We advise you to review all materials through which you communicate to consumers the intended uses of your products, and to either submit a new drug application (NDA) for products intended for use in treating, curing, mitigating, diagnosing, or preventing a disease or, alternatively, remove all statements indicating that your products are intended for such uses. Your drug products do not have FDA-approved applications as required by 21 U.S.C. Before a new drug may be marketed or otherwise introduced into interstate commerce, it must be approved by FDA on the basis of scientific data demonstrating that the drug is safe and effective under the conditions of use in its labeling. § 321(p) because they are not generally recognized as safe and effective for the uses recommended or suggested in their labeling. These products are also new drugs as defined under 21 U.S.C. As explained further below, the introduction of these products into interstate commerce for such uses violates the Federal Food, Drug, and Cosmetic Act. For example, your websites recommend or suggest the use of Combination Herpes Treatment, L-Lysine, Tribulus, Astragalus, Rhodiola, and Amino Acid Formula (or “Unique Amino Formula”) to treat or cure herpes simplex virus and heart disease. § 321(g)(1)(B) because they are intended for the treatment, cure, mitigation, or prevention of disease. Various claims and statements made on your websites and/or in other labeling establish that these products are drugs as defined in 21 U.S.C. Food and Drug Administration (FDA) reviewed your websites at and in November 2017 and has found that you take orders there for Combination Herpes Treatment, L-Lysine, Tribulus, Astragalus, Rhodiola, and Amino Acid Formula (or “Unique Amino Formula”). This letter is to advise you that the U.S. Synergy Health Combination Herpes Treatment, L-Lysine, Tribulus, Astragalus, Rhodiola, Amino Acid Formula (or “Unique Amino Formula”)
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