Claims made

A number of products designated GRAS are being scmtini2ed by the FDA because of advertisements and claims made by producers or manufacturers of these products. Statements that indicate that feeding such products improve animal performance may require substantive data to support such claims in the future. 

A proper assessment of the costs and benefits associated with standardization depends on having suitable baseline data with which to make a comparison. Several surveys have shown typical doUat returns for the investment in standardization in the range of 5 1—8 1 with occasional claims made for a ratio as high as 50 1. 

Class III Premarket Approval. Similar to a new dmg approval, a premarket approval grants the appHcant a Hcense to market a specific weU-characterized device. These devices are subject to the requirements of Section 515 of the Eood, Dmg, and Cosmetic Act. A post-amendment device is a device put ia commercial distribution after May 28, 1976. If it is not substantially equivalent to a preamendment device it is automatically ia Class 111, and a premarket approval appHcation (PMA) is required. The appHcation must iaclude reports of preclinical and clinical studies done ia support of claims of safety and efficacy as well as any labeling claims made for the device. Once the PMA is submitted, the PDA determines whether the appHcation iacludes the required information. If the PMA is suitable for scientific review, the PDA has 180 days from the filing date to approve or deny the appHcation. Polybutester, polydioxanone, polyglyconate, and ePTPE sutures are all regulated as Class 111 devices. 

Copolymers of vinyl chloride with 2-10% propylene became available in the USA in 1973 (Sta-Flow by Air Products and Chemicals Inc.). Compared with the vinyl chloride homopolymer these copolymers have a reduced tendency to dehydrochlorination and thus improved heat stability. This is of importance both in application and during processing, and one particular claim made for these products is their ease of moulding. 

Environmental claims made by the automakers to customers regarding conservation of natural resources, recycling, etc. may be compromised if environmental inspections of suppliers show disregard for such regulations. 

Whiter whites Brighter brights You ve heard such claims made by many manufacturers of laundry detergents. The chemical structure of the additives called optical brighteners provides the essential factors that make these superior detergents possible. 

Alex Rosenberg I actually don t see how you can endorse those claims on the basis of the arguments that you gave in your paper, because the arguments you gave in your paper would undercut those claims as effectively as they undercut the claims made by evolutionary psychologists. 

The European Union recently approved the Regulation on nutrition and health claims made on foods (European Parliament 2006). Regarding DF, it establishes that a food... 

J. W. Frings Occult Arts An Examination of the Claims Made for the Existence and Practice of Supernormal Powers, and an Attempted Justification (London Rider, 1913). 

Although all advertising material is expected to conform to ethical (medical) standards, inclusion in this publication does not constitute a guarantee or endorsement of the quality or value of such product or of the claims made of it by its manufacturer. 

The standards that have been developed to date are concerned with determining the properties of conventional wood products. There is now an urgent need to develop appropriate standards and agree them at an international level. At present, claims made with respect to modified wood are based upon the current set of standards, which may not always be appropriate to the performance of these new materials in real-life situations. This is an area that has to be addressed in the very near future. 

But how do lawn service providers themselves view such risks Applicators continue to claim publicly, of course, that their products are safe, including making the often-circulated and unverified claim that customers eating 300 cups of treated grass clippings would have consumed the equivalent toxicity of one cup of coffee. The structure of the applicator industry allows a tremendous diversity of firms, however, and differentially placed participants in the lawn chemical economy are differentially sanguine about health and safety claims made by the industry s public relations machine. 

Many people today believe that natural products are safer and at least as effective as synthetically produced medicines, such as antibiotics and anticancer agents. The variety of claims made for such products is very great, as shown in the chart above. The question is, however, how reliable are these claims ... 

Medical devices may be assisted in their function by pharmacological, immunological or metabolic means, but as soon as these means are not any more ancillary with respect to the principal purpose of a product, the product becomes a medicinal product. The claims made for a product, in accordance with its method of action may, in this context, represent an important factor for its classification as MD or medicinal product. Examples of MDs incorporating a medicinal substance with ancillary action include catheters coated with heparin or an antibiotic, bone cements containing antibiotic and blood bags containing anticoagulant. ... 

Complementary medicines (also known as traditional or alternative medicines) include vitamin, mineral, herbal, aromatherapy and homoeopathic products. They maybe registered or listed on the ARTG, depending on their ingredients and the claims made. Most complementary medicines are listed. 

Sponsors must be able to substantiate all claims made by them about their therapeutic products. On 30 September 2004, there were 2411 sponsors of therapeutic goods on the ARTG. 

Complementary medicines are most frequently listed rather than registered, but this depends on the ingredients and claims made. The document Guidelines for Levels and Kinds of Evidence to Support Indications and Claims was developed to assist sponsors in determining the appropriate evidence to support indications and claims made in relation to complementary medicines, sunscreens and other listable medicines, and is available from the TGA website. The Complementary Medicines Evaluation Committee (CMEC) provides scientific and policy advice relating to controls on the supply and use of complementary medicines, with particular reference to the quality and safety of products and, where appropriate, efficacy relating to the claims made. 

A product s principal use and the claims made are also key determinants of whether it is deemed to be a medicine or a food, or a medicine or a cosmetic. Guidance on these distinctions are available from the TGA website. 

The BPD defines biocides as materials intended to destroy, deter, render harmless, prevent the action of or otherwise exert a controlling effect on harmful organisms. Moreover, as indicted within Annex VI (paragraph 89) the biocidal product must he shown to give a defined benefit in terms of the level, consistency and duration of control or protection or other intended effects during normal use. Efficacy is therefore defined within the directive as the ability of a biocidal product to fulfill the label claims made for it on the proposed label. While there appears to be no official guidance of what constitutes an efficacy claim for the 23 product types the UK draft TGD tentatively listed the parameters that could constitute such a claim. For illustrative purposes the suggested claims are summarised in Table 1 below. 

Clinical pharmacology is well placed to support and instruct in the evaluation of medicines, the claims made for them, and the assessment of outcomes as a result of treatment interventions. This will increasingly be based on evidence-based medicine, drug utilisation data, drug costs and epidemiological data relevant to the country. 

Before the twentieth century, most government controls were concerned not with drugs but with impure and adulterated foods. Medicines were thought to pose problems similar to those presented by foods. Efficacy was questioned in two respects adulteration of active medicines by addition of inert fillers and false claims made for the so-called patent (secret) medicines or nostrums. Indeed, much of the development of the science of pharmacy in the nineteenth century was standardizing and improving prescription drugs. 

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