SILVER LEGALITY

"Silver Facts Outshine FDA" - article

An excellent article on silver products appears in the Legal Tips column in the October 2003 issue of Whole Foods Magazine. Whole Foods Magazine is the largest-circulation trade magazine in the healthy food industry. (It is not affiliated with Whole Foods Market retail stores.) The article is reprinted here by permission.

   •  Silver Facts Outshine FDA - article in Whole Foods Magazine

Food and Drug Administration's position

FDA Final Rule - 1999

The current legal status of ionic silver and colloidal silver products intended for oral consumption is shown on the web site of the Food and Drug Administration (FDA) in a Final Rule on the product category. The bottom line of the 1999 Rule is that such products may be sold as dietary supplements in adherence with applicable laws pertaining to dietary supplements (e.g., the Dietary Supplement Health and Education Act - DSHEA), and provided no disease claims are made (which would legally classify them as drugs).

DETAILS:

The FDA issued a final rule, effective September 16, 1999, finding and establishing that "all OTC drug products containing colloidal silver ingredients or silver salts for internal or external use are not generally recognized as safe and effective". A product is considered an "OTC drug" product if it is sold over-the-counter to prevent or treat a disease.

Essentially, all the ruling says is that such silver products are in the same category as all other products—they aren't to be sold "as drugs" unless they first go through the FDA drug approval process.

The reason the FDA finalized a rule that speaks specifically to products containing such silver products, even though the rule essentially just states that such silver products are under the same guidelines as virtually all other products, was apparently that there was confusion about whether such silver products were "grandfathered in". Certain companies had claimed that the sale of such silver products prior to 1938 "for drug use" meant that no FDA approval was needed for them to be sold "as drugs" today, citing "the grandfather exemption". The rule simply clarified that issue by finding and establishing that no such silver products are approved as drugs under the grandfather exemption because they're not made by the identical manufacturer through the identical manufacturing process and are not sold with the identical labeling that existed prior to 1938.

The FDA's rule made clear that such silver products may be sold as dietary supplements.

To further keep the FDA's rule in proper context, the language of the rule points out that if a product is sold to prevent or treat a disease for which it has not been proven to be effective, it is considered to be unsafe in that context, even if the substance was harmless, simply because it could preclude someone from using a drug that was proven to be effective for that disease.

It's important to understand that the FDA rule does not in any way find or establish that any dietary supplement products containing colloidal silver ingredients or silver salts have been determined to be unsafe. It doesn't even find or establish that they're not safe or effective for preventing or treating any disease conditions. It simply finds and establishes that such products are not grandfathered in as drugs, and therefore are not, at present, generally recognized as safe and effective "as drugs" since none have gone through the FDA drug approval process. That's all.

The FDA put no restrictions on the concentrations or recommended dosing levels for such silver products, implying that it doesn't have any serious concerns about the safety of such products. The rule only specifies that such products can be sold as dietary supplements but not as drugs.

The FDA rule conveys its concerns over the fact that "colloidal" silver products often contain silver concentrations that vary widely from what is stated on the label and from bottle to bottle, apparently due to the inconsistent nature of the process by which most colloidal silver is made.

Health Claims allowance under DSHEA

There is one situation under existing dietary supplement laws that would allow some degree of disease claims, called the "health claims" provision under DSHEA.

   •  Food and Drug Administration - Final Rule - OTC silver products - 1999

Dietary supplement "health claims" provision

There is a provision under DSHEA that allows dietary supplements to be sold with disease claims or, as DSHEA calls it, "health claims," provided that a petition for a specific health claim, along with scientific data supporting it, is submitted to the FDA and the FDA decides to allow a given health claim along with the disclaimers the FDA dictates. Such allowances have been quite infrequent since DSHEA became law in 1994, proving so difficult to obtain that the FDA was sued. In 1999, the FDA lost the court case and was ordered by the appellate court to draw up more realistic and more clearly defined guidelines as the criteria for evaluating petitions for health claims allowances. In 2002, the FDA finally issued those new guidelines.

   •  Food and Drug Administration - Guidance for Industry - Qualified Health Claims in the Labeling of Conventional Foods and Dietary Supplements- December 18, 2002

FDA Dietary Supplement Enforcement Report - 2002

As if to send a message, the FDA, on the same day it issued the new health claims guidelines under DSHEA as mandated by the court, it issued the Dietary Supplement Enforcement Report. It lists what the FDA refers to as some "clearly problematic" substances. In this Report, which is not not law but is more of a public policy statement, someone at the FDA makes the entirely unsupported statement, "Colloidal silver is completely ineffective." (See section III(A), at the bottom of the bulleted list in that section of the Dietary Supplement Enforcement Report.)

We find it quite noteworthy that the author of that statement isolated "colloidal" silver products and did not mention "ionic silver" or "silver ions," no doubt due to the high degree of respect for, and rapidly growing utilization of, ionic silver products in the medical and industrial fields. (The FDA did not overlook mentioning ionic silver products in the 1999 Final Rule.) Perhaps the person at the FDA who wrote that part of the report was targeting colloidal silver because it is generally not nearly as consistent and pure as an ionic silver complex is capable of being.

In any case, the statement "Colloidal silver is completely ineffective" is, in our opinion, extremely irresponsible. We doubt that the person who wrote it did any research before writing it. Perhaps it was an innocent oversight. We do know there is nothing cited in the report and, to our knowledge, nothing in existence in the way of meaningful scientific data to support such a statement. The FDA is notorious for taking the position that an enormous amount of research data is needed before making any claims as to whether a product may potentially help with a disease or not. It seems quite odd that the FDA would flatly state that "Colloidal silver is completely ineffective" while having or citing no data whatsoever to support such a statement. The statement also flies in the face of historical data and an enormous amount of historical usage regarding colloidal silver.

   •  Food and Drug Administration - Dietary Supplement Enforcement Report - December 18, 2002