Liability labelling

Facts on GMOs in the EU. http //europa.en.int/coimn/dgs/health consnmer/ libraiy/press/press63 en.pdf. Official site of the Emopean Conunission with directives on genetically modified organisms legislation, scientific committees, labellings, liability. 

The lack of target enzyme specificity is a critical liability for the use of affinity labels as drugs. The inherent chemical reactivity of these compounds almost ensures that... 

The partitioning of the activated inhibitor between direct covalent inactivation of the enzyme and release into solution is an important issue for mechanism-based inactivators. The partition ratio is of value as a quantitative measure of inactivation efficiency, as described above. This value is also important in assessing the suitability of a compound as a drug for clinical use. If the partition ratio is high, this means that a significant proportion of the activated inhibitor molecules is not sequestered as a covalent adduct with the target enzyme but instead is released into solution. Once released, the compound can diffuse away to covalently modify other proteins within the cell, tissue, or systemic circulation. This could then lead to the same types of potential clinical liabilities that were discussed earlier in this chapter in the context of affinity labels, and would therefore erode the potential therapeutic index for such a compound. 

The abuse liability of nicotine varies widely as a function of its formulation and speed of delivery. For example, in a cross-study comparison of abuse liability data, Henningfield and Keenan concluded that abuse liability was related to the speed of nicotine delivery and the nature of the nicotine formulation (Henningfield and Keenan 1993). This finding is consistent with data concerning other substances of abuse (Stitzer and De Wit 1998). Every medicinal nicotine product approved by the FDA has been considered for potential labeling and restrictions based on its presumed abuse liability. 

Any concern producing a product which may be dangerous to life or property has a legal responsibility to indicate the potential hazard by use of warning labels or other protective methods. The manufacturer must supply safe shipping containers and make certain that any hazards involved in their handling or use are clearly indicated. Legal liability also holds for defective or misrepresented products. 

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