REGULATORY ACTION GUIDANCE:
The following represents criteria for 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, and for direct citation by the appropriate Field Office within the Human and Animal Food Program*:
If the toothpicks contain an average of 18% or more by weight of cinnamaldehyde.
If the toothpicks contain between 13% and 18% by weight of cinnamaldehyde, refer to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) with all available injury information.
Article adulterated when introduced into and while in interstate commerce, within meaning of 21 U.S.C. 361(a), in that it contains an added poisonous or deleterious substance, namely, cinnamaldehyde, which may render it injurious to users under customary or usual conditions of use.
NOTE: Only use direct reference citation authority when prosecution is anticipated and evidence to support a prosecution is included with the adulteration charge. Evidence to support a prosecution is specified in existing regulatory procedures issuances.
*Material between asterisks is new or revised.*
Issued: 1/1/73 Revised: 10/1/80, 7/1/83, 9/1/86, 3/95, 5/2005 Updated: 11/29/05
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.