Omega XL Lawsuit: Class Action, FDA Letter & NAD Review

The Omega XL lawsuit was a 2017 class action filed in California against Great HealthWorks, Inc., alleging that customers who thought they were making a one-time purchase were secretly enrolled in a monthly auto-ship subscription. The case, Boyer et al v. Great Healthworks, Inc., was voluntarily dismissed without prejudice in March 2018. No settlement was paid, no court ruled on the merits, and no successor class action has been filed on the same grounds. The billing complaints that drove the case, however, have continued, and the company has separately faced an FDA warning letter and an advertising-industry review over how Omega XL is marketed.

What the 2017 Class Action Claimed

The case (No. 17-cv-734) was filed in California state court in March 2017 and moved to the U.S. District Court for the Southern District of California the following month.¹ The named plaintiff, Boyer, alleged that Great HealthWorks engaged in deceptive advertising by failing to disclose that ordering Omega XL would automatically enroll her in a recurring subscription, producing monthly charges she never knowingly authorized. The complaint sought to represent a class of consumers with the same experience.

It never got there. In March 2018 the case was voluntarily dismissed without prejudice, and the reasons were not made public.¹ A dismissal without prejudice leaves the door open to refile, but nothing similar has appeared in the public record since. There is no class fund, no claims process, and no settlement to join.

The Billing Pattern at the Heart of the Complaints

The subscription issue that prompted the lawsuit is still the most common complaint against the company. The Better Business Bureau, as of mid-2026, lists 111 complaints against Great HealthWorks over the preceding three years, with 50 closed in the past 12 months. Product issues top the list at 52, followed by service or repair issues at 21 and billing issues at 12.²

The pattern consumers describe is consistent. Someone orders a promotional deal, often a “Buy One, Get Two Free” offer, and later discovers they’ve been enrolled in a monthly auto-ship. When they try to cancel, they report phone numbers that don’t work, website interfaces that won’t process cancellations, and representatives who steer them toward “freezing” or “deferring” shipments rather than ending the plan.²

The 30-day money-back guarantee adds another wrinkle. Because Omega XL is marketed as taking about 30 days to show results, customers who conclude it isn’t working for them often find the refund window has already closed. Refunds that are granted exclude shipping and handling, and customers must ship products back, including empty or partially used bottles, at their own cost.³

Great HealthWorks tells the BBB that its subscription terms are clearly displayed at checkout and must be affirmatively accepted, that orders cannot be modified once shipped, and that returns require prepaid shipping. In some cases the company has issued refunds as a “gesture of goodwill” while maintaining the original terms were properly disclosed.² Of the 111 BBB complaints, 81 were marked answered and 30 resolved.

FDA Warning Letter Over Marketing Claims

Separate from the lawsuit, on June 23, 2021 the FDA issued a warning letter to Great HealthWorks finding that claims on the company’s website effectively turned Omega XL and a second product, ProbioticXL, into unapproved drugs under federal law.⁴ The agency pointed to language saying Omega XL could “relieve joint pain due to inflammation” and provide “relief from joint pain, as well as other inflammatory conditions.” ProbioticXL was flagged for claims about combating bacteria, inhibiting yeast growth, and reducing abdominal pain, along with unauthorized health claims about reducing cardiovascular disease risk factors that would have made it a misbranded food on their own.

The company was given 15 working days to respond. It did, and in January 2022 the FDA issued a closeout letter confirming the violations had been “addressed.”⁵ The FDA noted that closeout does not preclude future enforcement. A 2025 investigation by Truth in Advertising reported that some pain-relief claims had not been entirely removed from the company’s marketing, and the company did not respond to TINA.org’s questions.⁶

Advertising Industry Review

In 2015, the National Advertising Division reviewed Omega XL’s marketing in a challenge brought by the Council for Responsible Nutrition. NAD upheld the claim that the product was “supported by over thirty years of clinical research” but told the company to drop “breakthrough secret,” reasoning that a decades-old ingredient cannot be called novel. It let the company keep the promise that users could “get back what joint pain and inflammation are limiting you from doing,” but recommended removing the word “easy” because studies showed meaningful pain reduction could take several weeks. And it rejected the claim of “no levels of harmful toxins or PCBs,” finding that testing which shows “none detected” is not the same as zero.⁷

What the Research Actually Shows

Omega XL’s active ingredient is PCSO-524, a patented oil extract from the New Zealand green-lipped mussel (Perna canaliculus). It contains a mix of fatty acids, including eicosatetraenoic acid, that is not found in standard fish oils.⁸ The extract is manufactured by Pharmalink, a Singapore company, and sold globally under the brand names Lyprinol and Omega XL.⁹

The clinical evidence is limited. A 2013 study of 50 osteoarthritis patients found that those taking PCSO-524 reported a statistically significant reduction in pain compared with a standard fish oil group, but the study was not placebo-controlled and its second phase was not blinded, limitations the authors themselves noted.⁸ A separate study found no reduction in pain compared with an olive oil placebo. Independent testing found that Omega XL capsules contain far less DHA and EPA than typical fish oil supplements.¹⁰

Great HealthWorks says the product is “backed by more than 40 years of clinical research,” though the company itself was founded in 2003 and attributes the timeframe to research on the broader class of ingredients. When TINA.org asked in 2025 for copies of the studies supporting the claim, the company did not provide them.⁶

Who Great HealthWorks Is

Great HealthWorks, Inc. was founded in 2003 by Ken Meares and is headquartered in Fort Lauderdale, Florida. It is a Nevada foreign profit corporation registered in Florida, with active corporate status as of 2026.¹¹ The company describes itself as vertically integrated, handling procurement, formulation, bottling, and fulfillment in-house.¹²

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Truth in Advertising. Subscriptions Omega XL
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Better Business Bureau. Great HealthWorks, Inc. Complaints
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Better Business Bureau. Great HealthWorks, Inc. Complaints Page 2
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U.S. Food and Drug Administration. Warning Letter to Great Healthworks, Inc.
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U.S. Food and Drug Administration. Closeout Letter to Great Healthworks, Inc.
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Truth in Advertising. OmegaXL Backed by Research
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All About Advertising Law. NAD Finds Something Fishy With Claims That Contradict
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National Institutes of Health (PubMed Central). PCSO-524 Clinical Study
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FoodNavigator-Asia. Pharmalink Aroma NZ Patent Infringement
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ConsumerLab. Does Omega XL Work
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Florida Division of Corporations (Sunbiz). Great HealthWorks, Inc. Corporate Filing
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Great HealthWorks. About Us