MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

naturopathy

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Konjac glucomannan (KGM), also just called ‘glucomannan’, is a dietary fiber hydro colloidal polysaccharide isolated from the tubers of Amorphophallus konjac. It is used as a food, a food additive, as well as a dietary supplement in many countries. KGM is claimed to reduce the levels of glucose, cholesterol, triglycerides, and blood pressure.

The objective of this study was to evaluate the effect of the consumption of gummy candy enriched with KGM on appetite and to evaluate anthropometric data, biochemical, and oxidative stress markers in overweight individuals. Forty-two participants aged 18 to 45 years completed this randomized, double-blind, placebo-controlled clinical trial. Participants were randomly assigned to consume for 14 days, 2 candies per day, containing 250 mg of KGM or identical-looking placebo candy with 250 mg of flaxseed meal, shortly after breakfast and dinner. As a result, we observed that there was a reduction in waist circumference and in the intensity of hunger of the participants who consumed KGM. The authors believe that a longer consumption time as well as an increased dose of KGM would contribute to even more satisfactory body results.

These findings seem promising, yet somehow I am not convinced. The study was small and short-term; moreover, the authors seem uncritical and, instead of a conclusion, they offer speculations.

Our own review of 2014 included 9 clinical studies. There was a variation in the reporting quality of the included RCTs. A meta-analysis (random effect model) of 8 RCTs revealed no significant difference in weight loss between glucomannan and placebo (mean difference [MD]: -0.22 kg; 95% confidence interval [CI], -0.62, 0.19; I(2) = 65%). Adverse events included abdominal discomfort, diarrhea, and constipation. We concluded that the evidence from available RCTs does not show that glucomannan intake generates statistically significant weight loss. Future trials should be more rigorous and better reported.

Rigorous trials are required to change my mind, and I am not sure that the new study falls into this category.

The concept of ultra-processed food (UPF) was initially developed and the term coined by the Brazilian nutrition researcher Carlos Monteiro, with his team at the Center for Epidemiological Research in Nutrition and Health (NUPENS) at the University of São Paulo, Brazil. They argue that “the issue is not food, nor nutrients, so much as processing,” and “from the point of view of human health, at present, the most salient division of food and drinks is in terms of their type, degree, and purpose of processing.”

Examples of UPF include:

Ultra-processed food is bad for our health! This message is clear and has been voiced so many times – not least by proponents of so-called alternative medicine (SCAM) – that most people should now understand it.

But how bad?

And what diseases does UPF promote?

How strong is the evidence?

I did a quick Medline search and was overwhelmed by the amount of research on this subject. In 2022 alone, there were more than 2000 publications! Here are the conclusions from just a few recent studies on the subject:

Don’t get me wrong: this is not a systematic review of the subject. I am merely trying to give a rough impression of the research that is emerging. A few thoughts seem nonetheless appropriate.

  1. The research on this subject is intense.
  2. Even though most studies disclose associations and not causal links, there is in my view no question that UPF aggravates many diseases.
  3. The findings of the current research are highly consistent and point to harm done to most organs.
  4. Even though this is a subject on which advocates of SCAM are exceedingly keen, none of the research I saw was conducted by SCAM researchers.
  5. The view of many SCAM proponents that conventional medicine does not care about nutrition is clearly not correct.
  6. Considering how unhealthy UPF is, there seems to be a lack of effective education and action aimed at preventing the harm UPF does to us.

Drip IV is “Australia’s first and leading mobile healthcare company specialising in assisting with nutritional deficiencies”. They claim to provide a mobile IV service that is prescribed and tailored individually to your nutritional needs. Treatment plans and customised infusions are determined by a medical team to suit individual requirements. They deliver vitamins, minerals and amino acids directly to the body via the bloodstream, a method they state allows for optimal bioavailability.

These claims are a little puzzling to me, not least because vitamins, minerals and amino acids tailored individually to the nutritional needs of the vast majority of people would mean administering nothing at all. But I guess that virtually every person who consults the service will get an infusion [and pay dearly for it].

The Australian Therapeutic Goods Administration (TGA) seems to have a similarly dim view on Drip IV. The TGA has just issued 20 infringement notices totalling $159,840 to the company and to one of its executive officers. The reason: unlawful advertising of intravenous infusion products to Australian consumers on a company website and social media. Ten notices totalling $133,200 were issued to the company and ten notices totalling $26,640 were issued to an executive officer. The TGA considers the intravenous infusion products to be therapeutic goods because of the claims made about them, and the advertising to be unlawful because the advertisements allegedly:

  • contained prohibited representations, such as claims regarding cancer.
  • contained restricted representations such as that the products would alleviate fatigue caused by COVID-19, assist in the treatment of Graves’ Disease and Alzheimer’s Disease, and support the treatment of autoimmune diseases such as Multiple Sclerosis. No TGA approval had been given to make such claims.
  • referred to ingredients that are prescription only, such as glutathione. Prescription medicines cannot be advertised directly to the public in Australia.
  • contained a statement or picture suggesting or implying the products were ‘TGA Approved’. Advertising of therapeutic goods cannot include a government endorsement.
  • contained a statement or picture expressing that the goods were ‘miraculous’.

Vitamin infusions have become very popular around the globe. There are now thousands of clinics offering this service, and many of them advertise aggressively with claims that are questionable. Here is just one example from the UK:

Modern life is hectic. If you are looking to boost your wellbeing, increase your energy levels, lift your mood and hydrate your body, Vitamin IV Infusions are ideal. Favoured by celebrities such as Madonna, Simon Cowell and Rihanna, Vitamin IV Infusions are an easy, effective way of delivering vitamins, minerals and amino acids directly into your bloodstream via an IV (intravenous) drip. Vitamins are essential for normal growth and staying healthy – but our bodies can’t produce all of the nutrients we need to function and thrive. That’s why more than one in three people take daily vitamin supplements – often without realising that only 15% of the active nutrients consumed orally actually find their way into their bloodstream. With Vitamin IV Infusions, the nutrients enter your bloodstream directly and immediately, and are delivered straight to your cells. We offer four different Vitamin IV Infusions, so you can choose the best combination for your personal needs, while boosting your general health, energy and wellbeing.

My advice to consumers is a little different and considerably less costly:

  1. to ensure you get enough vitamins, minerals, and amino acids, eat a balanced diet;
  2. to boost your well-being, sit down and calculate the savings you made by NOT using such a service;
  3. to increase your energy levels, take a nap;
  4. to lift your mood, recount the money you saved and think of what nice things you might buy with it;
  5. to hydrate your body drink a glass of water.

Perhaps it is time the authorities in all countries had a look at what these clinics are offering and what health claims they are making. Perhaps it is time they act as the TGA just did.

 

The UK medical doctor, Sarah Myhill, has a website where she tells us:

Everyone should follow the general approach to maintaining and restoring good health, which involves eating a paleo ketogenic diet, taking a basic package of nutritional supplements, ensuring a good night’s sleep on a regular basis and getting the right balance between work, exercise and rest. Because we live in an increasingly polluted world, we should probably all be doing some sort of detox regime.

She also happens to sell dietary supplements of all kinds which must surely be handy for all who want to follow her advice. Dr. Myhill boosted her income even further by putting false claims about Covid-19 treatments online. And that got her banned from practicing for nine months after a medical tribunal.

She posted videos and articles advocating taking vitamins and other substances in high doses, without evidence they worked. The General Medical Council (GMC) found her recommendations “undermined public health” and found some of her recommendations had the potential to cause “serious harm” and “potentially fatal toxicity”. The tribunal was told she uploaded a series of videos and articles between March and May 2020, describing substances as “safe nutritional interventions” which she said meant vaccinations were “rendered irrelevant”. But the substances she promoted were not universally safe and have potentially serious health risks associated with them, the panel was told. The tribunal found Dr. Myhill “does not practice evidence-based medicine and may encourage false reassurance in her patients who may believe that they will not catch Covid-19 or other infections if they follow her advice”.

Dr. Myhill previously had a year-long ban lifted after a General Medical Council investigation into her claims of being a “pioneer” in the treatment of chronic fatigue syndrome. In fact, the hearing was told there had been 30 previous GMC investigations into Dr. Myhill, but none had resulted in findings of misconduct.

Dr. Myhill is also a vocal critic of the PACE trial and biopsychosocial model of ME/CFS. Dr. Myhill’s GMC complaint regarding a number of PACE trial authors was first rejected without investigation by the GMC, after Dr. Myhill appealed the GMC stated they would reconsider. Dr. Myhill’s action against the GMC for failing to provide reasoning for not investigating the PACE trial authors is still continuing and began a number of months before the most recent GMC instigation of her practice started.

The recent tribunal concluded: “Given the circumstances of this case, it is necessary to protect members of the public and in the public interest to make an order suspending Dr. Myhill’s registration with immediate effect, to uphold and maintain professional standards and maintain public confidence in the profession.”

The impact of drug-induced liver injury (DILI) on patients with chronic liver disease (CLD) is unclear. There are few reports comparing DILI in CLD and non-CLD patients. In this study, the researchers aimed to determine the incidence and outcomes of DILI in patients with and without CLD.

They collected data on eligible individuals with suspected DILI between 2018 and 2020 who were evaluated systematically for other etiologies, causes, and the severity of DILI. They compared the causative agents, clinical features, and outcomes of DILI among subjects with and without CLD who were enrolled in the Thai Association for the Study of the Liver DILI registry. Subjects with definite, or highly likely DILI were included in the analysis.

The researchers evaluated the causal relationship between the clinical pattern of liver injury and the suspected drugs or SCAM products with the Roussel Uclaf Causality Assessment Method (RUCAM) system. RUCAM is a validated and established tool to quantitatively assess causality in cases of suspected DILI and/or SCAM product-induced liver injury. They also used the Clinical Assessment of Causality Scale to assess the association as definite (>95% likelihood), highly likely (75–95%), probable (50–74%), possible (25–49%) or unlikely (<25%).

A total of 200 subjects diagnosed with DILI were found in the registry. Of those, 41 had CLD and 159 had no evidence of CLD. So-called alternative medicine (SCAM) products were identified as the most common class of DILI agents. Approximately 59% of DILI in the CLD and 40% in non-CLD group were associated with SCAM use. Individuals with pre-existing CLD had similar severity including mortality. Twelve patients (6%) developed adverse outcomes related to DILI including seven (3.5%) deaths and five (2.5%) with liver failure. Mortality was 4.88% in CLD and 3.14% in non-CLD subjects over median periods of 58 (8-106) days and 22 (1-65) days, respectively.

The authors concluded that, in this liver disease registry, the causes, clinical presentation, and outcomes of DILI in subjects with CLD and without CLD patients were not different. Further study is required to confirm our findings.

Consumers often prefer SCAM to conventional medicine because SCAM is viewed as gentle and safe. The notions are that they

  • are natural and therefore harmless;
  • have been in use for ages and thus have stood the test of time.

Readers of this blog will appreciate that both notions are, in fact, fallacies:

  • appeal to nature;
  • appeal to tradition.

This new paper is an impressive reminder that SCAM’s reputation as a safe option is not justified, and that SCAM relies more on fallacies than on facts.

The American Heart Association has issued a statement outlining research on so-called alternative medicine (SCAM) for heart failure. They found some SCAMs that work, some that don’t work, and some that are harmful.

Alternative therapies that may benefit people with heart failure include:

  • Omega-3 polyunsaturated fatty acids (PUFA, fish oil) have the strongest evidence among complementary and alternative agents for clinical benefit in people with heart failure and may be used safely, in moderation, in consultation with their health care team. Omega-3 PUFA is associated with a lower risk of developing heart failure and, for those who already have heart failure, improvements in the heart’s pumping ability. There appears to be a dose-related increase in atrial fibrillation (an irregular heart rhythm), so doses of 4 grams or more should be avoided.
  • Yoga and Tai Chi, in addition to standard treatment, may help improve exercise tolerance and quality of life and decrease blood pressure.

Meanwhile, some therapies were found to have harmful effects, such as interactions with common heart failure medications and changes in heart contraction, blood pressure, electrolytes and fluid levels:

  • While low blood levels of vitamin D are associated with worse heart failure outcomes, supplementation hasn’t shown benefit and may be harmful when taken with heart failure medications such as digoxin, calcium channel blockers and diuretics.
  • The herbal supplement blue cohosh, from the root of a flowering plant found in hardwood forests, might cause a fast heart rate called tachycardia, high blood pressure, chest pain and may increase blood glucose. It may also decrease the effect of medications taken to treat high blood pressure and Type 2 diabetes.
  • Lily of the valley, the root, stems and flower of which are used in supplements, has long been used in mild heart failure because it contains active chemicals similar to, but less potent than, the heart failure medicine digoxin. It may be harmful when taken with digoxin by causing very low potassium levels, a condition known as hypokalemia. Lily of the valley also may cause irregular heartbeat, confusion and tiredness.

Other therapies have been shown as ineffective based on current data, or have mixed findings, highlighting the importance of patients having a discussion with a health care professional about any non-prescribed treatments:

  • Routine thiamine supplementation isn’t shown to be effective for heart failure treatment unless someone has this specific nutrient deficiency.
  • Research on alcohol varies, with some data showing that drinking low-to-moderate amounts (1 to 2 drinks per day) is associated with preventing heart failure, while habitual drinking or intake of higher amounts is toxic to the heart muscle and known to contribute to heart failure.
  • There are mixed findings about vitamin E. It may have some benefit in reducing the risk of heart failure with preserved ejection fraction, a type of heart failure in which the left ventricle is unable to properly fill with blood between heartbeats. However, it has also been associated with an increased risk of hospitalization in people with heart failure.
  • Co-Q10, or coenzyme Q10, is an antioxidant found in small amounts in organ meats, oily fish and soybean oil, and commonly taken as a dietary supplement. Small studies show it may help improve heart failure class, symptoms and quality of life, however, it may interact with blood pressure lowering and anti-clotting medicines. Larger trials are needed to better understand its effects.
  • Hawthorn, a flowering shrub, has been shown in some studies to increase exercise tolerance and improve heart failure symptoms such as fatigue. Yet it also has the potential to worsen heart failure, and there is conflicting research about whether it interacts with digoxin.

“Overall, more quality research and well-powered randomized controlled trials are needed to better understand the risks and benefits of complementary and alternative medicine therapies for people with heart failure,” said Chow. “This scientific statement provides critical information to health care professionals who treat people with heart failure and may be used as a resource for consumers about the potential benefit and harm associated with complementary and alternative medicine products.”

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No doubt, this assessment is a laudable attempt to inform patients responsibly. Personally, I am always a bit skeptical about such broad statements. SCAM encompasses some 400 different therapies, and I doubt that these can all be assessed in one single overview.

It is not difficult to find SCAMs that seem to have not been considered. Take this systematic review, for instance. It included 24 RCTs (n = 1314 participants) of 9 different mind-body interventions (MBI) types: Tai Chi (n = 7), yoga (n = 4), relaxation (n = 4), meditation (n = 2), acupuncture (n = 2), biofeedback (n = 2), stress management (n = 1), Pilates (n = 1), and reflexology (n = 1). Most (n = 22, 95.8%) reported small-to-moderate improvements in quality of life (14/14 studies), exercise capacity (8/9 studies), depression (5/5 studies), anxiety and fatigue (4/4 studies), blood pressure (3/5 studies), heart rate (5/6 studies), heart rate variability (7/9 studies), and B-type natriuretic peptide (3/4 studies). Studies ranged from 4 minutes to 26 weeks and group sizes ranged from 8 to 65 patients per study arm.

The authors concluded that, although wide variability exists in the types and delivery, RCTs of MBIs have demonstrated small-to-moderate positive effects on HF patients’ objective and subjective outcomes. Future research should examine the mechanisms by which different MBIs exert their effects.

Or take this systematic review of 38 RCTs of oral TCM remedies. The majority of the included trials were assessed to be of high clinical heterogeneity and poor methodological quality. The main results of the meta-analysis showed improvement in total MLHFQ score when oral Chinese herbal medicine plus conventional medical treatment (CMT) compared with CMT with or without placebo [MD = -5.71 (-7.07, -4.36), p < 0.01].

The authors concluded that there is some encouraging evidence of oral Chinese herbal medicine combined with CMT for the improvement of QoL in CHF patients. However, the evidence remains weak due to the small sample size, high clinical heterogeneity, and poor methodological quality of the included trials. Further, large sample size and well-designed trials are needed.

Don’t get me wrong: I am not saying that TCM remedies are a viable option – in fact, I very much doubt it – but I am saying that attempts to provide comprehensive overviews of all SCAMs are problematic, and that incomplete overviews are just that: incomplete.

Onion water seems to be all the rage these days. Advocates claim that it is a natural cold and flu remedy that can help the body heal faster and kick symptoms like coughing and congestion. And many consumers who feel threatened by flu, COVID, and various respiratory infections believe them.

But what on earth is onion water? It is precisely what it sounds like: onion immersed in water. Preparation starts with cutting up raw red or yellow onions, placing them into a bowl, and adding water. The fresh onion and water mixture should then soak for about 12 hours. After that, the onion water is ready for consumption.

Besides being a recipe for bad breath, can onion water actually relieve any symptoms, or help the body heal from infections?

A review of the evidence concluded that “effect of onion and its constituents on oxidative stress, inflammatory and immune system were shown indicating their therapeutic value in treatment of various diseases associated with oxidative stress, inflammation, and immune-dysregulation.”

This may sound encouraging but the review was based mostly on pre-clinical evidence, and the question, therefore, remains: are there any good trial data?

Another recent review included clinical trials (where available) and concluded that “possible bronchodilatory and preventive effects of onion and Qt on asthma and other obstructive respiratory diseases. The effects of the plant and its constituents on lung cancer, lung infections, and allergic disorders were also reported both in experimental and clinical studies. However, before preparing drugs based on A. cepa and its constituents for clinical practice, further standard clinical trials are needed to be performed.”

In other words, compelling trial evidence that preparations from onion are effective against viral infections does not exist.

And what about homeopathy?

Homeopaths frequently use potentised onion as a remedy for conditions that cause eyes to water (because ‘like cures like’). Is there any sound evidence that homeopathic onion remedies are better than a placebo? You probably guessed: the answer is NO!

So, no good evidence for onion, potentised onion, onion water, or any other preparations of onion. My advice, therefore, is to continue using your onions in the kitchen rather than in the medicine cabinet.

It has been reported that a naturopath from the US who sold fake COVID-19 immunization treatments and fraudulent vaccination cards during the height of the coronavirus pandemic has been sentenced to nearly three years in prison. Juli A. Mazi pleaded guilty last April in federal court in San Francisco to one count of wire fraud and one count of false statements related to health care matters. Now District Judge Charles R. Breyer handed down a sentence of 33 months, according to Joshua Stueve, a spokesperson for the U.S. Department of Justice. Mazi, of Napa, was ordered to surrender to the Bureau of Prisons on or before January 6, 2023.

The case is the first federal criminal fraud prosecution related to fraudulent Centers for Disease Control and Prevention vaccination cards for COVID-19, according to the U.S. Department of Justice. In August, Breyer denied Mazi’s motion to withdraw her plea agreement after she challenged the very laws that led to her prosecution. Mazi, who fired her attorneys and ended up representing herself, last week filed a letter with the court claiming sovereign immunity. Mazi said that as a Native American she is “immune to legal action.”

She provided fake CDC vaccination cards for COVID-19 to at least 200 people with instructions on how to complete the cards to make them look like they had received a Moderna vaccine, federal prosecutors said. She also sold homeopathic pellets she fraudulently claimed would provide “lifelong immunity to COVID-19.” She told customers that the pellets contained small amounts of the virus and would create an antibody response. Mazi also offered the pellets in place of childhood vaccinations required for attendance at school and sold at least 100 fake immunization cards that said the children had been vaccinated, knowing the documents would be submitted to schools, officials said. Federal officials opened an investigation against Mazi after receiving a complaint in April 2021 to the Department of Health and Human Services Office of Inspector General hotline.

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On her website, Mazi states this about herself:

Juli Mazi received her doctorate in Naturopathic Medicine from the National University of Natural Medicine in Portland, Oregon where she trained in the traditional medical sciences as well as ancient and modern modalities that rely on the restorative power of Nature to heal. Juli Mazi radiates the vibrant health she is committed to helping her patients achieve. Juli’s positive outlook inspires confidence; her deep well of calm puts people at immediate ease. The second thing they notice is that truly she listens. Dr. Mazi’s very presence is healing.

On this site, she also advocates all sorts of treatments and ideas which I would call more than a little strange, for instance, coffee enemas:

Using a coffee enema is a time-tested remedy for detoxification, but it is not without risks. If you are not careful, the process can cause internal burns. In addition, improperly brewed coffee can lead to electrolyte imbalances and dehydration, and coffee enemas are not recommended for pregnant women or young children.

To make coffee enemas safe and effective, always choose quality organic coffee. A coffee enema should be free of toxins and pesticides. Use a reusable enema kit with stainless steel or silicone hosing for safety. Moreover, do not use a soft plastic or latex enema bags. It is also essential to limit the length of time that the coffee spends in the container.

A coffee enema should be held for 12 to 15 minutes and then released in the toilet. You may repeat the process as necessary. Usually, the procedure should be done once or twice a day. However, if you are experiencing acute toxicity, you can use a coffee enema as often as needed. Make sure you have had a bowel movement before making the coffee enema. Otherwise, the process may be hindered.

Perhaps the most interesting thing on her website is her advertisement of the fact that her peers not just tolerate such eccentricities but gave Mazi an award for ‘BEST ALTERNATIVE HEALTH & BEST GENERAL PRACTITIONER’.

To me, this suggests that US ‘doctors of naturopathy’ and their professional organizations live on a different planet, a planet where evidence counts for nothing and dangerously misleading patients seems to be the norm.

It has been reported that a Vancouver naturopath has been fined and temporarily suspended after a patient complained he failed to notice a rectal tumor during four months of treatment for hemorrhoids.

Jordan Atkinson will have to pay $5,000 and lose his license for 16 days after signing a consent agreement with the College of Naturopathic Physicians of B.C., according to a public notice posted by the COLLEGE OF NATUROPATHIC PHYSICIANS OF BRITISH COLUMBIA.

A former patient had filed the complaint when another medical professional diagnosed a tumor on the rectum following “several appointments” with Atkinson for hemorrhoid treatment. “The patient complained that Dr. Atkinson failed to detect the tumor because he did not perform a competent examination,” the college notice says.  ‘Doctor’ Atkinson disagreed with that allegation but admitted that he didn’t fully document his appointments with the patient.

The college’s inquiry committee, which investigates complaints, found that “Dr. Atkinson’s treatment of the patient fell short of the standard of practice required of a naturopathic doctor in these circumstances.”  Atkinson who is also the subject of a lawsuit from a patient who alleges he seriously injured her while injecting Botox into her face at the base of her nose, has also agreed to a reprimand and “to make reasonable efforts when a language barrier exists to ensure that his patients understand the treatment plan and provide informed consent.” 

Personally, I find it hard to believe that any health professional can administer a prolonged treatment for hemorrhoids, while the patient is actually suffering from a rectal tumor which might well be malign. I find it even harder to believe that, after a complaint had been filed by a victim, the professional body of this professional suspends his license for just 16 days.

In my view, this suggests that this professional body (like so many in the realm of so-called alternative medicine (SCAM)) is not fit for purpose. That is to say, it does clearly not fulfill its main task adequately which is to protect the public from the malpractice of its members. Rather it seems to prioritize the interests of the member over those of the public. Yet, on its website the COLLEGE OF NATUROPATHIC PHYSICIANS OF BRITISH COLUMBIA state that “the College protects the public interest by ensuring that naturopathic physicians in British Columbia practice safely, ethically, and competently.” As so often in SCAM, what is being stated and what is being done differs dramatically.

At the heart of this and many similar cases, I fear, is that consumers find it difficult to differentiate between well-educated healthcare professionals and poorly trained charlatans. And who could blame them? Calling naturopaths ‘doctors’ cannot be helpful, particularly if the ‘Dr.-title’ is used without a clear qualification that the person who carries it has never seen the inside of a medical school; instead he has learned an abundance of nonsense taught by a quack institution.

In summary one is tempted to conclude that this case yet again confirms that naturopaths are medically incompetent graduates of schools of incompetence protected by organizations of incompetence.

The U.S. Food and Drug Administration issued warning letters to seven companies for illegally selling dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease or related conditions, such as atherosclerosis, stroke or heart failure, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA is urging consumers not to use these or similar products because they have not been evaluated by the FDA to be safe or effective for their intended use and may be harmful.

The warning letters were issued to:

“Given that cardiovascular disease is the leading cause of death in the U.S., it’s important that the FDA protect the public from products and companies that make unlawful claims to treat it. Dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease and related conditions could potentially harm consumers who use these products instead of seeking safe and effective FDA-approved treatments from qualified health care providers,” said Cara Welch, Ph.D., director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition. “We encourage consumers to remain vigilant when shopping online or in stores to avoid purchasing products that could put their health at risk.”

Under the FD&C Act, products intended to diagnose, cure, treat, mitigate or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements. Unlike drugs approved by the FDA, the agency has not evaluated whether the unapproved products subject to the warning letters announced today are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns.

The FDA advises consumers to talk to their doctor, pharmacist or other health care provider before deciding to purchase or use any dietary supplement or drug. Some supplements might interact with medicines or other supplements. Health care providers will work with patients to determine which treatment is the best option for their condition.

If a consumer thinks that a product might have caused a reaction or an illness, they should immediately stop using the product and contact their health care provider. The FDA encourages health care providers and consumers to report any adverse reactions associated with FDA-regulated products to the agency using MedWatch or the Safety Reporting Portal.

The FDA has requested responses from the companies within 15 working days stating how they will address the issues described in the warning letters or provide their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to correct violations promptly may result in legal action, including product seizure and/or injunction.

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