The FDA Proposes Rules To Ban Menthol In Cigarettes, And More!

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According to the FDA news release:

"Today, the U.S. Food and Drug Administration is announcing proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors (other than tobacco) in  cigars. These actions have the potential to significantly reduce disease and death from combusted tobacco product use, the leading cause of preventable death in the U.S., by reducing youth experimentation and addiction, and increasing the number of smokers that quit." 

Read the full FDA news release: FDA Proposes Rules Prohibiting Menthol Cigarettes and Flavored Cigars to Prevent Youth Initiation, Significantly Reduce Tobacco-Related Disease and Death - FDA.gov

FDA - Two Proposed Rules Released to Implement FSMA

Updated October 15, 2016

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What to Expect Now that the First Big FSMA Compliance Dates Are Here

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FDA Law Blog: On FSMA’s Second Anniversary, FDA Releases Two Major Proposed Rules:

"FDA released two long-awaited proposed rules to implement key provisions of the Food Safety Modernization Act ("FSMA"): Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption."

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Shocking FDA Images For Cigarette Packages

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Wow! These are high impact and jarring images. You have to check out what the FDA is proposing as new required warnings, consisting of nine new textual warning statements accompanied by color graphics depicting the negative health consequences of smoking, Proposed FDA Graphic Health Warnings for Cigarette Packages and Advertisements.

More Information:
FDA Proposed Cigarette Product Warning Labels

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Drug Safety and Accountability Act of 2010

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Sen. Michael Bennet (D-CO) introduced a bill earlier this month, the Drug Safety and Accountability Act of 2010, which is designed to improve regulatory oversight of drug-manufacturing facilities and improve related quality standards and monitoring.

Bennet's press release, Senate Introduces New Bill on Drug-Manufacturing Quality Standards, says:

The bill would strengthen manufacturer quality standards, enhance the FDA’s ability to protect Americans through improved tracking of foreign manufacturing sites, and give the FDA much-needed authority to recall potentially dangerous drugs.

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Dietary Supplements - Legislation Introduced - S. 3414

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New dietary supplement legislation (S. 3414) has been introduced by Senators Harkin and Hatch, as reported by this Lexology article, Dietary supplements on the Hill - new legislation introduced.

In a nutshell:

1. It would allocate funds to the FDA to implement and enforce DSHEA.
2. It would require the FDA to make annual reports to Congress on its implementation and enforcement of DSHEA.
3. 180 days after the enactment of S. 3414, the FDA would be required to publish a guidance document on New Dietary Ingredients (“NDI”).

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FDA Releases Proposed Guidance On Combination Products

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Updated July 5, 2024:

Links broke in the original post.

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FDA - Combination Products Guidance Documents

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This Federal Register notice announces the FDA release of a proposed rule on combination products, Current Good Manufacturing Practice Requirements for Combination Products (pdf). According to the FDA Law Blog post, FDA Issues Proposed Rule on cGMPs for Combination Products:

The proposed rule does not independently establish new requirements, rather, it clarifies which set of existing cGMP regulatory requirements apply when drugs, devices, and biological products are combined to create a combination product.

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