FDA Struggles To Keep Products From Foreign Sources Safe

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This is required reading for consumers, and for professionals working in the GXP regulated industries (obtaining supplies, food, drugs, etc. from foreign suppliers). Gardiner Harris, a correspondent in The New York Times’s Washington bureau, writes about the very dangers and risk that are lurking out there in this NY Times news article, "The Safety Gap." The article is extremely well written and is full of anecdotes, statistics, and critical analysis that will make you think twice about the food and drugs that all of us are personally using. Here's what made me cringe . . .

1. It worries me that contributors to the story wanted to remain anonymous. It seems to me that perhaps the problem is much bigger than folks are willing to admit.
2. I'm guessing that the contaminated heparin from China incident is probably just the tip of a massive iceberg.
3. No surprise, the FDA is underfunded, understaffed, and ill-equipped to deal with the pent-up demand for foreign plant inspections.
4. It appears there is a danger that foreign plants are less committed to quality standards, and in some cases demonstrate a lack of ethical behavior.
5. I could go on, but it's much The Safety Gapfor you to read the news article.

Let the buyers beware (that means us as consumers, and companies partnering with foreign plants). 

Previous Posts: 

The Health, Drug, Prescription, and GMP Supersite: FDA Finds It Hard To Inspect Foreign Drug Manufacturing Plants 

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How The FDA Regulates Botanical Drugs

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You have to read this. In an issue of Nature Biotechnology, you'll learn how FDA personnel review applications to test botanical drugs in humans, and market those products in the US as reported in this article, "New therapies from old medicines - Although new botanical drugs pose many challenges for both industry and the FDA, approval of the first botanical prescription drug shows they can be successfully met (pdf)." In general, here's what it's all about . . .

1. From dietary supplements to new drugs
2. Current US regulatory environment
3. Review of botanical applications at CDER
4. Analysis of botanical drug IND submissions
5. Unique regulatory issues
6. Botanicals as variable, complex mixtures
7. Botanicals as multiple-plant combinations
8. Previous human use of botanicals
9. Botanicals marketed as dietary supplements

It's encouraging to me to see these kinds of articles appearing on the topic. Personally, I'd consider using more botanicals if I can see that some form of rigor is applied to them.

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Apple Cider Caution In The Autumn

I love the fall, and I've enjoyed having fresh apple cider. I'm sure many of you do to. Here's some things you should know about to avoid getting sick or making others sick from unpasteurized apple cider. Find more recommendations in this Medical News Today news article, "As Autumn Arrives Beware Of Unpasteurized Cider And Juices, Warns Iowa Department Of Public Health." Here are some, but not all, of the main points that I take away . . .

1. Unpasteurized cider can be a health risk, especially to children and those who have weakened immune systems
2. Cider should be kept refrigerated at 40 F or cooler
3. Risk of illness can be reduced by heating unpasteurized apple cider to at least 170 F before drinking

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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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Turn Your Clocks Back - Reduces Heart Attack Risk - Sweet!

Updated April 26, 2021

The original link broke.

You can still read about it in:

Daylight Saving Time May Affect Heart - WebMD.com

---  original post follows below  ---

It turns out that turning your clocks ahead in the Spring increases your risk of heart attack, and turning your clocks back (like this weekend) in the Fall reduces the risk of heart attack. I wanted to share the source New England Journal of Medicine article with you, but the best I could do was share this Medical News Today summary article for you, "Heart Attack Risk Raised When Clocks Go Forward, And Are Reduced Slightly When Clocks Go Back." Wishing you some extra health from turning your clocks back this weekend. 

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