To: bmart who wrote (2031 ) 8/27/1998 2:01:00 AM From: Graystone Respond to
Perhaps you disagree with the Company or I told you to get your trainer. AZNT SEC Filing : These statements are made by AZNT to the SEC. sec.gov The formulation, manufacturing, packaging, storing, labeling, advertising, distribution and sale of the Company's products are including the Food and Drug Administration ("FDA"), the Federal Trade Commission ("FTC"), the Consumer Product Safety Commission ("CPSC"), the United States Department of Agriculture ("USDA"), the Environmental Protection Agency ("EPA") and the United States Postal Service. The Company's activities are also regulated by various agencies of the states, localities and foreign countries in which the Company's products are manufactured, distributed and sold. The government regulations require the Company and its suppliers to meet relevant good manufacturing practice ("GMP") regulations for the preparation, packing and storage of these products. GMP for dietary supplements have yet to be promulgated but are expected to be proposed.1994 Dietary Supplement Health and Education Act ("DSHEA") revises the provisions of the Federal Food, Drug and Cosmetic Act ("FFDCA") concerning composition and labeling of dietary supplements and, the Company believes, generally favorable to the dietary supplement industry. The legislation created a new statutory class of "dietary supplements." This new class includes vitamins, minerals, herbs, amino acids and other dietary substances for human use to supplement the diet, and the legislation grandfathers, with certain limitations, dietary ingredients that were on the market before October 15, 1994. A dietary supplement which contains a new dietary ingredient (i.e., not on the market before October 15, 1994) will require evidence of a historical use or other evidence of safety establishing that it is reasonably expected to be safe. Manufacturers of dietary supplements which make a "statement of nutritional support" must have substantiation that the statement is truthful and not misleading.every product was available prior to 1994 on the market. I thought this Phytogenics was supposed to be new. If they have attracted no following in 4 years, then sales are not just poor, they are really bad. You can see where the testimonials come from can't you. The company says it has to comply, bmart says they don't. Is this a problem, of course it is, will bmart admit it, of course he won't. He still won't admit rickets are cured by sunlight, will he. So, back to my question, do you suppose they just Ask the Indians who sell them the plants, and that is the historical use and substantiation required by the DSHEA.
