BFAD Circular on Alcohol Disinfectant Claims

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BFAD BUREAU CIRCULAR NO. 3, S. 1999: BFAD Circular on Alcohol Disinfectant Claims

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Title Supreme Court: BFAD Circular on Alcohol Disinfectant Claims

Law: Bfad Bureau Circular No. 3, S. 1999

Decision Date: Feb 2, 1999

The Bureau of Food and Drugs clarifies that while 70% ethyl or isopropyl alcohol is effective as a disinfectant and antiseptic, it cannot be marketed as a sterilizing agent due to its limitations against certain microorganisms and its ineffectiveness on contaminated surfaces.

regulatory action

A

Composition and Uses of Rubbing Alcohol

Should contain 68.5% to 71.5% by volume of absolute ethyl or isopropyl alcohol.
Functions as a disinfectant for skin before injections or venipuncture.
Used as a solvent and pharmaceutical preservative.

Limitations of Alcohol as an Antiseptic and Disinfectant

Alcohol is bactericidal but ineffective against bacterial spores such as Clostridium tetani, welchii, and Bacillus anthracis.
Unsuitable for disinfection or sterilization of surgical and dental instruments.
Not appropriate for disinfecting surfaces or materials contaminated with blood or body fluids due to limited penetration of organic residue and rapid evaporation.

Regulatory Clarification on Advertising Claims

Claims of sterilizing activity for alcohol are considered false and unacceptable.
Using the term "sterilizing" to claim superiority over other alcohol products violates regulations.
Such violations are subject to sanctions enforced by the Bureau of Food and Drugs (BFAD).

Enforcement and Adoption

The BFAD issues this circular for clarification, rule-making, and regulatory action regarding advertising and promotional claims of 70% ethyl or isopropyl alcohol.
The circular was adopted on February 2, 1999, and signed by the BFAD Director, William D. Torres.

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