Tobacco Facts.

The Federal Food and Drug Administration (“FDA”) recently posted a new Guidance for the tobacco industry, entitled Listing of Ingredients in Tobacco Products, (the “Guidance”) concerning the mandatory listing of ingredients with a rapidly approaching deadline of December 22, 2009. Among several specific and noteworthy interpretations provided in the Guidance, the FDA has indicated it does not intend to enforce the December 22, 2009 deadline.

Under the authority of the Family Smoking Prevention and Tobacco Control Act (“Act”), section 904(a), signed into law on June 22, 2009, each tobacco product manufacturer or importer, or agent thereof, is required to submit a listing of all ingredients, including tobacco, substances, compounds, and additives that are added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product by brand and by quantity in each brand and subbrand. This requirement applies to tobacco products on the market prior to June 22, 2009. Any tobacco product which did was not marketed until after the June 22, 2009 deadline is obligated to submit a list of ingredients at least ninety (90) days prior to delivery for introduction into interstate commerce. Failure to comply with this requirement is deemed a “misbranding” of the tobacco product at issue and therefore is subject to enforcement action by the FDA. The enforcement actions can include warning letters, seizure of the product and possibly judicially enforced injunctive relief.

It is interesting to note that should the Guidance document language be found to supersede the statutory language, new products may be required to file ingredient listings before products which have been on the market for a period of time.

The Guidance provides several specifics as to how the FDA will interpret and enforce the requirements of the Act. The Guidance states that ingredient listings must be submitted by any tobacco product manufacturer or importer for all cigarettes, smokeless tobacco and roll your own tobacco for consumer use. In addition the FDA will, according to the Guidance, enforce ingredient listing filings for “manufacturers and importers of tobacco (leaf, reconstituted and bulk smokeless), papers filters, or pouches whether such products are for further manufacturing or, or for consumer use as regulated tobacco products.” Further, the Guidance offers the FDA’s interpretation of the Act’s requirement that each tobacco product manufacturer/importers are required to submit ingredient lists for “each tobacco product by brand and by quantity in each brand and subbrand” to mean “that tobacco product manufactures/importers submit ingredient lists individually for tobacco products that differ in any way, other than packaging differences that do not affect characteristics of the product.”

Finally, and quite significantly, the Guidance states that the FDA does not intend to enforce the December 22, 2009, deadline provided a tobacco manufacture/importer submits the ingredient list on or before June 22, 2010. This statement needs to be balanced against the FDA’s introductory statement wherein the FDA says that its “guidance documents, including this guidance, do not establish legally enforceable responsibilities.” This is consistent with historical statements by the FDA wherein the FDA has taken a very rigid position concerning such guidance language. Traditionally, the FDA’s position has been that guidance only reflects the current thinking of the agency on a topic and should only be viewed by the industry to which it is directed as recommendations. A guidance cannot and will not supersede statutory mandates.

Tobacco manufacturers/importers must exercise caution in following this newly issued Guidance. It does not create or confer any rights for or on any person and does not operate to bind the FDA or the public. So what is a manufacturer/importer to do? It may be worth considering filing the ingredient listing information that is available to the manufacturer/importer on each regulated product along with language which indicates further updates will be forthcoming if needed. Although this could be seen as a more conservative approach, it clearly places each manufacturer/importer in a position of good faith. For those that fail to file the ingredients listing by the December 22nd deadline, relying on the language in the Guidance may run a risk. The risk is inherent in the FDA’s own words, that this Guidance only reflects the agency’s current thinking, is not rule or law and therefore cannot change that which is mandated by law. A more risk adverse approach dictates submitting a listing of ingredients, even if incomplete, by the established deadline and supplementing the listing of ingredients if and when appropriate.

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