Brenda Fisher - Comment

1. The Family Smoking Prevention and Tobacco Control Act granting the FDA the authority to regulate tobacco products does not contain any provision allowing the FDA to request possible tobacco regulation violation reports from the public or other stakeholder groups. 2. The FDA has currently contracted with 38 states and the District of Columbia to conduct retail compliance inspections and these state inspectors receive extensive training on the tobacco regulations, how to conduct a compliance inspection, and how to recognize a potential tobacco regulation violation. This same training requirement is not required of the public or other stakeholder groups which means that they may not be knowledgeable enough about the tobacco regulations to understand what may or may not be a violation. The result could be the filing of inaccurate or false violation reports. 3. The use of this reporting form could also lead to members of the public and stakeholder groups targeting and harassing law-abiding retailers by submitting inaccurate or possibly even false violation reports. 4. An inaccurate or false report will result in the FDA inspecting a law-abiding retailer and burdening the retailer with unnecessary regulatory inspections. 5. President Barack Obama issued Executive Order No. 13563 in January of 2011 requiring government agencies to eliminate wasteful and unnecessary regulations. Authorizing the public and anti-tobacco organizations to report possible retail violations is unnecessary because state agencies have been thoroughly trained to conduct these inspections. This kind of action is contrary to the President's Executive Order. 6. The form proposed by the FDA for reporting possible violations is so general that the possible violations listed are vague and will lead to inaccurate, misleading and false reports. This kind of vagueness is also in conflict with the specific requirements of the President's Executive Order.