Data Quality Issues Raised During the Public Comment Period on Substantial Equivalence

 Several respondents raised questions concerning the scope and utility of the data being requested by the FDA.

Altria states:

“Congress excluded from the criteria for substantial equivalence under § 910(a), and for reporting under § 905(j), any consideration of behavioral effects such as initiation or cessation, or of consumer perception studies. This absence shows Congressional intent that the criteria should not be considered in the substantial equivalence evaluation.”

Altria quotes the following statement in an IOM  report in support of its conclusion:

“In the absence of any claim of reduced exposure or reduced risk, manufacturers of tobacco products should be permitted to market new products or modify existing products without prior approval of the regulatory Agency after informing the Agency of the composition of the product and upon certifying that the product could not reasonably be expected to increase the risk of cancer, heart disease, pulmonary disease, adverse reproductive effects, or other adverse health effects, compared to similar conventional tobacco products, as judged on the basis of the most current toxicological and epidemiological information.”


 CRE , in its comments on the ICR accompanying the NPRM ,  concluded that as a result of the following requirement proposed by FDA:

 “a detailed explanation of why a report intended to demonstrate substantial equivalence is not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for the protection of public health; a certification by a responsible official of the company, such as the chief executive officer, summarizing the supporting evidence and providing the rationale for the official’s determination that the modification will not increase the product’s toxicity, addictiveness, or appeal to or use by minors; and other information justifying an exemption.”


FDA’s unsupported estimate of 360 hours to respond to the exemption requests violates both the PRA and the Data Quality Act.

The following information,  provided by FDA  which were not available at the time CRE  comments were to be submitted  on the ICR  does not ameliorate CRE concerns:  

 “The proposed rule, if finalized, would establish a pathway for manufacturers to request exemptions from the substantial equivalence requirements of the Tobacco Control Act.  It would not establish categories of minor modifications, or identify specific modifications, that meet the statutory criteria for exemptions. As FDA acquires more information about the additives in tobacco products from which to establish such categorical exemptions, it may issue additional regulations or guidance.”

As of this date,  OMB will not permit the public to review the comments it recieved on the ICR.

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