Dietary Supplements Need More Regulation

By Emily Hemendinger and Katie Suleta

Dietary supplements are a big business. The industry made almost $39 billion in revenue in 2022, and with very little regulation and oversight, it stands to keep growing.

The marketing of dietary supplements has been quite effective, with 77% of Americans reporting feeling that the supplement industry is trustworthy. The idea of taking your health into your own hands is appealing, and supplements are popular with athletes, parents and people trying to recover more quickly from a cold or flu, just to name a few.

A 2024 study found that approximately 1 in 10 adolescents have used nonprescribed weight loss and weight control products, including dietary supplements.

Notably, that systematic review found that nonprescribed diet pill use was significantly higher than the use of nonprescribed laxatives and diuretics for weight management. These types of unhealthy weight control behaviors are associated with both worsened mental health and physical health outcomes.

As a licensed clinical social worker specializing in treating anxiety disorders and eating disorders and a biomedical research director, we’ve seen firsthand the harm that these supplements can do based on unfounded beliefs. The underregulated market of dietary supplements is setting consumers up to be misled and potentially seriously harmed by these products.

Supplements Often Mislabeled

The Food and Drug Administration specifies that supplements must contain a “dietary ingredient” such as vitamins, minerals, herbs, amino acids, enzymes, live microbials, concentrates and extracts, among others.

Unfortunately, manufacturers can claim that a product is a supplement even when it doesn’t meet those criteria, such as products containing the drug tianeptine, a highly addictive drug that can mimic the biological action of opioids. Some of these products are labeled as dietary supplements but are anything but.

Products containing kratom, a substance with opioid-like effects, which are sold over the counter in many gas stations, claim to be herbal supplements but are mislabeled.

Under a 1994 law, dietary supplements are classified as food, not as drugs. This means dietary supplements are not required to prove efficacy, unlike drugs. Regulators also don’t take action on a product until it is shown to cause harm.

However, the FDA’s website states that “many dietary supplements contain ingredients that have strong biological effects which may conflict with a medicine you are taking or a medical condition you may have. Products containing hidden drugs are also sometimes falsely marketed as dietary supplements, putting consumers at even greater risk.”

In other words, supplements are regulated as food instead of drugs, even though they can interact with medications and may be laced with hidden drugs not included on the label.

Manufacturers of dietary supplements can make claims about their products that fall into three categories: health claims, nutrient content claims and claims about the product’s function, structure or both, all without needing to provide supporting evidence.

Misbranding and false advertising are rampant with dietary supplements, including false claims of curing cancer, improving immune health, improving cognitive functioning, improving fertility, improving cardiovascular health and, of course, promoting weight loss and weight control.

Hidden Dangers

You can find supplements that claim to be good for just about every health condition, concern or goal, so it should be no surprise that there are supplements marketed for weight loss.

In August 2021, the FDA cracked down on some of these weight loss products because of the presence of undeclared drugs. For example, of the 72 products recalled, the drug sibutramine, sold as Meridia, was found in 68 of them.

While the FDA may take further action beyond the recalls, the agency acknowledged that it is not able to test every weight loss supplement for contamination with drugs.

These crackdowns demonstrate some progress, though several issues remain. Warning label placement, ingredients and beliefs based on misleading or false advertising are still highly problematic.

Some weight loss supplements may have FDA warnings on them. Of those that do, the disclaimers are rarely displayed on the front of the product label, so consumers are less likely to see them.

Ingredients in weight loss supplements can and do have adverse effects. They have caused people to be admitted to the emergency room for cardiovascular and swallowing problems, including in young, seemingly healthy people.

Mental health concerns and eating disorders are on the rise. As a result, researchers are examining unhealthy weight control behaviors, including the use of dietary supplements and how accessible they are to adolescents and children.

People who have eating disorders often suffer related health issues such as bone loss, osteoporosis and vitamin deficiencies. In response, their doctors may prescribe dietary supplements like calcium, vitamin D and nutritional supplement shakes. But these are not the dietary supplements of concern. The concern is with supplements that promote weight loss, muscle building or both.

People with eating disorders may be attracted to dietary supplements that claim quick and pain-free weight loss or muscle gain. Additionally, dietary supplement users may struggle with an increase in compulsive exercise or other unhealthy weight control behaviors.

Diet pill and supplement use has also been associated with increased risk for developing eating disorders and disordered eating, as well as low self-esteem, depression and substance use. While dietary supplements do not solely cause eating disorders or disordered eating, they are one contributing factor that may be addressed with preventive measures and regulations.

Protein powders and other fitness supplements also have wide appeal. Research shows that girls are more at risk than boys for using weight loss supplements. But a growing problem in boys is the use of fitness supplements such as protein powder and creatine products, a compound that supplies energy to the muscles.

Use of fitness supplements sometimes signifies a preoccupation with body shape and size. For example, a 2022 study found that protein powder consumption in adolescence was associated with future use of steroids in emerging adulthood.

Protein powders make claims of building lean muscles, while creatine boasts providing energy for short-term, intense exercise.

Protein itself is not harmful at recommended doses. However, protein powders may contain unknown ingredients, such as certain toxins or extra and excessive sugar. They can also be dangerous when used in excess and to replace other foods that possess vital nutrients.

And while creatine can usually be safely used in adults, overuse can lead to health problems and is not recommended for minors. Ultimately, the impact of long-term use of these supplements, especially in adolescents, is unstudied.

Possible Solutions

One proposed regulation by researchers at Harvard University includes taxing dietary supplements whose labels tout weight loss benefits.

Another policy recommendation involves banning the sale of dietary supplements and other weight loss products to protect minors from these underregulated and potentially dangerous products.

In 2023, New York successfully passed legislation that banned the sale of these products to minors, while states including Colorado, California and Massachusetts have considered or are considering similar action.

Ultimately, medical professionals recommend that parents and caregivers encourage their children to get protein and vitamins from whole foods instead of turning to supplements and powders. They also recommend encouraging teens to focus on balanced nutrition, sleep and recovery, and a variety of resistance, strength and conditioning training.

Emily Hemendinger, LCSW, is an Assistant Professor of Psychiatry at University of Colorado Anschutz Medical Campus.

Katie Suleta is a PhD Candidate in Medicine and Health at George Washington University.

This article originally appeared in The Conversation and is republished with permission.

How Do You Treat Long Covid? Patients Surveyed for Answers

By Esther Landhuis, Undark Magazine

In January 2020, Martha Eckey was working at a retail pharmacy in Champaign, Illinois, when she developed a sore throat, hacking cough, and stiff neck. A second bout of illness struck about a month later, leaving the pharmacist with a persistent fever and shortness of breath. Covid tests were unavailable at the time, but she tested positive for influenza.

The biggest challenge was “crushing, debilitating fatigue,” she told Undark. “No amount of sleep left me feeling even remotely refreshed,” she added by email. Three-and-a-half years later, Eckey has still not recovered.

Shortly after her initial illness, Eckey started reading about people with lingering post-Covid symptoms, and although she never knew for certain which virus caused her initial illness, those symptoms seemed strikingly similar to hers.

After connecting with patients navigating these conditions, Eckey wondered if she had developed myalgic encephalomyelitis/chronic fatigue syndrome, or ME/CFS, a long-lasting illness that can crop up after a viral infection.

She went to see several physicians, but they “told me they were not taught about post-viral illnesses,” she recalled. “It literally wasn’t in their curriculum.” Eckey had not learned about post-viral syndromes in her four-year doctor of pharmacy training, either.

MARTHA ECKEY

Long Covid and ME/CFS are complex illnesses. Up to 2.5 million Americans live with ME/CFS, and more than 65 million people worldwide may have long Covid — though estimates vary and the dozens of symptoms across multiple body systems can make these conditions hard to define and diagnose. In some people, symptoms linger or intensify with time, but in others they occur weeks or months after recovery from the initial infection, which could be mild or undiagnosed.

In a recent analysis of 9,764 adults enrolled in the federally funded initiative RECOVER, long Covid patients fell into four subgroups based on symptoms, many overlapping with ME/CFS and other conditions. By studying biological samples from these participants, researchers hope to identify markers that can inform future trials of potential therapeutics.

Yet for now, despite an influx of research funding, there are no widely accepted treatments approved by the U.S. Food and Drug Administration to ease sufferers’ symptoms. In that void, desperate patients have turned to a range of proposed solutions — from microbiome treatments to vitamin supplements to experimental techniques like “blood washing” — to find relief. In this vast array of possible therapies, some are exorbitant and most are unproven.

Eckey quit her pharmacy job in August 2020 to search for useful patterns amid that chaos. Unlike most national initiatives and large academic research programs, Eckey is employing a bottom-up approach: She polls patients on which interventions they’ve tried and how they fared, in the hope that this crowdsourced knowledge might contain valuable insights for improving long Covid care.

While surveys like Eckey’s come with inherent limitations, some researchers think such grassroots efforts can help inform more rigorous studies.

“Large clinical trials cost millions of dollars, and it’s impossible to test hundreds of different things at once,” said Akiko Iwasaki, whose lab at the Yale School of Medicine studies the immunology of long Covid. “Knowing what has benefited the patients already provides us with insights that can be tested in future trials.”

Medications and Supplements

Late in the summer of 2022, Eckey, known to social media followers and Substack subscribers as LongCovidPharmD, created several surveys using Google Forms and shared them on Twitter (more recently rebranded as X).

One of the surveys listed about two dozen medications — including Paxlovid, statins, and beta blockers— and had respondents tick boxes for the ones they had tried. It asked them to indicate if taking the drug seemed to “moderately improve,” “vastly improve,” worsen, or have little to no effect on long Covid symptoms or quality of life. Other sections asked if they had conditions that commonly occur alongside ME/CFS or long Covid, such as dysautonomia, mast cell activation syndrome, or a history of blood clots.

Eckey also grew curious about supplements — a category that includes probiotics or enzymes, herbs, minerals, vitamins, and other over-the-counter products with suggested uses that are not regulated by the FDA. In social media posts, she noticed that people commenting on supplements would say, “‘Oh, that didn’t work at all for me,’ and then other people say, ‘oh, that cured me,’” she said.

So she created another survey, listing eight types of supplements and asking to what extent they seemed to help with fatigue, cognitive function, and other symptoms. Motivation for that survey also came from Eckey’s own frustration with being unable to get any prescribed treatments, she said: “I thought, ‘Well, I think I just have to figure out how to treat myself.’”

With more than 200 respondents, the surveys gave a sense for which types of supplements seemed most helpful. Additional surveys focused on the most promising supplements — which doses were used and for what frequency and duration, whether patients improved or felt worse, and which symptoms patients noticed seemed to be affected.

Eckey analyzed the results and started posting detailed summaries on X. Then, in late 2022, her work caught the attention of the Open Medicine Foundation, a California-based nonprofit that has raised $40 million to diagnose and treat complex, multi-system diseases including ME/CFS, long Covid, and others that have eluded doctors.

No Approved Treatments

ME/CFS and long Covid have no FDA-approved treatments, and neither has a definitive diagnostic. The situation echoes that of early days of AIDS, which, decades ago, was defined by symptoms rather than measurable changes inside the body, said Wenzhong Xiao, a computational biologist at Harvard Medical School who directs the foundation’s efforts on ME/CFS treatments.

Regulators typically validate medical treatments through a formal application that specifies the substance’s composition and how it’s made. The application also proposes further study in clinical trials, which generally won’t launch without supportive data from smaller pilot studies. When the Open Medicine Foundation came across Eckey’s work, the organization was already trying to decide which potential treatments to test in pilot studies for long Covid, and was making a registry from which to recruit patients. 

Building on her initial surveys with information gleaned from published trials, case studies, patient feedback, and her “own pharmacist intuition,” Eckey created a more comprehensive version, called “TREAT ME,” and tweeted it on Feb. 5, 2023. 

The survey — which, by Eckey’s account, took about 1,000 hours to produce — covered more than 150 medications and supplements. After collecting details about a person’s symptoms, lab tests, and medical history, the survey asked about treatments: whether they appeared to help, which symptoms improved, how long it took to see benefits, how long the benefits lasted, and whether they were outweighed by side effects. If a medication did not seem to help, the survey asked how long it was tried and at which doses.

“No one has done that deep a dive,” said Linda Tannenbaum, the CEO of the Open Medicine Foundation.

By the time the survey closed for analysis in late March, the responses had climbed to nearly 4,000.

Survey Bias

Despite the potential, surveys have unavoidable, inherent biases that can influence how data is collected and results are interpreted, said internist Lucinda Bateman, founder of the nonprofit Bateman Horne Center — a clinical care, research, and educational organization in Salt Lake City, Utah, that focuses on chronic, complex disorders including long Covid. First, there’s selection bias: Who decides to participate and why? There’s sampling bias: Who never hears about it? There’s also non-response bias: People for whom a treatment has little to no obvious effect may be less likely to participate. 

Surveys also hinge on participants’ own accounts, which aren’t typically confirmed with other sourcing. Eckey’s survey, for instance, relied on respondents to indicate whether they had an official or presumed diagnosis of long Covid or ME/CFS.

The approach also can’t typically account for the placebo effects that result from other factors besides a specific treatment or from other ongoing illnesses or treatments, which may skew the results. And beyond the difficulties with diagnosing long Covid, people may “think they got sick during the pandemic, and it’s entirely something else,” said Bateman. The uncertainty in the data is “just what happens when you do surveys,” she added.

Eckey agreed with these caveats, noting that she tried “to limit bias to the extent that I could.” For instance, to ease non-response bias, the survey instructions encouraged participants to rate treatments “even if they had no effect,” she said.

She also prompted participants to specify underlying conditions and treatments, and responses could be filtered accordingly. And Eckey included one supplement that she believed would have little to no impact on symptoms, figuring questions about it “could act as a sort of ‘placebo’ against which other treatments could be compared.” On a similar vein, she asked about several treatments that were hyped at various times and found their reported benefits to be “underwhelming” or not statistically different from related drugs.

The supplement industry is vast and largely unregulated, with many products lacking solid evidence for health benefits. Research to produce that evidence is a complex, costly process that requires FDA input, often participation from the company that produces the supplement, and approval by an independent ethics committee. What’s more, such trials must follow a company’s best guess on the right doses, optimizing the supplement’s benefit while minimizing side effects.

This approach comes with substantial risks for illnesses like long Covid, which cause a range of symptoms that differ from one person to the next, said David Putrino, director of rehabilitation innovation for the Mount Sinai Health System in New York. A single treatment won’t necessary work for all of them, Putrino, who studies and treats long Covid patients, added in an email, and “you feel like you only have ‘one shot.’”

Eckey’s survey, he said in a phone interview, “allows me to actually make data-driven decisions on what seems to be working.”

The approach is already prompting new studies. Some researchers think that certain long Covid symptoms stem from tiny blood clots; more than 60 percent of Eckey’s survey respondents said they felt better after taking supplements containing enzymes that break down fibrin, the main protein that forms the clots.

These results helped Putrino and colleagues choose one of the enzymes, called lumbrokinase, for a long Covid trial planned for early 2024.

“My desire to get better and help others in similar situations is what keeps me going.”

— Martha Eckey

The Open Medicine Foundation team is also using the survey results to inform drug trials. In a more typical trial, the group mines published scientific literature and uses machine learning to predict which medications might help. These analyses would have likely missed lumbrokinase, since it appears in relatively few academic research papers, Xiao said. Based on Eckey’s survey findings, he said, his team is “definitely thinking about doing follow-up studies.”

Beyond her dataset, Xiao added, Eckey is herself is an inspiration: “I can imagine how much effort she put, despite her own symptoms, to make this happen.”

Eckey’s lingering fatigue still keeps her mostly housebound — and, on some days, stuck in bed — but she told Undark via email that her cardiovascular symptoms have improved. On her better days, she said, she plans to volunteer at a free ME/CFS clinic that treats post-Covid patients: “My desire to get better and help others in similar situations is what keeps me going.”

Esther Landhuis (@elandhuis) is a California-based science journalist and a senior contributor to Undark. She covers biomedicine at all stages — lab discoveries, clinical trials, biotech, healthcare and its intersections with law and business. Her stories have also appeared in Scientific American, Nature, Medscape, JAMA, Science News, Quanta and other outlets.

This article was originally published by Undark, a non-profit, editorially independent online magazine covering the complicated and often fractious intersection of science and society. You can read the original article here.

FDA Warns Amazon and Walmart About Selling Misbranded Drugs

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has issued another warning to consumers not to purchase or use dietary supplements marketed for pain relief under the brand names “Artri” or “Ortiga” due to potentially dangerous pharmaceutical ingredients. Use of the products has led to liver toxicity and at least one death, according to the agency.

The FDA issued its first first warning about the supplements in January and followed up with a second warning  in April. The latest warning includes Amazon, Walmart and another retailer that continued to sell the supplements, which are marketed with claims that they treat arthritis and osteoarthritis, restore cartilage, and stop joint deterioration.

In a warning letter sent to Amazon last week, the FDA said it had purchased Artri and Ortiga supplements through its website and had them delivered through the company’s delivery service.

Laboratory testing confirmed the supplements purchased through Amazon contained diclofenac, a non-steroidal anti-inflammatory drug (NSAID), and dexamethasone, a corticosteroid used to treat inflammatory conditions.

Neither drug is mentioned on product labels, which list ingredients such as glucosamine and turmeric. The FDA warned Amazon that introducing or delivering a misbranded drug is a violation of federal law.  

“Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction. Please submit a written response to this letter within fifteen working days from the date of receipt, explaining the specific steps you have taken to address any violations,” the FDA letter states.

Similar warning letters were sent to Walmart and Latin Foods Market, which had previously issued voluntary recalls for the supplements, but still continued to sell them.

It appears the Artri and Ortiga supplements have now been removed from the websites of all three companies. The supplements were being marketed primarily to Spanish-speaking consumers, with claims they are “highly effective in restoring cartilage” and “fights arthritis.”  

Diclofenac raises the risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal bleeding and damage. When used long term or in high doses, dexamethasone and other corticosteroids can result in serious withdrawal symptoms if a consumer suddenly stops taking them. Both drugs can also interact with other medications.

The FDA encourages healthcare providers and patients to report side effects involving use of the products to its Adverse Event Reporting System. .

Can ‘Medical Food’ Treat Chronic Pain?

By Pat Anson, PNN Editor

Do you keep a supply of gamma-aminobutyric acid in your medicine cabinet? What about hydroxytryptophan? Or the ominous sounding devil’s claw root?

They’re not exactly household names to the average person, but to Fabio Lanzieri they are essential ingredients in a new “medical food” product called Proleeva, a dietary supplement he developed that contains a blend of a dozen natural herbs, enzymes and amino acids.

“I fervently believe that prescription medications are very beneficial to man, but I also believe that nature does offer us the ability to find solutions to natural diseases. Because of this, I was always interested and read a lot about vitamins, supplements and bioflavonoids,” says Lanzieri, who spent nearly four decades in the pharmaceutical industry. “I believe that supplementing prescription medications with natural substances is the best way of treating chronic pain or any disease state.”

Several years ago, Lanzieri’s wife Maria began experiencing joint pain as a side effect of taking a hormone suppressant to help her recover from breast cancer.     

“I did start feeling the pain in my joints, particularly my fingers. I was having a really hard time sometimes just opening a bottle or doing simple things,” Maria told PNN.

To help his wife, Lanzieri began experimenting with different blends of herbs and other natural substances. Some, like ginseng and curcumin, have been used for centuries as natural remedies for pain and inflammation. Others, like choline bitartrate and L-arginine, have only recently been recognized as essential nutrients that help restore amino acids and neurotransmitters to healthy levels.

You can buy all of these supplements individually, but Lanzieri combined them all into one proprietary formula and gave it to Maria. Her joint pain slowly began to improve.

“After about a month, month and a half, I started having relief of those symptoms.  I didn’t have the joint pain. I felt like I could do a lot of those tasks that I couldn’t do before,” Maria said. “At one point I stopped taking it and it then was all coming back. It was weird. I didn’t think it was the Proleeva. I didn’t associate it with that. But then I went back on it and suddenly I was not feeling it again.”

The Lanzieri’s began sharing Proleeva with family and friends, who also reported positive results.

Only recently have they begun selling Proleeva to the general public on their website and through Amazon, marketing it as “the ultimate comfort food” that “helps bring your nervous system back into balance.”

A Proleeva bottle contains 120 capsules – about a month’s supply – and costs $40.

“I’ve been taking Proleeva for the last seven years and I don’t have any inflammation. I take it because it balances the body with the right ingredients that it needs to fight to heal itself,” says Lanzieri. “Your body needs amino acids and they are not reproduced naturally in the body. And over time, the older we get, the less we have of those amino acids. And therefore, we have to supplement them.”

For now, there is only anecdotal evidence to support these health claims, although a small clinical trial of Proleeva is underway.  Unlike pharmaceuticals, dietary supplements are only loosely regulated by the Food and Drug Administration, allowing supplement makers to introduce new products and make health claims without substantial evidence that they work.

‘One Formulation Makes a Lot of Sense’

Dr. Forest Tennant is intrigued by Proleeva. An expert in treating intractable pain, Tennant recommends that pain patients take gamma-aminobutyric acid (GABA), herbs and other supplements as part of their medical treatment to restore damaged nerve tissue and relieve pain.

“Having a lot of different supplements in one formulation actually makes a lot of sense, because we’re not certain which ones are going to work,” says Tennant. “But I do think there is some urgency or necessity in people with pain taking a variety of these supplements. They can’t hurt themselves and they probably are going to benefit themselves.

“And this particular product is doing something else. It recognizes that it’s got stuff in there like GABA that stimulates the nerve receptors that provide pain relief.”  

Tennant says the supplement industry has become more innovative than the pharmaceutical industry – particularly in an age when opioids and some other medications are harder to get.

“I think the innovation is really great,” Tennant said. “I really think that anyone who has chronic pain, particularly constant pain, really needs to be on a number of supplements right now. We’ll figure out exactly which ones work the best later, but right now I think taking a combination of these things is worthwhile.”

People who try Proleeva or other supplements should not expect instant results. It may take up to a month to feel any benefits.

“The biggest problem is making them stay with this for 30 days. We’re a society of instant gratification. Prescription drugs do that. But unfortunately, natural substances take time,” says Lanzieri.

The Hidden Benefits of Glucosamine

By Pat Anson, PNN Editor

Do you take glucosamine supplements to reduce joint pain and stiffness? You’re not alone if you do. According to a 2007 survey, nearly 20 percent of U.S. adults take glucosamine to prevent or treat pain from osteoarthritis, back pain and other conditions.

The evidence to support the use of glucosamine for joint pain is thin, but a large new study in The BMJ suggests regular use of the supplement can reduce the risk of cardiovascular disease.

Researchers at Tulane University analyzed 7 years of extensive health data for almost half a million adults aged 40 to 69 enrolled in the UK Biobank study. Those who regularly took glucosamine were about 15% less likely to develop heart disease or have a stroke.

Glucosamine occurs naturally in the fluid around joints and plays an importantly role in building cartilage. Glucosamine is extracted from shellfish and is often combined in supplements with chondroitin, a similar substance that is also found in joints.

People who took glucosamine in the BMJ study were more likely to be women, older, more physically active, have healthier diets and take other supplements.

Over the course of seven years, 2.2% of those who did not use glucosamine had a heart attack or stroke, compared to 2.0% of people who did use glucosamine. People who used glucosamine were also less likely to die from a heart attack or stroke, 0.5% vs. 0.7% of those who didn’t use the supplement.

The difference doesn’t appear to be significant, but when adjusted for risk and other factors, it means that glucosamine users had a 22% lower risk of dying from a heart attack or stroke.

For smokers, the benefits of regular glucosamine use were even greater. They had 37% less risk of having coronary heart disease compared to smokers who didn’t use the supplements.

Researchers didn’t establish the reason why glucosamine lowers the risk of cardiovascular disease (CVD), but they believe the supplements help reduce inflammation – one of the main factors involved in the development of heart disease, as well as chronic pain.

“Several potential mechanisms could explain the observed protective relation between glucosamine use and CVD diseases. In the National Health and Nutrition Examination Survey (NHANES) study, regular use of glucosamine was associated with a statistically significant reduction in C reactive protein concentrations, which is a marker for systemic inflammation,” researchers reported. “Other mechanisms might also be involved, and future investigations are needed to explore the functional roles of glucosamine in cardiovascular health.”

The UK’s National Health Service (NHS) downplayed the study findings, pointing out the cardiovascular benefits of glucosamine are “quite small.”

“If you want to reduce your risk of having a heart attack or stroke, it would be much better to concentrate on living a healthy lifestyle, rather than paying for glucosamine supplements,” the NHS said.

Supplements Often Tainted by Hidden Drugs

By Pat Anson, PNN Editor

Hundreds of dietary supplements – including some marketed to relieve joint and muscle pain – are tainted with pharmaceutical drugs, according to a new study published in JAMA Network Open.  

Researchers with the California Department of Public Health looked at 746 supplements that the Food and Drug Administration found to be adulterated from 2007 to 2016. About half of the supplements remained on the market, even after the FDA found they contained potentially harmful drugs.

"The FDA didn't even bother to recall more than half of the potentially hazardous supplements," Pieter Cohen, MD, a Harvard Medical School professor told NPR. "How could it be that our premier public health agency spends the time and money to detect these hidden ingredients and then doesn't take the next obvious step, which is to ensure that they are removed from the marketplace?"

Over half of American adults take dietary supplements that contain minerals, vitamins, herbs, fish oil and other “natural” substances.  Most of the adulterated supplements were marketed for sexual enhancement, weight loss or muscle building.

Of the 14 supplements that were promoted as treatments for arthritis, muscle and joint pain, osteoporosis or other painful conditions, half contained diclofenac, a nonsteroidal anti-inflammatory drug (NSAID) and five contained dexamethasone, a steroid used to treat inflammation.

One supplement promoted as a treatment for arthritis – Pro ArthMax -- was found to contain four different NSAIDs, as well as a muscle relaxant and a non-narcotic pain reliever that was never approved for use in the United States. The manufacturer of Pro ArthMax voluntarily recalled the supplement in 2014 after being warned by the FDA.   

Cohen chided the agency for relying on voluntary recalls to get tainted supplements off the market and accused the FDA of “dereliction of duty” in a JAMA commentary. He called on Congress to change the federal law that exempts the $35 billion dollar supplement industry from pre-market safety and clinical studies that are required for pharmaceutical drugs.   

“More than FDA action will be required to ensure that all adulterated supplements are effectively and swiftly removed from the market,” Cohen wrote. “The process that the FDA is required to follow to remove supplements from the marketplace (is) cumbersome and time-consuming; nevertheless, the agency’s failure to aggressively use all available tools to remove pharmaceutically adulterated supplements from commerce leaves consumers’ health at risk.”

Dietary supplements that are tainted with hidden drugs may interact with other medications and raise the risk of adverse events, particularly when consumers already may be using NSAID-containing products.  

Is Vitamin D Making Me Feel Better?

By Crystal Lindell, Columnist

This is the story of how I have turned into the crazy lady constantly telling everyone I meet to get their vitamin D level tested.

The thing about the vitamin D is that it could either be the cure I’ve been searching for, or have absolutely nothing to do with why I’ve been feeling better since about July. Either way though, I am feeling better these days.

Back in May, I went to visit a local weight loss clinic to try and lose some of the 60 lbs. I’ve gained since getting sick. While I was there they ran some routine blood work. And it turns out my vitamin D was low. Not like, “Oh, it’s just a little low, you should probably take a supplement” low.

My level was 6 ng/ml. It was literally the lowest the doctor at the weight loss clinic had ever seen.

To put it in perspective, the Vitamin D Council says it’s best to be between 40-80 ng/ml, while the University of Wisconsin recommends being between 30-80 ng/ml.

I had tested low before, like 19 ng/ml, but it was years before I suddenly woke up feeling like someone was stabbing me in the ribs. And I honestly don’t remember the doctor at the time impressing on me that it was any sort of an issue. I just figured it was like needing an oil change every 3,000 miles. Sure that’s the ideal, but your car isn’t going to just shut off if you wait until 5,000 miles.

So I told my primary care doctor about the results, and he and the weight loss doctor decided to put me on prescription-strength 50,000 IU vitamin D for three months, followed by a daily dose of 4,000 IU after that.

When I got home from my appointment, I looked through all my medical records — from Loyola University, the Mayo Clinic and the University of Wisconsin-Madison — and realized that not once had anyone thought to test my vitamin D.

I have literally had more than 35 blood tests, a handful of urine tests, and a more imaging than is probably healthy, but none of them were for vitamin D!

It turns out vitamin D is pretty important though, and has been shown to have direct links to chronic pain. It’s also not actually a vitamin, so much as a hormone. There’s all sorts of research on how low vitamin D can cause chronic pain, even specifically rib pain, which is what I have.

A recent study in The Pain Physician journal shows that, "Vitamin D, a hormone precursor essential for maintaining homeostasis of the musculoskeletal system, has long been proposed as an associated factor in CWP (chronic widespread pain). The most severe type of hypovitaminosis D, osteomalacia, features generalized body pain, especially in the shoulder, rib cage, and lumbar and pelvic regions."

And another study from the American Academy of of Pain Medicine showed that, “The prevalence and clinical correlates identified in this pilot study provide the basis for the assertion that vitamin D inadequacy may represent an under-recognized source of nociception and impaired neuromuscular functioning among patients with chronic pain.”

In other words, if low levels aren’t the cause, not having enough vitamin D can make chronic pain more severe. And, low Vitamin D can also make pain medications less effective.

According to an article on the Mayo Clinic website, “patients who required narcotic pain medication, and who also had inadequate levels of vitamin D, were taking much higher doses of pain medication — nearly twice as much — as those who had adequate levels.”

So I was cautiously optimistic that getting my vitamin D levels back up could at the very least make my pain medications more effective.

But for the first few months, I didn’t really feel much different. I only told a few people about the vitamin D because constantly talking about possible cures is exhausting — everyone wants it to work so much, and then when it doesn’t you feel like you have personally failed at something.

So I only told my mom, my boyfriend at the time, and my best friend. My then-boyfriend was hoping for a miracle by day two. But alas, nothing. My best friend was hoping for a miracle by month two. But alas, nothing. And my mom, who I live with, wasn’t really putting her hope in it all. She had seen too many things not work.

But then, in July, I started noticing things. Like little things. Like I could go for a walk and not die afterward. And then, in August, I cleaned the freaking bathroom! Seriously, I did the floors, washed the mirrors and scrubbed the tub, all without ending up in the hospital!! And by September, I was even able to make the four-hour round trip trek to work without having to spend the entire next day recovering.

Slowly, but surely, I have started feeling better. I mean, I’m not cured. And I’m not holding my breath that I ever will be. I’m also completely aware of the fact that I could backslide at any moment.

And, I still take morphine on a daily basis, for now anyway. But I have literally gone off almost all my other meds, including the sleeping pill amitriptyline and the nerve pain medication Cymbalta. As for the hydrocodone, I’m down to like one or two pills a week at the most. And sometimes, I can go the whole week without taking any at all — which is pretty much a miracle of God if there ever was one.

There’s also been some weight loss. I honestly never went back to the weight loss clinic because they wanted to put me on a weight loss drug, and over the last couple years I’ve come to a place where I just don’t want to be on any drugs unless I have to.

Even so though, feeling better has meant that I’ve been able to walk three to five miles about six days a week all summer, and I’m excited to report that since May I’ve lost 30 pounds! WHAT?

I had a visit with my amazing doctor last week, and we talked about whether or not the vitamin D deserved any credit for my newfound ability to shower almost every single day.

When I showed him that I had a whole bottle of hydrocodone left over — I honestly used to run out of the drug a week early each month — he literally said, “Congratulations!”

He tested my vitamin D, and I’m happy to report that I’m now at 35 ng/mL — a much healthier level than six. As my doctor remarked on the top of the lab results, “Your vitamin D level looks good. You can safely keep taking your current dose of vitamin D supplements.”

When we talked about it during the appointment, he told me that the vitamin D could be part of why I’m feeling better, or it could be that the nerve that they think was causing the pain had shifted somehow. Or it could be something else all together. Maybe it’s the placebo effect, or maybe it’s all those Taco Bell Cheesy Gordita Crunches I eat every other day that have something magical in them.

So yeah, I don’t know if the vitamin D is the reason I’m feeling better or how long-term this could be, but honestly, I don’t care. I’m just happy that I can clean the bathroom again.

Crystal Lindell is a journalist who lives in Illinois. She loves Taco Bell, watching "Burn Notice" episodes on Netflix and Snicker's Bites. She has had intercostal neuralgia since February 2013.

Crystal writes about it on her blog, “The Only Certainty is Bad Grammar.”

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.