Ron... AZNT as you can see has declared that they are exempt from regulation by the FDA. The filing is quite "interesting" in may aspects. BMart/Pugs of course is the resident expert here as we can see. We of course would want to defer to his "expertise". <g>
sec.yahoo.com
Risk Factors
1. Lack of Compliance with Federal Laws and Regulations. The Company believes that its products may be exempt from many of the regulations of one or more governmental agency, including the Food and Drug Administration ("FDA"), the Federal Trade Commission, the Consumer Product Safety Commission, the United States Department of Agriculture, the Environmental Protection Agency, United States Department of Customs and the United States Postal Service. The Company's further believes it does not have to comply with some, but not all of the regulations of various agencies of the states, localities and foreign countries in which the Company's products are manufactured, distributed and sold. The FDA, in particular may regulate the formulation, manufacture and labeling of foods and dietary supplements, such as those distributed by the Company if applicable unless exempted pursuant to the Dietary Supplement Health and Education Act of 1944 (DSHEA). The Company's legal basis for such is the DSHEA and accordingly, if the Company is incorrect in its position, the Company could be subjected to civil suits, which could result in the termination of the Company's operations. |
