Consumer safety concerns

Regulation That Meets Consumer Safety Concerns... 

The use of sodium carbonate is considered to be environmentally safe. There are concerns, however, regarding synthetic soda ash production, which can result in calcium chloride as well as ammonium and heavy metal compounds in the wastewater. The high alkalinity of sodium carbonate is also a consumer safety concern [16]. 

The pursuit of product quality over the last few decades has been intense in many companies around the world, but in many sectors of industry, reliability is considered to be the most important quality attribute of the product (Kehoe, 1996). As consumers become more aware than ever of quality, their expectations for reliability are also increasing. Even equipment without obvious safety concerns can have important reliability implications. Most products can, therefore, benefit from the use of sound reliability techniques (Burns, 1994). Reliability prediction, in turn, has the benefit that it gives a quantifiable estimate of the likely reliability that can be assessed to see if this is appropriate for the market (Stephenson and Wallace, 1996). 

Safety concerns include consumer safety and environmental hazards. 

Another advantage cited for organic electronics is their perceived low environmental impact and high expected consumer safety. This assumption is generally based on the notion that plastics are easily recycled and are considered safe to humans and animals. However, the materials used are often completely new compositions with poorly understood health and safety attributes. The assumption that all plastics are completely safe for humans is inaccurate, as is exemplified by recent concerns about the toxicity of polyvinyl chloride (PVC).39 In contrast, most inorganic nanoparticle materials are already on the consumer market and have extensive historical data on their safety in a variety of applications. Some materials, such as zinc oxide, are even considered reasonably safe for ingestion and therefore are commonly used in food and cosmetics. However, the health effects and interactions of nanoparticles on the human body are still a topic of debate.40... 

Two of the best known surveys that monitor consumer attitudes, concerns, and behaviors on various nutrition and food safety issues are the Trends survey developed by the Food Marketing Institute (FMI) and the Prevention Index published by Rodale Press (1996). 

From 1980 through June 2000, the FDA received a total of 34,011 reports describing adverse reactions attributed to food additives, food products, infant formula, medical foods, dietary supplements, and other substances in food. Adverse reaction reports were submitted by consumers, food companies, consumer advocacy groups, and by individuals commenting on various FDA initiatives and proposals. The food additives receiving the most complaints are shown in Table 7.1. The fat substitute olestra accounted for more than half of all complaints received by ARMS. The following six sections pertain to food additives that have generated controversy because of safety concerns. For each additive, pertinent data from the ARMS database are presented. 

An Institutional Review Board (IRB) and an Institutional Biosafety Committee (IBC) must approve each gene therapy clinical trial before it can be carried out. An IRB is a committee of scientific and medical advisors and consumers that reviews all research within an institution. An IBC is a group that reviews and approves an institution s potentially hazardous research studies. Multiple levels of evaluation and oversight ensure that safety concerns are a top priority in the planning and carrying out of gene therapy research. 

The fourth safety concern in the use of dietary supplements, that they may actually be harmful to users, is anything hut benign. Recall that the DSHEA places the responsihihty for safety testing with supplement manufacturers themselves. Consumers can only assume that products they purchase are safe for their use and will not cause health problems. It is only when such problems actually arise and the EDA is notified that regulators can deal with the safety of a supplement. 

The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) deals with questions concerning emerging or newly identified risks, and broad, complex, or mulfidisciplinary issues requiring a comprehensive assessment of risks to consumer safety or public health, and related issues not covered by other community risk assessment bodies (EU 2006f). 

Once the NDA has been filed, the sponsor must monitor the progress of the NDA review in order to detect problems or concerns at the earliest possible moment. This monitoring or tracking must be carried out with great sensitivity. If contacts are too frequent or poorly timed they can quickly become an annoyance, which can hamper further communications. The project manager or consumer safety officer is the usual point of contact. If there is difficulty with a particular review, then the reviewer should be contacted (with consideration, obviously, for the reviewer s time). 

Cosmetic ingredients are natural or synthesized chemicals entering in the preparation/formulation of cosmetic products. According to the Cosmetics Directive 76/768/EEC (1), cosmetic products placed on the market must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use. The cosmetics manufacturers have to ensure the safety of their cosmetic products prior to marketing. However, the European Commission can adopt, on the basis of advice of the Scientific Committee on Consumer Products (SCCP), measures to limit or to forbid the commercialization of cosmetic products containing ingredients with safety concerns. 

Once an equivalent authority receives an inspection report from another equivalent authority (post- or preapproval reports), the receiving authority will normally endorse the report, except under specific and delineated circumstances (e.g., material inconsistencies or inadequacies in inspection report, quality defects identified in postmarket surveillance, and specific evidence of serious concern in relation to product quality or consumer safety [39]. In these exceptional cases, the importing country s regulatory authority may request clarification from the exporting country, which could result in a request for reinspection. In addition, the importing country might conduct its own inspection of the production facility if attempts at clarification are not successful [40]. 

EB Second, control over the rate of degradation is necessary. Not all consumer items made of a photodegradable polymer would be stored or used under the same conditions. Some of them might begin to degrade prematurely, causing inconvenience or even safety concerns. 

Third, some committee members occasionally expressed their views about political decisions. For example, the Chair expressed his disagreement with the decision taken by the European Parliament (EP) to ban animal testing of cosmetics (Greim 2008). This is a classic clash of norms, which, at least on the surface, is about consumer safety versus animal rights. However, this also comes with the politically assigned mandate of SCHER, which concerns public health and the environment but not explicitly... 

The requirements in 16 CFR Parts 1000-1799 contain the provisions of the Consumer Product Safety Act and the Hazardous Substances Act that are designed to ensure consumer safety. Although these regulations primarily concern the final plastic products to customers, colorant and additive formulators are required to ensure these products, when used in the customer s final commercial product, will meet these regulatory requirements. Among these requirements are constituency limits for certain hazardous ingredients (such as toxic metals) and product flammability criteria. 

It is necessary that consumers feel that full and comprehensive actions are taken to tackle major food safety concerns. 

FDA-approved product labeling is not intended to set the standard of medical practice, but to ensure consumer safety. However, product labeling often reflects the manufacturer s regulatory or financial concerns rather than current literature-supported information. Pharmacists must possess good drug information skills, and have access to accurate and unbiased information to assess therapeutic appropriateness when dispensing medications for unlabeled indications. 

Although the safety of traditional lactic starter bacteria has never been in question, the more recent use of intestinal isolates of bacteria (bifidobacteria, intestinal lac-tobacilli, and enterococci), to be delivered as probiotics in high numbers to consumers with potentially compromised health, has raised the question of safety. These intestinal isolates do not share the centuries-old tradition of being consumed as components of fermented dairy products. However, their presence in commercial products over the past few decades has not given any indication of a safety concern. 

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