Code of Federal Regulations (CFR) is the codification of the general
and permanent rules published in the Federal Register by the
executive departments and agencies of the Federal Government. Please
click the link below provided for more information regarding
Colloidal Silver from the FDA.
Consumer information available from FDA
Website regarding Colloidal Silver
August 17, 1999
FDA ISSUES FINAL RULE ON OTC DRUG PRODUCTS
CONTAINING COLLOIDAL SILVER
has issued a Final Rule declaring that all over- the-counter (OTC)
drug products containing colloidal silver or silver salts are not
recognized as safe and effective and are misbranded.
silver is a suspension of silver particles in a colloidal
(gelatinous) base. In recent years, colloidal silver preparations of
unknown formulation have been appearing in stores. These products
are labeled to treat adults and children for diseases including HIV,
AIDS, cancer, tuberculosis, malaria, lupus, syphilis, scarlet fever,
shingles, herpes, pneumonia, typhoid, tetanus and many others.
to the Final Rule, a colloidal silver product for any drug use will
first have to be approved by FDA under the new drug application
procedures. The Final rule classifies colloidal silver products as
misbranded because adequate directions cannot be written so that the
general public can use these drugs safely for their intended
purposes. They are also misbranded when their labeling falsely
suggests that there is substantial scientific evidence to establish
that the drugs are safe and effective for their intended uses.
indiscriminate use of colloidal silver solutions has resulted in
cases of argyria, a permanent blue-gray discoloration of the skin
and deep tissues.
silver ingredients and silver salts include silver proteins, mild
silver protein, strong silver protein, silver chloride, and silver
iodide. The dosage form of these colloidal silver products is
usually oral, but product labeling also contains directions for
topical and, occasionally, intravenous use.
reaching its decision, FDA considered all of the information
described in the proposed rule (October 15, 1996) and submitted by
the public in response to that proposal, the Final Rule becomes
effective on September 16, 1999, 30 days after publication.
PLEASED BE ADVISED THAT RAPHA LABORATORIES HAS BEEN ACTIVELY WARNING
CONSUMERS AGAINST THE USE OF SILVER SALTS WHICH ARE KNOWN TO CAUSE
Code of Federal Regulations information on FDA
regarding Colloidal Silver
[63 FR 13528, Mar. 20, 1998]
Sec. 310.548 Drug products containing colloidal
silver ingredients or
salts offered over-the-counter (OTC) for the treatment
and/or prevention of
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
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
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 oxide, and
(b) Any OTC drug product containing
silver ingredients or
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
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.
[64 FR 44658, Aug. 17, 1999]
May 9, 2003
Media Inquiries: 301-436-2335
Consumer Inquiries: 888-INFO-FDA
FTC and FDA Crackdown on Internet Marketers
of Bogus SARS Prevention Products
Deceptive and Misleading Claims Must be Removed
Federal Trade Commission and the Food and Drug Administration (FDA)
are warning Web site operators, manufacturers and distributors who
suggest that their products will protect against, treat, or even
cure Severe Acute Respiratory Syndrome (SARS), that they are aware
of no scientific proof for such claims and that the Web site
operators must remove any misleading or deceptive claims from the
Internet. A coordinated Internet "surf" found 48 sites touting a
wide variety of SARS treatment or prevention products. The FTC also
retrieved seven promotions for SARS products from its spam database.
The two agencies sent warnings to Web site operators, and e mail
solicitors, cautioning that it is against the law to make claims
about SARS protection or treatment, or any other health benefit,
without rigorous scientific support. FDA has sent 8 warning letters
to manufacturers and distributors who are making misleading claims.
The FTC and FDA staff will follow up by revisiting the targeted
sites to determine whether the Web site operators have deleted or
revised unproven claims.
Discussion regarding dietary supplements being a Food or Drug