It is time to review the impact of taking dietary supplements while flying under FAA and DOT regulations. Many pilots take unregulated supplements. While this is seemingly a harmless activity for the general population, for pilots it brings additional risks.
Please keep in mind that dietary supplements are not regulated by the Food and Drug Administration (FDA). When a product is being researched to become a “medicine,” it must go through the FDA approval process. Any such substance, when it is designed to treat a specific illness, must go through an exhaustive and expensive protocol of the initial approval for the research project, the project itself (usually costing countless millions of dollars and taking several years), the post-research evaluation and peer-review period, and final FDA approval.
An important point to remember is that if a manufacturer is going to advertise or simply promote to health care providers that their “medication” is useful for the treatment of a specific disease, this challenging and time-consuming FDA approval process must be endured.
As is obvious, however, the drug manufacturers find this profitable enough to spend the money on the requisite research and then bombard us with advertisements via television, print, internet, and social media. Of course, most of the television advertisements spend more time on the obligatory disclaimers than the actual benefits of the product itself.
You know the schtick—for just about every medicine, the advertisement will warn you that it can cause “constipation or diarrhea, insomnia or sleepiness, weight gain or weight loss.” And that taking it “may cause death; death may be fatal,” and all sorts of similar nonsensical medicolegal statements and general disclaimers.
While many (if not most) medications are very useful and therapeutic for persons suffering from an ailment, there are indeed potential pitfalls. Hence, the advertising disclaimers.
It is difficult and potentially a medicolegal risk for physicians to recommend even the most formally evaluated and proven medications, but we all want to do what is best for our patients. So we accept the inherent risks in recommending medications or medical procedures. The physician must discuss potential side effects with anyone for whom they prescribe a medication.
This leads me to dietary supplements. These substances do not need to go through the intensive FDA approval process. Why is this?
We all know that when the salesperson at the grocery or vitamin store (or on the sponsored website on the internet) regales customers with the purported benefits of a supplement, they are not really recommending a formal treatment for anything. You will note that on the packaging of all such supplements, there is typically a single disclaimer. Usually, it reads something like this: “This product is not intended to diagnose, treat, prevent, or cure any disease.”
With that one simple disclaimer, the supplement manufacturer is off the hook for the expense and years of time involved in the FDA approval process.
Better yet, I say—tongue in cheek—the supplement manufacturer does not have to present any peer-reviewed research-based evidence that the product does, well, anything. While I support that some supplements potentially have valid uses and may be benign to ingest (many basic multivitamins, for example), there is no duty for the manufacturer to prove anything.
Many supplements sell like the proverbial hotcakes with no evidence that they do anything. Why would the manufacturer do any such research if they are not required to do so?
Especially if this research might show that the supplement doesn’t really do what is being advertised or that it could have significant potential side effects. With the simple disclaimer, supplement manufacturers are pretty much in the clear as far as liability goes.
Unproven supplements may have significant interactions with prescription medications a person is taking. The use of the supplement is often not disclosed to the person’s “treating physician,” so there is no way for the physician to know that a potentially dangerous interaction could occur.
Supplements that have excessive amounts of simple routine vitamins and minerals may potentially be harmful to the liver, cause kidney stones, or lead to any number of other problems.
More importantly, physicians cannot be trained as to the effects of the thousands upon thousands of supplements on the market. When a pilot brings a supplement to me and asks if it’s OK to take while flying, I look at the ingredients. If I have never even heard of some of the ingredients, I caution the pilot that I cannot give them an educated opinion.
Pilots who were reluctant to take prescribed medications for something routine (such as for the treatment of high blood pressure) have shown me a product they were sold at a back alley “nutrition” store in a distant overseas country. Usually, I cannot read the foreign language on the box or bottle anyway.
I inform the pilots that they are adults and they have to make their own decisions. I cannot help them when I have no idea about what they actually purchased.
I understand the reasoning here, since pilots are reluctant to disclose medical conditions to the FAA, given the “no good deed goes unpunished” philosophy. I get it. Pilots are concerned that a seemingly simple medical problem morphs into a never-ending “goat rope” in dealing with the FAA.
While that is sometimes true, as I have said many times before, we ultimately get over 99.9 percent of pilots flying even after disclosure of complicated medical conditions. But yes, sometimes the process seems overly frustrating—and worse so if the pilot is going to be grounded for a period of time as a result of disclosing the medication and condition.
Note that I said the pilot was disclosing both “the medication and condition” for which it is being taken. In addition to the medical condition that a medication is designed to treat, they are also often used additionally for any number of “off-label” conditions. Therefore, please always tell the AME not just the name of the medication, but what medical condition it is prescribed for.
But back to supplements. I am also asked by pilots if their supplement will cause a positive DOT test on a random screen. For most unregulated substances, once again I cannot give the pilot an informed decision.
Imagine my risk in doing so: the pilot claims the AME said it was OK to take, but yet it perhaps led to a false-positive DOT test. I am not going anywhere near that potential quagmire, and I have no interest in the liability lawsuit that might result.
The FAA’s forensic advisors are comfortable that the multiple fail-safe aspects of DOT testing should make false positives nearly nonexistent, and that, therefore, most positives are indeed true positives. What happens next is, if the positive sample was collected when the pilot was on duty, the pilot receives an Emergency Order of Revocation of both pilot and medical certificates.
Before a positive test is reported to the FAA, the Medical Review Officer (MRO) of the collecting lab will call the pilot and give them an opportunity to explain. Sometimes—not often—it winds up being simple.
For example, the pilot had a colonoscopy a day or so prior, and a sedating narcotic was found in the DOT urine sample. While the pilot should have known not to fly for at least several days after a procedure that requires sedation, sometimes they don’t do that. Maybe a trip at 150 percent pay shows up in “open time” and is too tempting to resist.
In this case, if the pilot gives the MRO the actual procedure and anesthesia report, and if the story is probably corroborated, the MRO might tell the pilot, “OK, this time only, no harm no foul, but be more careful about wait periods the next time a procedure is done.” This is, however, at the full discretion of the MRO.
There is no way to entirely prove that the pilot did not also take a restricted substance in addition to receiving legal anesthesia. Therefore, any ruling, favorable or not, is 100 percent at the discretion of the MRO.
Hint: don’t push the limits, even when confronted with the dreaded “pop-up” corporate trip. If you have a medical procedure that entails sedation, speak with your aeromedical advisor or AME about an appropriate waiting period before resuming flight status. Not all MROs are sympathetic about positive DOT screens, even when it seems the story holds water.
Recently, one of my pilot clients, who was already in a monitoring program for an alcohol issue, tested positive for alcohol on a screening test. Fortunately, this was not a formal DOT test. At first, the pilot denied consuming alcohol and denied that they were taking any supplements that could contain alcohol.
When confirmatory biomarkers were also tested, these too were positive—a definitive confirmation of alcohol ingestion.
The pilot finally confided that they were taking a new supplement, “recommended” by their sponsor, to treat separate new symptoms that had arisen. The pilot, entirely understandably, did not want to confide to their AME or the FAA that new symptoms were becoming an issue.
Please remember, however, that FAR 61.53 requires a pilot to self-assess. If they have a new medical condition or are using medications that might be contraindicated in flying, it is their responsibility to disclose the situation.
We researched the substance the pilot had begun taking, and the other ingredients listed included that it contained 30 to 40 percent alcohol. That came as no surprise to me, given that the supplement was marketed as being useful to ease the type of symptoms that this pilot was experiencing.
Nonetheless, the pilot had a positive test for alcohol and is once again grounded. It will be quite difficult to prove that the only alcohol ingestion was from the supplement and/or that the pilot was not aware of the alcohol content.
Every pilot is responsible for knowing what everything they ingest contains. This pilot will, once again, go through a lengthy evaluation process to determine if there is a recurrence of the alcohol-related problem that requires retreatment and/or if the other recent symptoms have manifested to the point where they must be formally evaluated and eventually discussed with the FAA.
Are the symptoms mild, or have they reached the point where a specific medical diagnosis or treatment will result? This is a pilot who has spent so much time, effort, and money (their own money, since they do not work for a company that pays for drug and alcohol evaluations and treatment) to get to where they are.
While I am sympathetic to their predicament, it is my role to objectively and ethically present to the FAA a case that is worthy of reconsideration. I am working on that in concert with my drug and alcohol experts, along with other advisors. Hopefully, this pilot will eventually return to the cockpit, but unfortunately, it will be a while before that happens.
One of the substance abuse psychiatrists I work with often is quite clear with his pilot clients. He states that unless the supplement is the simplest thing, tried and true, such as a routine generic multivitamin from a trusted pharmacy, pilots “should avoid all supplements.” This message was made abundantly clear in the unfortunate case described above.
Just as I have nagged you about the potential for positive DOT tests for THC (marijuana) from using the increasingly popular and easily available CBD products, today’s discussion includes the potential for other positive tests from seemingly “harmless” unregulated dietary supplements.
Be wary of everything that you ingest: your career may depend on it!
Dr. Robert Sancetta is a former DC-10 captain with 11,000 flight hours. He has worked as a Senior AME since 1993 and is appointed as AME Consultant to the FAA Federal Air Surgeon.
The opinions expressed in this column are those of the author and are not necessarily endorsed by AIN Media Group.