Export Rule Records Inspection Enforcement For Cosmetics Suspended – FDA
This article was originally published in The Rose Sheet
Executive Summary
FDA will temporarily refrain from enforcing the provision of its export notification and recordkeeping rule that requires companies to make records for cosmetics or foods exported under the law available to the agency during an inspection
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Export rule enforcement
As it considers changes to the reg, FDA will continue to "exercise enforcement discretion" on requirement in its export notification and recordkeeping rule that records for exported cosmetics or foods be made available to the agency for inspection. Also suspended is mandate that marketers of all regulated products prepare a notarized certification that an exported product does not conflict with the laws of the importing country. Enforcement of two provisions earlier was postponed until July 19 in response to a joint request by CTFA and the Grocery Manufacturers of America (1"The Rose Sheet" July 1, 2002, p. 8). In a July 22 letter to the groups' outside counsel, Peter Barton Hutt (Covington & Burling), FDA said it may issue an advanced notice of proposed rulemaking to seek public comment...
Export rule enforcement
As it considers changes to the reg, FDA will continue to "exercise enforcement discretion" on requirement in its export notification and recordkeeping rule that records for exported cosmetics or foods be made available to the agency for inspection. Also suspended is mandate that marketers of all regulated products prepare a notarized certification that an exported product does not conflict with the laws of the importing country. Enforcement of two provisions earlier was postponed until July 19 in response to a joint request by CTFA and the Grocery Manufacturers of America (1"The Rose Sheet" July 1, 2002, p. 8). In a July 22 letter to the groups' outside counsel, Peter Barton Hutt (Covington & Burling), FDA said it may issue an advanced notice of proposed rulemaking to seek public comment...
Export Recordkeeping Reg’s Implementation Period Too Short – CTFA
Three months "is too short a period of time" for firms to modify existing internal systems to meet new notification and recordkeeping requirements governing exported cosmetics, drugs and foods that cannot be sold domestically, the Cosmetic, Toiletry and Fragrance Association says in a March 12 petition to FDA