Nutrafol is Linked with Liver Injury

Just one more reason not to take it...

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I get asked a lot about supplements that claim to promote hair growth. If your Instagram is anything like mine, you probably also get fed a lot of advertisements and posts from brand partners promoting these products.

Many people take supplements to promote hair growth, even knowing the data is generally weak because they figure the product is likely safe and will cover all their bases. It’s a bit of a “What’s the harm?” approach. But as I’ve written before, supplements are a rising cause of liver failure. As supplements aren’t studied rigorously, we can’t explain risks as we can with pharmaceuticals; instead, researchers have to cobble together data from other sources. For example, looking at people who needed a liver transplant, between 1995 and 2003, supplements were the cause of 2.5% of non-acetaminophen-related liver failure, and between 2013 and 2020, that number jumped to 24.1%. That’s quite a dramatic leap.

I’ve been meaning to write about Nutrafol for a while, which is a “hair growth nutraceutical.” As a report was recently published linking Nutrafol with a severe case of drug-related liver injury, it seems like now is a good time to take a closer look.

The case was written up in the American Journal of Gastroenterology and details a 26-year-old woman who presented with jaundice, a yellowing of the skin, and the whites of the eyes that can be a sign of liver disease. Her blood tests indicated liver injury, and a thorough exam, blood work, and imaging studies ruled out medical conditions and viral infections as the cause. She reported drinking mullerian leaf tea, and her dermatologist had recommended Nutrafol, which she had been taking for five months. Based on the timeline and the test results, her medical team felt that Nutrafol was the most likely cause of her liver failure. She stopped it and fortunately recovered.

Let’s break it down.

What exactly is a nutraceutical? I love this description from Wikipedia:

Nutraceutical is a marketing term used to imply a pharmaceutical effect from a compound or food product that has not been scientifically confirmed or approved to have clinical benefits. In the United States, nutraceuticals are considered and regulated as a subset of foods (such as dietary supplements) by the Food and Drug Administration (FDA).

There are no internationally defined properties of nutraceuticals. Due to the vague, undiscriminating evidence for the biological effects of nutraceutical products, experts have proposed abandoning the term.

We have a case report of liver injury almost certainly due to Nutrafol, but is that single case a cause for concern? As we don't have any actual safety data, it’s impossible to put this case into perspective. Is it a one-in-a-million risk or one-in-a-thousand? Was this patient uniquely vulnerable, or is everyone at the same risk?

Despite not having quality studies for Nutrafol, I believe there are enough red flags to be concerned. Before we begin, it’s worth mentioning that Nutrafol has a whopping 23 ingredients (if I counted correctly, the font is small), so it’s possible that the ingredients are not toxic individually but may be in combination. Who knows? That’s the problem when there is a mega data void. Imagine if a pharmaceutical company created a medication with 23 active ingredients and pushed it out into the world without safety data. There would be an uproar! But of course, that’s not allowed because, unlike supplements, pharmaceuticals actually have to show data about safety and efficacy.

The case report discusses the ingredients in Nutrafol and their association with liver injury. The most likely culprits (but again, it could be a combination of ingredients) are:

• Turmeric, as turmeric-induced liver injury is well-reported (which I've previously written about here)

• Ashwagandha and horsetail, and while there is less evidence linking these two with liver injury, the consensus is that they are “probably linked” with liver injury

• Saw palmetto is another potentially concerning ingredient, and while even less is known about the risk, it is a possibility.

  

  Nutrafol label

Other potential safety concerns about Nutrafol that were not mentioned in the case report include:

• Two proprietary blends. The liver-injuring substances mentioned above are in these blends, meaning the actual amounts are unknown. It would be a good idea to know precisely how much potentially harmful substance is in a product, but you can’t say with proprietary blends as they are secret recipes. Proprietary blends are often linked with reports of liver injury. This should be a big, bright red warning flag about Nutrafol.

• Excessive amounts of vitamin A (as beta-carotene). Vitamin A supplements, including beta-carotene, are associated with increased mortality. As vitamin A deficiency is rare, there is no need for a vitamin A supplement.

• High levels of selenium, which is unnecessary as selenium deficiency is also rare, and selenium supplements have been linked with a variety of serious health complications as well as…wait for it…hair loss. It’s worth noting that the recommended upper daily limit of selenium from food and supplements combined is 400 mcg, but Nutrafol has 200 mcg. If the product is incorrectly formulated and contains more selenium than it claims, or someone gets a lot of selenium from their diet, there is a risk of excessive intake. The folks at the website PerfectHairHealth.com tested the Nutrafol product for men, which also has 200 mcg of selenium, and their test showed it had 274 mcg, so more than expected. You can read more about their take on Nutrafol here.

Another issue is that I can’t find an independent third-party testing seal on the website proving that the product contains what it claims and is free from impurities and harmful substances. I could not find Nutrafol on the USP or NSF sites, two of the standard third-party testing organizations. The Nutrafol website states:

We test the final product for label claim, microbiological safety, and heavy metals, a process that is reviewed by Quality Assurance to ensure it meets all established specifications.

This testing is performed at our manufacturers' in-house laboratory and a third-party ISO/IEC 17025:2017 certified laboratory.

In-house testing doesn’t count here because it’s not independent. While the statement on their website suggests they have third-party testing, it feels unnecessarily vague. Which organization? It’s important to know so a consumer can understand the scope of the testing and make an informed choice. I emailed Nutrafol to clarify, and while I have been redirected twice to different emails, there has still been no response to my inquiry. As Nutrafol is available on Amazon, which requires 3rd party testing of supplements, I suspect the testing has been done, but I’d like to see proof for myself. I will update you if I hear back.

Nutrafol contains biotin, so it’s worth mentioning that no quality studies support biotin for treating or preventing hair loss. If someone loses their hair, it is worth testing to ensure they don’t have a biotin deficiency, but because a deficiency can cause hair loss, it does not mean that excessive biotin can treat hair loss. Here’s my analogy: running out of gas is bad, but overfilling the tank is not helpful. According to the NIH Office of Dietary Supplements, “Biotin deficiency is rare, and severe biotin deficiency in healthy individuals eating a normal mixed diet has never been reported.” Biotin supplements can also interfere with testing for thyroid conditions and with some blood tests used to diagnose heart conditions.

What about studies that specifically evaluate Nutrafol? The website claims there are“20 clinical studies,” which sounds impressive, but below the claim about 20 clinical studies is a list of 13 references, and while I may not be a mathematician, I still know that 13 is not 20.

When consumers read “20 clinical studies,” they naturally think it means 20 quality peer-reviewed clinical trials, which sounds super impressive. However, several of the references above say “data on file,” which doesn't cut it (maybe they think people aren't going to read the fine print, but I learned to use progressive eyeglasses for a reason!). I cannot access the “randomized, placebo-controlled trials” in reference nine, as apparently, they are also in a file at Nutrafol. It’s irrelevant if a company has this data in its bat cave. If it’s not published in a peer-reviewed journal, I might as well assume it just doesn’t exist.

For fun, I decided to look up a few of their other references, and wow. What a collection. The first one is from 1975 and isn't even a clinical trial. There are studies of some of the individual ingredients, and one is in what I consider a predatory, or at least very low-quality, journal. There is also a review article on curcumin, and one of the co-authors, Bharat B. Aggarwal, PhD, is currently ranked at #27 on the Retraction Watch Leader Board for most retracted papers. Nice touch!

I did find three published peer-reviewed clinical trials, all funded by the manufacturer. Two are single-blinded, and as there is no placebo arm, so to me, they are the equivalent of, “My mom liked my supplement.” One of the papers is a six-month randomized-double blinded, placebo-controlled trial of women who felt they had hair loss, although the study is small and funded by the manufacturer. Interestingly, the exclusion criteria in the paper includes “hair loss disorders,” but isn’t that sort of the point of taking a hair growth supplement? I noticed this issue was also mentioned by the folks at PerfectHairHealth.com, who pointed out that the study criteria over at ClinicalTrials.gov exclude most people with hair loss disorders. They suggested that excluding anyone with an actual hair loss disorder would increase the likelihood that the participants could have a nutritional deficiency contributing to their hair loss, meaning the deck may have been stacked to include people who are most likely to benefit from a supplement (and therefore could also very likely have been helped with a much cheaper product). This paper also claims it’s a safety study, but the methods section doesn’t mention how they monitored safety beyond asking about adverse effects. I was looking for liver tests and selenium levels.

(Looking up and reading the articles in that reference section is several hours of my life that I will never get back).

Look, you couldn’t pay me to take Nutrafol for hair loss (which I’ve been experiencing and will write about soon, so stay tuned. I provide this context to emphasize that I have spent a lot of time lately thinking about what I will and will not take). I would never take a product with a proprietary blend or turmeric. In addition, Nutrafol is inadequately studied, and there is no real safety data, which is especially concerning given the high amounts of vitamin A and selenium. The one randomized double-blinded trial that I found seems to have excluded the most common causes of hair loss, and now, a case report links the product to liver failure.

Like many supplements—sorry, I mean nutraceuticals—there is a lot of flashy advertising and little else behind the curtain. Sadly, people are paying a lot of money to play the liver injury lottery, and really, we all deserve better.

References

Dugal J, Malhi A, Singh Y, Hsu M, Gill A, Patel P, Tun KM. Nutrafol's Hair Gains and Liver Strains. The American Journal of Gastroenterology 119(10S):p S2733-S2734, October 2024. | DOI: 10.14309/01.ajg.0001046328.13395.e1

Bjelakovic G, Nikolova D, Gluud LL, Simonetti RG, Gluud C. Antioxidant supplements for prevention of mortality in healthy participants and patients with various diseases. Cochrane Database of Systematic Reviews 2012, Issue 3. Art. No.: CD007176. DOI: 10.1002/14651858.CD007176.pub2

Fact Sheet on Vitamin A and Carotene. National Insitutes of Health, Office of Dietary Supplements https://ods.od.nih.gov/factsheets/VitaminA-Consumer/

Fact Sheet on Selenium. National Insitutes of Health, Office of Dietary Supplements https://ods.od.nih.gov/factsheets/Selenium-HealthProfessional%20/

Civas, E. and Akpınar, Ü. (2024), Selenium in the supplement as the probable cause of hair loss and nail dystrophy. J Cosmet Dermatol, 23: 361-363. https://doi.org/10.1111/jocd.15902

Wandrey F, Pickel C, Jongsma E, Ewald CY, Grothe T. Evaluation of the collagen-boosting effects of a Moldavian dragonhead extract. J Comm Med and Pub Health Rep 2021;2(7): https://doi.org/10.38207/jcmphr20210102 (Note, possible predatory journal)

Jagetia GC, Aggarwal BB. "Spicing up" of the immune system by curcumin. J Clin Immunol. 2007 Jan;27(1):19-35. doi: 10.1007/s10875-006-9066-7. Epub 2007 Jan 9. PMID: 17211725. (Co-author Aggarwal has had multiple articles retracted).

Sivamani RK, Ablon G, Nong Y, Maloh J, Hazan A, Raymond I. A Prospective, Multi-Center Study to Evaluate the Safety and Efficacy of a Vegan Nutraceutical to Improve Hair Growth and Quality in Females Following a Plant-Based Diet. J Drugs Dermatol. 2024 Aug 1;23(8):661-668. doi: 10.36849/JDD.8421. PMID: 39093662.

Stephens TJ, Berkowitz S, Marshall T, Kogan S, Raymond I. A Prospective Six-month Single-blind Study Evaluating Changes in Hair Growth and Quality Using a Nutraceutical Supplement in Men and Women of Diverse Ethnicities. J Clin Aesthet Dermatol. 2022 Jan;15(1):21-26. PMID: 35309272; PMCID: PMC8903234.

Ablon G, Kogan S. A Six-Month, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of a Nutraceutical Supplement for Promoting Hair Growth in Women With Self-Perceived Thinning Hair. J Drugs Dermatol. 2018 May 1;17(5):558-565. PMID: 29742189.