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Journal of Psychoactive Drugs, 34(3), 273283

For instance, in each of the warning letters to Xcel Research, Prime Vitality, Summit Research, and Swisschem, FDA observed that the companies marketed their products as for research use only, but also observed from the companies websites and social media pages that the companies intended the products to be used by human patients

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They make the product themselves in their own facility with their own equipment