Less reputable companies who manufacture dietary supplements often do not hesitate to market their colloidal silver products as “treatment for Lyme” or “stopping a cold or flu in its tracks” or “is effective against 650+ pathogens”…
It is critical to understand that these are all illegal statements, as they make definitive health claims. Any company making such statements about a Dietary Supplement, or any product that the FDA has not approved for such claims, is not acting in the best interest of the consumer and may be forced to do a market withdrawal (recall). They may also 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. As a practitioner, you are familiar with the claims that approved drugs are legally able to make which describe 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 must be evaluated and authorized by the FDA prior to use; such authorization is only provided to FDA-approved drugs. As you’re most likely aware, the approval process is lengthy and very expensive.
Natural Immunogenics, the parent company of the Argentyn 23® brand, takes very seriously the responsibility to abide by the regulations set forth in the Dietary Supplement Health Education Act (DSHEA) of 1994, thus doing its part to protect the right for practitioners, patients and consumer to have access to natural dietary supplements. Therefore, we do not make claims about our dietary supplement products, and hence 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.
The FDA authorizes only the following types of structure/function claims:
- 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.;
- 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
- A statement that describes the general well-being from consumption of a nutrient or dietary ingredient.
Argentyn 23® Bio-Active Silver HydrosolTM is marketed under the structure/function claim of “immune support;”* this does not mean that the product will replace the function of the immune system, nor will it be a magic bullet if the 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.
Inability to Publish Test 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:
(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.