Overview
Title
To amend the Federal Food, Drug, and Cosmetic Act to require a recall of electronic nicotine delivery systems that have not been subject to premarket review, and for other purposes.
ELI5 AI
H.R. 9367 is a bill that tries to make sure e-cigarettes and vapes go through safety checks before being sold. If they haven't been checked yet, they must be taken back until they are.
Summary AI
H.R. 9367, known as the "Preventing Vape Use Act," aims to amend the Federal Food, Drug, and Cosmetic Act by enforcing a recall of electronic nicotine delivery systems (ENDS), such as e-cigarettes and vape pens, which have not undergone premarket review. It mandates that these products be recalled unless they receive approval under the premarket review process. Additionally, the bill specifies that ENDS cannot be considered substantially equivalent to existing tobacco products, thereby requiring the same rigorous premarket evaluation as new products. The bill also outlines procedures for issuing recall orders and granting opportunities for informal hearings related to these recalls.
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AnalysisAI
General Summary of the Bill
House Bill 9367, known as the “Preventing Vape Use Act,” seeks to amend the Federal Food, Drug, and Cosmetic Act. It aims to regulate electronic nicotine delivery systems (ENDS), such as e-cigarettes and other vaping devices, by requiring them to undergo premarket review. If these products have not been reviewed prior to their sale, the bill calls for their recall. This legislation extends the definition of tobacco products to include ENDS and removes any existing exemptions, requiring that all such products undergo proper review to ensure they meet safety and health standards.
Significant Issues
A few key issues arise in the drafting of this bill:
Financial Responsibility for Product Recall: The bill does not specify who bears the financial burden of recalling these products, potentially placing a significant cost either on governmental bodies or industry stakeholders.
Ambiguity in Legal Procedures: The language around when the Secretary of Health may withdraw a recall order is vague. Additionally, there's a lack of clarity about the process for informal hearings, which could lead to inconsistent enforcement and legal disputes.
Complex and Technical Legal Terms: The bill uses complex legal jargon that might not be easily understood by the general public and affected businesses, creating potential challenges in comprehension and compliance.
Broad Public Impact
If enacted, this bill could have widespread impacts on public health, particularly by aiming to control the distribution of vaping products that have not been adequately reviewed for safety. It demonstrates an effort to protect consumers, especially minors, from unregulated nicotine delivery systems that could pose health risks.
By mandating rigorous premarket reviews, there is a likelihood of increased public confidence in the safety of available tobacco products. However, tightening regulations around ENDS could reduce the availability of these products, influencing consumer choices and potentially driving some users back to traditional cigarette smoking.
Impact on Specific Stakeholders
Industry and Retailers
For manufacturers, importers, distributors, and retailers of ENDS, this bill introduces new compliance burdens. The lack of clarity about financial responsibilities for recalls could cause considerable economic pressure on smaller businesses. The requirement for premarket approval could limit the ability to quickly bring new products to market, potentially stifling innovation and increasing operational costs.
Consumers
Consumers might face a reduction in the variety of ENDS available if manufacturers find the compliance costs too onerous or if they fail to meet the new regulatory standards. While this could improve product safety, it might also mean that current users of these devices will have fewer options, possibly affecting those who use them as a means to quit smoking traditional cigarettes.
Public Health Officials
Public health advocates may view this legislation positively, as it aligns with efforts to curb youth vaping and ensure that only safe products are available in the market. However, clear guidelines and consistent enforcement will be crucial to realize these health benefits effectively.
Overall, this bill represents a significant step in regulating the vaping industry but requires careful examination of its procedural and financial mandates to ensure its objectives are achieved equitably and efficiently.
Issues
The bill does not specify who will bear the cost of recalling the tobacco products, which could result in a significant financial burden either on the industry or the government. (Section 3: Mandatory recall of ENDS pending premarket review)
The conditions under which the Secretary may withdraw the recall order are vague, lacking sufficient checks to ensure such withdrawals serve the public interest. This ambiguity may pose a legal concern. (Section 3: Mandatory recall of ENDS pending premarket review)
There is no clear mechanism outlined for how the informal hearing process will be conducted, which could lead to inconsistencies or unfair practices. This procedural ambiguity is a legal issue. (Section 3: Mandatory recall of ENDS pending premarket review)
The amendment involves legal changes that require further interpretation to understand the full implications, such as terms like 'not substantially equivalent' and 'requirement for premarket review'. These could be confusing for businesses and consumers. (Section 4: No exemptions allowed for ENDS)
The phrase 'appropriate person' is broad, potentially leading to disputes over responsibility among manufacturers, importers, distributors, and retailers. This ambiguity could result in financial or legal conflicts. (Section 3: Mandatory recall of ENDS pending premarket review)
The language used in the bill is complex and may be difficult for the general public to understand, including legal references that are not immediately clear to those without legal expertise. This could raise ethical concerns regarding accessibility. (Section 4: No exemptions allowed for ENDS)
Sections
Sections are presented as they are annotated in the original legislative text. Any missing headers, numbers, or non-consecutive order is due to the original text.
1. Short title Read Opens in new tab
Summary AI
The first section of this bill states that the official short name for the law is the "Preventing Vape Use Act".
2. Inclusion of ENDS in definition of tobacco product Read Opens in new tab
Summary AI
The text amends the Federal Food, Drug, and Cosmetic Act to confirm that electronic nicotine delivery systems (ENDS), like e-cigarettes and vape pens, are included in the definition of a tobacco product. It also defines ENDS as electronic devices that deliver nicotine or other substances via aerosol to users.
3. Mandatory recall of ENDS pending premarket review Read Opens in new tab
Summary AI
The section mandates that any electronic nicotine delivery systems (ENDS), like e-cigarettes, that haven't been approved through a specific review process must be recalled and distribution stopped. The law provides a chance for an informal hearing and requires notices to be given about the risks, but doesn't allow for recalling these products from individuals.
4. No exemptions allowed for ENDS Read Opens in new tab
Summary AI
The text amends the Federal Food, Drug, and Cosmetic Act to specify that electronic nicotine delivery systems (ENDS) are not considered the same as any existing tobacco product and require premarket review starting 60 days after the enactment of this amendment. It further clarifies that ENDS will be deemed adulterated if they do not meet the requirements set 60 days after the amendment's enactment.