The Nutrafol lawsuit most consumers are asking about is a consolidated class action in the U.S. District Court for the Southern District of New York accusing Nutraceutical Wellness, Inc. of falsely marketing its hair growth supplements as “clinically proven” and “medical-grade” and of selling them as unapproved drugs. As of November 2025, the case is still pending: the company’s motion to dismiss has been fully briefed since March 2024, and Judge Paul G. Gardephe has not yet ruled.
What the Lawsuits Allege
Three related complaints were filed against Nutraceutical Wellness in 2023. The first, Smith v. Nutraceutical Wellness, Inc., was dismissed with prejudice in August 2023 following a notice of settlement.1MoreLaw. Smith v. Nutraceutical Wellness Inc. The two that remain, Sheehan v. Nutraceutical Wellness and Malich v. Nutraceutical Wellness, were consolidated in August 2023 under the caption In re Nutraceutical Wellness, Inc. Consumer Fraud Litigation.
Across the surviving complaints, plaintiffs press three basic theories.
The first is that the “clinically proven” and “clinically effective” language on Nutrafol’s labels and marketing is not supported by rigorous science. The Sheehan complaint calls Nutrafol’s flagship 2018 study a “curated exercise in self-affirming data manipulation,” pointing out that only 40 women participated, that the placebo group was older on average and reported higher baseline stress than the treatment group, and that the trial excluded women with alopecia areata, androgenetic alopecia, telogen effluvium, diabetes, and thyroid disorders. Women using hormonal contraception, hormone therapy, or medications with hair-related side effects were also excluded.2ClassAction.org. Nutrafol Women Falsely Advertised as Clinically Proven to Treat Hair Loss, Class Action Alleges Plaintiffs argue this means the product was never tested on the population most likely to buy it.
The second theory is that Nutrafol markets its supplements as drugs without going through FDA drug approval. The Federal Food, Drug, and Cosmetic Act defines a “drug” as any article intended to diagnose, cure, treat, or prevent disease. Because Nutrafol promotes its products for hair growth and references specific hair loss conditions, the complaints argue the supplements fall within the FDA’s classification of new drugs and cannot legally be sold without an approved new drug application.3ClassAction.org. Nutrafol Class Action Says Misbranded Hair Growth Products Not Clinically Proven as Advertised
The third theory is that Nutrafol makes disease-related health claims (about conditions like alopecia areata, telogen effluvium, and hormonal or metabolic health) without the standard FDA disclaimer that the products have not been evaluated by the agency and are not intended to diagnose, cure, or prevent disease.
The Malich complaint, filed by the law firm Milberg, extends the consumer protection claims to buyers in California, New Jersey, and Illinois in addition to New York, and adds an allegation that some Nutrafol ingredients could be harmful at recommended dosages, though it does not document specific consumer injuries.4Truth in Advertising. Malich v. Nutraceutical Wellness Complaint
The financial injury alleged is straightforward: plaintiffs say they paid premium prices for products they would not have purchased, or would have paid less for, had they known the marketing claims were unsupported.
The Clinical Studies at the Center of the Dispute
Nutrafol relies most heavily on a 2018 randomized, double-blind, placebo-controlled trial published in the Journal of Drugs in Dermatology by Glynis Ablon and Sophia Kogan. It reported statistically significant increases in hair count at 90 and 180 days versus placebo. The trial enrolled 40 women in total, 26 in the treatment arm and 14 in the placebo arm, all with “self-perceived thinning hair” rather than diagnosed hair loss conditions.5National Library of Medicine. A Six-Month, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of a Nutraceutical Supplement
A second study, published in 2022, was a single-arm, open-label trial of 98 participants across various ethnic groups. It reported significant improvements in hair growth, density, and quality, but lacked a placebo control and relied partly on subjective assessments. Four of the five authors were employees of Nutraceutical Wellness.6National Library of Medicine. A Prospective Six-Month Single-Blind Study Evaluating Changes in Hair Growth and Quality
An independent review by McGill University’s Office for Science and Society noted that both major studies were funded by Nutrafol’s manufacturer and that neither accounted for participants’ baseline nutritional status, a significant variable in hair growth research, making the results difficult to generalize.7McGill University Office for Science and Society. Nutrafol: Holy Grail for Hair Loss or Overpriced Supplement
Where the Case Stands Now
The consolidated action proceeds as In re Nutraceutical Wellness, Inc. Consumer Fraud Litigation, Case No. 1:23-cv-05652, before Judge Gardephe in the Southern District of New York.
On March 29, 2024, Nutraceutical Wellness filed a motion to dismiss the consolidated class action complaint, supported by a memorandum of law, a request for judicial notice, and exhibits including product labels and the studies the company says support its marketing. Nutrafol requested oral argument, and plaintiffs filed their opposition brief the same day.8CourtListener. Erin Sheehan v. Nutraceutical Wellness Inc. Docket
As of November 2025, the court has not ruled on that motion. No class has been certified. The docket shows no discovery activity, no scheduling order, and no settlement discussions since briefing closed; the most recent activity involves plaintiffs’ counsel withdrawing from the case. Until the motion is decided, the substantive claims cannot move forward.
The FTC and FDA Complaint That Preceded the Lawsuits
The private litigation was preceded by a regulatory complaint. On April 4, 2023, the advertising watchdog Truth in Advertising, Inc. (TINA.org) sent a formal letter to the Federal Trade Commission and the Food and Drug Administration urging both agencies to investigate what it called a “widespread deceptive marketing campaign.”9Truth in Advertising. Complaint to FTC and FDA Regarding Nutrafol
TINA.org cataloged more than 100 health and disease-treatment claims it said Nutrafol had made without FDA approval, including representations that the supplements are “medical-grade” and “clinically proven” to increase hair growth and balance hormones. The letter also alleged that Nutrafol enrolled consumers in automatically renewing subscription plans without clearly disclosing the terms, potentially violating the Restore Online Shoppers’ Confidence Act, and that influencers promoted the products without disclosing paid relationships with the company.10Truth in Advertising. Nutrafol Brand Page TINA.org’s review of the underlying clinical studies found that they were funded by the manufacturer, sometimes co-authored by company employees or co-founders, relied on small and homogeneous samples, used subjective self-assessments, and in some cases tested earlier formulations or single ingredients rather than the products actually sold.
Neither the FTC nor the FDA has publicly announced enforcement action in response.
A Separate Suit Against Sephora
A separate consumer class action was filed against Sephora in August 2023 over its role in promoting Nutrafol. That case is against the retailer, not Nutraceutical Wellness, and alleges Sephora falsely touted the supplement’s ingredients as “clinically proven,” “clinically tested,” “physician-formulated,” and “standardized,” while testing of product samples purportedly revealed “drastic inconsistencies.”11The Recorder. Lawsuit Accuses Sephora of Falsely Touting Nutrafol Hair Growth Supplement
Liver Injury Case Report
A medical case study presented at the 2024 American College of Gastroenterology Annual Meeting and published in the American Journal of Gastroenterology is not part of the lawsuits, but readers looking into Nutrafol often encounter it alongside the litigation. The report described severe drug-induced liver injury in a 26-year-old woman who had used Nutrafol for five months. She presented with jaundice and sharply elevated liver enzymes. After doctors ruled out viral hepatitis, autoimmune disorders, and other causes, a liver biopsy confirmed moderate portal inflammation, necroinflammatory injury, and cholestasis. Her liver function improved after she stopped the supplement.12MDLinx. A Popular Hair Growth Supplement Linked to Liver Failure
The researchers identified several Nutrafol ingredients with known hepatotoxic potential, including turmeric, ashwagandha, horsetail, saw palmetto, kelp minerals, and resveratrol.13Conexiant. Nutrafol Safety Signal Emerges in Case Study This is a single reported case, and physicians quoted in coverage noted that the risk is not unique to Nutrafol; other supplements containing high doses of similar ingredients could pose comparable risks, particularly for people with undiagnosed liver conditions or those combining multiple supplements.