What we can’t say and why

Around the web, you may read that colloidal silver, or other competing products, "cure cancer," or "stops a cold or flu in its tracks," or can "wipe out an infection" or "is effective against 650+ pathogens"…

It is critical to understand that these are all illegal statements, as they make Health Claims. Any company making such statements about a Dietary Supplement may be forced to do a market withdrawal (recall), and face further legal action by the FDA, FTC or even the Attorney General.

Natural Immunogenics does not make claims about its Dietary Supplement products for these reasons. That is why our supplements are marketed under the general structure/function claim of "Immune Support."* It does not mean it will replace the function of your immune system, nor to be a magic bullet if it is not functioning, just as taking some calcium will not create a bone where one does not exist, but may likely contribute to bone health by taking it.

Many ask why we don't make and market a nasal spray. The reason is simple: dietary supplements are meant for oral ingestion only. To instruct users to use it in any other way is to go "off-label", and such direction may not be given, except by a practitioner in a medical context. Although other brands may label their Colloidal silver products as a Nasal Spray, it will inevitably be discovered by the FDA and forced to withdraw from the market.

For these same reasons, we cannot advise that customers use our supplement product topically, even though a customer may choose to do with any product whatever they choose. However, we developed a topical gel for precisely that reason.

Inability to publish testing results

Why don't we publish any of the routine in vitro third-party laboratory test results such as bacteriology, microbiology, challenge testing, or results from human case studies?

Regulations governing Dietary Supplements, as established by DSHEA, FDA and FTC, consider that in vitro studies are not proof that, when the substance is ingested, it will produce the same physiological effects. Consequently, FDA and FTC deem extrapolation from such studies suggests that they prove a benefit in humans is false and misleading or, in the case of the FTC, deceptive advertising.

The FDA has concluded that products containing colloidal silver, silver salts, silver ions, and silver proteins are not generally recognized as safe and are misbranded when they are sold for a therapeutic purpose. The agency rule on point reads as follows:

21 CFR 310.548 -- Drug products containing Colloidal silver ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease.

(a) Colloidal silver ingredients and silver salts have been marketed in over-the-counter (OTC) Drug products for the treatment and prevention of numerous disease conditions. There are serious and complicating aspects to many of the diseases these silver ingredients purport to treat or prevent. Further, there is a lack of adequate data to establish general recognition of the safety and effectiveness of Colloidal silver ingredients or silver salts for OTC use in the treatment or prevention of any disease. These ingredients and salts include, but are not limited to, silver proteins, mild silver protein, strong silver protein, silver, silver ion, silver chloride, silver cyanide, silver iodide, silver oxide, and silver phosphate.

(b) Any OTC Drug product containing Colloidal silver ingredients or silver salts that is labeled, represented, or promoted for the treatment and/or prevention of any disease is regarded as a new Drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act) for which an approved application or abbreviated application under section 505 of the act and part 314 of this chapter is required for marketing. In the absence of an approved new Drug application or abbreviated new Drug application, such product is also misbranded under section 502 of the act.

(c) Clinical investigations designed to obtain evidence that any Drug product containing Colloidal silver or silver salts labeled, represented, or promoted for any OTC Drug use is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs as set forth in part 312 of this chapter.

(d) After September 16, 1999, any such OTC Drug product containing Colloidal silver or silver salts initially introduced or initially delivered for introduction into interstate commerce that is not in compliance with this section is subject to regulatory action.

Consequently, any claim that Colloidal silver or silver hydrosol reduces or eliminates, or otherwise treats infections, will be viewed as a claim that the product treats disease and will render the product misbranded, thus an unapproved new drug, and subject to enforcement action under the relevant sections of Federal Food, Drug, and Cosmetic Act.

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