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321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body." FDA's letters to the other manufacturers are similar in their complaints about why their products fall under the agency's regulatory oversight and why the companies are not allowed to market them, despite their oft-cited claims that the products, especially the triple agonists, are for research only

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[1] Always inspect the solution in good light before withdrawing a dose: it should appear clear and free of particles or haze

neither is a medicine

some are prescription only, to be administered by a physician

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