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FDA Tobacco Product Regulation: Regulatory History and Overview of Pending Legislation. Mitch Zeller Pinney Associates 2009 Virginia Forum on Youth Tobacco Use April 15, 2009. Topics to Cover. Overview of FDA regulatory initiative in the 1990s Resulting litigation
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2009 Virginia Forum on Youth Tobacco Use
April 15, 2009
One key benefit of creating a new chapter is that it frees Congress to establish new standards by which FDA will evaluate tobacco products. Had the bill placed tobacco products under the existing drug and device sections of the statute, exceptions to the safety and efficacy standard would have had to been created.
Instead, in this new chapter, a completely different and more sensible standard exists built around the recognition of the inherent toxicity of tobacco products and captured in a broad standard that calls for regulation that is appropriate for the protection of public health.
Section 904 mandates FDA receive brand-specific information on ingredients, nicotine delivery, and any smoke constituent FDA identifies as harmful or potentially harmful.
Companies must also provide FDA with all documents developed after the bill is enacted related to health, toxicological, behavioral, or physiologic effects of current or future products.
One criticism…documents created prior to the enactment of the bill do not need to be provided to FDA. But section 904(b) requires the companies to provide any such pre-enactment materials that FDA asks for (e.g. health, toxicological, etc.). The difference is that FDA has to make a request. So this is a minor defect in the bill.
For other products, FDA issues performance standards to prohibit or limit the allowable levels of substances in a finished product. FDA is granted this power in section 907. Products that don’t comply with the levels established in product standards can’t be sold.
Critics point to a limitation on the agency’s power in section 907. While nicotine can be reduced (even to the point below some as-yet-unknown threshold level of addiction), FDA may not ban nicotine.
Any product (even if only test-marketed) or product modification that was introduced after February 15, 2007 is considered a new product that must be evaluated by FDA.
The only way to get around this is to demonstrate to FDA’s satisfaction that the new product is “substantially equivalent” to a pre-February 15, 2007 product.
Section 910 of the bill defines "substantially equivalent" as a product that "has the same characteristics" as the product being compared to, or has different characteristics but "the product does not raise different questions of public health.” "Characteristics" is defined as "materials, ingredients, design, composition, heating source, or other features of a tobacco product."
A provision in section 910 allows a product introduced up to 21 months after the bill is signed into law to remain on the market unless FDA makes a determination that such a product is not substantially equivalent to a product marketed prior to February 15, 2007.
The 21-month provision was added because FDA would not be able to have a regulatory program in place any time soon following enactment of the law. According to this rationale, no new products would be able to come to market until FDA devised and implemented the new product approval process.
But this 21-month provision makes it essential that FDA be prepared to rule that a given product is not substantially equivalent.
21 months and one day after the bill is enacted into law, the provision disappears. From that point forward, a company files a new product application with FDA for marketing approval, or notifies FDA 90 days prior to marketing that a product is substantially equivalent.
FDA has 90 days to say the product is not substantially equivalent and that a new product application is required.
While this creates a duty on FDA to take an action, by issuing a “not substantially equivalent” ruling, this seems reasonable and not too difficult a burden to meet.
The bill provides an exception for certain exposure reduction claims that could theoretically be approved without meeting the rigorous standards outlined above. Those of us who fought to prevent even the possibility of exposure reduction claims lost.
Under this exception, an exposure reduction claim can be approved if a company can demonstrate that a substantial reduction in morbidity and mortality in individual users is anticipated in future studies.
A company must also present consumer perception data proving that consumers will not be misled into believing that the product is less harmful or presents less of a risk of disease than a currently marketed product.
The bill does away with the FTC testing method and orders FDA to develop regulations to require testing and reporting of ingredients and smoke constituents by brand and sub-brand.
FDA must determine how to disclose ingredient/constituent information to the public in a way that will not mislead consumers about the risk of tobacco-related disease.
The bill reinstates the comprehensive final rules promulgated by FDA in 1996 to restrict youth access to tobacco products, and the advertising and marketing of tobacco products to young people.
FDA need not re-issue the 1996 rules as proposed rules. This would have entailed considerable delay in implementation of the rules.
One bad provision in the bill forbids FDA from raising the minimum age for sale of tobacco products above the age of 18. States remain free to do so.
The bill gives FDA the authority over warnings on tobacco packages and in advertising. A new set of rotating warnings is specified, including a warning that cigarettes are addictive.
FDA has the power to revise the label warnings, including mandating graphic warnings, and increase the size of the warning to/up to 50 percent of the front and rear panels.
Warnings in advertising can also be revised, but cannot exceed more than 20 percent of the area of an advertisement.