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FDA is proposing a regulation to establish requirements for the administrative detention of tobacco products. This rule, if finalized, would allow FDA to administratively detain tobacco products believed to be adulterated or misbranded that are encountered during inspections of manufacturers, vape shops, or other establishments that manufacture, process, pack, or hold tobacco products. The intent of administrative detention is to protect public health by preventing the distribution or use of tobacco products that are believed to be adulterated or misbranded until FDA has had time to consider the appropriate action to take and, where appropriate, to initiate legal action. This rule, if finalized, would be a critical enforcement tool to stop the distribution and sale of unauthorized tobacco products, such as illegal shipments of unauthorized e-cigarettes originating from overseas. 

Statement of Need:

Currently, Federal law prohibits the adulteration or misbranding of a tobacco product, as well as the introduction, delivery for introduction, or receipt in interstate commerce of such product.  Adulterated products include those that are contaminated, held under unsanitary conditions, or lack required marketing authorization.  (Section 902(1)-(2), (6) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Misbranded products include those with false or misleading labeling or those that do not bear labeling that is required by an applicable tobacco product standard.  (Section 903(a)(1) and (a)(9) of the FD&C Act.)  Notably, large quantities of tobacco products such as e-cigarettes continue to be illegally imported and marketed without required marketing authorization.  This proposed rule, if finalized, would allow FDA to administratively detain non-compliant tobacco products.  The period of administrative detention provides FDA with valuable time to consider further action, if appropriate, including time to engage the Department of Justice, who could go to court on FDA’s behalf to pursue legal action such as a seizure of the products in question.  Without the ability to administratively detain non-compliant products, manufacturers, distributors, and retailers could unlawfully transport the products to evade their seizure, and market them from a different location.

This proposed rule mirrors existing regulatory authority for the administrative detention of devices and drugs.  FDA’s administrative detention authority with respect to drugs allows FDA to better protect the integrity of the drug supply chain.  For foods, FDA can exercise administrative detention authority to prevent potentially harmful food from reaching U.S. consumers and thereby improve the safety of the U.S. food supply.  Similarly, FDA can administratively detain devices that are suspected of being in violation of the Act.  This proposed rule is needed with respect to tobacco products so that FDA has an additional enforcement tool to better protect the public health.  The ability for FDA to issue administration detention orders against new, unauthorized tobacco products, including ENDS, may encourage manufacturers to submit premarket applications requesting authorization for their products to be lawfully marketed, rather than continue to flood the market with additional unauthorized products.  FDA would be able to use our resources to review these applications under streamlined procedures under development and authorize those that are appropriate for the protection of the public health.

Summary of the Legal Basis:

The legal basis for this action is sections 304(g) and 701 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Section 304(g) of the FD&C Act provides FDA with administrative detention authority with respect to tobacco products pursuant to duly promulgated regulations.  Section 304(g)(1) states that [i]f during an inspection conducted under section 704 of a facility or a vehicle, a device, drug, or tobacco product which the officer or employee making the inspection has reason to believe is adulterated or misbranded is found in such facility or vehicle, such officer or employee may order the device, drug, or tobacco product detained (in accordance with regulations prescribed by the Secretary) for a reasonable period which may not exceed twenty days unless the Secretary determines that a period of detention greater than twenty days is required to institute an action under subsection (a) or section 302, in which case he may authorize a detention period of not to exceed thirty days.   Additionally, section 701 of the FD&C Act gives FDA general rulemaking authority to issue regulations for the efficient enforcement of the FD&C Act.

Alternatives:

FDA has considered a delay in the effective date of the regulation, i.e., a greater than 30-day period before the rule becomes effective.  While a delay may discount FDA’s cost estimates, it would not have an impact on the cost of regulated entities reading and understanding the rule.  On the other hand, a delay in the effective date would increase the risk of adulterated or misbranded tobacco products being released into U.S. commerce and to the public.  For these reasons, FDA did not pursue this regulatory alternative.

Anticipated Costs and Benefits:

The estimated primary costs of the proposed rule include the one-time costs incurred by industry to read and understand the regulation, if finalized, annual costs to FDA associated with marking or labeling the detained product, and costs associated with potential appeals of detention orders; however, other costs, such as loss in market value of a detained tobacco product or additional costs associated with appeals of detention orders to affected entities, could be incurred if FDA revokes the detention order on appeal.  Given the history of administrative detention use with medical devices, foods, and human and animal drugs, the most likely outcomes are the firm would choose to destroy the detained tobacco product voluntarily or that FDA would initiate a seizure of the product.

The primary public health benefit from adoption of the proposed rule would be the value of the illnesses, injuries, or deaths prevented because the Agency administratively detained a tobacco product it has reason to believe is adulterated or misbranded.  These benefits would occur only if the tobacco product would not have been prevented from entering the market using one of the Agency’s other regulatory and enforcement tools.  Additionally, should firms choose to voluntarily destroy the detained tobacco products, or a federal seizure action is otherwise avoided, potential cost-savings would be realized.  There would also be benefits from deterrence if administrative detention increases the likelihood that adulterated or misbranded products would not enter commerce in the future. 

Risks:

None.