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From the legal perspective, the question is whether the substance is legal in Australia. The legal root of the matter is the Therapeutic Goods Administration. Dosages above 100 mg are on "Schedule 4" meaning they require a prescription. There are also apparently state regulations. In Queensland, there is an amendment to the Drugs Misuse Regulation ...


No. Congress, in the Federal Food, Drug and Cosmetic Act, gave the the power to regulate drugs to the FDA, not the President. In addition to giving the FDA jurisdiction, Congress also set up requirements and procedures that the FDA must use to classify and reclassify drugs. (The FDA, acting under the APA and other statutes, has engaged in further procedural ...


This is a duck You can label it a chicken if you like but you won’t fool anyone who knows about ducks. The FDA knows about diagnostic devices; calling it something else isn’t going to fool them.

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