyme, oregano and eucalyptus oils: not detected, other oils: 0.002 mg/kg – 0.015 mg/kg), Cd (0.001 mg/kg – 0.022 mg/kg), Cu (0.06 mg/kg – 0.184 mg/kg), Ni (0.025 mg/kg – 0.144 mg/kg) and Pb (0.06 mg/kg – 0.097 mg/kg). Therefore, their application to lining leather should not impair the quality of footwear understood in terms of its safety for the user. Given the limited number of analyses of heavy metal contents in essential oils of various applications, in the context of the study conducted, which, although in small numbers, nevertheless confirmed the presence of metals in oils, it was concluded that such analyses should be conducted on a larger scale. In order to ensure the quality and safety of products enriched with essential oils, it is necessary to continuously monitor an important property of essential oils, namely their content of harmful heavy metals.
Journal Article
Better safe than sorry : how consumers navigate exposure to everyday toxics
\"How toxic are the products we consume on a daily basis? Whether it's triclosan in toothpaste, formaldehyde in baby shampoo, endocrine disruptors in water bottles, or pesticides on strawberries, consumers are increasingly concerned about the chemicals in their food and personal care products. This book chronicles how ordinary people try to avoid exposure to toxics in grocery store aisles using the practice of 'precautionary consumption.' Through an innovative analysis of environmental regulation, the advocacy work of environmental health groups, the expansion of the health-food chain Whole Foods Market, and interviews with consumers, Norah MacKendrick ponders why the problem of toxics in the U.S. retail landscape has been left to individual shoppers--and to mothers in particular. She reveals how precautionary consumption, or 'green shopping,' is a costly and time-intensive practice, one that is connected to cultural ideas of femininity and good motherhood but is also most available to upper- and middle-class households. Better Safe Than Sorry powerfully argues that precautionary consumption places a heavy and unfair burden of labor on women and does little to advance environmental justice or mitigate risk.\"--Provided by publisher.
Book
The Constitution of Private Governance
In quantity and importance, private standards are rapidly taking over the role of public norms in the international and national regulation of product safety. This book provides a comprehensive overview of the rise, role and status of these private product safety standards in the legal regulation of integrating markets. In international and regional trade law as in European and American constitutional and administrative law, tort law and antitrust law, the book analyses the ways in which legal systems can and do recognise private norms as ‘law’. This sociological question of law‘s recognition of private governance is indissolubly connected with a normative question of democratic theory: can law recognize legal validity and democratic legitimacy outside the constitution, without constitutional political institutions and beyond the nation state? Or: can law ‘constitute’ private transnational governance? The book offers the first systematic treatment of European, American and international ‘standards law’ in the English language, and makes a significant contribution to the study of the processes of globalization and privatization in social and legal theory. For the thesis on which this book was based Harm Schepel was awarded the first EUI Alumni Prize for the \"best interdisciplinary and/or comparative thesis on European issues\" written at the EUI in recent years.
eBook
No more tears : the secret history of Johnson & Johnson
\"When reporter Gardiner Harris met a woman at an airport bar whose entire family has been shattered by her nephew's use of the drug Risperdal, one she sold to his doctor as a drug sales rep, he began to wonder how many similar stories are out there. This was in 2004, and since then, Harris has been investigating one of the largest players in Big Pharma, continuously reporting on it despite simultaneous landmark journalistic accomplishments, like exposing the extremely toxic mining conditions ignored by coal companies. For decades, pharmaceutical giant Johnson & Johnson was seen as a paragon of ethical conduct, especially considering the company's child-friendly products like baby powder and tearless shampoo. However, Harris has uncovered reams of evidence of deceitful and dangerous corporate practices that reveal a historic threat to the health of the American public. He covers several disasters: tissue death caused by J & J's touted hip replacements, their coverup of baby powder's linkage to cancer, the teen-directed marketing of the life-altering drug Risperdal, and more. The Hatch-Waxman Bill, which is meant to pave the way for lower-priced generic drugs, passed in 1984, and inadvertently created loopholes in the drug approval process which allowed urgency and profit maximization to take precedence over diligence and patient protection. Johnson & Johnson's subsequent lack of oversight, money-grubbing, and flat out lies have resulted in the death or serious injury of millions of people. To many, the peril of falsified science seems distant, but Harris reveals how a combination of misrepresented data and bribe culture directly impact doctors' decisions-which are devastatingly revealed to be not at all in the interests of patients\"-- Provided by publisher.
BOOK
The relative nature of the standards for proof of safety: a review of FDA’s safety standards for various consumer products
Are all food ingredients, dietary supplement ingredients and even foods, required to meet the same safety standards? Are they all equally safe? If so, then why do the various categories have different expressions describing their safety, such as “reasonable certainty of no harm” for food ingredients and “reasonable expectation of no harm” for dietary supplement ingredients? The basis for these different expressions is that they are not standards of safety, but standards of proof of safety. Just as in criminal vs. civil courts, the threshold for proving guilt or fault is different, so too are there differences between various categories of consumer products regulated by the US Food and Drug Administration. This manuscript describes the threshold requirements for each standard, as well as to the identity of the decision makers on what is safe, their credentials as decision makers and the databases mandated for their use.
Journal Article