On Friday, January 28, 2011, the Food and Drug Administration (FDA) released its Final Guidance on the definition of the term Harmful and Potentially Harmful Constituents (HPHCs). However, that final guidance adopted, word-for-word, the language set forth in the FDA's draft guidance published in June 2010. FDA defines the statutory phrase "harmful and potentially harmful constituents" to include those constituents that directly cause disease as well as those that are indirectly harmful. The agency defines "indirect" to includes constituents that "increase the exposure to the harmful effects of a tobacco product constituent by:

  1. potentially facilitating initiation of the use of tobacco products;
  2. potentially impeding cessation of the use of tobacco products;  
  3. potentially increasing the intensity of tobacco product use (e.g., frequency of use, amount consumed, depth of inhalation)."[1]

The lack of specific and useful guidance is especially pressing for industry given the looming March 22, 2011 deadline for the filing of initial Substantial Equivalence reports under Section 905(j). Under guidance issued January 5, 2011 for filing of 905(j) reports, FDA has instructed that these reports include a comparison of HPHCs contained in the product to those contained in the predicate product. However, the agency has provided nothing to guide manufacturers on how to select which constituents to report.

While it is evident that the HPHC requirements will be difficult to fulfill in the short-term, FDA has stated that it will allow manufacturers to submit initial "good faith effort" Substantial Equivalence filings by March 22, 2011 so long as the manufacturers supplement those reports in a timely fashion. Manufacturers must ensure that they fulfill FDA's expectations for a good faith filing prior to March 22, 2011 or they face having to remove their products from the market permanently.

Wiley Rein's Food & Drug and Product Safety Practice can assist you in:

  • Developing formats for "good faith" 905(j) applications;
  • Determining what information available to a specific manufacturer should be reported to the agency in a "good faith" application and later supplements;
  • Working with FDA to negotiate the scope and content of 905(j) applications tailored to your particular product.