The warning letter was sent to polyDNA on April 28, 2011. See here. The issues mentioned in this letter were considered, and according to Lilac Corp’s attorneys, the Gene-Eden-VIR/Novirin website is in full compliance with the requirements of the FDA and FTC.
Note that the letter warns against using particular words or claims on the websites, which were found at the addresses gene-eden.com and polydna.com. These websites are no longer available.
The warning letter does NOT make any statements against the Gene-Eden-VIR product itself, against the ingredients, or against the label on the bottle.
Consider the following section from the letter (see underlined words):
“This is to advise you that the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) has reviewed your websites at the internet addresses, www.polyDNA.com and www.gene-eden.com in March 2011. FDA has determined that the product “Gene-Eden” is promoted for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of the product with these claims violates the Act.”
In other words, the FDA letter does not warn the public against the Gene-Eden-VIR product. It only warns the public against certain wordings on the gene-eden.com and polydna.com websites.
But even the legal argument against these wordings is unfounded.
Please also note the phrase “The therapeutic claims on your website establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease.”
According to Lilac Corp’s attorneys, the officials at both the FDA and FTC erred in their legal arguments. The original websites at the adresses gene-eden.com and polydna.com said that the Gene-Eden product targets latent viruses. Note the word latent. Even according to the FDA itself, a latent virus is not a disease. See the following quote from the FDA website:
“Some viruses, however, can enter a state known as latency in which the virus is not being replicated. In the latent state, the virus does not cause disease.”
So, since a latent virus is not a disease, the Gene-Eden product, unlike what the FDA says in its warning letter, “The therapeutic claims on your website (DO NOT) establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease.” And therefore, “The marketing of the product with these claims (DOES NOT) violates the Act.”
The letter also explains why the wordings on the original website “violate the Act.” It says that the claims made on the website are not supported by scientific evidence (see underlined words).
“In addition, it is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made.” Recently, several clinical studies were published in peer reviewed medical journals that provide “competent and reliable scientific evidence substantiating” that the claims that Gene-Eden-VIR decreases symptoms of a viral infection are true.