FDA’s Regulatory Agenda in 2011

FDAThe Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) was enacted in June of 2009 and granted the FDA the authority to regulate cigarettes, roll-your-own tobacco and smokeless tobacco products. Under this law, the FDA has been issuing and implementing various tobacco regulations. This year, there are several major regulations under consideration by the FDA’s Center for Tobacco Products.

The Tobacco Control Act does not require tobacco retailers to implement a clerk training program. However, in July of 2010, the FDA issued what is called a “guidance” document that sets forth recommended elements for a training program. The FDA accepted public comments on the proposed training program elements, and should be issuing a final set of recommended elements soon. If a retailer uses a training program that meets the FDA recommended requirements, then a lower penalty structure will apply if a clerk violates the law and sells tobacco products to an under-aged individual.

As a part of the FDA’s implementation of retail tobacco regulations, the Tobacco Control Act granted the FDA the authority to contract with states to perform surveillance inspections and compliance checks in retail stores. While the FDA intends to contract with every state to assist in inspecting tobacco retailers, to date the FDA has contracted with Alabama, Arkansas, Arizona, Colorado, Idaho, Illinois, Kansas, Maine, Maryland, Massachusetts, Mississippi, Missouri, Pennsylvania, Tennessee and Washington. The first round of inspections recently occurred in Mississippi and 95% of 493 Mississippi inspected retailers passed the compliance checks.

A third major regulatory action by the FDA this year will be a decision on what action to take, if any, on menthol cigarettes. The Tobacco Control Act banned all flavored cigarettes, except menthol cigarettes. However, the law also established the Tobacco Product Scientific Advisory Committee (TPSAC) to study the “impact of the use of menthol in cigarettes on the public health, including such use among children, African-Americans, Hispanics, and other racial and ethnic minorities.” A report by the TPSAC, with its recommendation on menthol cigarettes, will be submitted to the FDA by the end of March 2011.

One other significant regulatory action by the FDA is the requirement that new text health warnings accompanied by graphic pictures be printed on the top half of the front and back of cigarette packages. The FDA law requires that nine new text health warnings appear on a rotating basis on cigarette packages. These new text warnings will replace the current Surgeon General’s health warnings that appear on cigarette packages.

The wording for each of the nine new warnings is as follows:

  • WARNING: Cigarettes are addictive
  • WARNING: Cigarettes cause cancer
  • WARNING: Tobacco smoke can harm your children
  • WARNING: Cigarettes cause fatal lung disease
  • WARNING: Cigarettes cause strokes and heart disease
  • WARNING: Smoking during pregnancy can harm your baby
  • WARNING: Smoking can kill you
  • WARNING: Tobacco smoke causes fatal lung disease in nonsmokers
  • WARNING: Quitting smoking now greatly reduces serious risks to your health

Each of these new text warning labels will need to be accompanied by a pictorial health warning that shows the health consequences of smoking. The FDA has proposed 36 different color graphic health warning pictures, and will select nine of the 36 pictures to print on cigarette packages.

The following list contains what the Agency and Commissioner hope to spend most of their time on in 2011:


• Standards for making comparative claims in prescription drug promotion
• DTC television advertisements—FDA Amendments Act of 2007 DTC Television Pre-Review Program, with particular emphasis on how the Agency intends to address the issue of certifying the legality and safety of content for TV ads going forward. FDA has been harshly criticized by consumer groups for acting with ambivalence in this key area of drug promotion.
• Promotion of prescription drug products using social media tools. This includes creating clear guidelines in setting legal boundaries between what may constitute a simple exchange of information and commercially oriented promotion.


• defining oncology endpoints in clinical trials for non-small cell lung cancer
• General clinical pharmacology consideration for pediatric studies for drugs and biological products


• standards for superiority in adaptive trial designs

Combination Products:

• building a clear regulatory pathway for incorporating drug diagnostics in co-development programs with small molecules and biologics.

Current Good Manufacturing Practices Compliance:

• Importation of active pharmaceutical ingredients for use in human drugs, standards to enhance safety and efficacy in international trade.

Drug Safety Information:

• Best practices for conducting pharmacovigilance studies using electronic healthcare data

The list should not be seen as exhaustive or definitive—given the Agency’s vast remit, priorities can shift or be overtaken by events. In that regard, the list includes enough new initiatives in areas outside the remit of pharmaceutical regulation—such as food safety—to suggest FDA resources will continue to be stretched to the limit next year. This guidance will also need to pass muster with the new GOP majority in the House of Representatives, which is likely to tone down any hint of regulatory activism in the Agency as it moves forward.

For the complete agenda, please visit the Federal Register website entry for December 7, 2010.

One response to “FDA’s Regulatory Agenda in 2011

  1. Great post with lots of imorptant stuff.

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