REGULATORY ACTION GUIDANCE:
The following represents criteria for deciding when direct reference seizure to *the Office of General Counsel* through Division of Compliance Management and Operations (HFC-210) is appropriate:
Any cosmetic product intended for use in the eye area which contains Pseudomonas aeruginosa.
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.
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.*
Revised: 8/96, 5/2005