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Doctor Reviews: Nutrafol

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In 2023, a lawsuit was filed against Nutrafol, a popular hair growth supplement, alleging false advertising. The claim is that Nutrafol misleadingly promotes its products as “clinically proven” to reduce hair shedding, based on flawed studies.

Legal issues aside, it’s essential to determine whether Nutrafol actually delivers on its promises. While the lawsuit casts doubt, Nutrafol has undergone various clinical trials. But how trustworthy are these studies? And what kind of results can you realistically expect from using Nutrafol for hair growth? Let’s delve into the lawsuit and scrutinize Nutrafol’s clinical trials to find out.

Problems with Nutrafol’s studies

High Risks of Bias

The validity of Nutrafol’s studies is under scrutiny due to potential bias. On their website, Nutrafol cites four studies: one focusing on women, two on menopausal women, and one on both men and women with ethnic hair. However, the lawsuit alleges that all these studies were funded by Nutrafol and conducted by its own employees.

It’s worth noting that indeed, Nutrafol financed all of these studies. What’s more, all four studies were co-authored by Sophia Kogan, MD, who also serves as their research investigator.

Interestingly, Dr. Kogan is also a co-founder of Nutrafol. This setup raises concerns akin to having a referee simultaneously playing for one of the teams, potentially compromising impartiality.

Unverified Products

According to the lawsuit, Nutrafol offers over a dozen products on its website, but only one of them, Nutrafol Women’s Balance, has undergone testing in a randomized controlled trial (RCT). This type of study, often referred to as a double-blind RCT, is crucial for scientifically evaluating the effectiveness of a supplement.

In these trials, participants are randomly assigned to either receive the supplement or a placebo (a fake product), allowing researchers to compare results and determine the supplement’s impact.

There are two main types of RCTs: single-blind and double-blind. In a single-blind trial, only the participants are unaware of which group they belong to, while in a double-blind trial, neither the participants nor the researchers know who is receiving the supplement or the placebo. Double-blind trials are considered more reliable because they reduce the risk of bias.

Nutrafol claims to have conducted two double-blind RCTs and two single-blind RCTs. However, only Nutrafol Women’s and Nutrafol Women’s Balance were tested in the double-blind RCTs. The lawsuit argues that just because a couple of Nutrafol’s products were tested in these trials, it doesn’t mean that all related products sold on their website can be considered clinically studied.

This is an important point because you can’t generalize study results from one product to others that haven’t been tested. It’s akin to assuming your entire family are expert chefs just because one member is skilled in the kitchen.

Issues with Test Groups

Now let’s talk about the actual studies themselves. The lawsuit brings up concerns about how these studies were conducted, particularly regarding the groups selected for testing the supplement against the placebo. This process, called sampling, is crucial. It’s essential to have a diverse sample population, and both the supplement and placebo groups should be as similar as possible at the beginning of the trial.

For example, in a 2018 study, out of 40 participants, 32 were Caucasian, 6 were Hispanic, and 2 were Asian. Another study in 2021 included 60 individuals, with 40 being Caucasian, 12 Hispanic, 5 Asian, 2 Pacific Islanders, and 1 Mixed. Then, in a 2022 study meant to assess Nutrafol’s effectiveness across diverse ethnicities, 87 patients were involved, with more than half being Caucasian, 24 Asian, and 16 African American. Surprisingly, this study wasn’t even one of the double-blinded trials.

The lawsuit also points out a lack of representation. Despite Nutrafol targeting black men and women in its marketing, none were included in its double-blinded RCTs. Only seven black men and nine black women were studied taking Nutrafol, and this was in one of the weaker studies.

These sampling issues raise significant concerns. Proper sampling ensures that the participants represent the population you’re trying to benefit. However, based on Nutrafol’s studies, the results mostly reflect Caucasian women. Moreover, the small sample sizes, ranging from 30 to 87 individuals, further weaken the validity of the findings.

Issues with Exclusion Criteria

Beyond the sampling concerns, the lawsuit also raises red flags about the exclusion criteria used in Nutrafol’s studies. Exclusion criteria are specific factors or conditions that disqualify individuals from participating in a clinical trial.

Interestingly, Nutrafol’s studies excluded many individuals who might be seeking a hair growth supplement in the first place. This includes people with common hair loss conditions like alopecia areata or androgenetic alopecia, those using other hair regrowth treatments, and even individuals with severe hair loss. In one study, even people who recently experienced stressful events, a known cause of temporary hair loss, were excluded.

What’s more, in the 2021 study, the exclusion criteria allowed the investigator, who co-founded Nutrafol, to decide whom to exclude based on their own opinion of potential risk or interference with evaluations. This raises concerns about impartiality.

Remarkably, all of Nutrafol’s studies focused on individuals with “self-perceived hair thinning,” rather than those with actual hair loss. This means they tested the supplement on healthy people who simply felt their hair was thinning, not on those experiencing measurable hair loss. This approach is akin to testing an acne cream on people with healthy skin who think they might have pimples, rather than on individuals with actual acne.

Self-perceived hair thinning is subjective and can be influenced by various factors, including styling habits and environmental conditions. In contrast, actual hair loss involves a measurable reduction in hair density due to underlying factors like genetics or medical conditions. Unlike self-perceived thinning, actual hair loss often requires medical intervention or specialized treatments to address effectively.

Dr. Brian’s review

So, what do I think about all this? Well, it’s pretty clear that the studies on Nutrafol have some serious issues and are highly likely to be biased. From what I’ve seen, these studies mostly suggest that Nutrafol might help with self-perceived thinning, particularly in Caucasian women. However, there’s no evidence to support its effectiveness in treating actual hair loss. It’s crucial to remember that Nutrafol is just a nutritional supplement, not a treatment for hair loss. Unfortunately, Nutrafol doesn’t seem to acknowledge this and keeps marketing itself as a cure-all for hair loss.

Things get even more troubling when these flawed studies end up in systematic reviews. This can mislead reviewers into thinking there’s strong evidence backing these supplements. But in reality, that’s far from the truth. And when the media reports on these studies, they often don’t scrutinize the data as they should.

One concerning aspect is the involvement of physician-owned supplement companies. Dr. Sophia Kogan, for instance, is a certified dermatologist. With her expertise, she could design a study to skew results in her favor. I’m not saying she did, but when there’s a $150 million incentive involved, it certainly raises eyebrows. This kind of conflict of interest is something we need to be wary of.

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Citations

Ablon G, Kogan S. A Randomized, Double-Blind, Placebo-Controlled Study of a Nutraceutical Supplement for Promoting Hair Growth in Perimenopausal, Menopausal, and Postmenopausal Women With Thinning Hair. J Drugs Dermatol. 2021;20(1):55-61. doi:10.36849/JDD.5701

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;17(5):558-565.

ClassAction.org. Sheehan et al. v. Nutraceutical Wellness, Inc. https://www.classaction.org/media/sheehan-et-al-v-nutraceutical-wellness-inc.pdf Accessed Feb 29, 2024

ClassAction.org. Smith v. Nutraceutical Wellness, Inc. https://www.classaction.org/media/smith-v-nutraceutical-wellness-inc.pdf Accessed Feb 29, 2024

Drake L, Reyes-Hadsall S, Martinez J, Heinrich C, Huang K, Mostaghimi A. Evaluation of the Safety and Effectiveness of Nutritional Supplements for Treating Hair Loss: A Systematic Review. JAMA Dermatol. 2023;159(1):79-86. doi:10.1001/jamadermatol.2022.4867

Feldman PR, Gentile P, Piwko C, et al. Hair regrowth treatment efficacy and resistance in androgenetic alopecia: A systematic review and continuous Bayesian network meta-analysis. Front Med (Lausanne). 2023;9:998623. Published 2023 Jan 23. doi:10.3389/fmed.2022.998623

Hey SP, Kimmelman J. The questionable use of unequal allocation in confirmatory trials. Neurology. 2014 Jan 7;82(1):77-9. doi: 10.1212/01.wnl.0000438226.10353.1c. Epub 2013 Dec 4. PMID: 24306005; PMCID: PMC3873626.

Ring C, Heitmiller K, Correia E, Gabriel Z, Saedi N. Nutraceuticals for Androgenetic Alopecia. J Clin Aesthet Dermatol. 2022 Mar;15(3):26-29. PMID: 35342503; PMCID: PMC8944288.

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.

TruthinAdvertising.org Lawsuit: https://truthinadvertising.org/wp-content/uploads/2023/04/4_4_23-Complaint-to-FTC-and-FDA-re-Nutrafol.pdf Accessed Feb 29, 2024


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