§ 321(g)(1)(B) because they are intended for the treatment, cure, mitigation, or prevention of disease. 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. As explained further below, the introduction of these products into interstate commerce for such uses violates the Federal Food, Drug, and Cosmetic Act. These products are also new drugs as defined under 21 U.S.C. § 321(p) because they are not generally recognized as safe and effective for the uses recommended or suggested in their labeling. 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. Your drug products do not have FDA-approved applications as required by 21 U.S.C.
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.
This would include reviewing your websites, product labels, catalogs, brochures, flyers, package inserts, audio and video, e-commerce and social media accounts you operate (e.g., Amazon, eBay, Facebook and Twitter accounts), as well as any other promotional materials, and removing product claims, consumer testimonials, metatags, and anything else that states or implies that your products are useful in treating, curing, mitigating, diagnosing, or preventing diseases.įor more information on the kinds of claims that establish that a product is intended for use as a drug, please see 21 CFR 101.93(f)-(g) and. Within 30 calendar days of the date of this letter, please correct the violations described in this letter and notify FDA, via electronic mail at or via mail to ORA Health Fraud, 12420 Parklawn Drive, #4041, Rockville, MD 20857, that the violations have been corrected. They do note though that this does not result in immunity to herpes, and people can still be reinfected.Include the Online Advisory Letter Reference number (located in the upper right portion of this letter) in all your communications to FDA regarding this matter.Īfter 30 days from the date of this letter, if your website or other labeling continue to demonstrate that your products are intended to treat, cure, mitigate, or prevent diseases, the name of your firm and this letter will be posted on the FDA webpage for unapproved new drugs illegally marketed for serious diseases. Bloomberg and CBS wrote articles about it that gives me the hint that it might actually be real. Normally I'm skeptical of all of these "cures", but I'm finding several articles about how the tests they conducted did actually result in some, not all, of the participants going from testing positive to negative after about a ~90 day treatment. What exactly they all are, I'm not sure yet, I have to read more into them.
These 5CC are effective inhibitors of herpes viral DNA synthesis and interferon (IFN)-induced cellular antiviral response and were found to neutralize antiviral reproduction by blocking cell-to-cell infection.īasically, a combination of 5 different pills. The treatment consisted of five immunotherapeutic core compounds (5CC) comprising of Rhodiola, Tribulus, Astragalus, Lysine and a proprietary Amino Acid Formula. I just stumbled upon these articles about Synergy Pharmaceuticals and their apparent natural cure for herpes using:
I tried crossposting this from r/herpes, but it wasn't working, but anyways:
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