FDA Warns Of E-Cigarette Risk

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The FDA Warns of Health Risks Posed by E-Cigarettes. Also known as "e-cigarettes," electronic cigarettes are battery-operated devices designed to look like and to be used in the same manner as conventional cigarettes. Sold online and in many shopping malls, the devices generally contain cartridges filled with nicotine, flavor, and other chemicals. They turn nicotine, which is highly addictive, and other chemicals into a vapor that is inhaled by the user. “The FDA is concerned about the safety of these products and how they are marketed to the public,” says Margaret A. Hamburg, M.D., commissioner of food and drugs. In the FDA Consumer Update - FDA Warns of Health Risks Posed by E-Cigarettes (pdf), they state that they're concerned about:

• e-cigarettes can increase nicotine addiction among young people and may lead kids to try other tobacco products, including conventional cigarettes, which are known to cause disease and lead to premature death
• the products may contain ingredients that are known to be toxic to humans
• because clinical studies about the safety and efficacy of these products for their intended use have not been submitted to FDA, consumers currently have no way of knowing: 1) whether e-cigarettes are safe for their intended use, or 2) about what types or concentrations of potentially harmful chemicals, or what dose of nicotine they are inhaling when they use these products

For folks in the regulated industries, you'll be interested to know that the FDA has been examining and detaining shipments of e-cigarettes at the border and the products it has examined thus far meet the definition of a combination drug-device product under the Federal Food, Drug, and Cosmetic Act.

More FDA Information About E-Cigarettes

Previous Posts: Smoking Is Too Expensive - It is time to quit e-Cigarettes In The News (video) Fire Safe Cigarettes Are A Good Thing

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FDA Issues Final Regulation on Dental Amalgam

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Updated April 21, 2017

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Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy - Guidance for Industry and FDA Staff

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I'm pleased to say that after having a mouthful of these things, I'm now down to just one amalgam. OK, so the rest of my teeth are crowns, oh well. This FDA News Release, FDA Issues Final Regulation on Dental Amalgam, reports:

• The regulation classifies dental amalgam into Class II (moderate risk). By classifying a device into Class II, the FDA can impose special controls (in addition to general controls such as good manufacturing practices that apply to all medical devices regardless of risk) to provide reasonable assurance of the safety and effectiveness of the device.
• The special controls that the FDA is imposing on dental amalgam are contained in a guidance document that contains, among other things, recommendations on performance testing, device composition, and labeling statements.

To learn more about dental amalgams from the FDA, go to: Dental Amalgam
Previous Posts:
FDA Expected To Rule On Mercury Dental Amalgams
Mercury-Containing Dental Fillings - Health and Environmental Concerns


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FDA Medical Device Controversies - Approvals and Clearance

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I thoroughly enjoyed reading this Health News Digest article, Is That Medical Device Safe And Effective? Who Knows? It's a great overview of:

• medical device classification
• premarket approval (PMA)
• premarket notification (510(k))
• substantially equivalent
• anecdotes that highlight controversies in the items above. This is the best part of the article.

For me, I get the sense that it's generally about business, and that some unethical companies might be putting our collective safety at risk.

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Colon Cleansing - Myth and Reality

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OK. I just have to comment on this. Just today, one of my co-workers mentioned that they were on a cleansing this week. Fast forward to me reading this article today, Myths and Realities: Colon Cleansing: Healthful or just a load of @$%!. The article is well-written and is certainly food for thought. As for me, I view the cleanse as something I dread. I get a prescribed cleanse every now and then, and it's only in preparation for a scheduled colonoscopy, not something that I look forward to. Cheers! Bottoms up! 

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Is FDA Watching Over Cell Phones as Medical Devices?

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Updated March 24, 2021

People also search for the:

Digital Health Center of Excellence - FDA.gov

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Lately at work I've been noticing some buzz about mHealth, mobile health. The intersection of mHealth, cell phones, and FDA regulation of medical devices seems to be happening, reports this Bob on Medical Device Software post, When Cell Phones Become Medical Devices. According to the post:

Mobile devices are quickly becoming the conduit of choice for collecting and disseminating clinical data. The FDA will soon be forced to step in and take regulatory control. It’s going to happen eventually.

In a nutshell, it's time to start watching this, and paying attention to the possibility of having to follow FDA medical device regulations.  

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Rx-360 - A non-profit to help secure the supply chain (podcast)

Updated July 29, 2020

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Rx-360 - About Us

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Learn about Rx-360. Listen to this Pharmaceutical Technology podcast (~ 11 mins), Podcast: A Look at Rx-360. Here's how Pharmaceutical Technology describes this podcast:

Join Angie Drakulich, Managing Editor of Pharmaceutical Technology, as she speaks with Martin Van Trieste, Vice-President of Quality for Amgen and Interim Director of Rx-360, a new nonprofit international pharmaceutical consortium, about the need for industry to come together to secure the supply chain. They will explore shared supplier audit models and FDA's take on the consortium's proposals.

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FDA Guidance on ANDA Drug Impurities

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Updated October 11, 2020

The original link broke.

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ANDAs: Impurities in Drug Substances - an FDA webpage

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This guidance, FDA Guidance - ANDAs: Impurities in Drug Substances, provides revised recommendations on what chemistry, manufacturing, and controls (CMC) information to include regarding the reporting, identification, and qualification of impurities in drug substances produced by chemical synthesis when submitting: 1) Original abbreviated new drug applications (ANDAs), 2) Drug master files (DMFs) including type II DMFs, and 3) ANDA supplements for changes in the synthesis or processing of a drug substance.

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HIV AIDS Update - Obama strategy and more (podcast)

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Listen to Ernest Hopkins, the San Francisco AIDS Foundation's Director of Federal Affairs, as he talks about the Obama administration's progress on the National AIDS Strategy, the recent White House reception with LGBT leaders on the 40th anniversary of the Stonewall riots and the progress being made toward lifting the US ban on HIV-positive foreign travelers, in this podcast, SFAF.org Podcast #58 - A Federal HIV/AIDS Update with Ernest Hopkins. 

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Dementia - Mod Drinking Good - Heavy Drinking Bad

I guess I'm more prone to dementia :( This article, Can Wine Fight Dementia? - A Glass a Day in the Golden Years May Protect Against Dementia, Study Says, a "glass or two of wine a day – but no more -- appears to protect older adults from developing dementia, researchers reported here at the International Conference on Alzheimer's Disease." It's sad to say, but according to this study's criteria, I guess I'm a heavy drinker, yikes! 

P.S. I needed a new clean/dirty dishwasher magnet, and found this fun wine lover's dishwasher magnet. 

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FDA Draft Guidance on Anti-Counterfeiting

“Drug counterfeiting is a serious public health concern,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “We look forward to working with industry to help ensure that consumers are not exposed to products containing unknown, ineffective, or harmful ingredients,” reports this FDA news release, FDA Issues Draft Guidance for Industry on Drug Anticounterfeiting - Focus on physical chemical identifiers. The U.S. Food and Drug Administration (FDA) today issued a draft guidance on the use of inks, pigments, flavors, and other physical-chemical identifiers (PCIDs) by manufacturers to make drug products more difficult to duplicate by counterfeiters, and to make it easier to identify the genuine version of the drug. This draft guidance is an important step in working with manufacturers to make drug products more difficult to duplicate by counterfeiters: Draft Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting (pdf). 

Related Posts: FDA On Drug Counterfeiting Gambling With Life - Counterfeit Drugs - Like ED Drugs (Viagra) 

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FDA Regulated Businesses - Will you be compliant with the new FTC rule?

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If you're in the FDA regulated industries, you might want to pay attention to the FTC's new rule according to this Casetext post, August 1, 2009 - FTC’s New Identity Theft Rule Probably Requires You To Comply. In a nutshell, Koustas & Fleder say:

Given the apparent reluctance of the FTC to create exemptions from this regulation, most companies regulated by FDA must determine if the Rule applies to them. If the answer is yes, there is an August 1, 2009 deadline fast approaching to develop and implement a compliance plan. Failure to comply may subject the entity to administrative enforcement action by FTC as well as civil liability to consumers.

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Free Tips To Keep Your Kids Safe From Top 6 Summer Dangers

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Updated March 2, 2021

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Top Six Summer Dangers: ER Doctor Offers Tips for Keeping Kids Safe - Health.am

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It's summer now, and there's a much higher incidence of injuries caused by accidents and sports, reports this Medical News Today article, Top Six Summer Dangers: ER Doctor Offers Tips For Keeping Kids Safe. In a nutshell, watch out for these 6 Summer dangers:

1. All-Terrain Vehicles
2. Trampolines
3. Bikes, Inline Skates and Skateboards
4. Drowning
5. Car Accidents
6. Heat and Dehydration

According to the article:

As the temperatures rise, so do trips to pediatric emergency rooms. Severe cuts, broken bones and head injuries are the most common causes for trips to the emergency room during the summer

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FDA On Drug Counterfeiting

In this American Society of Health-System Pharmacists (ASHP) article, Drug Counterfeiting Burden Remains a Guess, Experts Say, the Director of Pharmacy Affairs in FDA's Office of the Commissioner says, "We have no idea what the prevalence of counterfeiting is in the United States." Here's what I get out of this article, counterfeiters have been assisted by the globalization of the pharmaceutical industry and a shift to making both active pharmaceutical ingredients (APIs) and finished products outside of the developed world. 

Related Posts: FDA Draft Guidance - Drug Supply Chain and SNIs FDA - Global Drug Supply Chain Needs Better Oversight Gambling With Life - Counterfeit Drugs - Like ED Drugs (Viagra) Counterfeiters Can Get Life In Jail 

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FDA Wants Your Input On Tobacco Regulation

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Updated March 2, 2020

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Tobacco Products - Rules, Regulations, and Guidance (on FDA.gov)

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The U.S. Food and Drug Administration (FDA) announced that it is seeking public input on the implementation of its historic new authority overseeing tobacco products in the United States. If you feel strongly about tobacco as I do, I hope you'll submit some feedback to the FDA.

More References:
The Federal Register Notice
FDA and Tobacco Regulation

Related Posts:
NPR On FDA Tobacco Oversight (audio)
Smoking Is Too Expensive - It is time to quit
e-Cigarettes In The News (video)
Fire Safe Cigarettes Are A Good Thing
3rd Hand Tobacco Smoke - A Danger To Your Loved Ones

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FDA GMP - Tips on Penicillin Drugs

Updated Aug 18, 2016:
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)

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Here's a little refresher in the form of 4 questions, answered by the FDA, Questions and Answers on Good Manufacturing Practices Questions and Answers on Good Manufacturing Practices - Penicillin Drugs.

In a nutshell, all penicillin finished pharmaceutical manufacturers, including repackers, are required by the CGMP regulations to establish a comprehensive control strategy designed to prevent cross-contamination of other drugs with penicillin. These requirements include:

• 21 CFR 211.42(d): Separation of facility and equipment
• 21 CFR 211.46(d): Separate air handling systems (HVAC)
• 21 CFR 211.176: Test for traces of penicillin where possible exposure exits.

Related Posts:
2009 FDA Orange Book Online - Brand New 29th Edition
Easy FDA Orange Book Search Widget
About The FDA Orange Book - Slide Deck (free)
FDA Orange Book - Online

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cGMP Posters

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Updated 8/5/2015:

GMP posters by SkillsPlus International Inc. are no longer available.

- - - -  Original Post below - - - -

If you're looking to make your GMP training or quality programs more robust, consider using posters to reinforce your key messages.

SkillsPlus International Inc. announces, "Poster! Posters! and More Posters!" in the release of their brand new GMP poster series, SkillsPlus International Inc. - GMP Good Manufacturing Practice and QSR Quality System Regulation - Large Posters (23" x 35"). Alternatively, you can also scan their offerings in the SkillsPlus GMP Poster Catalog. I find these posters strikingly beautiful, and convey very simple and understandable messages.

Folks have been clamoring for more GMP-related posters, so it's great to see these new additions to poster offerings. Check it out!

#FDA #GMP #training #cGMP

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Hidden Health and Financial Liabilities of Nanotechnology

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Updated October 15, 2022:

The original link broke.

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GUIDANCE DOCUMENT - Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry - APRIL 2022 - FDA.gov

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I found this article somewhat thought provoking, Mesothelioma and the Potential Costs of Nanotechnology. Whatever you believe to be science or risk, about mesothelioma, nanotechnology, or nanotubes, the article raises the possibility of repeating the history of asbestos mesothelioma. More specifically, the highlights for me are:

• Billions of dollars in potential litigation costs, much like that of asbestos litigation, are hidden from nanotechnology investors due to weak regulations governing disclosures and liabilities
• Many feel the litigation and health risks surrounding asbestos exposure and malignant mesothelioma cases may be repeated with the widespread use of nanotechnology in consumer products
• Many companies producing nanotechnology have failed to disclose to investors whether the nanotubes they are making are in the dangerous form (carbon nanotubes) and if there is a potential liability for future side effects of exposure to nanomaterials

I want to be an informed investor and consumer. I need to be able to make my own decisions about my health, and need to know if the products I choose are potentially putting my personal health at risk. 'nuff said.

Related Posts: University Researcher Compares Carbon Nanotubes to Asbestos (video) CDC Says Mesothelioma Deaths Increasing Asbestos.com - HONcode Certified Reputable Mesothelioma Resources Are Nanoparticles Dangerous Like Asbestos?

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FDA Publishes Paper on cGMPs (Current Good Manufacturing Practices)

The Food and Drug Administration (FDA) just released this paper, Facts About Current Good Manufacturing Practices (cGMPs). They've published it because of the recent rash of regulatory actions they've taken against drug manufacturers for not following cGMPs. They say:

Current Good Manufacturing Practices (cGMPs) for human pharmaceuticals affect every American. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. Most people, however, are not aware of cGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives. Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of cGMPs. This paper discusses some facts that may be helpful in understanding how cGMPs establish the foundation for drug product quality.

Knowing about and following cGMPs is critical for drug and supplement manufacturers. As a consumer it's important for me to know that there's oversight. Cheers to compliant and ethical manufacturers. 

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GMP Training Tree - Trainers, formats, methods, etc.

I ran across this GMP Training Tree by GMP Coach recently, and thought folks might get some GMP training ideas from this. I've never seen anything like this before, and think it's quite novel. The tree is organized hierarchically and when nodes are expanded, eventually lead you to training providers, resources, and more. Very cool! 

Related Posts: ASQ Announces Certification Exam For GMP Professionals Try This GMP Training Tip To Start The New Year (free) GLP Training Tips (free) Free GMP Training Tips - Follow adult learning principles 7 Deadly Sins Of Trainers - free tips 

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