CPG Sec 590.300 Direct Reference Authority for Pseudomonas Contamination of Cosmetics Used in the Eye Area

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

CPG Sec. 590.300 Direct Reference Authority
for Pseudomonas Contamination of Cosmetics
Used in the Eye Area
REGULATORY ACTION GUIDANCE:
The following represents criteria for deciding when direct reference seizure *requests to the
Office of Human and Animal Food Operations (OHAFO) in consultation with the Office of
Enforcement and Import Operations (OEIO) and CFSAN) is appropriate:
Any cosmetic product intended for use in the eye area which contains Pseudomonas aeruginosa.
REMARKS:
Direct reference seizure recommendations should be accompanied by complete labeling and
worksheets. Positive identification using the method found in Chapter 25 of the Bacteriological
Analytical Manual (BAM) is necessary to support the charge. Speciate Pseudomonas isolates
using biochemical tests (BAM, Chapter 25) or appropriate commercial identification kits.
SPECIMEN CHARGE:
The article (was adulterated when introduced into and while in interstate commerce) (is
adulterated while held for sale after shipment in interstate commerce) within the meaning of the
Act, 21 U.S.C. 361(a), in that it contains a poisonous or deleterious substance, Pseudomonas
aeruginosa, which may render it injurious to users under such conditions of use as are customary
or usual.
*Material between asterisks is new or revised.*
Issued: 4/10/91
Revised: 8/96, 5/2005
Updated: 11/29/05