FDA Proposes to Apply Recordkeeping Regs to Tobacco Exports, Etc.
The Food and Drug Administration has issued a proposed rule to amend certain of its general regulations to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the 2009 Family Smoking Prevention and Tobacco Control Act. Among other things, the proposed rule would affect tobacco product labeling and require certain recordkeeping for exports of tobacco products.
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Comments are due by June 13, 2011.
Labeling Would Have to Reveal Material Facts and Not be Misleading
The proposed rule would amend 21 CFR 1.21 so that tobacco product labeling would be "deemed misleading" if such labeling failed to reveal material facts. In addition, tobacco product labeling, like the labeling of other FDA-regulated products, could not have a statement of differences of opinion regarding the warnings on tobacco packages or advertisements.
Notification and Recordkeeping Would be Required for Exports
FDA's proposed rule would amend 21 CFR 1.101 on the notification and recordkeeping requirements for exports of FDA-regulated products to indicate that tobacco products exported under 801(e)(1) of the FD&C Act would be subject to to those recordkeeping regulations. According to FDA, each tobacco product exporter may have to maintain records up to 3 times a year, at a total of 22 hours per recordkeeper. Comments on the information collection aspects of recordkeeping are due by May 13, 2011.
Rules for Voluntary Recalls Would be Clarified, Regulatory Rights Would be Available
FDA adds that the proposed rule would also clarify FDA's practices and procedures with respect to voluntary recalls of tobacco products. It would also guarantee that tobacco product manufacturers have the same rights as other FDA-regulated entities, where appropriate, such as the right to regulatory hearings.
(See proposed rule for complete details. See ITT's Online Archives or 06/24/09, 09062415, for BP summary of the 2009 law, which highlights its trade provisions.)
FDA contact: Gerie Voss 1-877-CTP-1373, or gerie.voss@fda.hhs.gov
(D/N FDA-2001-N-0121, FR Pub 04/14/11)