WHAT WE CAN/CAN’T SAY….AND WHY
You may read that colloidal silver or another competing product “cures cancer” or “stops a cold or flu in its tracks” or can “wipe out an infection” or “is effective against 650+ pathogens”…
As discussed in the previous section, How Dietary Supplements Are Regulated, these are all illegal statements, as they make health claims. Any company making such statements about a Dietary Supplement, or any product that the FDA has not approved for such claims, may be forced to do a market withdrawal (recall) and face further legal action by the FDA, FTC, or even the Attorney General.
A health claim is an explicit or implied characterization of a relationship between a substance and a disease or a health-related condition. A health claim or drug claim describes the effect a substance has on reducing the risk of or preventing a disease, e.g., “Calcium may reduce the risk of osteoporosis” or something “helps to prevent blindness.” This type of claim requires significant scientific agreement and must be evaluated and authorized by the FDA prior to use; such authorization is only provided to FDA-approved drugs. The approval process is lengthy and very expensive.
Natural Immunogenics, the parent company of the Sovereign Silver® brand, 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*.”
A Structure/Function claim describes the role of a substance intended to maintain the structure or function of the body. Structure/function claims do not require preapproval by FDA. However, manufacturers making structure/function claims in their products’ labeling must possess substantiation that such statements are truthful and not misleading. They must also include the standard FDA disclaimer and notify FDA no later than 30 days after the first marketing of the product that they are making the statement.
Examples of such structure/function claims are more categorical and include: Bone Health, Immune Support, etc.
The FDA authorizes only the following types of structure/function claims:
1. A statement that claims a benefit related to a classical nutrient deficiency disease and that discloses the prevalence of such disease in the U.S.;
2. A statement that describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, or characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function; or
3. A statement that describes the general well-being from consumption of a nutrient or dietary ingredient.
Sovereign Silver products are marketed under the structure/function claim of “immune support*”; this does not mean that the product will replace the function of your immune system, nor will it be a magic bullet if your immune system is not functioning. Similarly, taking calcium will not create a bone where one does not exist, but taking it may likely contribute to bone health.
Why these claims may be made at all – and, in fact, why supplements still exist and may be marketed to consumers – is the direct result of the Dietary Supplement Health Education Act (DSHEA) of 1994, enacted when people demanded their right to natural medicines and prevented regulators from removing them from the market altogether. (Your right to choose the remedies you want is constantly at risk.)
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. While many Practitioners may recommend off label use of dietary supplement products to include silver hydrosol, Sovereign Silver is required by the FDA and FTC to only label and recommend our products within the guidelines of DSHEA (Dietary Supplement Health and Education Act of 1994), and therefore can only advise for oral ingestion for the structure/function claim of Immune Support* and not any specific ailment or symptom. Although other brands may label their colloidal silver products as nasal sprays, this will inevitably be discovered by the FDA and they will be forced to withdraw them 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 whatever they choose with any product. However, we developed our First Aid 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 or 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, 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.
Stay Informed if you want to stay in on the action.