Roaches, Zika virus, and vaping-addicted kids: FDA warning letters are back!

Yesterday US Food and Drug Administration (FDA) warning letters came back, and they indicate the agency’s actions on novel and critical public health risks. The recent federal government shutdown appeared to slow the weekly issuance of FDA warning letters. I am glad these inspections and enforcement actions have recommenced. Read below for a few highlights.


A reproductive health clinic (i.e. fertility clinic) in Miami received a warning for failures in screening for Zika virus and other infectious diseases. Inspectors noted inadequate labeling of specimens (including semen). In addition, the clinic gave some donors an “eligible” approval before receiving the results of infectious disease testing.

There is also a worrying observation about issues at the clinic that go back four years, to 2015:

In response to Observations 3 and 4, you stated that your corrective action was to review and sign the appropriate forms in a timely manner based on the results of donor screening and testing. However, we note that these two observations were also cited during the previous inspection of your establishment conducted from November 19, 2015 to December 2, 2015. Your corrective actions, if any, after the previous inspection were not adequate to prevent recurrence of the same violations, as they were cited again during the current inspection.

Reading this letter I get the impression that basic laboratory controls are missing. This is unfortunate especially since the clinic is affiliated with a university. The letter mentioned Zika virus, west Nile virus, and a prion disorder called Creutzfeldt-Jakob disease. I sometimes wonder if we are failing to learn the required lessons from these emerging diseases. A few years on from the worst of the Zika outbreak, we still have inadequate screening and testing, even in a high-risk region such as south Florida.

Underage vaping

The FDA warned an online store for vaping juice and devices after the store sold these nicotine products to a minor.

If you are curious about vaping and teenagers, check out this recent New York Times article that paints a sad portrait of addicted kids. It also cites a statistic that “3.6 million middle and high school students are now vaping regularly.” I happen to believe that a teenager is better off vaping than smoking. However the addictive potential and long-term health risks of vaping are unknown. In addition the kids can vape anywhere, they can easily conceal these small devices, and they have no clear path to quitting.

It is in this context that the FDA has warned this and other companies that sell electronic nicotine delivery system (ENDS) products. Get used to that ENDS acronym because vaping is an issue that will not go away any time soon.

Also, I have to point out the cake, candy and fruit-flavored nicotine e-juice this company is selling. Some of them are even in a fruit juice box-style packaging! It’s hard to deny that they are marketing to kids:

Imported over-the-counter drugs

A manufacturer in China was cited for producing over-the-counter drugs (which are sold in the US) in the same equipment as non-drug products. This practice is unacceptable under the Good Manufacturing Practice (GMP) regulations.

The inspector cited other ongoing violations, including inadequate stability-indicating methods on the drugs and distributing drug batches without the quality unit’s review of failing test results. Interestingly, the company’s previous response was deemed inadequate because it did not include a root cause analysis. To me this shows the importance of thorough investigations when a failure occurs.

Pest-ridden food distributors

This one is gross. At a food storage and distribution facility in Florida, an inspector observed:

· One live cockroach on the wall along the east side of your freezer, under racking storing various food products.

· Three dead cockroaches in between packages of “United Sugars, Extra Fine Granulated, Pure Sugar Cane” packaged in 5lb paper bags. These packages were on a pallet along the wall on the west storage area, near the north end of the facility.

· An apparent birds’ nest along the ceiling in a center aisle, in the east storage area, across from the freezer and cooler.

· Apparent bird excreta on several boxes of “Loty Chicken Flavor Bouillon,” which were stored on a pallet near the wall shared with the south end of the freezer.

· Five dead cockroaches in Cooler #1 along the wall on both sides of the door. This cooler is used to store rice and other products which require a cool environment.

· Apparent cockroach parts (e.g., wings and exoskeleton parts) too numerous to count throughout your facility, along the east and center aisles in between racking systems, and along the walls.

· A powder, identified by your firm as a mix of corn flour and ground-up rodent bait blocks, throughout your entire facility along the walls, and in between racking systems of stored packaged food products. The bait was identified to be “Bell Contrac All Weather Blox” used to kill rats, mice and meadow voles.

· Your three dock doors used for shipping and receiving along the north end of the facility are open during business hours and are not screened to exclude any type of rodent or pest from entering the facility.

I appreciate the inspector’s thoroughness! They counted the roaches, poop and other animal signs, and noted their location. An audit finding should always be specific so that a follow-up inspection can verify whether corrective actions were effective.

Another food processing facility in Florida was warned over a repeated failure to follow a specific pathogen reduction process in their fruit juices. Because of the repeated nature of the violations, the letter included an interesting note about how the FDA is authorized “to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs.”

If they have to keep coming back to help you get your act together, you might have to pay!

Final comments

FDA warning letters are a treasure trove of information to help you understand the agency’s enforcement priorities on a wide array of medical and consumer products. I think it’s just a coincidence that three of the five entities cited here are in Florida.

The FDA website noted early on in the shutdown that “agency operations continue to the extent permitted by law, such as activities necessary to address imminent threats to the safety of human life and activities funded by carryover user fee funds.” I am not sure if this included the inspections referenced in this letter. However, I wouldn’t be surprised if there is a gap in warning letter postings three to six months from now.

The letter to the fertility clinic highlights a real risk: what if you or your fetus contracted the Zika virus from an anonymous sperm donor? For its part the underage vaping issue is big and it will only get bigger. The only apparent requirement for getting this nicotine vape juice from the site above is a credit card and a mailing address. The over-the-counter drugs could be part of a recall if the company’s response is deemed inadequate. This means American consumers could have to search their medicine cabinets for the bad pills. Finally, the pest issues at the food facilities are just gross.


Centers for Disease Control and Prevention:

“No instances of Zika virus transmission during fertility treatment have been documented, but transmission through donated gametes or embryos is theoretically possible.”


Recently Posted Warning Letters

New York Times:

“Addicted to Vaped Nicotine, Teenagers Have No Clear Path to Quitting”

Nexus Vapour:

Check out these kid-friendly nicotine vaping juices

Business book review: “Essentialism: The Disciplined Pursuit of Less” by Greg McKeown

Essentialism: The Disciplined Pursuit of Less is a business bestseller from 2014. This slim paperback is lively and readable in describing the principles of separating the essential from the nonessential in work and life. The author provides the briefest possible guidance on how to hone your skills of judgement and discrimination in order to focus on doing what is essential, and eliminating the rest.

I picked up the Kindle version of Essentialism after a webinar host recommended it. In addition, Tim Ferriss read some passages from it on his podcast that resonated with me. Lastly, I was attracted to the message of decluttering and simplifying in general, and this book promised another writer’s perspective on this issue. Essentialism is not specific to any particular industry or profession.

In this review I will explain why Quality professionals should consider picking up this book. If you don’t have time to read it, I hope this review will give you a couple of key takeaways and quotes. I will also direct you to some good YouTube summaries, because that is an excellent way to absorb quick messages from the huge yearly tide of business books.

McKeown argues that hardworking, smart people are overextended and distracted by many projects and tasks, and that many of these tasks are unimportant. Part of what drives this may be technology. But there are other factors, including the pattern of success distracting a person from what made them successful in the first place (such as a technically skilled engineer who becomes a manager and finds himself doing less and less of the skilled work). Another pattern is the many unimportant choices that a person faces in the typical day.

By applying a few simple methods of sorting the essential from the nonessential, one can eliminate many unimportant tasks and focus on what truly matters. Part of this means getting better at saying no (though this is not at all the bulk of the book).

A simple tactic for how to say no is the following:

Use the words “You are welcome to X. I am willing to Y.” For example, “You are welcome to borrow my car. I am willing to make sure the keys are here for you.” By this you are also saying, “I won’t be able to drive you.” You are saying what you will not do, but you are couching it in terms of what you are willing to do. This is a particularly good way to navigate a request you would like to support somewhat but cannot throw your full weight behind.

Another chapter goes into greater detail about the Pareto Principle, which suggests that in any given problem, 80 percent of consequences come from 20 percent of the causes. McKeown often restates this to say that 90 percent of the causes come from 10 percent of the causes. I like this latter, starker ratio because it encourages you to be even more ruthless in eliminating the nonessential and focusing on that essential 10 percent.

For the most part the author accomplishes the stated purpose of the book: defining essentialism and providing some tactics for getting there. In addition, he does not overstate the advantages of this approach. Since it is an all-encompassing outlook on life and business, essentialism requires constant discipline, as stated in the book’s title.

A strength of the book is the short examples of how to make a small essentialist win (such as the story of saying no above). Techniques and methods that bridge the gap between a proposed way of thinking and the day-to-day workplace tasks is helpful. Another thing I like is the numerous small tables that highlight the differences between an essentialist and non-essentialist with respect to the chapter’s topic.

I also like the simple black-and-white art. One illustration in particular from early in the book asks the reader: Do you want to make a millimeter of progress in all directions or a mile of progress in one direction? Accompanying this challenge is a diagram to keep in mind when you are considering what you want to “go big on.”

One weakness of the book (as with much business literature) is the anecdotes. As a business consultant the author has a wealth of illustrative stories to draw on and most of them are memorable. However, some do not support the underlying arguments of essentialism in the way the author intends.

For example, a highly practical part of the book provides hints on how to avoid lengthy, pointless meetings and do the work via an email instead. But a later chapter opens with a Silicon Valley CEO who insists on a 3-hour, unskippable meeting every Monday of every week that includes every executive in the global company. In fact they are required to schedule their travel to never conflict with this meeting.

This example is meant to illustrate how a firm routine can “eliminate the mental costs involved in planning the meeting or thinking about who will or won’t be there.” However, in my view it was another example of a large chunk of time that each meeting participant will subtract from the finite number of productive hours in his or her workweek.

A second criticism is the book’s short length. I wish it was longer! This makes it an ambivalent criticism because it shows that the author managed to light a fire with readers like me. I want more examples, more diagrams, more how-to’s. I want a book on essentialism in daily life. I want a book on essentialism in relationships. I want a book on essentialism in higher education and job training.

I hope this kind of guidance is forthcoming. It’s now 2019 so five years have passed since the book’s publication. To continue honing essentialist skills, one may have to look elsewhere. A few resources I have found in this strain of thought are Cal Newport’s book Deep Work, Tim Ferriss’s podcast (and his somewhat dated book The 4-Hour Workweek) and Marie Kondo’s rapidly expanding corpus of decluttering guidance.

Another book echoing this philosophy (in my opinion) is Your Money or Your Life by Vicki Robin and Joe Dominguez. Why? Because it addresses the concept of enough. In my opinion, enough is tied conceptually to essentialism. I would recommend this personal finance gem to anyone who felt a spark from Essentialism. I am always happy when I come across a book that helps tie together a few different authors in the same way of thinking.

At this point I would like to highlight two connections between essentialism and Quality.

First, Quality professionals will instantly recognize the Pareto principle. This principle is in the quality curriculum and it’s worth revisiting again and again. As much as I like essentialism, it may be no more than a sexy rebranding of the Pareto principle. By adhering to the view that a small number of causes are truly important, and disregarding or de-prioritizing the rest, one can make a lot of progress. This would conform to my view that all the winning principles of Quality are known, they just need to be implemented and maintained.

Second, Quality professionals need to be constantly vigilant about straying from their core role of checking. The purpose of a Quality group within a company boils down to checking the work of the operations/production part of the company. Too often, due to misunderstandings, mission creep, and the good nature of individuals, Quality professionals take on projects that belong to operations. Sure, they might do a good job. But the question is, who will check their work? The better arrangement is the traditional one: Quality, in the course of their work, identifies a gap. They recommend (or require) operations to fix it. Quality checks the fix and reports back, continuing the cycle.

Thus it is the checking that is essential. Quality professionals should keep that in mind. Reading Essentialism will help them maintain vigilance at the dividing line between the doing and the checking.

Quality professionals should read this book. I would also recommend it to technical people who feel they spend too much time on meetings, email and other ancillary projects (isn’t that everyone?).

The image is from Columbia Park in Portland, Oregon today (20 Jan 2019). The quote from Lao-tzu is from one of the chapter headings in Essentialism.

Lastly for a taste of the language of Essentialism and a few nuggets, see my Kindle highlights below.

“I have a vision of everyone – children, students, mothers, fathers, employees, managers, executives, world leaders – learning to better tap into more of their intelligence, capability, resourcefulness, and initiative to live more meaningful lives.”

“Essentialists see trade-offs as an inherent part of life, not as an inherently negative part of life. Instead of asking, “What do I have to give up?” they ask, “What do I want to go big on?” The cumulative impact of this small change in thinking can be profound.”

“Essentialists spend as much time as possible exploring, listening, debating, questioning, and thinking. But their exploration is not an end in itself. The purpose of the exploration is to discern the vital few from the trivial many.”

“Richard S. Westfall has written: “In the age of his celebrity, Newton was asked how he had discovered the law of universal gravitation. ‘By thinking on it continually’ was the reply.… What he thought on, he thought on continually, which is to say exclusively, or nearly exclusively.”3 In other words, Newton created space for intense concentration, and this uninterrupted space enabled him to explore the essential elements of the universe.”

“You can think of this as the 90 Percent Rule, and it’s one you can apply to just about every decision or dilemma. As you evaluate an option, think about the single most important criterion for that decision, and then simply give the option a score between 0 and 100. If you rate it any lower than 90 percent, then automatically change the rating to 0 and simply reject it. This way you avoid getting caught up in indecision, or worse, getting stuck with the 60s or 70s. Think about how you’d feel if you scored a 65 on some test. Why would you deliberately choose to feel that way about an important choice in your life?”

“In the first pattern, the team becomes overly focused on winning the attention of the manager. The problem is, when people don’t know what the end game is, they are unclear about how to win, and as a result they make up their own game and their own rules as they vie for the manager’s favor. Instead of focusing their time and energies on making a high level of contribution, they put all their effort into games like attempting to look better than their peers, demonstrating their self-importance, and echoing their manager’s every idea or sentiment. These kinds of activities are not only nonessential but damaging and counterproductive.”

“As Ralph Waldo Emerson said, “The crime which bankrupts men and states is that of job-work;—declining from your main design to serve a turn here or there.””

“Nonessentialists say yes because of feelings of social awkwardness and pressure. They say yes automatically, without thinking, often in pursuit of the rush one gets from having pleased someone. But Essentialists know that after the rush comes the pang of regret. They know they will soon feel bullied and resentful—both at the other person and at themselves. Eventually they will wake up to the unpleasant reality that something more important must now be sacrificed to accommodate this new commitment.”

“Use the words “You are welcome to X. I am willing to Y.” For example, “You are welcome to borrow my car. I am willing to make sure the keys are here for you.” By this you are also saying, “I won’t be able to drive you.” You are saying what you will not do, but you are couching it in terms of what you are willing to do. This is a particularly good way to navigate a request you would like to support somewhat but cannot throw your full weight behind.”

“In a reverse pilot you test whether removing an initiative or activity will have any negative consequences.”

“As Alan D. Williams observed in the essay “What Is an Editor?” there are “two basic questions the editor should be addressing to the author: Are you saying what you want to say? and, Are you saying it as clearly and concisely as possible?”7 Condensing means saying it as clearly and concisely as possible.”

“This may seem a little counterintuitive. But the best editors don’t feel the need to change everything. They know that sometimes having the discipline to leave certain things exactly as they are is the best use of their editorial judgment. It is just one more way in which being an editor is an invisible craft. The best surgeon is not the one who makes the most incisions; similarly, the best editors can sometimes be the least intrusive, the most restrained.”

“The way of the Essentialist is different. Instead of trying to accomplish it all—and all at once—and flaring out, the Essentialist starts small and celebrates progress. Instead of going for the big, flashy wins that don’t really matter, the Essentialist pursues small and simple wins in areas that are essential.”

“Research has shown that of all forms of human motivation the most effective one is progress. Why? Because a small, concrete win creates momentum and affirms our faith in our further success.”

“On the basis of these hundreds of thousands of reflections, Amabile and Kramer concluded that “everyday progress—even a small win” can make all the difference in how people feel and perform. “Of all the things that can boost emotions, motivation, and perceptions during a workday, the single most important is making progress in meaningful work,” they said.”

“My experience has taught me this about how people and organizations improve: the best place to look is for small changes we could make in the things we do often. There is power in steadiness and repetition.”

“Similarly, we can adopt a method of “minimal viable progress.” We can ask ourselves, “What is the smallest amount of progress that will be useful and valuable to the essential task we are trying to get done?” I used this practice in writing this book. For example, when I was still in the exploratory mode of the book, before I’d even begun to put pen to paper (or fingers to keyboard), I would share a short idea (my minimal viable product) on Twitter. If it seemed to resonate with people there, I would write a blog piece on Harvard Business Review. Through this iterative process, which required very little effort, I was able to find where there seemed to be a connection between what I was thinking and what seemed to have the highest relevancy in other people’s lives.”

“The way of the Nonessentialist is to think the essentials only get done when they are forced. That execution is a matter of raw effort alone. You labor to make it happen. You push through. The way of the Essentialist is different. The Essentialist designs a routine that makes achieving what you have identified as essential the default position. Yes, in some instances an Essentialist still has to work hard, but with the right routine in place each effort yields exponentially greater results.”

“And routines can indeed become this—the wrong routines. But the right routines can actually enhance innovation and creativity by giving us the equivalent of an energy rebate. Instead of spending our limited supply of discipline on making the same decisions again and again, embedding our decisions into our routine allows us to channel that discipline toward some other essential activity.”

“In an interview about his book The Power of Habit Charles Duhigg said “in the last 15 years, as we’ve learned how habits work and how they can be changed, scientists have explained that every habit is made up of a cue, a routine, and a reward.”

“The question is, “Which is your major and which is your minor?” Most of us have a little Essentialist and a little Nonessentialist in us, but the question is, Which are you at the core?”

“I still fight the urge to impulsively check my phone; on my worst days I have wondered if my tombstone will read, “He checked e-mail.” I’ll be the first to admit, the transition doesn’t happen overnight.”

“This story captures the two most personal learnings that have come to me on the long journey of writing this book. The first is the exquisitely important role of my family in my life. At the very, very end, everything else will fade into insignificance by comparison. The second is the pathetically tiny amount of time we have left of our lives. For me this is not a depressing thought but a thrilling one. It removes fear of choosing the wrong thing. It infuses courage into my bones. It challenges me to be even more unreasonably selective about how to use this precious—and precious is perhaps too insipid of a word—time. I know of someone who visits cemeteries around the world when he travels. I thought this was odd at first, but now I realize that this habit keeps his own mortality front and center.”

“If you take one thing away from this book, I hope you will remember this: whatever decision or challenge or crossroads you face in your life, simply ask yourself, “What is essential?” Eliminate everything else.”


Essentialism (Amazon)

Your Money or Your Life (Amazon)

The Life-Changing Magic of Tidying Up (Amazon)

Tim Ferriss Podcast episode with Essentialism quotes and reaction

How to Say “No” Gracefully and Uncommit (#328)

The 4-Hour Workweek (Amazon)

Deep Work (Amazon)

A couple of YouTube summaries of Essentialism: