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

Trashed Tests Put FDA on Notice as China Pushes Drug Exports - Bloomberg Business

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Read the full article: Trashed Tests Put FDA on Notice as China Pushes Drug Exports - Bloomberg Business:

"“It’s not just for the U.S. FDA, also the China FDA is understaffed as well,” said Jonathan Chan, an analyst in Hong Kong with Decision Resources Group, citing the size of the industry and the large number of drug applications. “It’s quite overwhelming. With agencies being understaffed, quality control and standards will get compromised.”"

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New FDA sunscreen label standards delayed until winter

Updated August 16, 2021

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Tips to Stay Safe in the Sun: From Sunscreen to Sunglasses - FDA.gov

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New FDA sunscreen label standards delayed until winter - WMBFNews.com, Myrtle Beach/Florence SC, Weather:

"New standards for the labeling sunscreen, intended to help you identify which will protect you best, won't be going into affect before you hit the sands on your summer vacation.

If you're going to spend a lot of time in the hot sun this summer, you'll have to fend for yourself when it comes to picking sunscreen. The FDA has pushed back the new label standards for six months.

The new standards are supposed to make it easier for you to pick up the best bottle of sunscreen off the shelf. They force companies to make a variety of changes like make all label font sizes to be the same so you won't get distracted by what's in bold."

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FDA Issues MDDS Final Rule

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Updated March 11, 2021

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FDA finalizes regulation for certain software, hardware used with medical devices - Rule provides more predictable path to market.

The FDA announced a final rule that provides a less-burdensome path to market for certain hardware and software products used with medical devices. The rule classifies these products, known as Medical Device Data Systems or MDDS, as Class I or low-risk devices, making them exempt from premarket review but still subject to quality standards.

Medical Device Data Systems are off-the-shelf or custom hardware or software products used alone or in combination that display unaltered medical device data, or transfer, store or convert medical device data for future use, in accordance with a preset specification. Examples of MDDS products include: devices that collect and store data from a blood pressure cuff for future use or that transfer thermometer readings to be displayed at a nursing station for future use.

Here's a thought-provoking article, Final MDDS rule deems hospitals medical device manufacturers. In this article, it mentions, "The final MDDS rule will apply to “all manufacturers,” the FDA says. Critically, this includes hospitals, health care facilities or any other organization that does any of the following: . . ."

As of this writing, the Medical Device Data Systems rule will be published in the Federal Register. Read the rule here: Medical Devices; Medical Device Data Systems - FDA Final Rule (PDF).

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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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FDA Draft Guidance - Drug Supply Chain and SNIs

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Updated October 24, 2022:

I'm glad to see these new proposed standards. With the presence of drug counterfeiting, diversion, and quality issues, I'm hopeful these standards can bring greater safety and confidence to the supply chain. This FDA Guidance for Industry Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages - Draft Guidance is the first of several guidances and regulations that the FDA may issue to implement Section 913 of the Food and Drug Administration Amendments Act of 2007. This guidance recommends the standards that industry should use for the identification of individual packages containing prescription drugs. These standards will facilitate the adoption of a uniform electronic track and trace system for prescription drugs to further improve their safety and security. The details of the draft guidance follow . . . TABLE OF CONTENTS I. INTRODUCTION II. BACKGROUND A. Food and Drug Administration Amendments Act of 2007 B. Scope of this Guidance III. STANDARDIZED NUMERICAL IDENTIFIERS A. What should be designated as a package-level SNI? B. Does the SNI include expiration date and/or lot or batch number? C. Why did FDA select the serialized NDC for package-level SNI? Do you agree with the direction this FDA draft guidance is taking us? 

Related Posts: FDA Draft Guidance On Good Importer Practices FDA - Global Drug Supply Chain Needs Better Oversight CA E-Pedigree - Pedigree and Serialization 

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Prescription Drug Reimportation and Safety - Both Presidential Candidates Support It

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Election time is near, sometimes the candidates have the same view, and sometimes they differ. They happen to agree and reaffirmed their support for allowing Americans to import cheaper prescription drugs from abroad, but both campaigns note that concerns over international drug safety will take precedence in determining this policy, commonly known as drug reimportation. Read this Henry Kaiser Foundation post for more details, "Election 2008 - Both Major Presidential Candidates Support Prescription Drug Reimportation, Cite Need To Ensure Safety." In a nutshell, here are the high points . . .

1. Recent incidents like the tainted heparin from China, highlight the need to ensure drug safety abroad.
2. There's a need to focus on global areas with strong track records of safety.
3. We need to make sure that all imported drugs meet state and federal standards for safety.

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