On April 17th, 2018 the FDA sent a warning letter to BioStar Technology International for making claims about products they were selling that would establish them as drugs under the Federal Food, Drug, and Cosmetic Act. I want to focus on one dietary supplement mentioned in the letter, Myomin. Chi’s Enterprise, the manufacturer of Myomin, says Myomin is taken to “help maintain healthy chi levels”. But BioStar Technology was warned for claiming Myomin could treat breast cancer and diabetes. This wasn’t the first time the FDA had warned a company for making absurd claims about Myomin. In 2016, the FDA sent a warning letter to Aurora Health for claiming Myomin was effective at reducing estrogen levels, and as a result would prevent prostate enlargement, blood clots, pulmonary embolisms, stroke, heart disease, and prostate cancer in men. In 2002, the ‘Herbal Healing Academy’ was warned for claiming Myomin could treat fibroid tumors, endometriosis, and cysts. It’s really anyone’s guess what Myomin is supposed to be used for; unless you look at the ingredients in Myomin.
Astragalus membranaceus, Curcuma zedoaria, and Cyperus rotundus are the three ingredients in Myomin. Dr. Axe, a popular online
nonsense peddling Dr. Mike wannabe chiropractor, claims that “Astragalus has proven benefits such as slowing or preventing the growth of tumors, protecting the cardiovascular system, and boosting the immune system”. The NIH says on their website that no high-quality studies have found Astragalus treats any medical condition. There have been trials looking at Astragalus as a treatment for diabetic nephropathy, nephrotic syndrome, viral myocarditis, fatty liver disease, and advanced lung cancer; all of which were very low-quality, found no benefit, or both. Of the 21 participants treated with Astragalus in the advanced lung cancer trial, 12 were removed from the study due to disease progression and 9 patients withdrew. The viral myocarditis study found that Astragalus “may have a positive effect on heart function”, but “the evidence from these trials is inconclusive because they were poorly designed and of low-quality and there was no certainty that all the participants were correctly diagnosed with myocarditis”.
Curcuma zedoaria is commonly known as white turmeric. turmericforhealth.com claims it’s demonstrated anti-microbial, anti-cancer, antioxidant, anti-allergic, anti-cancer, liver healing, and painkiller properties. I’m unable to find any evidence to support the use of white turmeric in humans to treat any disease despite various health websites’ claims. The NCCIH states that the supposed anti-inflammatory properties of Turmeric “are not supported by strong studies”. The Natural Medicines Comprehensive Database reports that white turmeric is likely unsafe during pregnancy, and may cause abortions.
The last ingredient in Myomin, Cyperus rotundus, sounds like something out of Harry Potter, and its proposed health benefits are a work of fiction too. It’s commonly referred to as nutgrass, and its peddled to treat a laundry list of health conditions such as dementia, hypertension, coughs, respiratory problems, candida infections, weight loss, high cholesterol, high blood sugar in diabetics, nausea and vomiting. I can’t find any studies looking at the health benefits of this supplement in humans. Despite the lack of evidence to support using it for any medical reason, you can still find six pages of Cyperus rotundus supplements on Amazon.
There’s no evidence to suggest any of the ingredients would provide the benefits that the sellers claimed. However, there is evidence the ingredients in Myomin can interfere with medications or worsen existing health conditions. Astragalus for example, can cause problems for people with diabetes, hypertension or blood disorders. It would be easier for physicians to take the effects of Myomin into account if the amount of each ingredient in one pill was on the label. But Chi’s Enterprise may not know how much of each ingredient is in a single Myomin pill either. Chi’s Enterprise received a warning letter from the FDA on April 30th, 2018 following an inspection of their production facilities. The FDA collected records for Myomin 500mg capsules, and found that Chi Enterprises didn’t provide component specifications for the ingredients in Myomin such as the ingredients’ purity, strength, or composition. They also didn’t have specifications for dietary supplement labels, nor specifications to ensure the product they received from their contract manufacturer was what they actually ordered.
Despite the shady marketing and negligent manufacturing practices, Myomin is still on the market. The supplement industry has always enjoyed this kind of regulatory leniency. Supplement companies do not have to get approval or notify the FDA before bringing a supplement to market. They don’t even have to prove their products are safe. Companies aren’t allowed to claim their supplement is a treatment or cure for any disease, but the internet has them covered. You can easily find blogs and YouTube videos making the exact same claims about Myomin that companies have been warned by the FDA for making. The barrier to entry to become an online health blogger is non-existent, anyone with two brain cells to rub together can start a YouTube Channel or build a blog with WordPress or Jekyll. Anyone can purchase a supplement from Amazon and turn on their webcam to say it cured their chronic health condition. This sort of thing just isn’t possible with prescription medications. I can’t just walk into a pharmacy and purchase every ADHD medication and start my health blogging career as a connoisseur of prescription speed. No doctor is going to write me a prescription for every medication that could be used to treat a disorder I have. Imagine how strange it would be if we had prescription medication reviewers on YouTube. How is having online dietary supplement reviewers any less weird?
There’s no reason for supplements to be regulated this leniently when there are serious risks involved. Supplements can be as dangerous as regular medications, an estimated 23,000 ER visits each year are for adverse events caused by dietary supplements. You can argue that prescription medications cause more ER visits, and you would be right. But prescription medications serve a legitimate medical purpose, supplements don’t in most cases. Research has consistently shown that there is no significant benefit in taking vitamins, it would not be the downfall of public health to regulate the supplement industry more sensibly. I don’t think it would be unreasonable to require supplement manufacturers to prove the claims on a supplement label are truthful and accurate before selling them. It wouldn’t be unreasonable to expect supplement companies to show their production facilities meet the FDA’s Current Good Manufacturing Practices (CGMP’s) guidelines before producing and selling supplements. The supplement industry is continuing to grow, and supplements being created and marketed like Myomin are becoming more and more common. Maybe it’s time for some ground rules?