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
21 CFR 310.548 is the regulation titled “Drug products containing colloidal silver ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease” in 21 CFR Part 310, New Drugs. Since 2021, 3 FDA warning letters have cited it.
- Letters citing it
- 3 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 2 on the same dates in 2025
- Most often cited with
- 21 CFR 201.128, in 3 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
All are drug letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 310.548 most often, as written in the letters.
- 1 letter“Intimate/flora gel” and “V-gel” are unapproved new drugs marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Introduction or delivery for introduction of these products into interstate commerce…
- 1 letterBased on the above labeling evidence “Silver Bullet elite douche” and “Silver D elite douche” are over-the-counter (OTC) colloidal silver-containing drug products intended for use in the treatment of vaginal infections
The regulation
Read the text of 21 CFR 310.548 (eCFR, as of Sep 1, 2026)
(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.
[64 FR 44658, Aug. 17, 1999]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 310.548.
- 21 CFR 201.128Meaning of “intended uses”3 letters cite both
- 21 CFR 101.3Identity labeling of food in packaged form1 letter cites both
- 21 CFR 101.36Nutrition labeling of dietary supplements1 letter cites both
- 21 CFR 101.5Food; name and place of business of manufacturer, packer, or distributor1 letter cites both
- 21 CFR 101.9Nutrition labeling of food1 letter cites both
- 21 CFR 201.10Drugs; statement of ingredients1 letter cites both
- 21 CFR 201.66Format and content requirements for over-the-counter (OTC) drug product labeling1 letter cites both
- 21 CFR 210.3Definitions1 letter cites both
Latest letters citing it
The 3 letters citing 21 CFR 310.548 that FDA posted most recently.
- DrugsView Nefeteri WellnessOTC colloidal silver vaginal gelsIssuedMay 30, 2025PostedJun 17, 2025
- DrugsView Bio Wellness 444 LLCColloidal silver douche productsIssuedMay 30, 2025PostedJun 10, 2025
- DrugsView BioLyte Laboratories, LLCBioPharmaIssuedMar 18, 2021PostedMar 22, 2021
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Counts include every citation in a letter, as the Letters filter does. How this database is built.