The Death-Strewn Backstory of Big Supplement

History is about to repeat itself

I published this post a year ago, but I have many new followers (welcome!), and it’s an important topic, so I wanted to share it again in case you missed it the first time around or if you are game for a re-read, because sadly it’s very timely.

On Monday, January 20, 2025, many aspects of health care in the United States are likely to change for the worse. A self-serving, anti-vaxxer who ignores science in favor of personal profit (Robert F. Kennedy Jr.) will almost certainly be in charge of the Department of Health and Human Services. Dr. Marty Makary, a forced birther whose telemedicine company sells compounded GLP-1s, is poised to take charge of the Food and Drug Administration. In 2023, Makary said to Congress, “Nothing speaks more to the intellectual dishonesty of public health leaders than their complete dismissal of natural immunity.” Perhaps he forgot about the 350,000 people in the United States who died from COVID-19 in 2020 alone? I shouldn’t have to say this, but the rush to make a vaccine happened because natural immunity wasn’t exactly working out for hundreds of thousands of people. Hey, nothing says “I respect the sanctity of life” more than being indifferent to the deaths of hundreds of thousands of people because it interferes with your contrarian views.

Both Kennedy and Makary are deep in the MAHA movement, which I can best describe as a mob of anti-science, pro-supplement super grifters. While it’s true the FDA is relatively toothless when it comes to holding supplement companies accountable, they still provide some critical consumer protection, but this could easily be weakened or even evaporate altogether. For example, we rely on the FDA for safety alerts when health concerns regarding supplements are raised. We rely on the FDA to investigate harm related to supplements, bar dangerous products from entering the country, and even seize adulterated or mislabeled products. And we rely on the FDA to ensure that tampons are being made safely.

Now consider all the supplement shills involved with the MAHA movement. Do you have faith that if one of their products is linked with liver failure, the Trump FDA will intervene? Or what if one of them wants to sell a new tampon infused with an herb? Do you think Trump’s FDA will visit the factory in Bulgaria to see how the product is made or seize any product entering the United States because it hasn’t been studied for safety? I don’t.

Big Supplement has a terrible back story in the United States, and what we need here is more regulation, not less, but I don’t think that’s in the cards. So, with that in mind, I think this post is an essential primer on how we got where we are supplement-wise because, sadly, I think history is about to repeat itself.

(This is a shortened version of the original post; I have removed some material unrelated to regulations. If you want to read the original, you can find it here).

The Shit Show Before the Shit Show

Adulterated and contaminated foods were all too common in the 1800s. If a cherry wasn’t red enough, add dye to the bottle, and if it’s toxic, who cares? Need a medication that makes people feel better? Add fortified wine. Want to dye your lashes? Who cares if the active ingredient causes blindness? And yes, these are all real examples. 

Then, in 1906, in an attempt to protect the American public, The Pure Food and Drug Act was passed, requiring accurate labeling and listing of additional, potentially harmful ingredients. While an important step, many dangerous over-the-counter cosmetics and medications remained, including Radithor, radioactive water (no, really), and Koremlu, a permanent hair-removing cream that contained thallium acetate (a rat poison that has since been banned due to its extreme toxicity to humans). Even when applied to the upper lip, the result could be hair loss all over the body, paralysis, and damaged vision. Yes, known poisons were on the market disguised as helpful remedies, people suffered, and the government had little recourse. 

A bill was introduced in the early 1930s to create more regulation, which was sorely needed,  but it went nowhere until, sadly, in 1937, a predictable tragedy struck. S.E. Massengill Co., in response to the demand for a liquid form of an antibiotic, sulfanilamide, created Elixir Sulfanilamide, primarily intended for children. The problem was the solvent, diethylene glycol, is highly toxic (it’s in antifreeze). Over 100 people in 15 states, many of whom were children, died. The Food and Drug Administration launched a massive cross-country investigation to track every ounce sold. It was awful because the company initially sent telegrams to pharmacies just stating there was a recall, omitting the key information that the medication was a poison that could be fatal even in very small amounts, so there was little urgency with the recall. 

Here’s a quote from the FDA commissioner at the time, Walter Campbell, pleading for more regulation:

"These unfortunate occurrences may be expected to continue because new and relatively untried drug preparations are being manufactured almost daily at the whim of the individual manufacturer and the damage to public health cannot accurately be estimated. The only remedy for such a situation is the enactment by Congress of an adequate and comprehensive national Food and Drugs Act, which will require that all medicines placed upon the market shall be safe to use under the directions for use. ..."

Honestly, when you consider that supplements are a growing cause of liver damage, Ayurvedic medicines are routinely contaminated with lead, and many supplements contain medications banned by the FDA, that quote from 1937 is sadly still on the nose today. 

Spurred on by the public outcry over Elixir Sulfanilamide, the 1938 Food, Drug, and Cosmetic Act was passed into law. The law required manufacturers to prove the drugs were safe and effective, prohibited false claims about efficacy, and legislated factory inspections. This is also where homeopathic remedies found their way into a sort of no-man’s land of medication. Senator Royal Copeland, a physician who became a homeopath, added homeopathic remedies in such a way that essentially excluded them from proof of efficacy as they had already “met” safety standards. 

Laws work for a while but must be updated or rewritten as beliefs change, new technology brings new products, and people find ways around the law. The 1960s and 1970s saw an explosion of the “natural” movement; health food stores began popping up everywhere, and vitamins, food additives, herbal products, and other remedies flooded the market. It became clear that more regulation was needed, but governments are rarely proactive regarding health; instead, they are reactive regarding tragedy. In 1989, another preventable mass poisoning occurred when over 1,500 people were affected by eosinophilia myalgia due to supplements containing L-tryptophan, and thirty-eight died. The exact source was never identified but was hypothesized to be a contaminant created or introduced during manufacturing. L-tryptophan products were removed from the market, and the illnesses stopped. This event spurred renewed interest in increasing regulation. In 1991, the FDA started implementing regulations to protect consumers and hold these companies to safety and advertising standards. 

The Dietary Supplement Health and Education Act of 1994

Not surprisingly, the industry pushed back. Legal battles ensued. Senator Orin Hatch, a Republican from Utah, stepped in and crafted a bill to let supplement companies essentially do whatever they wanted with the Dietary Supplement Health and Education Act of 1994, or DSHEA. Hatch was from Utah, a haven for supplements and multilevel marketing, which earned it the nickname  “cellulose valley.” Hatch was apparently a personal believer in supplements. Although the cynic in me thinks if supplement companies are among your biggest donors and your son is a lobbyist for a supplement company, you might develop a public taste for them. Apparently, Hatch displayed supplements in his office. Before Hatch stepped in, supplements in the United States were a $9 billion-a-year business; now it’s $50 billion. 

Hatch removed all regulations, not just for vitamins and minerals (think vitamin B12 or iron, things people might actually need to supplement their diets), but herbs, botanicals, amino acids…you name it. As long as the product doesn't make a specific medical claim, for example, ‘“treats yeast infections,” and somewhere, even in the tiniest print, has the get-out-of-jail free card statement, “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease,” the product can literally be dirt scooped up from someone’s backyard, and it is perfectly legal. 

So yes, someone could remake Elixir Sulfanilamide and sell it because the American government doesn’t require any safety testing or proof the product contains what it claims. And lest you think the idea of antifreeze in supplements is absurd today, in late 2023, the FDA warned that multiple supplements labeled as tejocote (Crataegus mexicana) root were really yellow oleander (Cascabela thevetia), a poisonous plant that can kill even with very small doses. Nine of the ten products tested contained yellow oleander. Let’s say that one more time, 90% of products tested were poison. The investigation and subsequent warning to the public was the result of a toddler ingesting some of the product and ending up in the emergency room with heart problems. 

Here’s the real kicker. Products labeled as tejocote have been known since at least 2021 to contain the poisonous yellow oleander, and there have already been several reports of serious cardiac complications from ingesting products labeled as tejocote.  

In any other industry (other than gun manufacturing), if a known poison/manufacturing flaw that puts lives at risk had been identified, something would have happened. For example, all Boeing 737 Max 900 planes were grounded after part of the fuselage blew out of one plane at 16,000 feet. Hundreds or even thousands of people could be harmed by an unsafe supplement, so the carnage could easily be on the same scope as an aviation incident. but because it’s a supplement, maybe the FDA sends a warning letter to the manufacturer. That lacks the negative PR punch of a plane grounding and is certainly not very scary for a multimillion-dollar product. 

(And for my Canadian friends, don’t think things are much better. Even though supplements must be licensed by Health Canada, which means they have been “found to be safe, effective and of high quality,” Health Canada does no testing and relies on the word of the manufacturer.)

Once in a while, if an outcome is especially tragic, the FDA will sue a manufacturer or even file criminal charges. For example, two former dietary supplement company executives were sent to prison, and two companies paid over $10 million in fines over the fraudulent and dangerous Jack3d and OxyElite Pro supplements. Two U.S. Army soldiers died after taking Jack3, which contains the stimulant dimethylamylamine or DMAA, which is an amphetamine. DMAA was banned in 2013 but is still widely available. In fact, some guy at the website “Lift Vault” is only too happy to tell you where you can get it. 

According to Kyle, the “real” reason it’s hard to get DMAA isn’t that it killed two people and is illegal in the United States, but that it’s the result of a “rocky relationship the FDA and other regulatory agencies have with DMAA and DMHA.”

Killing two people and illegal…rocky relationship. It’s the same thing, right?

Adulteration of supplements with active pharmaceuticals is common. Some of these pharmaceuticals are dangerous because the compound is dangerous, like DMAA, and sometimes, they are contaminated with approved pharmaceuticals. I’ve written previously about a study of “sports enhancers,” and 12% contained an ingredient banned by the Food and Drug Administration (FDA). One supplement contained four banned ingredients, and one even contained a substance that has never been approved for human use anywhere. Even if the added pharmaceutical isn't itself dangerous, there is a risk of negative medication interactions that can’t be predicted. And of course, not every person can safely take every pharmaceutical. Supplements for weight loss, metabolism boosters, muscle building, and libido seem to be the most common ones that are adulterated with pharmaceuticals. Still, of course, you never know because the system is designed, so you can’t know. A supplement for hot flashes could contain estrogen, so it may actually work, but then you are taking estrogen, and you don’t know how much. Could you get a blood clot? What about endometrial cancer? Real possibilities for harm. 

Don’t Forget the Dangerous Microbials

As there is no enforcement of good manufacturing practices, contamination of products by harmful bacteria, mold, and yeast is a real concern (echos of L-tryptophan, which is now back on the market, by the way, and there has since been a case report of eosinophilia myalgia). A study by V.H. Tournas looked at 183 dietary supplements, and “Potentially toxigenic molds were found in alfalfa, coriander, echinacea, garlic, ginkgo, juniper, licorice, psyllium and St. John's wort supplements.” Products containing kratom have been contaminated with Salmonella, resulting in 50 people needing hospitalization, and probiotics have been linked with liver abscesses. Contamination with microorganisms is a concern for everyone, but especially risky to immunosuppressed people. 

Then there is Heavy Metal Contamination…

Studies tell us that 20% of Ayurvedic products are contaminated with lead. Really, 20%. If 20% of chickpeas were contaminated with lead, chickpeas would be banned, and the story would be on the front page above the fold of every newspaper. But it’s a supplement, so have at it. A study from Canada showed that of 121 supplements tested, 5% exceeded the safe level of arsenic, and 1.7% exceeded the levels for lead, cadmium, and aluminum. In many studies, there are heavy metals, although not enough in an individual product to be a concern. However, considering many people take more than one supplement, the possibility of tipping over into concerning exposure is very real. 

Supplements are so lucrative it’s actually painful.

Thinking back to the DMAA disaster, one manufacturer initially refused to destroy or turn over their stock to the FDA. When the FDA was ultimately successful, the amount destroyed was worth more than $8 million on the market. That’s one product line from one company. The the top ten menopause supplements generated $3,363,997 in sales on Amazon in one month. One month (read more about that here). It’s easy to see why supplements are so appealing, business-wise. But how can they make American healthy again if they don’t diagnose, treat, cure, or prevent disease?

I bet either the requirement for a supplement disclaimer will be gone in a year, or there will simply be no ramifications for those who decide to skip this fine print. When that happens, you can say you read it here.

Sigh.

Supplements are Untested, Unregulated Pharmaceuticals

There is no greater example of buyer-beware in medicine than supplements. The FDA is barely looking out for you as it is because they have been so hamstrung by legislation.

Buying a supplement is like buying gas from a guy selling it out of a can on the side of the road; all you can do is hope that it’s actually something that can cure an empty tank and not something that could wreck your engine or cause your car to blow up. 

References

The 1906 Food and Drugs Act and Its Enforcement https://www.fda.gov/about-fda/changes-science-law-and-regulatory-authorities/part-i-1906-food-and-drugs-act-and-its-enforcement

Ballentine C. Sulfanimamide Disaster. FDA Consumer Magazine, June 1981 https://www.fda.gov/files/about%20fda/published/The-Sulfanilamide-Disaster.pdf

1938 Food, Drug, Cosmetic Act https://www.fda.gov/about-fda/changes-science-law-and-regulatory-authorities/part-ii-1938-food-drug-cosmetic-act

Pray WS. Orrin Hatch and the Dietary Supplement Health and Education Act: Pandora’s Box Revisited. Journal of Child Neurology. 2012;27(5):561-563. doi:10.1177/0883073812441064

Podolsky SH, Kesselheim AS. Regulating Homeopathic Products — A Century of Dilute Interest

N Engl J Med 2016; 374:201-203

Swygert LA, Back EE, Auerbach SB, Sewell LE, Falk H. Eosinophilia-myalgia syndrome: mortality data from the US national surveillance system. J Rheumatol. 1993;20:1711–17.

Eosinophilia-myalgia syndrome and L-tryptophan-containing products--New Mexico, Minnesota, Oregon, and New York, 1989. Centers for Disease Control (CDC) MMWR Morb Mortal Wkly Rep. 1989;38:785–8. 

Allen JA, Peterson A, Sufit R, Hinchcliff ME, Mahoney JM, Wood TA, Miller FW, Whitfield ML, Varga J. Post-epidemic eosinophilia-myalgia syndrome associated with L-tryptophan. Arthritis Rheum. 2011 Nov;63(11):3633-9. doi: 10.1002/art.30514.

Belongia EA, Hedberg CW, Gleich GJ, White KE, Mayeno AN, Loegering DA, Dunnette SL, Pirie PL, MacDonald KL, Osterholm MT. An investigation of the cause of the eosinophilia-myalgia syndrome associated with tryptophan use. N Engl J Med. 1990 Aug 9;323(6):357-65. 

Hiltzik M. Orin Hatch is Leaving the Senate, but his Deadliest Law Will Live On. LA Times Accessed 01/17/24 https://www.latimes.com/business/hiltzik/la-fi-hiltzik-hatch-20180105-story.html

Shin D, Kang HS, Park EM, Kim J, Kwon J, Suh J, Moon G. Authentication of tejocote (Crataegus mexicana) dietary supplements based on DNA barcoding and chemical profiling. Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2021 Dec;38(12):1985-1994.

Berland N, Kababick J, Santos C, Calello DP. Notes from the Field: Online Weight Loss Supplements Labeled as Tejocote (Crataegus mexicana) Root, Substituted with Yellow Oleander (Cascabela thevetia) - United States, 2022. MMWR Morb Mortal Wkly Rep. 2023 Sep 15;72(37):1016-1017. 

White CM. Dietary Supplements Pose Real Dangers to Patients. Annals of Pharmacotherapy. 2020;54(8):815-819. doi:10.1177/1060028019900504

Tournas VH. Microbial contamination of select dietary supplements. J Food Safe 2009;29:430-442.

Genuis SJ, Schwalfenberg G, Siy AK, Rodushkin I. Toxic element contamination of natural health products and pharmaceutical preparations. PLoS One. 2012;7:e49676.

Us Department of Justice, Press Release. Two Individuals And Two Companies Sentenced In Scheme To Fraudulently Sell Popular Dietary Supplements. https://www.justice.gov/opa/pr/two-individuals-and-two-companies-sentenced-scheme-fraudulently-sell-popular-dietary