Altria Reportedly Distributing Summary of FDA Bills


Lobbyists for Altria have reportedly been distributing the following precis of the upcoming FDA bills to members of Congress, a precis which displays an intimate knowledge of the bills far in advance of any public notification. "Why not?" some in the tobacco control movement have wryly commented, "they wrote them."

Overview of Kennedy/Cornyn and Waxman/Davis Bills

Authority to Ban Tobacco Products

The bills explicitly provide that FDA will not be permitted to prohibit the sale of any tobacco product to adults age 18 and over.

Moreover, the bills explicitly state that one of "the purposes of this Act" will be "to continue to permit the sale of tobacco products to adults in conjunction with measures to ensure that they are not sold or accessible to underage purchasers".

The product standard section explicitly provides that only Congress could impose a new product standard "banning all cigarettes" or require "the reduction of nicotine yields of a tobacco product to zero".

Product Standards

Cigarettes will not be able to have a "characterizing flavor", other than tobacco or menthol.

FDA will be able to impose general product standards that it finds to be "appropriate to protect the public health", without any specific language regarding consumer acceptability. In addition, the bills explicitly direct FDA to consider whether a standard would create a significant new demand for contraband products, in determining what would, and would not, be "appropriate to protect public health".

In addition, a performance standard may not have the effect of "banning all cigarettes" or reducing nicotine yields "to zero"; this power is explicitly reserved to Congress.

Product Liability/States Ability to Regulate Advertising

The bills would amend FCLAAs preemption section so as to restore States ability to regulate cigarette advertising, while retaining the status quo as to the statute's preemptive effect in tort cases.

The new language will permit States and localities to enact new statutes and regulations that specifically restrict or ban the "time, place and manner, but not content" of cigarette advertising and promotions. So, for example, they can attempt to ban cigarette billboards, so long as the regulation does not dictate what a billboard may and may not say. Moreover, any State action in this area will be subject to analysis under the First Amendment's guarantee of commercial free speech.

Regulatory Uniformity

The bills provide that FDA product standards will apply nationwide, without States authority to impose conflicting standards.

Uniformity also applies in the areas of premarket approval, adulteration, misbranding, labeling, registration, good manufacturing practices and "modified risk tobacco products" (discussed below).

States will be expressly permitted by the bills to regulate in the areas of sales, distribution, possession, public place smoking, access, marketing, information reporting to the State (like the Massachusetts ingredients reporting law) and "fire safety standards".

"Modified Risk Tobacco Products"

The bills define as a "modified risk tobacco product" any product where the label, labeling or advertising makes a risk-reduction or exposure-reduction claim, or where the manufacturer has communicated to consumers, by other means, in a way that "would be reasonably expected to result in consumers believing" that the product reduces risk or exposure. In addition, the use of brand descriptors such as "light", "mild" or "low" results in the product being a "modified risk tobacco product". Any "modified risk tobacco product" that has not been pre-approved by FDA may not be sold or distributed.

The bills would require FDA, in order to approve an application for a "modified risk tobacco product", to find that the product, as actually used by consumers, would result in harm reduction to both individual users and the population as a whole.

In addition, the bills expressly empower FDA to approve applications for products that make exposure-reduction claims for five-year (renewable) periods, utilizing criteria that appear to have been substantially derived from the IOM Report. This kind of "modified risk tobacco product" can be approved if FDA determines that (i) the approval would be appropriate to protect public health; (ii) it's not yet possible to scientifically demonstrate that a reduced-exposure product will actually reduce the risk of contracting tobacco-related disease; (iii) the reduced exposure from the product is anticipated to lead to "a measurable and substantial reduction in morbidity or mortality among individual tobacco users"; (iv) the exposure reductions are "substantial", the substances to which exposure is reduced are "harmful", and "the product as actually used exposes consumers to the specified reduced level of the substances"; (v) based on actual use, the product won't result in "higher! levels of other harmful substances...unless such increases are minimal and the anticipated overall impact" of the product is anticipated to reduce morbidity and mortality; (vi) the product's claims won't misleadingly convey a "reduced risk" message and (vii) approval of the application is expected to benefit the population as a whole.

In addition, the bills contain a provision requiring FDA itself to publish (starting three years after enactment) an annual by-brand list, "in a format that is understandable and not misleading to a lay person", setting forth the "harmful and potentially harmful constituents" to health in each brand.

The bills permit FDA to approve cross-category claims between, for example, smokeless tobacco products and cigarettes.

Brand Descriptors

Terms like "light" and "low tar" would cause a tobacco product to be considered a "modified risk tobacco product" and, therefore, could not be used absent advance FDA approval. All manufacturers will be required to stop using these terms until such time, if ever, as FDA approved them under its approval authority.

Good Manufacturing Practices

FDA will be able to require GMPs of all manufacturers/importers, without any specific reference either to medical devices or agricultural products.

Foreign Manufacturers

The bills provide that foreign manufacturers and importers will need to register with FDA and submit all required product reports, and that their factories will be subject to inspection by the agency.

Counterfeit/Illicit Trade

The bills direct FDA to take an array of measures designed to combat counterfeit and otherwise illicit tobacco products, including the promulgation of regulations relating to recordkeeping for tracking and tracing. Manufacturers and distributors with knowledge that "reasonably supports the conclusion" that their products are being smuggled would be required to notify the Attorney General of their knowledge.

Pre-market Approval

The bills require a determination by FDA prior to the launch of a "new product" that the product is either (i) "substantially equivalent" from a health perspective to other tobacco products then being marketed or (ii) required to undergo an extensive "pre-market approval" review process. The definition of "new product" appears to be focused on ingredients and other content issues.

FDA will have the ability to create a "fast track" procedure for "new products" that are basically the same as existing ones, but merely add or delete ingredients.

Exports

The bills require that exported tobacco products need to comply with the product standards of the destination country, not with FDAs product standards.

In addition, FDA will collect information about the public health impact, if any, of the export of tobacco products from the US that don't comply with domestic product standards, and report to Congress periodically on the issue.

Codification of FDA Rule

The bills will codify the marketing and access (but not label) restrictions from the 1996 FDA rule, with specific authority for the agency to review the regulations and propose any appropriate amendments.

To the extent not amended by FDA, the rule must take effect not later than one year after the bill is enacted.

The First Amendment aspects of the FDA rule are still subject to legal challenge.

User Fee

The user fee language provides for quarterly (rather than annual) assessments, and contemplates that FDAs calculation of relative market shares for its assessments will be based on federal excise tax filings. In addition, specific language has been included providing that "no manufacturer or importer of tobacco products shall be required to pay a user fee in excess of the market share of such manufacturer or importer."

The annual aggregate user fee for the industry starts at the $85 million level for Fiscal Year 2008, rises to $175 million for Fiscal Year 2009, then to $300 million for Fiscal Year 2010, and is adjusted thereafter for inflation.