THE FDA TAKES ACTION

On September 16, 1999, The FDA issued a final ruling on any and all colloidal silver products. With a brisk pen-stroke invoking the FDA's broad power, the ruling proclaimed and entered into law that any silver substance in a gelatinous solution could not be sold as a medicinal substance. The ruling categorized colloidal silver as an unclassified drug. Any colloidal silver products marketed as having medicinal properties are now in violation of federal law.However, due to the fact that silver is both a natural substance AND not a controlled substance, it is still protected under the The Dietary Supplement Health and Education Act. Under this law, any labeling and/or advertising referring to any health benefits of the substance in question is unlawful. The substance must be labeled as a dietary supplement and may NOT be marketed for external use.

The innocent bystander might assume that the FDA took this action based on collected research data that demonstrates that colloidal silver is a harmful substance, and thus the public should be protected from its use. HOWEVER, this is not the case. The following letter, written by the FDA in compliance with the Freedom of Information Act, clearly shows that the FDA's action to ban colloidal silver sales was NOT motivated by ANY data suggesting harm:

The FDA Admits it has no Clinical Data Suggesting Isolated Silver is Unsafe for Human Use

October 14th, 1999Food and Drug Administration U.S. Department Of Health and Human Services Public Health Service 5600 Fishers Lane Rockville, MD 20857

Dear Sirs/Madam,Pursuant to the Freedom of Information Act and in regard your August 17th, 1999 ruling regarding colloidal silver, could you please supply the following documentation on which you based your decision?1. The number of deaths related to the consumption of colloidal silver.2. The number of allergic reactions to the consumption of colloidal silver.3. The number of harmful drug interactions from both OTC and prescription drugs when combined with colloidal silver.4. The number of reported cases of Argyria from colloidal silver made with the AC or DC electrical process.5. The number of cases of Argyria from colloidal silver that did not contain protein stabilizers.Thank you for your time and consideration of this request.Sincerely,

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The FDA response:

Public Health Service Center for Drug Evaluation and Research Office of Training and Communication Freedom of Information Staff HFD-205 5600 Fishers Lane 12 B 05 Rockville, Maryland 20857 DEPARTMENT OF HEALTH AND HUMAN SERVICESNovember 3, 1999In Response Refer to File: F99-22589

[ Name Removed ], WA 98408Dear [ name removed ]:

This is in response to your request of 10/14/99, in which you requested adverse events associated with the use of Colloidal Silver. Your request was received in the Center for Drug Evaluation and Research on 10/25/99.

We have searched the records from FDA's Adverse Event Reporting System (AERS) and have been unable to locate any cases that would be responsive to your request.Charges of $3.50 (Search $3.50, Review $0, Reproduction $0, Computer time $0) will be included in a monthly invoice. DO NOT SEND ANY PAYMENT UNTIL YOU RECEIVE AN INVOICE.If there are any problems with this response, please notify us in writing of your specific problem(s). Please reference the above file number.

Sincerely,Hal Stepper

Freedom of Information Technician Office of Training and Communications Freedom of Information Staff, HFD-205

EVALUATING COLLOIDAL SILVER BASED ON THE FDA RULING

The conscientious person, armed with the above knowledge, would no doubt consider that the FDA has simply determined that colloidal silver has either no value in human health applications, or that any possible value remains highly questionable due to lack of scientific evidence. The FDA, one would think, is sincerely following its primary purpose of protecting the public from potential abuse by unscrupulous companies and unduly optimistic dreamers-- protecting them from turning blue from argyria and naivety.

Unfortunately, this is not the truth. While the FDA does have valid points against the "colloidal silver industry" as a whole, none of these points has anything to do with whether or not isolated silver is safe in reasonable quantities or whether or not it is effective in fighting infections. Not only has the FDA approved at least one silver product for use in wound care, but the FDA has done its own research to determine if colloidal silver has potential as a significant medicinal substance:"The FDA has tested colloidal silver extensively and found that different microorganisms succumb to its action at a wide variety of concentrations and exposure times. If any of this information entered the public domain, the FDA would consider their own research "unsubstantiated medical claims" and reason enough to classify colloidal silver as a new drug..." - Peter Lindeman, long before the FDA's September 16 ruling

FDA's underlying motives reveal themselves when examining their public relations strategies:

The FDA, knowing full well the distinction between different kinds of silver products, purposefully and maliciously attempts to confuse the public by misrepresenting silver products. The FDA highlights the antiquated use of silver proteins and compounds, while sidestepping the truth that isolated silver is no more like these products than hydrogen alone is like water.
In doing so, the FDA fails to uphold the public trust.
The FDA bullies organizations (as will be shown below) that are not in a position to know the letter of the law, rather than educate them as a matter of public responsibility and interest.
The FDA has mounted an \increasingly hostile campaign against colloidal silver.

It is deeply troubling that such a necessary agency as the FDA can no longer be trusted to uphold the public trust it was founded to preserve. The FDA needs to be held accountable both for its true motives and its actions. It is true that the letter of the law must be honored. However, the spirit of the law should define how the letter of the law is enforced.Both the FDA and the FTC's definition of colloidal silver is sadly lacking: "'Colloidal Silver product' shall mean any product containing or purporting to contain colloidal silver or silver salts, including but not limited to Aaron’s Colloidal Silver."Language that the FDA and FTC use is usually very ambiguous. At least three classifications of silver products are truly required to accurately cover the wide range of silver products in use today. The FDA would truly be doing a public service if it established three separate classifications, and prioritized their actions based on scientifically available evidence on safety:

1) Silver compounds known to be toxic - classified as not generally regarded as safe, retaining the unclassified drug status.

2) Mild silver proteins, silver proteins, various silver compounds (the ones which have adequately been researched) and solutions with more than 50 ppm silver content - classified as "no information that establishes these products as safe", retaining the unclassified drug status.

3) Isolated silver products, meaning ionic and particulate silver in isolated form, between 1 and 50 PPM, in distilled water in colloidal ( and/or ionic ) form - classified as GRAS ( Generally Regarded as Safe ) with the unclassified drug status REMOVED.The FDA likes to argue that there are no USP standards for production. This can be settled in very short order to varying degrees of excellence based on currently available studies endorsed by the EPA.

None of these efforts would change the reality of the law or allow companies to make unsubstantiated medical claims about products. What it WOULD do, however, is deprioritize the critical attention of isolated silver products and properly focus the energy involved in law enforcement.After all, scientifically, silver is no more a drug in the body than simple H2O. By the letter of the law, if I say "H2O cures dehydration" I am making a drug claim.

FDA LOSES SUPPLEMENTS FIGHT

From The March 1999 Issue of Natural Foods Merchandiser News Pamela Wyngate

Court rules that health claims are OK, information helps, not hurts, on labels

The FDA lost a key legal battle recently, and now the agency must define just what it means by "significant scientific agreement" for health claims on supplements labels.The U.S. Court of Appeals ruling validated what many in the supplements industry have been saying for years: more information on supplements' labels translates into better educated consumers.

The natural products industry has served as the voice of the dietary supplements consumers in this matter, according to Susan Haeger, president and CEO of Boulder, Colo.-based Citizens for Health, a plaintiff in the five-year lawsuit. "[We are] extremely pleased that the appellate court has told FDA to define significant scientific agreement," she said. "This landmark decision is absolutely essential to allow consumers to make informed choices about their health care and is likely to have far-reaching implications."

The ruling overturned a lower court decision that had ruled that the FDA could continue to operate the way it had in the past. Lawyers for the FDA have not yet announced if they will appeal the latest decision to the Supreme Court.

Some of the implications of the appeal court's intent are apparent in the sharply worded comments in the ruling directed at the FDA. The court criticized the agency's argument that health claims lacking significant agreement are inherently misleading: "...It would be as if the consumers were asked to buy something while hypnotized, and therefore they are bound to be misled," according to the judges of the District of Columbia Appeals Court. "We think this contention is frivolous."The ruling also included the right for dietary supplements manufacturers to put more information on labels than is currently acceptable. This includes disclaimers as well as health claims.The ruling went on: "Although the government may have more leeway in choosing suppression over disclosure as a response to the problem of consumer confusion where the product affects health, it must still meet its burden of justifying a restriction on speech--here the FDA's conclusory assertion falls far short."Retailers said they were excited about the ruling. "From where we are sitting, we see it as a good decision," said Jim Lee, president of Boulder, Colo.-based Wild Oats. "To define significant scientific agreement--simply put, it means that more information will be provided to our customers. And we know our customers want that."

The January decision came in a case originally filed by a group that included the American Preventative Medical Association, Citizens for Health, People against Cancer and others. In 1994 those groups filed a lawsuit against the FDA, asking the agency to define "significant scientific agreement"--the standard FDA phrase for regulating health claims allowed on supplements' labels."I am absolutely thrilled that the court has recognized the validity of our position and instructed the FDA, finally, to define significant scientific agreement," said Ralph Miranda, M.D., president of the preventative medicine association. "Now, the FDA will no longer be able to get away with continually raising the bar for supplements manufacturers in an effort to prohibit the dissemination of truthful, scientific information."

In addition to defining "significant scientific agreement," the court ordered the FDA to reconsider the following four claims made in the 1994 lawsuit:

* Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancers.

* Consumption of fiber may reduce the risk of colorectal cancer.

* Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease.

* A supplement with 0.8 milligrams of folic acid is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form.

Watch for more work on this issue in the courts later this year, said Tony Martinez, New Jersey- and Washington D.C.-based attorney and lobbyist who worked for the natural products industry on the Dietary Supplement Health and Education Act of 1994. "This decision represents an important and significant victory for the attorneys involved. They deserve the thanks and congratulations from the industry," he said. "It will be interesting and significant to see what objective criteria the FDA develops for significant scientific agreement."-- Substitute for a drug, through a name such as "Herbal Prozac" or claims that they contain aspirin or another well-known drug.But supplement claims clearly targeted to help a well person stay well would be OK. The FDA said naming a supplement "Cardio health," for instance, is legal, as is saying it "supports the immune system," "reduces stress" or "helps maintain cardiovascular function."

THE FDA TAKES ACTION

EVALUATING COLLOIDAL SILVER BASED ON THE FDA RULING

FDA LOSES SUPPLEMENTS FIGHT

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