The U.S. Food and Drug Administration (FDA) kicked off the Summer of 2022 with a new initiative aimed at educating physicians and other medical professionals about dietary supplements.

Produced in collaboration with the American Medical Association (AMA), this three-part online continuing medical education (CME) “course”—and I use that term loosely—is entitled “Dietary Supplements: What Physicians Should Know.” It purports to give practitioners “a deeper understanding of dietary supplements.”

This series of three 10-minute didactic videos carries 0.5 AMA PRA Category 1 continuing education credits for physicians. It’s a cornerstone in the FDA’s new “Supplement Your Knowledge” educational campaign.

“Supplement Your Knowledge resources will help provide consumers and healthcare professionals with facts to make informed decisions when determining if they want to use or recommend dietary supplements,” promises Douglas Stearn, deputy director for regulatory affairs in FDA’s Center for Food Safety and Applied Nutrition (CFSAN).

In principle, this is a great idea. Over two-thirds of all Americans already use dietary supplements. Research on things like probiotics, vitamin D, omega-3 fatty acids, and a host of phytochemicals has exploded over the last decade. Quality assurance initiatives within the industry are on the rise. Many companies now make products to pharmaceutical good manufacturing practice (GMP) standards; some are even launching drug development spin-offs.

There’s never been a greater need for well-rounded, evidence-based content to educate practitioners about the strengths and drawbacks of supplements, the laws that regulate them, and their role in clinical practice.

If only that’s what the FDA and AMA had actually produced!

A Familiar Refrain

Alas, a few minutes into the first video, it becomes clear that the intention of this series is not to educate and inform, but to dissuade.

Here’s the opening salvo, delivered in chirpy tones by a smug, nameless narratrix who walks about in a lavender-walled medical office setting as she speaks: “As a physician, you play a leadership role in guiding your patients’ health and wellbeing. They look to you not only for medical diagnosis and treatment, but also for your knowledge and expertise on a wide range of topics. Dietary supplement use is one of these important topics.”

“Yes, supplements can have benefits. But they may also come with risks. For example, they can cause adverse reactions or interact with medications and other supplements. And many of your patients probably don’t realize that unlike prescription drugs, dietary supplements are not approved by the government for safety and efficacy.”

That refrain—“Unlike prescription drugs, dietary supplements are not approved by the FDA”—is uttered four times (yes, I counted) within the first 7 minutes of Module 1, and at least as many times during the second and third ones.

The program lays out the basic history of the Dietary Supplement Health and Education Act (DSHEA), the specific definition of “dietary supplement” (a category of food, products must be ingested, intended to augment essential nutrients that some people might not get from their diets).

Then comes the core message of Module 1: “It is also important to understand that dietary supplements are not intended to treat, diagnose, prevent, mitigate, or cure diseases. Products bearing such claims are classified as DRUGS.” The latter word is spelled out in big, screen-filling letters.

Our guide gives the following examples: “Treats Heart Disease”; “Cures Cancer”; “Prevents Alzheimer’s Disease.”

She then underscores that, “Products bearing such claims are classified as DRUGS, and must meet all requirements that apply to DRUGS.” (Again, big screen-filling letters.)

The video explains the basic principle of structure/function claims. It lays out what must and must not be included on a supplement label; the need for inclusion of the FDA disclaimer statement; the requirement that marketers notify FDA within the first 30 days of introducing a new product with a structure/function claim; and the obligation to ensure that all claims are truthful and accurate.

Our intrepid presenter lets us know that FDA conducts post-market product surveillance, inspects manufacturing facilities, and works in tandem with the Federal Trade Commission to nix noncompliant, adulterated, unsafe, or misbranded products from the market.

But she adds that, “even with this authority … the ever-expanding number of supplements presents a challenge for FDA.”

Along the way, she finds occasions to let us know that supplements should never be taken as meal substitutes, and that: “Conventional food should always be the primary source of nutrients”—another carping refrain that the FDA zealously repeats like the Mister Softee jingle on a hot summer day.

Risk and Blame

Module 2 is all about the clinical encounter. It’s main message? Talk to your patients about supplements, warn them that “Unlike prescription drugs, the FDA does not …” (you know the rest), let them know that supplements can interfere with the drugs they’re taking, and could very possibly throw off their lab test results.

“Combining dietary supplements with certain prescription and OTC medications could have dangerous and even life-threatening consequences,” our all-knowing presenter says, as a big black exclamation point waggles against a bright orange “caution” background.

By way of examples, the video states:

• St. John’s Wort can reduce the efficacy of some medications for heart disease, cancer, HIV, depression, seizures, and birth control.
• Vitamin K, high doses of vitamin E, and Ginkgo biloba can interact with warfarin.
• Vitamin C and vitamin E might reduce the effectiveness of cancer chemotherapy.

Taking too much of certain supplements can have detrimental health effects, the video warns. “For example, consuming more than 100% of the daily value of certain vitamins and minerals such as calcium, iron, vitamin A, and vitamin D, from supplements in addition to food sources that contain these nutrients may be harmful to your patients’ overall health.”

Then comes the lab test warning. The video states that some supplements can interfere with diagnostic tests, causing incorrect results which may go undetected. The example cited is biotin—“often found in multivitamins, prenatal vitamins, and dietary supplements marketed for hair skin and nail growth”—the taking of which can cause, “a falsely low result for troponin, a clinically important biomarker that helps with diagnosing heart attacks. An inaccurate result could lead to a missed diagnosis and potentially serious clinical implications.”

FDA issued a warning back in 2019 about the potential for biotin to alter troponin tests, and there is some evidence to support this warning. Ithiel, Frame and colleagues at the University of Texas Southwestern Medical Center published a thorough study on this matter in the American Journal of Clinical Pathology. It is a legitimate concern.

But then the script writers make a leap of such aerodynamic audacity that even gymnast Simone Biles would be envious: “While biotin is just one example, it is possible that other dietary supplements could also interfere with diagnostic tests. If a lab test result does not match the clinical presentation of your patient, consider supplement interference as a possible source of error. And communicate with the lab conducting the test if you suspect supplement interference.”

So, basically, any time there’s an aberrant or unexpected lab test result, a doctor should suspect the patient’s supplements? As if lab processing errors, mishandling of samples, and interactions between the dozen or so medications a patient is taking never happen? Yeah, go ahead, just blame the supplements.

Then comes a warning that some products marketed as supplements contain undisclosed pharmaceutical ingredients. The most common hidden drug ingredients are: sibutramine, sildenafil, tadalafil, phenolphthalein. Again, it is a legitimate concern, but hardly news to anyone in the medical field.

The program then goes on to its other main take-home for doctors:

“Because dietary supplements are not approved and often are not even reviewed by FDA before they are sold to the public, it is particularly important that you and your patients report any adverse events or reactions to FDA.”

The narrator urges clinicians to “notify FDA if you suspect that a dietary supplement may have caused an adverse or an unanticipated reaction for your patient. Report to FDA if your patient exhibits allergic, cardiovascular, gastrointestinal, gynecological, musculoskeletal, neurological, ocular, psychiatric, pulmonary, rheumatologic, urologic or other reactions, or if the situation requires an emergency room visit or hospitalization.

She explains how to do this via the federal government’s online safety reporting portal (www.safetyreporting.hhs.gov).

No doubt, some supplement ingredients can be toxic in high doses. Some can trigger adverse reactions, and may interact with prescription meds. It is also possible that adverse events have been under-reported for decades. Without mandatory adverse events reporting (AER)—as is the case for drug-related side effects—practitioners may not bother to log suspicious incidents.

The industry’s cherished mantra that “supplements cause far fewer problems than drugs” may or may not be valid, given that doctors are required by law to report suspected drug side effects, but not required to report potential problems with supplements. But let’s keep in mind that every year, FDA-approved pharmaceuticals cause roughly 1.3 million adverse events serious enough to warrant emergency room visits, according to the CDC.

To assume that supplements are the culprit whenever someone ends up in the ER—as is suggested by this video—errs on the extreme of potential over-reporting.

‘The Talk’

Module 2 carries on with the narrator announcing (without even a trace of irony): “Now that you know more about dietary supplements, FDA strongly encourages you to talk to your patients about them.”

Mind you, in nearly 20 minutes of content, viewers have yet to learn anything about supplements themselves, other than that they are potentially dangerous, probably unnecessary, not regulated like drugs, and possibly going to muddy up important diagnostic test results.

I suppose this all meshes well with the nearly nonexistent nutrition education that most physicians and nurses get during their training. But sure, go ahead, talk to your doctor—if you have one. Keep in mind that nearly one in 10 U.S. adults—that’s 31 million people—do not have health insurance, and one in four do not have regular access to primary care services, according to federal government statistics.

Module 2 peaks with a simulated clinical vignette in which a physician asks her patient if he’s taking supplements. He responds that indeed he’s taking a multivitamin, occasional melatonin to help with sleep, and calcium, “because dairy doesn’t always agree with me.”

Doctor: “Did another doctor recommend that you take these?”

Patient: “No.”

Doctor: “Just keep in mind that dietary supplements have both benefits and risks. I sometimes recommend supplements for my patients who are not getting enough essential nutrients from their diets—like the calcium you mentioned.”

But she then goes on to voice concerns that supplements may contain “unproven ingredients or be falsely marketed,” and that “people might use a supplement in place of a prescription drug.”

Oh, and by the way, she tells her now-alarmed patient: “Did you know that dietary supplements aren’t approved by FDA?”

The video encourages medical professionals to include discussion of supplements when taking medical histories, and to always ask what patients are taking, how much, and if they’ve had any adverse reactions.

That’s in line with a longstanding AMA mission to get doctors to have “the talk” with patients. In a statement announcing the CME collaboration with FDA, the AMA noted that the organization’s work in developing this content, “stems in part from policy adopted by the House of Delegates in 2020 urging physicians to inquire about patients’ use of dietary supplements and engage in risk-based conversations with them about dietary supplement product use.”

Scare Tactics & Smear Campaigns

Module 3 of the CME program seems to be written more for a lay consumer audience than a medical one, which is a head-scratcher given that this is an accredited education series explicitly for health professionals.

“When it comes to taking dietary supplements, it is important to be an informed consumer. And don’t believe everything you read,” it starts out.

This is followed by a remix of major themes from the first two videos: supplements may sometimes be helpful in providing essential nutrients but they are not intended to prevent or treat diseases, should never be used in place of Rx drugs, and are not substitutes for a healthy diet.

It cautions people to watch out for products that claim to be “totally safe” or to have “no side effects,” to remain ever-vigilant about claims that sound “too good to be true,” and to immediately report any potential adverse events to the FDA.

“Staying safe when you’re taking dietary supplements might seem challenging,” the announcer states. “But you don’t have to do it alone. Always talk to your doctor, pharmacist, or other healthcare professional about any dietary supplements you are taking, and before you decide to use a new supplement.”

The video ends by warning consumers that supplements could be dangerous for pregnant and nursing women, and small children, and encouraging everyone to keep accurate records of the supplements they’re taking using a handy template created by the National Institutes of Health’s Office of Dietary Supplements.

And that, friends, is the length and breadth of what the federal government’s leading regulatory agency and the country’s oldest and largest physicians’ organization (current membership over 270,000), think physicians should know about dietary supplements.

In 30 minutes, there is not a word about the potential benefits of probiotics, vitamin D, omega-3s, antioxidants, or botanical remedies. Not even a mention of the possibility that certain supplements may support mitochondrial activity or immune system resilience, or maintain epithelial integrity, or promote relaxation.

On the rare occasions that these videos acknowledge that some supplements might sometimes be helpful for some people, the statement is always followed by a “But …” And then a restatement of the FDA’s limited authority, or the axiom that supplements must never be used in place of drugs or actual foods.

And you know what else is missing from this “education” series? References!

There’s not a single literature citation in either the videos themselves or the accompanying PDF downloads. That’s curious, given that all CME activities are supposed to be “evidence-based,” and that the AMA’s CME review boards are known for their merciless scrutiny of programs produced by other organizations. I’ve attended and viewed thousands of CME presentations over my career. Nearly all contain journal references to support their main points.

Simply put, this video series is a scare campaign, not an education program. To call it the latter is a misleading claim and a gross misrepresentation. I’d call the FTC, but …

I suppose I should not be surprised by the overt anti-supplement attitude permeating this program. From its earliest days, the AMA has been hostile toward naturopathy, herbal medicine, nutrition, Asian and Indigenous medical traditions, and basically anything that did not conform to the pharmaceutical, surgical, or medical device models of healthcare.

The FDA, for its part, clearly wants greater authority over the supplement industry. With Senator Dick Durbin (D-IL) calling for mandatory product listings, the agency just might get its wish someday.

Yet I can’t help but think that in the midst of a pandemic that laid bare the limitations of allopathic medicine, in the glare of countless studies showing diet and lifestyle factors are the main drivers of chronic disease, and in the face of the obvious fact that many Americans do not follow healthy nutritious diets, that the AMA and FDA might show a little humility and drop their ossified stances for the benefit of the greater good.

Credit where credit is due: the “FDAMA” did a commendable job of inclusiveness and virtue signaling. The producers cast a young Asian-American woman as narrator, and an African-American woman to play the role of “Doctor” to a Euro-American dude-bro “Patient.” That’s “progress,” I suppose. But that’s the only thing even remotely forward-looking about this program.

For the most part, this series simply rehashes decades-old canards: supplements are dangerous at worst, unnecessary at best; those with measurable biological effects should probably be reclassified as drugs; the FDA doesn’t have enough power to safeguard the public; physicians should be suspicious of these products.

The truth is, we really do need well-informed practitioners who can counsel patients on how to use supplements, how to select the good products, and how to avoid the crap (and yes, we all know there’s plenty of crap out there).

With their aggregate resources and collective brain trusts, the AMA and FDA might have created something truly interesting and impactful on public health. They chose not to do so, opting instead to push out a smear job masquerading as a CME program.

“Dietary Supplements: What Physicians Should Know” would be laughable if it weren’t so damned frustrating.

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About the Author: Erik Goldman is co-founder and editor of Holistic Primary Care: News for Health & Healing, a quarterly medical publication reaching about 60,000 physicians and other healthcare professionals nationwide. He is also co-producer of the Practitioner Channel Forum, the nation’s leading conference focused on opportunities and challenges in the practitioner segment of the dietary supplement industry.